(66 days)
This product is designed to provide a direct method to remove fog from the endoscope and laparoscope.
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.
This 510(k) submission describes an anti-fog solution for endoscopes and laparoscopes, not a medical device that requires a study to demonstrate performance against acceptance criteria in the typical sense (e.g., accuracy, sensitivity, specificity). The submission is focused on demonstrating substantial equivalence to predicate devices for its intended use, which is simply to prevent fogging. Therefore, most of the requested information about acceptance criteria and study details for device performance (such as sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.
Here's a breakdown based on the provided text, highlighting what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense for a performance study. The "performance" described is the solution's ability to eliminate troublesome cloudiness that prevents clear vision and poor picture images. The acceptance is based on the claim that "After application of the solution the device is ready for use." There are no quantitative metrics or thresholds provided in the document for this claim as it is a fundamental functional claim for an anti-fog solution.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Elimination of troublesome cloudiness preventing clear vision and poor picture images. | "After application of the solution the device is ready for use." |
| Solution will not harm the lens. | "The solution will not harm the lens." |
| Ingredients are sterile. | "All ingredients are sterile." |
2. Sample size used for the test set and the data provenance
Not applicable. No formal test set or corresponding data provenance is mentioned as this is a functional claim for an anti-fog solution, not a diagnostic or AI device requiring such validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" does not apply here. The effectiveness is a direct observation of the absence of fogging after application.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
5. 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
Not applicable. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For a product claiming to prevent fog, the "ground truth" is simply the visual observation of whether fog is present or absent on the lens after application.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
Summary of the Study (as inferred from the 510(k) submission):
The provided document is a 510(k) summary for a medical device called "Visual Endoscopic Non-Alcohol Ultracell Sponge (VENUS II) and Visual Endoscopic Non-Alcohol Urethane Sponge (VENUS I)" which also includes the "ULTRACELL ANTI-FOG KIT". The core "study" is the demonstration of substantial equivalence to predicate devices already on the market prior to May 28, 1976.
The "study" demonstrating the device meets its acceptance criteria is not a formal clinical trial or performance study with quantitative outcomes. Instead, it relies on:
- Statement of Intended Use: The device's purpose is "to provide a direct method to remove fog from the endoscope and laparoscope."
- Functional Claims:
- It eliminates "troublesome cloudiness which prevents clear vision and poor picture images."
- "After application of the solution the device is ready for use."
- "The solution will not harm the lens."
- "All ingredients are sterile."
- Substantial Equivalence: The FDA's review and determination that "the device is substantially equivalent for the indications for use stated... to devices marketed in interstate commerce prior to May 28, 1976." This implies that the sponsor provided information (chemical composition, manufacturing processes, safety data, etc., though not detailed in this specific document) that allowed the FDA to conclude that this new device is as safe and effective as existing legally marketed predicate devices for the same intended use.
In essence, for this type of basic anti-fog solution, the "study" is the submission itself, arguing that its properties and function are demonstrably similar to products already deemed acceptable by the FDA, therefore meeting its acceptance criteria by association and inherent functional design.
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ורי ול
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.
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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
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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)
§ 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.