The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures. The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.

AI/ML Overview

The provided text is a 510(k) Summary and related FDA correspondence for the "Disposable Re-New Forceps Laparoscopic Surgical Tips." This document primarily focuses on establishing substantial equivalence to a predicate device and gaining market clearance. It does not contain information about acceptance criteria or specific studies proving the device meets particular performance metrics.

The device in question is a manual surgical instrument, not an AI/ML-driven medical device. Therefore, many of the requested fields related to AI/ML device evaluation (like MRMC studies, training set details, or ground truth for AI) are not applicable.

Here's a breakdown based on the provided text, highlighting the absence of the requested information:

Acceptance Criteria and Device Performance Study

As this device is a manual surgical instrument and the documentation is for 510(k) premarket notification, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria. The document states:

"The technical characteristics of the Disposable Re-New Forceps Laparoscopic Surgical Tips are identical to those of the Microline Re-New Forceps (K974066)."
"Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Disposable Re-New Forceps relative to its predicate."

This indicates that the acceptance criteria are implicitly met by demonstrating sameness or non-inferiority in safety and effectiveness compared to the predicate device. Specific quantitative performance metrics and acceptance thresholds are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence in safety and effectiveness to predicate device (Microline Re-New Forceps, K974066) for indicated uses.	Technical characteristics are identical; differences in specs, materials, and physical appearance do not affect relative safety or effectiveness compared to the predicate.

2. Sample size used for the test set and the data provenance

Not applicable. The 510(k) summary does not describe a "test set" in the context of an AI/ML or diagnostic device validation. The evaluation is based on a comparison of device characteristics to a predicate, not on clinical performance data from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" or expert consensus is described for device validation in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

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 a manual surgical instrument, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth is described. The evaluation relies on demonstrating substantial equivalence to a predicate device based on technical characteristics, materials, and intended use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable. As there's no training set, there's no ground truth establishment for it.

Summary

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

A. Submittor Information

Microline, Inc. 1100 Cummings Center Suite 350-G Beverly, MA 01915

Telephone:	(978) 922-9810
Contact Person:	Mr. Hughes de Laforcade
	President

April 13, 1997 Date Prepared:

B. Device Identification

Common/Usual Name:	Manual Detachable Surgical Instruments
Proprietary Name:	Disposable Re-New Forceps Laparoscopic Surgical Tips

C. Identification of Predicate Device(s)

The Disposable Re-New Forceps Laparoscopic Surgical Tips are substantially equivalent to their predicate. Re-New Forceps (K974066), previously cleared and currently marketed.

D. Device Description

The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.

E. Substantial Equivalence

The technical characteristics of the Disposable Re-New Forceps Laparoscopic Surgical Tips are identical to those of the Microline Re-New Forceps (K974066). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Disposable Re-New Forceps relative to its predicate.

The Disposable Re-New Forceps Laparoscopic Surgical Tips are intended for use to cut, grasp, and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

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

K981389 Re : Trade Name: Disposable Re-New Forceps Regulatory Class: II Product Code: GEI April 13, 1998 Dated: April 16, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. प्र 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 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 requlations.

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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

Celia M. Witten, Ph.D., M.D. 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: Disposable Re-New Forceps Laparoscopic Surgical Tips

Indications For Use:

Cutting, Grasping, 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)

coee

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K981399

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.