For Vascular Work: Suitable for veins and arteries. Performs efficiently on either diseased or normal vessels. Provides occlusion of atherosclerotic vessels without excessive closing forces. Minimizes intimal damage and fragmentation of atherosclerotic material. Can be clamped over indwelling catheters. For Gastrointestinal Work: Replaces bulky, rubber shod clamps. Cushion-design of inserts enables occlusion without crushing the bowel.

Device Description

Slimline Surgical Clamp and Slimline Jaw Inserts

AI/ML Overview

The provided text is related to a 510(k) submission for a medical device: the "SlimLine Surgical Clamp and SlimLine Jaw Inserts." This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a study proving performance against acceptance criteria in the manner one might expect for a novel AI/software medical device.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this document. The 510(k) summary focuses on comparing the new device to existing predicate devices based on intended use, principles of operation, and basic technological characteristics, rather than detailed performance metrics from a clinical study.

Here's an assessment based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a study. Instead, it asserts substantial equivalence based on:

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Claimed Equivalence)
Intended Use	Equivalent to predicate devices (vascular/general surgery)
Principles of Operation	Equivalent to predicate devices (squeezing jaws for occlusion)
Basic Technological Characteristics	Equivalent to predicate devices
Target Population	Equivalent to predicate devices (surgical disciplines)
Safety & Effectiveness	Claimed equivalent to predicate devices

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

Sample Size: Not applicable. This document is not describing a study with a test set of data in the context of an algorithm or diagnostic performance. It's a regulatory submission for a physical medical device.
Data Provenance: Not applicable.

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

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: 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

MRMC Study: No. This is not an AI-assisted device.

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

Standalone Study: No. This is a physical surgical clamp, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable in the context of an AI/diagnostic study. The "ground truth" for this 510(k) is the established performance and safety of the legally marketed predicate devices (Allegiance Healthcare's Fogarty Surgical Clamp and Baxter International's Safejaw Inserts). The claim is that the new device performs similarly.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Ground Truth for Training Set: Not applicable.

Summary based on the 510(k) document:

The provided document is a 510(k) Pre-Market Notification for a surgical clamp. Its purpose is to demonstrate "substantial equivalence" of the new device (Slimline Surgical Clamp and Slimline Jaw Inserts) to legally marketed predicate devices. This type of submission relies on comparing intended use, basic technology, and principles of operation to existing devices, and often provides performance data through bench testing or literature review rather than a formal clinical study with performance metrics (like sensitivity/specificity) against a ground truth.

The document states: "Minumys' Slimline Surgical Clamp with Slimline Jaw Inserts and Allegiance's Fogarty Surgical Clamp with Baxter's Safejaw Inserts are surgical clamps intended for use in vascular or general surgery. The Slimline Surgical Clamp and Slimline Jaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines."

The "study" in this context is the submission demonstrating that the device aligns with the predicate devices' characteristics, and by extension, is safe and effective for its stated indications for use. No clinical trial data, performance metrics, or AI-specific study details are present in this 510(k) summary.

Summary

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Ky42600

SEP 18 1999

510(K) SUMMARY

Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850

This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR §807.92.

Minumys Surgical intends to introduce into commercial distribution the Slimline Surgical Clamp and Slimline Jaw Inserts. The equivalent predicate devices are Allegiance Healthcare's Fogarty Surgical Clamp (preamendment) and Baxter International's Safejaw Inserts (see copy of Product Insert Sheet in Attachment 2).

The FDA has classified surgical instruments for clamping as Class I devices (21CFR878-4800). The FDA has also classified vascular clamps as Class II devices (21CFR870-4450). Minumys' Slimline Surgical Clamp and Slimline Jaw Inserts are a Class II medical device. The common name for Minumys' device is: Surgical Clamp.

Minumys' Slimline Surgical Clamp with Slimline Jaw Inserts and Allegiance's Fogarty Surgical Clamp with Baxter's Safejaw Inserts are surgical clamps intended for use in vascular or general surgery. The Slimline Surgical Clamp and Slimline Jaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines.

The princible of operation for occlusion with these clamps is the squeezing together of the jaws to temporarily occlude vessels. The need for clamping is present in most surgical specialties. The device labeling supports the use of these devices for vascular and general surgical applications in surgery.

Kermit R. Pope, Jr. Date
8/2/99

Kermit R. Pope President/CEO Date

Minumys Surgical 10231 Bubb Road Cupertino, CA 95014 (408) 873-3161

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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 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 with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP == 8 1999

Mr. Noel Messenger Regulatory Consultant Minumys Surgical, Inc. 10231 Bubb Road Cupertino, California 95014

Re: K992640

Trade Name: SlimLine Surgical Clamp and SlimLine Jaw Inserts Regulatory Class: II Product Code: DXC Dated: July 28, 1999 Received: August 6, 1999

Dear Mr. Messenger:

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 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 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 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 - Mr. Noel Messenger

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,

pcoolly

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: K992640

Device Name: SlimLine Surgical Clamp and SlimLine Jaw Inserts

Indications For Use

For Vascular Work

Suitable for veins and arteries. .
Performs efficiently on either diseased or normal vessels. ●
Provides occlusion of atherosclerotic vessels without excessive closing . forces.
Minimizes intimal damage and fragmentation of atherosclerotic material. ●
Can be clamped over indwelling catheters. .

For Gastrointestinal Work

Replaces bulky, rubber shod clamps .
Cushion-design of inserts enables occlusion without crushing the bowel. .

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992640

Prescription Use		OR	Over-The-Counter Use
------------------	---------------	----	----------------------	---------------

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).