The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.

Device Description

The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is a single fire applier that applies EVI Sutured-Clips™ for vascular anastomsis and tissue approximation applications. The Sutured-Clip consists of a vascular clip with a needle swaged or connected to one end. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

AI/ML Overview

The provided document, K971588, is a 510(k) premarket notification for the EVI Sutured-Clip™ and Sutured-Clip™ Applier. This device is a Class I (Exempt) Clip Applier and Class II Implantable Clips, intended for use in endoscopic and non-endoscopic creation and repair of arteriovenous fistulae, creation of everting anastomoses in blood vessels, grafts, and other tubular structures, and approximation of other soft tissue structures.

Due to the nature of this submission being a 510(k) for a medical device (an implantable clip and applier), the acceptance criteria and study detailed differ significantly from what would be expected for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through design analysis and in vitro testing, rather than performance metrics like sensitivity, specificity, or AUC, which are common for diagnostic algorithms.

Here's an analysis of the provided information, framed to address your specific points where applicable, and noting where the information is not relevant to a traditional AI/SaMD assessment:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" revolve around established safety and effectiveness of predicate devices, and the "reported device performance" demonstrates equivalence through mechanical testing.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary of In Vitro Data)
Mechanical integrity equivalent to predicate devices	Design analysis and in vitro data confirm that basic functional characteristics are substantially equivalent.
Force required to open or dislodge clip within specifications	All data fell within both internal specification requirements as well as external standard requirements and predicate performance expectations.
Biocompatibility	Biocompatibility information provided in pre-market notification. (Specific results not detailed in this summary)

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

This information is not provided in the 510(k) summary for the in vitro testing. The summary states "In Vitro Test Data" and refers to "design analysis and in vitro data," but does not explicitly detail the number of clips, appliers, or specific test configurations used. Data provenance generally refers to the source of patient data. Since this is an in vitro study, there are no patient data, and thus no country of origin or retrospective/prospective classification in the typical sense for clinical studies.

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

This applies to studies assessing diagnostic accuracy or subjective interpretation. For this pre-market notification of a mechanical device, there is no ground truth established by experts in the context of interpreting images or clinical outcomes. The "ground truth" for mechanical performance is defined by engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

This is typically relevant for studies involving human interpretation or subjective assessments where discrepancies need resolution. For an in vitro mechanical test, no adjudication method between human interpreters is mentioned or 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

A MRMC study evaluates human reader performance with and without AI assistance, common for AI-powered diagnostic tools. This is a mechanical surgical device, not an AI or diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is applicable to algorithms. The EVI Sutured-Clip™ and Applier is a physical medical device, not an algorithm. Therefore, no standalone performance study of an algorithm was conducted or is applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the in vitro testing was based on engineering specifications, internal specification requirements, external standard requirements, and predicate performance expectations. This is not pathology, outcomes data, or expert consensus in the clinical sense, but rather defined mechanical and functional parameters.

8. The Sample Size for the Training Set

This refers to the data used to train an AI model. Since this is a mechanical device with no AI component, there is no training set, and therefore, no training set sample size.

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

As there is no training set for an AI model, this question is not applicable. The "ground truth" for the device's design and manufacturing would be established through engineering design principles, material science, and quality control processes.

In Summary for K971588:

The provided document describes a 510(k) application for a physical medical device. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to existing predicate devices through in-vitro mechanical testing and design analysis, rather than clinical efficacy through human studies or performance metrics typical of AI or diagnostic software. Many of the questions posed are specifically designed for evaluating AI/SaMD and are therefore not applicable to this type of device submission.

Summary

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<171588

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K971588

Applicant Information:

Date Prepared:	April 28, 1997
Name:	Elective Vascular Intervention EVI)
Address:	2915 McClureOakland, California 94609 510-834-1210
Contact Person:	Michael A. Daniel
Phone Number:	(415) 237-7036
Facsimile Number:	(415) 526-2060

Device Information:

Classification:	Class I (Exempt) Clip Applier
	Class II Implantable Clips
Trade Name:	EVI Sutured-Clip™ Applier
	EVI Sutured-Clip™
Common Name:	Implantable Clip, Vascular Clip, Vascular/Hemostatic Clip Applier
Classification Name:	Surgical Devices: Implantable Clip, 21 CFR 878.4300
	Cardiovascular Prosthetic Devices: Vascular Clip, 870.3250

Predicate Devices:

The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip™ Applier is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

	Pilling Weck	Hemoclip S15 Automatic Applier
1.	U.S. Surgical	ENDO CLIP Applier
2.	Ethicon	LIGACLIP Endoscopic Clip Applier

Device Description:

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510(k) SUMMARY

(Continued)

Intended Use:

The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is intended for use in endoscopic and non-endoscopic creation and repair of arteriovenus fistulae and the creation of everting anastomoses in blood vessels, grafts and other tubular structures and in the approximation of other soft tissue structures.

Comparison to Predicate Device(s):

The Elective Vascular Intervention (EVI) Sutured-Clip™ Clip and Clip Applier are substantially equivalent to the US Surgical VCS Clip and Clip Applier in terms of intended use. Both devices are intended for application of vascular clips to everted tissue for purposes of performing vacular anastomosis. The EVI Sutured-Clip and Clip Applier is substantially equivalent to the Ethicon LIGACLIP Clip and Clip Applier in terms of the single clip application option.

The System differs from the currently marketed predicate devices in that the Sutured-Clips™ have a needle swaged on to one end to facilitate precise placement. In this regard it is similar to currently marketed suture needles.

In Vitro Test Data:

Design analysis and in vitro data confirm that basic functional characteristics are substantially equivalent to the predicate devices sited. Testing included evaluation of mechanical integrity and the force required to open or dislodge clip. All data fell within both internal specification requirements as well as external standard requirements and predicate performance expectations.

Summary:

Based upon the product technical information provided, intended use, performance and biocompatibility information provided in this pre-market notification, the EVI Sutured-Clip™ and Sutured-Clip™ Applier has been shown to be substantially equivalent to currently marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 1997

Mr. Michael A. Daniel EVI Elective Vascular Intervention 2915 McClure Oakland, California 94609

Re: K971588 Trade Name: EVI Sutured-Clip™ and Sutured-Clip™ Applier Regulatory Class: II Product Code: FZP Dated: September 14, 1997 Received: September 17, 1997

Dear Mr. Daniel:

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 requirements , 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. Michael A. Daniel

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 vours,

Sincerely, yours,

Colin McWhirter, Ph.D., M.D.

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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K971588 510(k) Number (if known):

Elective Vacular Intervention (EVI) Sutured-Clip™ Applier Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K971588

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
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(Optional Format 1-2-96)

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.