VG 200 VIDEO GASTROSCOPE by WELCH ALLYN, INC.

The VideoGastroscope is used for Esophagogastroduodenoscopy (EGI), the internal examination of the upper gastrointestinal tract. The instrument is passed via the mouth, and phariyix through the lumen of the esophagus, stomach, and pylorus to the proximal portion of the duodenum.

Medical Indications Include:

Confirm upper G.I. radiologic findings
Biopsy of known or suspected abnormalities
Identify the source of acute upper G.I. hemorrhage
Monitor the status of chronic disease (e.g., ulcers)
Therapeutic uses (c.g. removal of foreign bodies, stricture, dilatation, etc.)

Device Description

VG 200 Video Gastroscope

AI/ML Overview

This response is based solely on the provided text, and it appears the provided documents are regulatory letters (FDA 510(k) clearance) rather than a detailed study report. Therefore, much of the requested information about acceptance criteria and study details is not available in the given text.

Here's an attempt to answer based on what's present:

The provided documents are a 510(k) clearance letter and an Indications for Use statement for the "VG 200 Video Gastroscope" (later referred to as "VIDEO GASTROSCOPE MODEL 31750"). These documents describe the device's intended use and FDA's determination of substantial equivalence, but they do not contain a formal study report or explicit acceptance criteria with performance metrics.

Information Not Available in the Provided Text:

A table of acceptance criteria and the reported device performance: The document is a regulatory clearance, not a study report. It does not list specific performance metrics or acceptance criteria that were quantitatively assessed in a study.
Sample size used for the test set and the data provenance: No study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
Adjudication method: No study details are provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a video gastroscope, not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant to this device's type.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical imaging device, not an AI algorithm.
The type of ground truth used: No study details are provided.
The sample size for the training set: Not applicable as this is a medical imaging device, not an AI algorithm.
How the ground truth for the training set was established: Not applicable as this is a medical imaging device, not an AI algorithm.

What can be inferred from the provided text regarding device functionality and regulatory approval:

The device, a "VG 200 Video Gastroscope" (also "VIDEO GASTROSCOPE MODEL 31750"), is cleared for "Esophagogastroduodenoscopy (EGI), the internal examination of the upper gastrointestinal tract." Its intended uses, listed under "Medical Indications," imply its expected performance:

Confirm upper G.I. radiologic findings
Biopsy of known or suspected abnormalities
Identify the source of acute upper G.I. hemorrhage
Monitor the status of chronic disease (e.g., ulcers)
Therapeutic uses (e.g. removal of foreign bodies, stricture, dilatation, etc.)

Implied Acceptance Criteria (based on 510(k) substantial equivalence):

For a 510(k) clearance, the primary "acceptance criterion" is to demonstrate substantial equivalence to a predicate device already legally marketed. This means the new device must be:

Having the same intended use as the predicate device; AND
Having the same technological characteristics as the predicate device; OR
Having different technological characteristics from the predicate device and the new device:
- Does not raise different questions of safety and effectiveness; AND
- Demonstrates that the device is as safe and effective as the predicate device.

The FDA letter confirms that the device "is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This implies that Welch Allyn, Inc. presented data (likely including comparisons to the predicate device) satisfying the FDA that the video gastroscope met these criteria, but the specific performance benchmarks are not detailed in this regulatory correspondence.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, which are designed to resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1997

Mr. Lawrence E. Marocco Senior Quality-Engineer ...................................................................................................................................................... Welch Allyn, Inc. Medical Division 4341 State Street Road Skaneateles Falls, New York 13153-0220 Re: K971734 . . . . . . . . . VG 200 Video Gastroscope Dated: May 5, 1997 Received: May 12, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FDS

Dear Mr. Marocco:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.ida.gov/cdrludsmamain.html".

Sincereiv yours,

h.T.Liau Yu
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

VIDEO GASTROSCOPE MODEL 31750 Device Name:

Indications For Use:

Medical Indications Include:

Confirm upper G.I. radiologic findings Biopsy of known or suspected abnormalities Identify the source of acute upper G.I. hemorrhage Monitor the status of chronic disease (e.g., ulcers) Therapeutic uses (c.g. removal of foreign bodies, stricture, dilatation, etc.)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_L (Per 21 CFR 801.109)

JMK6/96 Rev. RRG 8/15/96

Over-The-Counter Use_ (Optional Format 1-2-96)

Robert R. Salling

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

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.