Luminelle DTx Hysteroscopy System

K181909 · Uvision360, Inc. · FAJ · Aug 16, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181909
• Device Name: Luminelle DTx Hysteroscopy System
• Applicant: Uvision360, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Aug 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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 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.

Device Story

Luminelle DTx Hysteroscopy System provides direct visualization of cervical canal, uterine cavity, and lower urinary tract. System components: reusable flexible hysteroscope (integrated LED light, CMOS sensor), sterile 360° rotatable disposable sheath (operative channel, fluid management lines), communication cable, and control hub. Physician operates device in clinical setting; control hub processes CMOS sensor data, converts to HDMI for monitor display, and enables still image capture via handle button. Disposable sheath provides fluid inflow/outflow and operative channel for surgical instruments. Rotatable sheath allows independent camera positioning while maintaining handle grip. System facilitates diagnostic and therapeutic procedures; provides real-time visualization to assist clinical decision-making and surgical intervention. Benefits include improved access and visualization for gynecological and urological procedures.

Clinical Evidence

Bench testing only. Testing included optical resolution (ISO 8600), biocompatibility (ISO 10993), electrical/thermal safety (IEC 60601-1), EMC (IEC 60601-1-2), endoscope safety (IEC 60601-2-18), usability, reprocessing validation, sterilization validation (ISO 11135), shelf life/packaging, and software validation.

Technological Characteristics

Reusable flexible hysteroscope with integrated LED light source and CMOS sensor. Sterile disposable 360° rotatable sheath (HIPS/PETG materials). CMOS sensor resolution 400x400 pixels. Connectivity: HDMI (monitor), USB (PC). Electrical safety: IEC 60601-1, IEC 60601-2-18. Sterilization: Ethylene oxide (EO) for disposable components. Biocompatibility: ISO 10993.

Indications for Use

Indicated for patients requiring diagnostic or surgical hysteroscopy (e.g., abnormal bleeding, infertility, pelvic pain, biopsy, polypectomy, myomectomy, adhesion/septa transection, ablation) or endoscopic access/examination of the lower urinary tract and bladder.

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.

Predicate Devices

• Cogentix Flexible Video Cystoscope with Digital Video Processor and Disposable EndoSheath Systems (K072180)
• Vision-Sciences Flexible Cystoscope with EndoSheath System (K071127)

Submission Summary (Full Text)

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August 16, 2018

UVision360 Inc. % Dave Yungvirt Official Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K181909

Trade/Device Name: Luminelle DTx Hysteroscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FAJ, HIH Dated: July 14, 2018 Received: July 17, 2018

Dear Dave 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 ([e-mail]) or phone [phone] 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) K181909

#### 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 System allows the user to perform various diagnostic and therapeutic 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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| Date Summary<br>Prepared: | August 15, 2018 | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | UVision360 Inc. | |
| Contact Person: | Allison London Brown | |
| | CEO, UVision360 Inc. | |
| | 4441-106 Six Forks Road, #179 | |
| | Raleigh, NC 27609 | |
| Device Name: | Trade Name: | Luminelle DTx Hysteroscopy System |
| | Common Name: | Hysteroscope (and accessories); Cystoscope<br>(and accessories) |
| | Regulation: | 876:1500 Endoscope and accessories |
| | Class: | II |
| | Product Code: | FAJ, HIH |
| Predicate Device(s): | Primary<br>Predicate | K072180 Cogentix Flexible Video Cystoscope<br>with Digital Video Processor and Disposable<br>EndoSheath Systems |
| | Secondary<br>Predicate | K071127 Vision-Sciences Flexible Cystoscope<br>with EndoSheath System (with additional<br>Hysteroscope Indications for use) |
| | | The predicate devices have not been subject to a<br>design related recall. |
| Device Description: | The Luminelle DTx Hysteroscopy System is comprised of four<br>components: | |
| | 1) Luminelle DTx Hysteroscope - a non-sterile, reusable flexible<br>hysteroscope with an integrated light source, light fiber bundle and<br>CMOS sensor. | |
| | 2) The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile,<br>two-part sheath installed over the insertion tube of the Hysteroscope<br>and comprised of the Operative Introducer and the 360° RotoSheath.<br>The Operative Introducer contains an operative channel for inserting<br>surgical accessories, two fluid management lines (inflow/outflow),<br>and a channel to protect the scope insertion tube. The 360°<br>RotoSheath allows for rotational positioning of the camera and<br>provides rigidity to the Scope/Introducer assembly. | |
| | 3) Luminelle Communication Cable - a cable that provides both the<br>power to the hysteroscope and transmits the image. | |
| | 4) Luminelle Control Hub - the main power supply, image converter<br>and visualization connection. The Control Hub has both HDMI and | |

## 510(k) Summary

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USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package.

The Luminelle DTx Hysteroscope, Communication Cable, Control Hub, USB and HDMI cables and power cord are provided together in a single package. The 360° Rotatable Disposable Sheath is provided in a separate sterile package. The 360º Rotatable Disposable Sheath is required for use with the Hysteroscope, therefore it is a component of the system and not an accessory to the system.

The CMOS sensor and fiber optic illumination bundles are contained in the Hysteroscope Insertion Tube. The insertion tube length is 29.8 cm (11.73 in.) and the outside diameter is 1.95 mm (0.077 in.). The Luminelle DTx Hysteroscope is packaged in a white form fit tray with a clear slide-on cover. The tray is made of high-impact polystyrene (HIPS). The clear cover is made of polyethylene terephthalate with glycol (PETG).

The Luminelle 360° RotoSheath has a working length of 24.0 cm (9.45 in.) with an outside diameter of 5.7 mm (0.244 in.). The Luminelle Operative Introducer has an outside diameter of 4.8 mm (0.189 in.) and the inside diameter of the operative channel is 1.85 mm (0.073 in.).

Both the Luminelle 360º RotoSheath and Luminelle Operative Introducer are supplied as a single assembled unit packaged in a bottom tray with retaining lid made of polyethylene terephthalate with glycol (PETG) and sealed with Tyvek. The assembled package is sterilized using ethylene oxide (EO).

The Control Hub supplies power to the Hysteroscope via a reusable Communication Cable. The CMOS sensors have a processor that converts the visual image into data to be transferred. A processor in the Control Hub converts this image data into streaming HDMI language, takes still images when the button is pushed, and also controls the light exposure during changing light conditions.

Visualization on a video monitor is provided via a HDMI cable, and image transfer to a PC is provided via a Type A USB cable. A 12V DC, 3A power adapter is also provided. Technical specifications for these reusable components are provided in the Instructions for Use.

Indications for Use Statement: 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.

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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.

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| Device Comparisons | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Proposed Luminelle DTx<br>Hysteroscopy System | Primary Predicate<br>Cogentix (K072180) | Secondary Predicate<br>Vision-Sciences<br>(K071127) |
| Product Codes | HIH<br>FAJ | FAJ (primary) | HIH (Primary)<br>FAJ |
| | Conclusion: Both predicate devices combined have the same product<br>codes as the subject device. | | |
| Indications for<br>Use<br>(hysteroscopy) | Used to permit direct<br>viewing of the cervical<br>canal and uterine cavity<br>for the purpose of<br>performing diagnostic and<br>surgical procedures. | n/a | Used to permit direct<br>viewing of the<br>cervical canal and<br>the uterine cavity for<br>the purpose of<br>performing<br>diagnostic and<br>therapeutic/surgical<br>procedures. |
| | Conclusion: The proposed device and the secondary predicate device have<br>the same indications for use for hysteroscopy. | | |
| Feature | Proposed Luminelle DTx<br>Hysteroscopy System | Primary Predicate<br>Cogentix (K072180) | Secondary Predicate<br>Vision-Sciences<br>(K071127) |
| Indications for<br>Use<br>(Cystoscopy) | The Luminelle DTx<br>Hysteroscopy System is<br>intended for use in<br>endoscopic access to and<br>examination of the lower<br>urinary tract including the<br>bladder. When combined<br>with accessory<br>instruments, the System<br>allows the user to perform<br>various diagnostic and<br>therapeutic procedures. | The Cogentix Medical<br>CST-5000/ 5000i<br>Flexible Video<br>Cystoscope/<br>Hysteroscope with Slide-<br>On® EndoSheath®<br>Technology is intended<br>to be used for<br>endoscopic access to and<br>examination of the lower<br>urinary tract, including<br>the bladder. When<br>combined with accessory<br>instruments, the<br>endoscopic system<br>allows the user to<br>perform various<br>diagnostic and<br>therapeutic procedures. | The CST-2000A and<br>Slide-On<br>EndoSheath System<br>provides for<br>endoscopic access<br>and examination of<br>the lower urinary<br>tract, including the<br>bladder, and using<br>additional<br>accessories, to<br>perform various<br>diagnostic and<br>therapeutic<br>procedures. |
| Conclusion: All three devices have the same indications for use<br>regarding cystoscopy. | | | |
| System<br>Overview | Handheld AC powered<br>hysteroscope/cystoscope,<br>consisting of a reusable<br>handle and insertion tube,<br>and a sterile disposable<br>sheath | Handheld AC powered<br>hysteroscope/<br>cystoscope, consisting of<br>reusable handle and<br>insertion tube, and a<br>sterile disposable sheath. | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate. |
| Conclusion: Both the proposed and primary predicate are comprised<br>of the same general system. | | | |
| Cannula<br>Diameter | 5.7 mm outer diameter | 5.6 mm outer diameter | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate. |
| Conclusion: Slight differences in the outer diameter do not raise<br>different questions of safety and effectiveness. | | | |
| Scope Working<br>Length | 240 mm | 370 mm | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate. |
| Conclusion: Both the proposed and primary predicate have scope lengths<br>typical for devices of this type and the differences do not raise different | | | |
| Device Comparisons | | | |
| Feature | Proposed Luminelle DTx<br>Hysteroscopy System | Primary Predicate<br>Cogentix (K072180) | Secondary Predicate<br>Vision-Sciences<br>(K071127) |
| Image<br>Processing and<br>Display | Image Processing: Digital<br>Video Processor<br>Display: Standard HD<br>Monitor/TV. | Image Processing:<br>Digital Video Processor<br>Display: LCD Display | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate. |
| | Conclusion: The differences in types of do not raise different questions of<br>safety and effectiveness. | | |
| Image<br>Transmission | Image transmitted from a<br>video camera to the<br>Digital Video Processor<br>then to the display. | Image transmitted from a<br>video camera to the<br>Digital Video Processor<br>then to the display. | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate. |
| Conclusion: Both the proposed and primary predicate transmit the<br>image the same way. | | | |
| Image Capture | Still image capture during<br>a procedure by depressing<br>a camera button on the<br>handle. | Image and Video capture<br>and retrieval capabilities<br>on Digital Video<br>Processor | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate. |
| | Conclusion: Predicate device requires purchase of a separate Digital Video<br>Processor that has more recording capabilities than the proposed device.<br>These differences do not raise different questions of safety and effectiveness<br>for the intended uses. | | |
| Instrument<br>Channel<br>Diameter | 5 Fr. (1.7 mm) | 6.3 Fr (2.1 mm) | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate |
| Conclusion: While the subject device accommodates slightly smaller<br>instruments than the predicate, this does not raise different questions of<br>safety and effectiveness, as operative instruments are readily available in<br>both sizes. | | | |
| Illumination<br>Light Source | Integrated solid state LED<br>light source with fiber<br>optic transmission. | Integrated solid state<br>LED light source with<br>fiber optic transmission. | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate |
| Conclusion: Both the proposed and primary predicate have the same<br>illumination light source. | | | |
| Device Comparisons | | | |
| Feature | Proposed Luminelle DTx<br>Hysteroscopy System | Primary Predicate<br>Cogentix (K072180) | Secondary Predicate<br>Vision-Sciences<br>(K071127) |
| Objective Lens<br>- Focal Length<br>- Field of Vie<br>- Direction of<br>View | Focal Length: 5 – 50 mm<br>Field of View: 120° in air<br>Direction of View:<br>Forward (0°) | Focal length: 3 – 50 mm<br>Field of view: 110° in air<br>Direction of View:<br>Forward (0°) | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate |
| Conclusion: Both the proposed and primary predicate have similar objective<br>lens characteristics. The differences do not raise different questions on safety<br>or effectiveness of the device. | | | |
| Image<br>Resolution | CMOS chip is 400 x 400<br>pixels.<br>USAF 1951 bar code<br>Group-Element: 1-5 | CCD chip specifications<br>not stated in product<br>literature. | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate |
| Conclusion: Different chip technologies are used, but differences do not<br>raise different questions on safety or effectiveness. | | | |
| Mode of<br>Operation | Continuous | Continuous | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate |
| Conclusion: Both the proposed and primary predicate are used in a<br>continuous mode of operation. | | | |
| Electrical<br>Safety | Compliant with<br>requirements of<br>IEC 60601-1;<br>IEC 60601-2-18 | Compliant with<br>requirements of<br>IEC 60601-1;<br>IEC 60601-2-18 | N/A: All technical<br>information for the<br>SE comparison will<br>be taken from the<br>primary predicate |
| Conclusion: Both the proposed and primary predicate are compliant<br>with the requirements of IEC 60601-1 and IEC 60601-2-18 for<br>electrical safety. |…