(78 days)
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No
The summary does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
Yes
The "Intended Use / Indications for Use" section explicitly lists "Therapeutic uses (e.g. removal of foreign bodies, stricture, dilatation, etc.)" as one of its medical indications.
Yes
The device is used for internal examination and biopsy to "Confirm upper G.I. radiologic findings," "Biopsy of known or suspected abnormalities," "Identify the source of acute upper G.I. hemorrhage," and "Monitor the status of chronic disease (e.g., ulcers)." These activities are all diagnostic in nature.
No
The device description explicitly states "VG 200 Video Gastroscope," which is a hardware device used for internal examination. The intended use also describes the physical process of passing an "instrument" through the body. There is no indication that this is a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed directly on the patient's body (internal examination of the upper gastrointestinal tract) using an instrument passed through the mouth.
- Device Description: The device is a "Video Gastroscope," which is a tool used for direct visualization inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples outside of the body (in vitro), such as blood, urine, tissue, etc. The indications for use are all related to direct examination and intervention within the patient's body.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
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.)
Product codes
78 FDS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper gastrointestinal tract, mouth, phariyix, esophagus, stomach, pylorus, proximal portion of the duodenum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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:
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.)
(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
OR
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 .
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