(172 days)
For laparoscopic minimally invasive surgery to provide sight access for use with operative and diagnostic instrumentation.
The VerreScope is intended for use during laparoscopic minimally invasive surgery to provide access for use of operative and diagnostic instrumentation. It is made of Stainless Steel and uses Fiber Optics.
The provided document is a 510(k) summary for the Cooper VerreScope, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance reporting. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device must be comparable in intended use and technological characteristics to a legally marketed predicate device. | The VerreScope's intended use and technological characteristics are stated to "not vary significantly" from the Gynescope Laparoscopes. |
| Material | Material should be Stainless Steel | VerreScope: Stainless Steel |
| Optics | Optics should be a recognized type for medical visualization (e.g., Rod Lens as in predicate). | VerreScope: Fiber Optics |
| Safety and Effectiveness | Safety and effectiveness must be comparable to the predicate. | The safety and effectiveness of the CooperSurgical's VerreScope are stated to be "comparable to that of the Gynescope Laparoscope." |
Explanation: The "acceptance criteria" here are implicitly defined by the FDA's 510(k) pathway, which requires demonstrating substantial equivalence to a predicate device already on the market. The reported performance is a direct comparison of the VerreScope's characteristics against the Gynescope Laparoscopes using a comparison table. There are no quantitative performance metrics (e.g., accuracy, sensitivity, specificity) reported in this document.
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a test set or any specific testing involving human subjects or data. The comparison is based on the design and material specifications of the device itself and its predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No test set requiring ground truth established by experts is mentioned.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
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 device is a surgical instrument (laparoscope), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established as there is no specific clinical study data presented in this 510(k) summary. The "truth" in this context is the comparison of device specifications to a legally marketed predicate.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is not an AI/machine learning device. The design and manufacturing processes implicitly involve experience and data, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set or ground truth establishment for a training set is mentioned.
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E ATTACHMENT
SUMMARY OF SAFETY AND EFFECTIVENESS COOPER VERRESCOPE
NOV - 7 1997
(971836
PIGI
The Summary of Safety and Effectiveness on VerreScope reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
The VerreScope is intended for use during laparoscopic minimally invasive surgery to provide access for use of operative and diagnostic instrumentation.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Substantial Equivalency Information
The VerreScope is similar to the Gynescope Laparoscopes.
| GynescopeLaparoscopes | VerreScope | |
|---|---|---|
| Material: | Stainless Steel | Stainless Steel |
| Optics: | Rod Lens | Fiber Optics |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the CooperSurgical's VerreScope are comparable to that of the Gynescope Laparoscope.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/4 description: The image shows the date November 7, 1997. The month is abbreviated to NOV. The day is 7 and the year is 1997. The text is in bold font.
Ms. Debra A. Pekar Manager of Quality Assurance and Regulatory Affairs CooperSurgical 15 Forest Parkway Shelton, Connecticut 06484
Re: K971836
VerreScope Light Cable - Light Source Adaptor Dated: October 6, 1997 Received: October 7, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET
Dear Ms. Pekar:
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, 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 practice, labeling, 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 marked 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 questions on the promotion 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. Liao 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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ATTACHMENT C
ol Page
510(k) Number (if known): _ K971836 VerreScope Device Namc:
Indications For Usc:
For laparoscopic minimally invasive surgery to provide sight access for use with operative and diagnostic instrumentation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deler D. Suthuy
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971836
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.