The enlightenVue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the microendoscope.

Device Description

The enlightenVue Microendoscopy System is comprised of the surgiVue microendoscope and surgiTrac laser light source. This system is used to provide imaging capability of internal anatomy for both diagnostic and interventional procedures. The small laser light source focuses light onto a small fiber in the form of white light. The surgiTrac interfaces with the disposable surgiVue microendoscope and a PC to allow for illumination of the captured image.

AI/ML Overview

The provided document is a 510(k) summary for the enlightenVue Microendoscopy System. It focuses on demonstrating substantial equivalence to a predicate device rather than outlining detailed acceptance criteria for an AI/ML-driven medical device and a study proving it meets those criteria.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria for an AI/ML device and a study proving device performance against those criteria. The provided text is for a traditional medical device (endoscopy system) and relies on functional, mechanical, and biocompatibility testing for substantial equivalence, not AI/ML performance metrics.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

No AI/ML Component: The enlightenVue Microendoscopy System is described as a system for visualization using a microendoscope, light source, and camera. There is no mention of artificial intelligence, machine learning, image processing algorithms for diagnostic aid, or similar features that would necessitate AI-specific acceptance criteria.
Performance Metrics are for Device Functionality, Not AI Accuracy: The "Performance Testing" section (page 6-7) lists tests like "Accelerated Aging," "Real-Time Aging," "Cytotoxicity Test," "Dimensional Verification," "Electrical Characteristics," and "Functional Verification: surgiVue Microendoscope." These are standard tests for endoscopes to ensure their physical and functional integrity, not for evaluating the performance of an AI algorithm (e.g., sensitivity, specificity, AUC).
No "Ground Truth" for AI/ML: Since there's no AI component, there's no need for establishing ground truth from expert consensus, pathology, or outcomes data, which are crucial for validating AI models.
No Test Set/Training Set Sizes: Similarly, the concepts of training and test sets are absent because there's no AI model being developed or validated.
No Multi-Reader Multi-Case (MRMC) Study: MRMC studies are used to assess how AI impacts human reader performance, which isn't applicable here.
No Standalone Performance: Standalone performance refers to the AI algorithm's performance without human intervention, which is not relevant to this device.

In summary, the provided document describes information relevant to a traditional medical device K-clearance, not an AI/ML-powered device. Therefore, a table of acceptance criteria for an AI/ML device and details of a study proving its performance against those criteria cannot be extracted.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 20, 2020

enlightenVue. Inc. Giacomo Basadonna 1111 Race Street, Suite 6a Denver, Colorado 80206

Re: K192300

Trade/Device Name: enlightenVue Microendoscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 21, 2020 Received: February 25, 2020

Dear Giacomo Basadonna:

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. You must comply with all the Act's

{1}------------------------------------------------

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-regulatory-information/postmarketing-safety-reportingcombination-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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192300

Device Name enlightenVue Microendoscopy System

Indications for Use (Describe)

The enlighten Vue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other deving inside diameters larger than the outer diameter of the microendoscope.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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 (K192300) for the enlightenVue Microendoscopy System (per 21CFR 807.87(h))

1. SUBMITTER/510(K) HOLDER

enlightenVue 1111 Race Street, Suite 6a Denver, CO 80206

Contact Person: Giacomo Basadonna M.D. Telephone: 202-427-5177

Date Prepared: March 19, 2020

2. DEVICE NAME

Proprietary Name: enlightenVue Microendoscopy System Common/Usual Name: Endoscope Classification Name: Endoscope

3. PREDICATE DEVICE

Galileo Disposable Endoscope (K981928)

4. DEVICE DESCRIPTION

5.0

{4}------------------------------------------------

5. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The enlightenVue Microendoscopy System is substantially equivalent in function, and intended use to the predicate, the Galileo Disposable Endoscopes, subject of K981928.

The intended use of the enlightenVue Microendoscopy System and the predicate device is identical in that they are all indicated for visualization of body cavities, hollow organs, and canals. They are designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the endoscopes.

The technological characteristics of the enlightenVue Microendoscopy System and the predicate device are identical in that they both offer a channel for either viewing body cavities, tissues, organs, or canals and an optional channel for passing instruments or fluids into the desired anatomical sites. Both devices are provided sterile and intended for single use only. The devices are different in that the subject device includes an expandable tip, two accessory channels, a light source, and a camera. A reference device is used for comparison to validate the technological differences.

Table 1, on the next page, compares the subject device with the predicate.

{5}------------------------------------------------

PRODUCTCHARACTERISTICS	ENLIGHTENVUEMICROENDOSCOPYSYSTEM	PREDICATEGALILEODISPOSABLEENDOSCOPE
Intended Use	The intended use of the enlightenVueMicroendoscopy System is intended for thevisualization of body cavities, hollow organs, andcanals. It is also designed to be introduced throughnatural body orifices cavities or surgical incisionsthrough introducers, trocars, needles, sheaths, orother devices with lumens having inside diameterslarger than the outer diameter of the endoscope
Product Code	GCJ	GCJ
Classification	Class II	Class II
Materials	surgiVue: PolypropyleneImpact Copolymer,Polyimide, Pebax 7233,Pebax 5533, Pebax 3533,Nylon, Polysulfone,Polyester,PolymethylmethacrylateFluorinated Polymer,Stainless Steel,Polycarbonate, Polyolefin,Pebax 4033, ABS,Polyvinylidene Fluoride	N/A
Reusable or Disposable	Disposable	Disposable
Light Source	Class 3R Laser	External
Field of View	120°	40°-70°
Direction of View	90°	0°-30°
Biocompatible	Yes	Yes
Sterilization Method	EtO	EtO
Accessories	Accessory tools with amaximum diameter of1.0mm can be used inconjunction with the whiteinstrument channel femaleluer. Active endoscopicaccessories, such as laserprobes and electrosurgicalequipment may not be usedin conjunction with theenlightenVueMicroendoscopy System.	N/A
Regulatory Status	K192300	K081028

Table 1: Side-by-Side Comparison of enlightenVue Microendoscopy System with Predicate Device

{6}------------------------------------------------

7. PERFORMANCE TESTING

Biocompatibility, packaging, mechanical and functional testing demonstrate that the enlightenVue Microendoscopy System is biocompatible and mechanically and functionally similar to the predicate device. The following tests have been performed:

Accelerated Aging, 6 and 12 months ●
Real-Time Aging, 3 months ●
Shelf life Verification ●
Cytotoxicity Test ●
Irritation Test
Sensitization Test
. Verification Test: PEMS System, Video System
Verification Test: PEMS System ●
Verification Test: PEMS System, FPGA ●
Dimensional Verification ●
- 0 Cable Length
- o Working Length
- Working Diameter o
- Secondary Channel Color and Symbol O
- Working Channel Color and Symbol o
- Handpiece Gap O
- o Heat Shrink
- Sharp Edges o
Verification Test: surgiTrac ●
- Physical Characteristics o
- Electrical Characteristics o
- Safety Features о
- Functional Characteristics о
- Video System Communications O
- Video Stream o
Functional Verification: surgiVue Microendoscope ●
- Cameral Specifications o
- о Endoscope functionality
- Endoscope Strength and Durability o
- Serialization Check Test O
- Radiant Power Distribution Test O
- о Secondary Channel Camera Rinse Test
- o Water Ingress Test
Usability Testing ●

{7}------------------------------------------------

. Laser Safety Testing
Evaluations were performed to determine the material and mechanical characteristics of the enlightenVue Microendoscopy System according to FDA recognized standards. In conclusion, the functional verification and validation testing have been performed which demonstrate that enlightenVue Microendoscopy System functions as intended and is safe and effective for its intended use.

CONCLUSION 8.

The subject device is substantially equivalent to the predicate device. These conclusions are based upon the facts that the subject device is identical in intended use to the predicate, extensive validation testing was performed, and a reference device is used for comparison to validate different technological characteristics - the camera and light source - to the subject device. Any differences do not raise new types of questions of safety and effectiveness.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.