(79 days)
Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
Verres Needle and Cannula
The provided text is a 510(k) Summary of Safety and Effectiveness for a Verres Needle and Cannula, which is a medical device for establishing pneumoperitoneum and providing access in laparoscopic surgery. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed results from a clinical study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to AI or human reader improvement) are not applicable or not present in this type of regulatory submission. The document relies on the equivalence of material and design to established devices rather than new performance data.
Here's an analysis based on the provided text, addressing the points where information is available or relevant:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The acceptance criteria for the Verres Needle and Cannula are implicitly based on its substantial equivalence to predicate devices, namely the Gynescope Trocar and Sleeves and the Marlow Verres Needle. The study described is a comparison of technological characteristics and intended use to these predicate devices.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are defined by the comparable characteristics of the predicate devices. The "reported device performance" is the Verres Needle and Cannula's characteristics, which are shown to be similar.
| Feature / Acceptance Criteria (based on predicate) | Verres Needle and Cannula Performance (reported) |
|---|---|
| Material: Stainless Steel (like predicate) | Stainless Steel |
| Needle Type: Spring-Loaded (like Marlow Verres Needle) | Spring-Loaded |
| Diameter Range: Comparable to predicate devices (2.0mm to 11.5mm) | 2.0 - 5.0mm (within the range of predicate devices) |
| Intended Use: Establish pneumoperitoneum and provide access in minimally invasive surgical procedures | Intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation. |
| Safety and Effectiveness: Comparable to predicate devices | Stated as comparable to the Gynescope Trocar and Sleeves and the Marlow Verres Needle. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a clinical study involving a test set of patient data. The comparison is based on the design and material specifications of the device itself against established predicate devices.
- Data Provenance: Not applicable. The "data" are the specifications of the device and its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" and no "ground truth" in the sense of expert assessment of clinical data for this type of submission. The ground truth for substantial equivalence is the established safety and effectiveness of the predicate devices based on their historical use and regulatory clearances.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was used. The regulatory body (FDA) makes the final determination of substantial equivalence based on the submitted comparison.
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
- No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device does not involve algorithms or AI.
7. The type of ground truth used
- The "ground truth" implicit in a 510(k) substantial equivalence submission is the established safety and effectiveness of legally marketed predicate devices. The new device is compared against these established devices to demonstrate it raises no new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. This device does not involve algorithms or machine learning, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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SUMMARY OF SAFETY AND EFFECTIVENESS VERRES NEEDLE AND CANNUI
The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the 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
Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.
Substantial Equivalency Information
The Verres Needle Cannula is similar to the Gynescope Trocar and Sleeves and the Marlow Verres Needle.
| GynescopeTrocar andSleeves | MarlowVerresNeedle | Verres Needleand Cannula | |
|---|---|---|---|
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle | N/A | Spring-Loaded | Spring-Loaded |
| Diameter | 5.0 - 11.5mm | 2.0 mm | 2.0 - 5.0mm |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Verres Needle and Cannula are comparable to that of the Gynescope Trocar and Sleeves and the Marlow Verres Needle.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 1997
Ms. Debra A. Pekar Manager of Quality Assurance and Regulatory Affairs CooperSurgical, Inc. 15 Forest Parkway Shelton, Connecticut 06484
Re: K971837
VerreScope Verres Needle and Cannula . Dated: May 16, 1997 Received: May 19, 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 Device 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Sincerely yours,
Lillian Yin, 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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Page 9 ર 3 of
510(k) Number (if known):
Verres Needle / Cannula Device Name: _
Indications For Use:
Verres Needle and Cannula 1s intended for use in laparoscopic surgery that utilizes minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE:BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) productive, Abdominal, ENT, Prescription lise > Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
(Optional Format 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.