K181977 · OTU Medical, Inc. · FGB · Aug 14, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K181977
Device Name
WiScope Digital Endoscope System
Applicant
OTU Medical, Inc.
Product Code
FGB · Gastroenterology, Urology
Decision Date
Aug 14, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, 3rd-Party Reviewed
Indications for Use
WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
Device Story
Single-use digital ureteroscope system; includes flexible insertion tube with distal-end CMOS camera and LED lighting; control body with articulation and accessory ports. Image system processes signals for output to external monitor via standard video connectors (CVBS/HDMI). Used by physicians in clinical settings for urinary tract/kidney visualization and therapeutic procedures. Enables delivery of accessories like biopsy forceps, laser fibers, and retrieval baskets. Benefits include improved access via smaller shaft diameter (8.6Fr) and increased working length (670mm) compared to predicate. System is AC powered; does not include integrated monitor or battery, allowing flexibility in OR setup. Output viewed by physician on external display to guide diagnostic and therapeutic interventions.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), and functional performance (ISO 8600).
Technological Characteristics
Single-use flexible ureteroscope; 8.6Fr outer diameter; 670mm working length; 275° up/down deflection. CMOS image sensor; distal-end LED illumination. Connectivity via CVBS/HDMI to external monitor. Sterilization: EO (SAL 10^-6). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993, ISO 11135, ISO 11607, ISO 8600, ASTM F1980, ASTM D3078, ASTM F1929, ASTM F88/F88M, DIN 58953-6.
Indications for Use
Indicated for physicians to access, visualize, and perform procedures in the urinary tract and kidney, including delivery of endo-therapy accessories (biopsy forceps, laser fibers, graspers, retrieval baskets).
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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August 14, 2018
OTU Medical Inc. % David Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041
Re: K181977
Trade/Device Name: WiScope™ Digital Endoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: July 20, 2018 Received: July 24, 2018
Dear David Yungvirt:
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
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statutes and regulations administered by other Federal agencies. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Glenn B. Bell -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K181977
Device Name WiScope™M Digital Endoscope System
#### Indications for Use (Describe)
WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# Section 5 510(k) Summary
[As required by 21 CFR 807.92]
# 1. Submission Sponsor
OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131 Phone: (408) 797-7313 Contact: Geping Liu Email: info@otumed.com
# 2. Submission Correspondent
Shanghai CV Technology Co., Ltd. Room 903 of Dongbao Building, No. 19 Dongbao Road, Songjiang Area, Shanghai, China 201613 Phone: 86 21-31261348 Fax: 86 21-57712250 Contact: Doris Dong(Consultant) Email: doris_d@126.com
# 3. Date Prepared
May 14, 2018
# 4. Device Identification
Trade/Proprietary Name: WiScope™ Digital Endoscope System Common Name/Classification Name: Ureteroscope and Accessories, Flexible/rigid Product Code: FGB Regulation Number: 21 CFR 876.1500 Endoscope and Accessories Regulation Class: Class II Review Panel: Gastroenterology/Urology
# 5. Predicate Devices
The proposed devices are substantially equivalent to the following predicate devices:
| Applicant | Device name | 510(k) Number | Product code |
|----------------------------------------------|-----------------------------------|---------------|--------------|
| Zhuhai Pusen Medical<br>Technology Co., Ltd. | Medical Video<br>Endoscope System | K171076 | FGB |
# 6. Device Description
WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform
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procedures in the urinary tract for diagnosis and treatment. This system includes a single-use digital ureteroscope and an image system.
The single-use ureteroscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image system processes the images from the ureteroscope and outputs video signals to a display.
# 7. Indication For Use Statement
WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
# 8. Comparison of Technological Characteristics
The following table compares the proposed device with the predicate device in terms of intended use, technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalences.
| ITEM | Proposed Device | Predicate Device | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Trade name | WiScope™ Digital<br>Endoscope System | Medical Video Endoscope<br>System | |
| 510(K)<br>Submitter | OTU Medical Inc. | Zhuhai Pusen Medical<br>Technology Co., Ltd. | |
| 510(K) Number | | K171076 | |
| Classification<br>Regulation | 21CRF 876.1500 | 21CRF 876.1500 | SE |
| Classification<br>and Code | Class II,<br>FGB | Class II,<br>FGB | SE |
| Common name | Ureteroscope and<br>Accessories, Flexible/rigid | Ureteroscope and<br>Accessories, Flexible/rigid | SE |
| Ureteroscope | Single-Use | Single-Use | SE |
| Image System | Not including OS, monitor,<br>and battery | Including a touch PC and<br>battery | Analysis 1 |
| | 2231A Fortune Drive, San Jose, CA 95131 | | |
| Intended Use | WiScope™ Digital<br>Endoscope System is intended<br>to be used by physicians to<br>access, visualize, and perform<br>procedures in the urinary tract<br>and the kidney. The<br>instrument enables delivery<br>and use of accessories such as<br>biopsy forceps, laser fibers,<br>graspers and retrieval baskets<br>at a surgical site. | This instrument has been<br>designed to be used with<br>endo-therapy accessories<br>such as a biopsy forceps and<br>other ancillary equipment for<br>endoscopy and endoscopic<br>surgery within urinary tract<br>and interior of the kidney. | Note 1 |
| Digital video<br>technology | CMOS | CMOS | Note 2 |
| Illumination | LED | Optical fiber | Analysis 2 |
| Field of View<br>(Diagonal) | 100° | 120° | Note 3 |
| Outer Shaft<br>Diameter | 8.6Fr | 9.0Fr | Note 4 |
| Working Length<br>(mm) | 670 | 630 | Note 4 |
| Working<br>Channel<br>Diameter<br>(Fr) | 3.6Fr | 3.6Fr | SE |
| Up/Down<br>Deflection | UP: 275°<br>DOWN: 275° | UP: 270°<br>DOWN: 270° | SE |
| Direction of<br>View | 0° | 0° | SE |
| Brightness<br>Control | Yes | Yes | SE |
| White Balance | Yes | Yes | SE |
| Output Formats | USB/AV/HDMI | USB/AV/HDMI | SE |
| Image/Video<br>Capture | No | Yes | Analysis 3 |
| Camera Head<br>Configurable | Yes | Yes | SE |
| Sterilization | EO<br>SAL: 10-6 | EO<br>SAL: 10-6 | SE |
| Packaging | Ureteroscope is packaged in a<br>tray which is sealed by sterile<br>barrier | Ureteroscope is packaged in<br>a tray which is sealed by<br>sterile barrier | SE |
| Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SE |
| Safety Testing | *AAMI / ANSI ES60601-1:2012 | *AAMI / ANSI ES60601-1:2012 | Performed |
| | *AAMI / ANSI / IEC | *IEC 60601-1-2:2007 | more |
| | 60601-1-2:2014 | *IEC 60601-2-18:2009 | testing than |
| | *IEC 60601-2-18:2009 | *ISO 10993-5:2009 | the |
| | *AAMI / ANSI / ISO | *ISO 10993-10:2010 | predicate to |
| | 10993-5:2009 | *ISO 11135:2014 | show safety |
| | *ISO 10993-10:2010 | *ISO 11607:2006 | |
| | *ISO 11135:2014 | *ISO 8600 | |
| | *ISO 10993-7:2008 | | |
| | *ISO 11607-1:2006 | | |
| | *ASTM F1980-16 | | |
| | *ISO 11737-2:2009 | | |
| | *ASTM D3078-2013 | | |
| | *ASTM F1929-15 | | |
| | *DIN 58953-6:2010 | | |
| | *ASTM F88/F88M-15 | | |
| | *ISO 8600-1-2015 | | |
| | *ISO 8600-3-1997 | | |
| | *ISO 08600-4-2014 | | |
| | *ISO 8600-6-2005 | | |
Table 5A - General Comparison
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# Note 1:
WiScope™ Digital Endoscope System and the predicate device are similar in terms of indication for use. They are all used in the urinary tract and the kidney. They are both for endoscopic examinations/diagnoses and therapeutic procedures with endoscopic accessories.
# Note 2:
WiScope™ Digital Endoscope System and the predicate device use the similar CMOS image sensor technology, i.e., an CMOS image sensor at the ureteroscope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system.
#### Note 3:
WiScope™ ureteroscope has a field of view (FOV) of 100°, and the predicate device claimed a field of view of 120°. However, a comparison study between the proposed and the predicate device by physicians demonstrates that the optical parameter is similar and it does not affect safety and effectiveness.
# Note 4:
WiScope™ ureteroscope's outer shaft diameter (8.6Fr) is smaller than the predicate device's 9.0Fr. The shaft working length (670mm) is longer than the predicate device's 630mm.
The longer working length allows for better operating flexibility of the proposed device than the predicate.
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The smaller outer shaft diameter is even better, which allows for better performance of the proposed device than the predicate, because it facilitates passage of the ureter and into the kidney.
#### Analysis1:
OTU's image system does not include the Operating System (OS), the monitor, and the battery, while the predicate does include a PC with a touch screen, and a battery. OTU's image system is connected to a single-use ureteroscope and an existing monitor in the operating room via a standard video connector, i.e., CVBS or HDMI, and is AC powered up for a clinical procedure. As compared to the predicate device, using the external monitor offers better flexibility to use the proposed device. In addition, the proposed image system has passed all safety and EMC testing. Therefore, we consider both devices are substantially equivalent.
#### Analysis 2:
The proposed device has an LED lighting source directly installed at the distal-end, while the predicate device has the optical fibers at the distal-end and the LED source at the proximal-end. The LED lighting sources ensure high image quality of the ureteroscope. In addition, the proposed device has passed all distal tip temperature tests, and it meets the requirements of IEC 60601-1. Thus we consider that both devices are substantially equivalent.
#### Analysis 3:
The proposed device doesn't have integrated image/video capture function in the system. However, this feature can be implemented by using legally marketed video recorder or software. The implementations also comply with cybersecurity requirements, and more detailed analysis is described in the report of Cybersecurity Risk Assessment. Therefore, both devices are the same in this aspect.
| ITEM | Proposed Device | Predicate Device | Remark |
|---------------|-------------------------------------------------------|-----------------------------|--------|
| Cytotoxicity | Comply with ISO<br>10993-5, no<br>cytotoxicity effect | Comply with ISO<br>10993-5 | SE |
| | | | |
| | | | |
| Irritation | Comply with ISO<br>10993-10, not an<br>irritant | Comply with ISO<br>10993-10 | SE |
| | | | |
| | | | |
| Sensitization | Comply with ISO<br>10993-10, not a<br>sensitizer. | | SE |
| | | | |
| | | | |
#### Table 5B - Biocompatibility Comparison
#### Conclusion:
The proposed devices share the same indications for use, device operation, overall technical and functional capabilities, meets the same standards and requirements and therefore are substantially
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equivalent to the predicate device.
#### 9. Non-Clinical Test Conclusion
The WiScope™ Digital Endoscope System has been verified for its safety and effectivity based on the following performance data.
Electrical safety of the system was evaluated in accordance with IEC 60601-1:2012, and AAMI/ANSIES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-2-18:2009. Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2014. All evaluation acceptance criteria were met.
The biocompatibility evaluation for the Medical Video Endoscopy system was conducted in accordance with the Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.
Biocompatibility of the patient contacting materials were evaluated safe in accordance with ISO 10993-1:2009/(R)2013.
Sterile barrier systems were evaluated in accordance with ISO 11607-1:2006. Sterilization Process has been validated accordance with ISO 11135:2014.
Technological characteristics has been tested for its functions as intended including verification of performance characteristics per ISO8600 (Appearance, The minimum bending radius, The Working length of shaft, Perimeter, Depth of field, Field of view, Direction of view) and performances characteristics relevant to functions as intended(Resolution, Rigid distal tip temperature, Illumination, Articulation, Working channel freedom from leakage, Waterproof, Flow rate of water, Function keys, OLED display).
The results of Non-Clinical Performance testing demonstrate that the WiScope™ Digital Endoscope System is considered safe and effective for its intended use.
# 10. Clinical Test Conclusion
No clinical study is included in this submission.
#### 11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.
It has been shown in this 510(k) submission that the difference between the proposed devices and
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the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use. Therefore the proposed devices are determined to be substantially equivalent to the referenced predicate Devices.
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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.
