(66 days)
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Not Found
No
The device description focuses on a chemical solution for anti-fogging and does not mention any computational or algorithmic components related to AI/ML.
No
The device is designed to remove fog from endoscopes and laparoscopes to improve image quality, not to treat or diagnose a medical condition.
No
Explanation: The device is designed to remove fog from endoscopes and laparoscopes, improving vision during procedures. It does not analyze or interpret medical data for diagnostic purposes.
No
The device description explicitly states it is an "anti-fog solution aid," which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this product is designed to remove fog from the endoscope and laparoscope lenses, which are instruments, not biological specimens.
- The purpose is to improve visualization during a procedure. The product's function is to enhance the clarity of the image captured by the endoscope/laparoscope, not to analyze biological samples for diagnostic purposes.
The device is an accessory used during endoscopic and laparoscopic procedures to improve the quality of the visual output, but it does not perform any diagnostic testing on biological material.
N/A
Intended Use / Indications for Use
This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.
Product codes
78 FEB
Device Description
The use of an anti-fog solution aid to eliminate troublesome cloudiness which prevents clear vision and poor picture images. After application of the solution the device is ready for use. All ingredients are sterile. The solution will not harm the lens and can be used as often as necessary.
Mentions image processing
poor picture images.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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K 973 558
510(K) Summary
NOV 24 1997
The use of an anti-fog solution aid to eliminate troublesome cloudiness which prevents clear vision and poor picture images. After application of the solution the device is ready for use. All ingredients are sterile. The solution will not harm the lens and can be used as often as necessary.
1
Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1997
Mr. George P. Korteweg Vice President Ultracell Medical Technologies, Inc. 183 Providence New London Turnpike P.O. Box 326 North Stonington, Connecticut 06359
Re: K973558
Visual Endoscopic Non-Alcohol Ultracell Sponge (VENUS II) and Visual Endoscopic Non-Alcohol Urethane Sponge (VENUS I) Dated: October 21, 1997 Received: October 23, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FEB
Dear Mr. Korteweg:
We have reviewed your Section 510(k) notification of intent to market the device 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, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (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. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
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
Enclosure
2
1' .. [c_ ] of __ ]___ of __ 1___
973558 `(k) Number (if known): K
Device Name: ULTRACELL ANTI-FOG KIT
Indications For Use:
This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Riker D. Sathia/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 32-28 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use
(Optional Formal 1-2-10)