The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.

AI/ML Overview

The provided text describes a 510(k) summary for the "3 MM Selec-Tip" Laparoscopic Instruments, a medical device. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a study with performance metrics in the same way an AI/ML device would.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets them because it's a submission for a traditional medical device, not an AI/ML diagnostic tool that would typically involve such studies.

Specifically:

No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance criteria for the "3 MM Selec-Tip" Laparoscopic Instruments. Its purpose is to demonstrate substantial equivalence to predicate devices, not to measure specific clinical performance.
No sample size for the test set or data provenance: No test sets or data for performance evaluation are mentioned.
No number of experts or qualifications for ground truth: No ground truth establishment is described as there is no diagnostic or AI/ML component being evaluated.
No adjudication method: Not applicable given the nature of the device and submission.
No multi-reader multi-case (MRMC) comparative effectiveness study: This is not an AI-assisted diagnostic device, so such a study would not apply.
No standalone (algorithm only) performance study: This is not an algorithm-based device.
No type of ground truth used: Not applicable.
No sample size for the training set: Not applicable, as there is no AI/ML model being trained.
No description of how ground truth for the training set was established: Not applicable.

The document primarily focuses on:

Device Identification: "3 MM Selec-Tip" Laparoscopic Instruments
Predicate Devices: "Selecta-Tip" (K970826) and Richard Wolf Medical Instruments (K973648)
Device Description: Non-sterile, reusable small diameter instruments for cutting and dissecting abdominal tissue in endoscopic/laparoscopic procedures, usable with monopolar electrosurgical generators.
Substantial Equivalence: Claiming that technical specifications, materials, and physical appearance differences do not affect safety or effectiveness compared to predicates.
Indications For Use: Cutting and dissecting various abdominal tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

Summary

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10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

MAR 2 7 1998

A. Submitter Information
Microline, Inc. 100 Cumminas Center Suite 350-G Beverly, MA 01915

(978) 922-9810 Telephone:

Contact Person: Mr. Huges de Laforcade President

Date Prepared: February 25, 1998

B. Device Identification

Common/Usual Name: Proprietary Name:

Manual Detachable Surgical Instruments "3 MM Selec-Tip" Laparoscopic Instruments

C. Identification of Predicate Device(s)

The "3 MM Selec-Tip" Laparoscopic Instruments are substantially equivalent to their predicate, "Selecta-Tip (K970826) and Richard Wolf Medical Instruments (K973648), previously cleared and currently marketed.

D. Device Description

E. Substantial Equivalence

The Microline "3 MM Selec-Tip" Laparoscopic Scissors Instruments are substantially equivalent to the Microline "Selecta-Tip (K970826) and Richard Wolf Medical Instruments (K973648). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "3 MM Selec-Tip" relative to its predicates.

"3 MM Selec-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where small diameter instruments are introduced into the body through a cannula.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 1998

Ms. Jacqueline E. Masse Sr. Consultant Microline, Incorporated c/o Interactive Consulting Incorporated 70 Walnut Street Wellesley, Massachusetts 02181

K980758 Re: 3MM Selec-Tip Laparoscopic Scissors Trade Name: Regulatory Class: II Product Code: GEI February 25, 1998 Dated: February 27, 1998 Received:

Dear Ms. Masse:

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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, 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 II (Special Controls) or 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 Requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Masse

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) 594-4595. 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,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: "3 MM Selec-Tip" Laparoscopic Scissors

Indications For Use:

Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

lleza

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980758

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.