The Pacific Surgical Innovations, Inc. Titanium Micro-Ligation Hemostatic Clip is designed for temporary or permanent implantation for use in ligating blood vessels. The clip has applications in many surgical procedures including where hemostasis is required or radiographic marking is necessary, in general or intracranial procedures.

Device Description

Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient. Especially designed to prevent slippage when properly applied.

AI/ML Overview

This document is a 510(k) summary for the PSI Titanium Micro-Ligation Hemostatic Clip. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria and study report in the format typically used for software or AI-based medical devices.

Based on the provided text, here's an attempt to extract the requested information, with notable limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating equivalence in materials, manufacturing, and functional performance to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Manufactured from the same materials as the predicate device, meeting the same standards and dimensional specifications.	"The PSI Titanium Micro-Ligation Hemostasis Clip is manufactured from the same materials, meeting the same standards and dimensional specifications and manufactured by the same contract manufacturer as the predicate hemostasis clip." (Page 13)
Functional Equivalence: Functions in the same manner as the predicate device in occluding blood vessels when used with the appropriate clip applier.	"When used with the appropriate clip applier, as used with the predicate device, the PSI hemostasis clip functions in the same manner as the predicate device in occluding blood vessels." (Page 13)
Safety and Effectiveness: Deemed safe and effective for its intended use.	"The PSI Titanium Micro-Ligation Hemostatic Clip is safe and effective for its intended use and meets all regulatory requirements to be found substantially equivalent to the predicate device." (Page 13)

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The submission relies on a comparison to a predicate device, implying that prior performance data for both the predicate and the proposed device were considered, but no specific "test set" or sample sizes for testing are mentioned in the provided text. This is typical for a 510(k) for a physical medical device demonstrating substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided. The concept of "ground truth established by experts" is more relevant to diagnostic or AI-driven devices assessing conditions. For a mechanical device like a hemostatic clip, performance is typically assessed through engineering tests, material analyses, and possibly animal or cadaveric studies, rather than expert interpretation of a "test set."

4. Adjudication Method for the Test Set

This information is not applicable/provided. No "adjudication method" for a test set is mentioned, as the device is not a diagnostic tool requiring expert review of outputs.

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

This information is not applicable/provided. An MRMC study is relevant for AI-assisted diagnostic devices. This document describes a physical hemostatic clip, not an AI system.

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

This information is not applicable/provided. This device is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic or AI devices is not directly applicable here. For this physical device, "ground truth" for its performance would implicitly be based on:

Material properties and manufacturing specifications: Verification that the materials and dimensions match the predicate and established standards.
Functional tests: Verification that the clip physically occludes vessels as intended, likely through bench testing or possibly animal models not detailed here. The primary "truth" is its ability to perform its mechanical function.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to a physical medical device. The concept of a "training set" is exclusive to machine learning or AI models.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable to a physical medical device.

Summary of Limitations:

The provided text details a 510(k) submission for a physical medical device (hemostatic clip), focusing on demonstrating substantial equivalence to a predicate device. Many of the questions (especially those related to sample sizes, expert ground truth, adjudication, and AI studies) are highly relevant to software-as-a-medical-device (SaMD) or AI/ML medical devices but are not typically part of a 510(k) for a mechanical implant. Therefore, the requested information for many points is either not present in the document or not applicable to the type of device described.

Summary

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Image /page/0/Picture/1 description: The image shows a stylized text graphic with the words "KAHIOOZ" in bold, black brushstroke-like letters. Below the word, centered horizontally, is the text "Page 12" in a smaller, simpler font. The overall impression is that of a title or heading, possibly for a document or publication.

SECTION 6 510(k) SUMMARY

Submitter Name:

Submitter's Address:

Contact Person:

Phone Number:

Facsimile Number:

Date Prepared:

Device Trade Name:

Device Common Name:

Classification Name:

Predicate Device:

Device Description:

Intended Use:

Pacific Surgical Innovations, Inc.

360 Industrial Road, Unit H San Carlos, CA 94070

Terry Johnston, President

650-802-6988

650-802-0120

March 12, 1999

PSI Titanium Micro-Ligation Hemostatic Clip

Micro-Ligation Hemostatic Clip

Implanted Malleable Clip

Vitalitec International Titanium Hemostatic Clip Spetzler Titanium Aneurysm Clip

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Page 13

Technological Characteristicsand Comparison to Predicate	The PSI Titanium Micro-Ligation Hemostasis Clipis manufactured from the same materials, meetingthe same standards and dimensional specificationsand manufactured by the same contract manu-facturer as the predicate hemostasis clip.
Performance Data:	When used with the appropriate clip applier, asused with the predicate device, the PSI hemostasisclip functions in the same manner as the predicatedevice in occluding blood vessels.
Conclusion:	The PSI Titanium Micro-Ligation HemostaticClip is safe and effective for its intended use andmeets all regulatory requirements to be foundsubstantially equivalent to the predicate device.

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Public Health Service

JUN 11 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terry Johnston President Pacific Surgical Innovations, Inc. 360 Industrial Road, Unit H San Carlos, California 94070

Re: K991002

Trade Name: Titanium Micro-Ligation Hemostatic Clip Regulatory Class: II Product Code: FZP Dated: March 19, 1999 Received: March 25, 1999

Dear Mr. Johnston:

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 (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Terry Johnston

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

Enclosure

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K991002

Page 11

SECTION 5 INDICATIONS FOR USE

PSI Titanium Micro-Ligation Hemostatic Clip

Temporary or Permanent Occlusion of Blood Vessels Including Intracranial Blood Vessels

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

Prescription ! !s: (Per 21 CFR 801.109)

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.