K210512 · Uvision360, Inc. · FAJ · Jun 30, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K210512
Device Name
LUMINELLE DTx System
Applicant
Uvision360, Inc.
Product Code
FAJ · Gastroenterology, Urology
Decision Date
Jun 30, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Hysteroscopy: The LUMINELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: Abnormal bleeding; Infertility and pregnancy wastage; Evaluation of abnormal hysterosalpingogram; Intrauterine foreign body; Amenorrhea; Pelvic pain. Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy; Polypectomy; Submucous myomectomy; Transection of intrauterine adhesions; Transection of intrauterine septa; Endometrial ablation. Cystoscopy: The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
Device Story
LUMINELLE DTx System is an endoscopic visualization system for hysteroscopy and cystoscopy. Input: optical images from the cervical canal, uterine cavity, or lower urinary tract via a reusable scope. Transformation: scope transmits images to a Control Hub, which acts as an image converter and visualization interface for display on a standard HD monitor. Output: real-time video feed for physician viewing. Used in hospitals and physician offices by clinicians. The system supports diagnostic and surgical procedures; specific disposable sheaths (Diagnostic or Biopsy) limit the system to diagnostic-only use. The new Bx 360° Rotatable Disposable Sheath allows for biopsy via syringe aspiration. The device benefits patients by enabling minimally invasive visualization and tissue sampling for gynecological and urological conditions.
Clinical Evidence
No clinical data. Bench testing only. Included design verification/validation, usability testing per IEC 62366-1/ANSI/AAMI HE75 in simulated models, reprocessing validation, biocompatibility per ISO 10993, electrical safety/EMC per IEC 60601 series, and shelf-life/distribution testing per ASTM standards.
Technological Characteristics
System includes reusable scope, communication cable, and control hub. Sheaths use PEEK (flexible) or 304 stainless steel (rigid). Imaging via CMOS chip (400x400 pixels). Power: 120V AC to 12V DC conversion. Connectivity: HDMI/USB for monitor/computer. Sterilization: Ethylene Oxide (EO) or V-PRO Low Temperature. Disinfection: 0.6% OPA or Steris Revital-Ox RESERT. Standards: ISO 10993, IEC 60601-1, IEC 60601-2-18, ISO 8600 series.
Indications for Use
Indicated for patients requiring diagnostic or surgical hysteroscopy (e.g., abnormal bleeding, infertility, pelvic pain) or endoscopic access/examination of the lower urinary tract/bladder. Biopsy sheath indicated for endometrial or lower urinary tract biopsy via aspiration.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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June 30, 2021
UVision360, Inc. % Rita King CEO and Senior Consultant MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560
Re: K210512
> Trade/Device Name: LUMINELLE DTx System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, FAJ, HFF, FCK Dated: June 1, 2021 Received: June 2, 2021
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K210512
Device Name LUMINELLE DTx System
#### Indications for Use (Describe)
#### Hysteroscopy:
The LUMNELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- · Pelvic pain
Generally recognized indications for use for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation
#### Cystoscopy:
The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.
NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
| Submitter: | UVision360 Inc.<br>158 Wind Chime Ct.<br>Suite 201<br>Raleigh, NC 27615<br>Phone: 888-855-9360 |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: ritaking@methodsense.com<br>Phone: 919-313-3961<br>Fax: 919-313-3979 |
| Company Contact: | Allison London Brown<br>CEO |
| Date Prepared: | June 1, 2021 |
| Device Name and Classification | |
| Trade Name:<br>Common Name:<br>Classification:<br>Regulation Number: | LUMINELLE DTx System<br>Hysteroscope and accessories, Endoscope and accessories<br>Class II<br>21 CFR 884.1690 Hysteroscope and accessories<br>21 CFR 876.1500 Endoscope and accessories<br>21 CFR 884.1060 Endometrial Aspirator<br>21 CFR 876.1075 Gastroenterology-urology biopsy instrument |
| Classification Panel: | Obstetrics/Gynecology<br>Gastroenterology/Urology |
| Product Code: | HIH Hysteroscope (And Accessories)<br>FAJ Cystoscope And Accessories; Flexible/Rigid<br>HFF Aspirator, Endometrial<br>FCK Instrument, Biopsy, Suction |
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| | Predicate Device |
|---------------------------|-------------------------------------------------------------------------------------------|
| Trade Name | LUMINELLE DTx System |
| Common Name | Hysteroscope (and accessories); Cystoscope<br>(and accessories) |
| 510(k) Submitter / Holder | UVision360 Inc. |
| 510(k) Number | K192278 |
| Regulation Number | 21 CFR 884.1690 Hysteroscope and accessories<br>21 CFR 876.1500 Endoscope and accessories |
| Classification Panel | Gastroenterology/Urology<br>Obstetrics/Gynecology |
| Product Code | HIH Hysteroscope (And Accessories)<br>FAJ Cystoscope And Accessories; Flexible/Rigid |
Predicate Device:
The predicate device has not been subject to a design-related recall.
#### Device Description
The LUMINELLE DTx System, previously known as the LUMINELLE DTx Hysteroscope System, originally received 510(k) clearance in 2018 as a hysteroscopic system (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827) and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) (K19227).
The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures.
The LUMINELLE DTx System is comprised of the following components:
- LUMINELLE DTx Scope;
- . LUMINELLE Communication Cable;
- LUMINELLE Control Hub: ●
- USB cable: .
- HDMI cable, and;
- power cord.
UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278).
The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital
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Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System.
Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.
### Indications for Use
Hysteroscopy:
The LUMINELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not. in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 3600 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- . Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain ●
Generally recognized indications for use for operative hysteroscopy include:
- Directed endometrial biopsy .
- . Polypectomy
- Submucous myomectomy
- Transection of intrauterine adhesions ●
- Transection of intrauterine septa
- . Endometrial ablation
# Cystoscopy:
The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.
NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
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NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
#### Substantial Equivalence
The table below provides a detailed comparison of the LUMINELLE DTx System to the predicate device.
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# Detailed Comparison of the Subject and Predicate Devices
| Item | Subject Device | Predicate Device | Comparison |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| Indications for<br>Use | Hysteroscopy:<br>The LUMINELLE DTx System is used to permit<br>viewing of the cervical canal and uterine cavity for<br>the purpose of performing diagnostic and surgical<br>procedures.<br><br>NOTE: Hysteroscopes are used as tools to access<br>the uterine cavity and are not, in and of themselves,<br>a method of surgery. When LUMINELLE DTx<br>System is specifically used with the LUMINELLE<br>Dx 360° Rotatable Disposable Sheath (Diagnostic),<br>the system is limited to performing diagnostic<br>procedures only. When the LUMINELLE DTx<br>System is used with the LUMINELLE Bx 360°<br>Rotatable Disposable Sheath (Biopsy), the system is<br>limited to performing diagnostic procedures only.<br>The Bx Sheath can be used for endometrial or lower<br>urinary tract (including bladder) biopsy by<br>aspiration with a syringe during diagnostic<br>procedures.<br><br>Generally recognized indications for diagnostic<br>hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal<br>hysterosalpingogram | Hysteroscopy:<br>The LUMINELLE DTx Hysteroscopy System is<br>used to permit viewing of the cervical canal and<br>uterine cavity for the purpose of performing<br>diagnostic and surgical procedures.<br><br>NOTE: Hysteroscopes are used as tools to<br>access the uterine cavity and are not, in and of<br>themselves, a method of surgery. When<br>LUMINELLE DTx Hysteroscopy System is<br>specifically used with the LUMINELLE Dx 360°<br>Rotatable Disposable Sheath (Diagnostic), the<br>system is limited to performing diagnostic<br>procedures only<br><br>Generally recognized indications for diagnostic<br>hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal<br>hysterosalpingogram<br>• Intrauterine foreign body<br>• Amenorrhea<br>• Pelvic Pain<br><br>Generally recognized indications for use for<br>operative hysteroscopy include: | The Indications for Use of the<br>LUMINELLE DTx System is<br>the same as the Indications for<br>Use of the primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | Intrauterine foreign body Amenorrhea Pelvic pain Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy:<br>The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.<br>NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.<br>NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | NOTE: When the LUMINELLE DTx System is<br>used with the LUMINELLE Bx 360° Rotatable<br>Disposable Sheath (Biopsy), the system is limited to<br>performing diagnostic procedures only. The Bx<br>Sheath can be used for endometrial or lower urinary<br>tract (including bladder) biopsy by aspiration with a<br>syringe during diagnostic procedures. | | |
| Intended Use | Hysteroscopy Intended Use:<br>The LUMINELLE DTx System is used to permit<br>direct viewing of the cervical canal and uterine<br>cavity for the purpose of performing diagnostic and<br>surgical procedures.<br>NOTE: When LUMINELLE DTx System is<br>specifically used with the LUMINELLE Dx 360°<br>Rotatable Disposable Sheath (Diagnostic), the<br>system is limited to performing diagnostic<br>procedures only. | Hysteroscopy Intended Use:<br>The LUMINELLE DTx Hysteroscopy System is<br>used to permit direct viewing of the cervical<br>canal and uterine cavity for the purpose of<br>performing diagnostic and surgical procedures.<br>NOTE: When LUMINELLE DTx Hysteroscopy<br>System is specifically used with the<br>LUMINELLE Dx 360° Rotatable Disposable<br>Sheath (Diagnostic), the system is limited to<br>performing diagnostic procedures only. | The Intended Use of the<br>LUMINELLE DTx System is<br>the same as the Intended Use of<br>the Primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| | Cystoscopy Intended Use:<br>The LUMINELLE DTx System is intended for use<br>in endoscopic access to the examination of the lower<br>urinary tract, including the bladder. When combined<br>with accessory instruments, the System allows the<br>user to perform various diagnostic and therapeutic<br>procedures. | Cystoscopy Intended Use:<br>The LUMINELLE DTx Hysteroscopy System is<br>intended for use in endoscopic access to the<br>examination of the lower urinary tract, including<br>the bladder. When combined with accessory<br>instruments, the System allows the user to<br>perform various diagnostic and therapeutic<br>procedures. | |
| | NOTE: When LUMINELLE DTx System is<br>specifically used with the LUMINELLE Dx 360°<br>Rotatable Disposable Sheath (Diagnostic), the | NOTE: When LUMINELLE DTx Hysteroscopy<br>System is specifically used with the<br>LUMINELLE Dx 360° Rotatable Disposable | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | system is limited to performing diagnostic<br>procedures only. | Sheath (Diagnostic), the system is limited to<br>performing diagnostic procedures only. | |
| | NOTE: When the LUMINELLE DTx System is<br>used with the LUMINELLE Bx 360° Rotatable<br>Disposable Sheath (Biopsy), the system is limited to<br>performing diagnostic procedures only. The Bx<br>Sheath can be used for endometrial or lower urinary<br>tract (including bladder) biopsy by aspiration with a<br>syringe during diagnostic procedures. | | |
| Product Code | HIH (Hysteroscope and Accessories)<br>FAJ (Cystoscope and Accessories) | HIH (Hysteroscope and Accessories)<br>FAJ (Cystoscope and Accessories) | The Product Codes of the<br>LUMINELLE DTx System are<br>identical to the product codes of<br>the primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| Patient<br>Contacting<br>Materials<br>(Biocompatibility<br>) | ISO 10993 Compliant | ISO 10993 Compliant | The biocompatibility compliance<br>of patient contacting materials of<br>the LUMINELLE DTx System<br>is identical to the compliance of<br>the primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| Components | ● LUMINELLE DTx Hysteroscope<br>● LUMINELLE DTx 360° Rotatable<br>Disposable Sheath | ● LUMINELLE DTx Hysteroscope<br>● LUMINELLE DTx 360° Rotatable<br>Disposable Sheath | The main components of the<br>LUMINELLE DTx System are<br>identical to the main components<br>of the primary predicate |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) LUMINELLE Bx 360° Rotatable Disposable Sheath (Sheath) | LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) | LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). The only difference<br>is the addition of a new<br>accessory, LUMINELLE Bx<br>360° Rotatable Disposable<br>Sheath (Biopsy). This difference<br>does not affect the safety and<br>effectiveness of the device as<br>validation and verification has<br>been performed on the new<br>sheath. |
| Rigid/Flexible<br>Sheath | Flexible and rigid sheaths available:<br>Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a PEEK<br>(polyetheretherketone) hypotube for flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid,<br>LUMINELLE Dx 360° Rotatable Disposable<br>Sheath (Diagnostic) and LUMINELLE Bx 360°<br>Rotatable Disposable Biopsy Sheath) contains a<br>304 stainless steel inner tube for rigidity. | Flexible and rigid sheaths available:<br>Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a<br>PEEK (polyetheretherketone) hypotube for<br>flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid and<br>LUMINELLE Dx 360° Rotatable Disposable<br>Sheath (Diagnostic)) contains a 304 stainless<br>steel inner tube for rigidity | The LUMINELLE DTx System<br>is substantially equivalent to the<br>primary predicate, LUMINELLE<br>DTx Hysteroscopy System<br>(K192278), as they both contain<br>rigid and flexible sheaths.…
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
