Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

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June 6, 2019 UVision360, Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy, Suite 410 Morrisville, NC 27560 Re: K190827 > Trade/Device Name: LUMINELLE DTx Hysteroscopy System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH, FAJ Dated: May 6, 2019 Received: May 10, 2019 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. {1}------------------------------------------------ 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, Sharon M. Andrews Assistant Division 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190827 #### Device Name LUMINELLE DTx Hysteroscopy System #### Indications for Use (Describe) Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit direct 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 of themselves, a method of surgery. 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 operative hysteroscopy include: - · 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 user to perform various diagnostic and therapeutic procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|----------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 1em;">☑</span> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 1em;">☐</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # UVision360 Inc. K190827 | Submitter: | UVision360 Inc.<br>158 Wind Chime Ct.<br>Suite 201<br>Raleigh, NC 27615<br>Phone: 888-855-9360<br>Fax: | |------------------|--------------------------------------------------------------------------------------------------------------------| | 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 4, 2019 ## Device Name and Classification | Trade Name: | LUMINELLE DTx Hysteroscopy System | |-----------------------|-------------------------------------------------| | Common Name: | Hysteroscope with sheath | | Classification: | Class II | | Regulation Number: | 21 CFR 884.1690 Hysteroscope and accessories | | | 21 CFR 876.1500 Endoscope and accessories | | Classification Panel: | Obstetrics/Gynecology, Gastroenterology/Urology | | Product Code: | HIH Hysteroscope (And Accessories) | | | FAJ Cystoscope And Accessories; Flexible/Rigid | ## Predicate Device: | | Predicate Device | Reference Device | |---------------------------|--------------------------------------------------------------------|----------------------------------------------------------| | Trade Name | LUMINELLE DTx<br>Hysteroscopy System | Schoelly<br>Cystoscopies/Hysteroscope<br>and Accessories | | Common Name | Hysteroscope (and<br>accessories); Cystoscope<br>(and accessories) | Hysteroscope and<br>accessories | | 510(k) Submitter / Holder | UVision360 Inc. | Schoelly Fiberoptic GmbH | | 510(k) Number | K181909 | K150158 | | Regulation Number | 21 CFR 876.1500<br>21 CFR 884.1690 | 21 CFR 876.1500<br>21 CFR 884.1690 | | Classification Panel | Gastroenterology/Urology<br>Obstetrics/Gynecology | Obstetrics/Gynecology | | Product Code | FAJ, HIH | FAJ, HIH | The predicate device has not been subject to a design-related recall. {4}------------------------------------------------ ### Device Description The LUMINELLE DTx Hysteroscopy System previously received 510(k) clearance (K181909) in 2018 as a hysteroscopic and cystoscopic system. To provide the user with a more rigid option for the RotoSheath and Introducer, UVision360, Inc. (hereafter UVision) proposes the addition of a new component to the system, the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid in addition to the currently available flexible Rotatable Disposable Sheath option cleared during the previous submission (K181909). No changes are proposed for the previously cleared components or the principles of operation of the LUMINELLE DTx Hysteroscopy System. The proposed change includes only the addition of a new component which is a modification to the previously cleared flexible LUMINELLE DTx 360° Rotatable Disposable Sheath. The LUMINELLE DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx Hysteroscopy System is also 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. #### Indications for Use Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit direct 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. 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 operative hysteroscopy include: - 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. {5}------------------------------------------------ ## Substantial Equivalence The table below provides a detailed comparison of the LUMINELLE DTx Hysteroscopy System to the predicate device. {6}------------------------------------------------ | Item | Subject Device | Predicate Device | Comparison | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | LUMINELLE DTx<br>Hysteroscopy System | LUMINELLE DTx<br>Hysteroscopy System<br>(K181909) | | | Intended Use | | | | | Indications for Use | Hysteroscopy:<br>The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.<br>NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery<br>Generally recognized indications for diagnostic hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal hysterosalpingogram | Hysteroscopy:<br>The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.<br>NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery<br>Generally recognized indications for diagnostic hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal hysterosalpingogram<br>• Intrauterine foreign body<br>• Amenorrhea<br>• Pelvic Pain | The Indications for Use of the LUMINELLE DTx Hysteroscopy System are identical to the Indications for Use of the previously cleared LUMINELLE DTx Hysteroscopy System (K181909). | | Item | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx<br>Hysteroscopy System | LUMINELLE DTx<br>Hysteroscopy System<br>(K181909) | | | | 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 Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access and examination of the lower | Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various | | | Item | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx<br>Hysteroscopy System | LUMINELLE DTx<br>Hysteroscopy System<br>(K181909) | | | | urinary tract, including<br>the bladder. When<br>combined with<br>accessory instruments,<br>the System allows the<br>user to perform various<br>diagnostic and<br>therapeutic procedures. | diagnostic and therapeutic<br>procedures. | | | Technological Characteristics | | | | | Rigid/Flexible<br>Sheath | Flexible and rigid<br>sheaths available:<br>• Flexible sheath<br>(LUMINELLE DTx<br>360° Rotatable<br>Disposable Sheath)<br>contains a PEEK<br>(polyetheretherketone)<br>hypotube for<br>flexibility.<br>• Rigid sheath<br>(LUMINELLE DTx<br>360° Rotatable<br>Disposable Sheath<br>Rigid) contains a<br>304 stainless steel<br>inner tube for<br>rigidity. | Flexible sheath only<br>(LUMINELLE DTx 360°<br>Rotatable Disposable<br>Sheath), contains a PEEK<br>(polyetheretherketone)<br>hypotube for flexibility. | The flexibility of the LUMINELLE DTx 360° Rotatable<br>Disposable Sheath of the LUMINELLE DTx<br>Hysteroscopy System is identical to the flexibility of the<br>sheath of the previously cleared LUMINELLE DTx<br>Hysteroscopy System (K181909).<br><br>The rigidity of the LUMINELLE DTx 360° Rotatable<br>Disposable Sheath Rigid of the LUMINELLE DTx<br>Hysteroscopy System is higher than that of the predicate<br>Rotatable Disposable Sheath. However, this difference<br>does not raise different questions of safety and<br>effectiveness. The reference device, Schoelly<br>Cystoscopes/ Hysteroscopes and Accessories<br>(K150158) includes a rigid sheath similar to the<br>proposed device.<br><br>All other technological characteristics are the same<br>between the subject and predicate device. | Detailed Comparison of the Subject and Predicate Device UVision360 LUMINELLE DTx Hysteroscopy System Special 510(k) {7}------------------------------------------------ K190827 Page 5 of 8 {8}------------------------------------------------ K190827 Page 6 of 8 {9}------------------------------------------------ ## Testing ### Sterility and shelf-life LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid is packaged in the same packaging as the predicate Rotatable Disposable Sheath, with the same sealing parameters. As the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid has the same dimensions as the predicate LUMINELLE DTx 360° Rotatable Disposable Sheath and the packaging materials and sealing parameters are identical, previous sterilization, simulated distribution and packaging shelf-life test documentation from the predicate was leveraged to support the sterilization and seal integrity of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid. The shelf-life of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid of 1 year was demonstrated through pull testing on the stainless steel hypotube bond. The device was demonstrated to maintain specifications after accelerated aging. #### Design validation Design validation testing and usability testing was conducted on the LUMINELLE DTx Hysteroscopy System with the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to confirm that the sheath performs to its intended use in in vivo models, the user is able to operate the system as intended, and the product conforms to user needs. Testing was identical to that conducted on the predicate LUMINELLE DTx 360° Rotatable Disposable Sheath. The LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid met all predefined acceptance criteria. ### Biocompatibility There is no difference in patient-contacting materials, manufacturing or processing between the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid and the predicate Rotatable Disposable Sheath. Therefore, biocompatibility data from the predicate was leveraged to support the biocompatibility of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid. #### Electrical Safety Due to the additional stainless steel utilized in the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid, dielectric strength testing was conducted for the LUMINELLE DTx Rigid 360° Rotatable Disposable Sheath Rigid to confirm that the rigid sheath can withstand dielectric strength voltages in accordance with IEC 60601-1:2005/(R)2012 and A1:2012. Results of the testing were acceptable per IEC 60601-2-2 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, which is specified by IEC 60601-2-18 Particular requirements for the basic safety and essential performance of endoscopic equipment. ## Substantial Equivalence Discussion The intended use for LUMINELLE DTx Hysteroscopy System is the same as that of the previously cleared LUMINELLE DTx Hysteroscopy System (K181909). The technological characteristics of the LUMINELLE DTx Hysteroscopy System are different from the LUMINELLE DTx Hysteroscopy System (K181909) in that the LUMINELLE DTx Hysteroscopy System includes the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid, a modified version of {10}------------------------------------------------ the LUMINELLE DTx 360° Rotatable Disposable Sheath (K181909). However, this difference does not raise different questions of safety and effectiveness. Performance testing shows that the LUMINELLE DTx Hysteroscopy System is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K181909). ## Conclusion The LUMINELLE DTx Hysteroscopy System is substantially equivalent to the legally marketed predicate device K181909.