The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.

Device Description

The IVS Clip Closure System consists of an extravascular implantable nitinol clip mounted on an Introducer Sheath. A clip applier acts to release the clip into vascular tissue where it closes vascular puncture wounds.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IVS Clip Closure System:

The provided document (K020879 510(k) summary) does not detail specific quantitative acceptance criteria or a dedicated clinical study with performance metrics for the IVS Clip Closure System. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Angiolink EVS™ Vascular Closure System) through technological characteristics and general testing.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance are not available in this document.

The document indicates that "Testing: The IVS Clip Closure System has been tested in vitro, in vivo and in human model systems. Test results show that the device is safe and effective for the intended use." This is a general statement about the testing performed, but it lacks specific details about performance metrics against acceptance criteria.

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

Acceptance Criteria (Inferred/General)	Reported Device Performance
Safety	"Test results show that the device is safe and effective for the intended use." "All components which contact the fluid path or tissue are biocompatible in accordance with ISO Standard 10993."
Effectiveness for intended use	"Test results show that the device is safe and effective for the intended use." "Performance testing of the IVS system demonstrates that there are no new issues of safety or effectiveness associated with this difference [in clip material]."
Substantial Equivalence to Predicate	"The IVS Clip Closure System is substantially equivalent to the Angiolink EVS™ Vascular Closure System."
Biocompatibility	"All components which contact the fluid path or tissue are biocompatible in accordance with ISO Standard 10993."

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

Sample Size for Test Set: Not specified in the provided document. The document mentions "in vitro, in vivo and in human model systems" but does not give specific numbers for these tests or delineate a "test set" in a statistically rigorous sense for performance metrics.
Data Provenance: Not specified in the provided document.

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/not specified. The document does not describe a process for establishing ground truth via expert review for performance against specific metrics. The evaluation is focused on substantial equivalence and general safety/effectiveness.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

Adjudication method: Not applicable/not specified.

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: Not applicable. This device is a mechanical closure system, not an AI-assisted diagnostic or interpretation tool. The concept of "human readers improve with AI assistance" does not apply.

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

Standalone Performance: Not applicable. This is a mechanical medical device, not an algorithm or AI system.

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

Type of Ground Truth: Not explicitly defined in terms of a specific "ground truth" used for performance metrics. The demonstration of safety and effectiveness appears to be based on:
- Biocompatibility testing (against ISO Standard 10993).
- Functional testing (in vitro, in vivo, human model systems) to demonstrate the device performs its intended function (tissue approximation, hemostatic closure) and that the design differences (nitinol clip vs. titanium staple, clip/carrier on introducer sheath) do not introduce new safety/effectiveness issues.
- Comparison to a predicate device for substantial equivalence rather than establishing de novo performance against a "ground truth" outcome.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not specified. This is a mechanical device, not a machine learning model.

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

Ground Truth for Training Set: Not applicable.

Summary

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K020879 page 1/2

Integrated Vascular Systems, Inc.

SEP 2 5 2002

510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C. F.R. § 807.92.

Submitted by:	Susan Turner, Ph.D.Director, Regulatory Affairs & Quality AssuranceIntegrated Vascular Systems, Inc.743 N. Pastoria Ave.Sunnyvale, CA 94085Telephone: (408) 328-9090Fax: (408) 328-9099
Date prepared:	July 2, 2002
Device name:	IVS Clip Closure System
Common name:	Clip, clip applier, catheter introducer
Classification names:	Regulation # andProduct Code	Classification Name
	21 C.F.R. § 878.4300FZP	Implantable clip
	21 C.F.R. § 870.1340DYB	Catheter introducer
Predicate devices:	The IVS Clip Closure System is substantially equivalent tothe Angiolink EVS™ Vascular Closure System.
Device description:	The IVS Clip Closure System consists of an extravascularimplantable nitinol clip mounted on an Introducer Sheath.A clip applier acts to release the clip into vascular tissuewhere it closes vascular puncture wounds.
Indication for Use:	The IVS Clip Closure System is intended for use toapproximate vascular tissue for achieving hemostaticclosure of puncture sites to aid healing in minimallyinvasive procedures under direct or endoscopicvisualization.
Technologicalcharacteristics:	The subject and predicate devices have the same intendeduse and principles of operation. Both systems stabilize thesite, guide and center on the wound and deliver a clip/stapleto the wound site for tissue approximation and immediatemechanical extravascular closure. The IVS systems uses anitinol clip; the EVS system uses a titanium staple. The clipapplier and stapler are both manually operated although themechanisms are different. Performance testing of the IVSsystem demonstrates that there are no new issues of safetyor effectiveness associated with this difference.The IVS implantable clip is mounted on an IntroducerSheath. The sheath is a standard 6 French sheath andperformance testing demonstrates that there are no newissues of safety or effectiveness associated with the presenceof the clip/clip carrier assembly on the catheter introducer.
Testing:	The IVS Clip Closure System has been tested in vitro, invivo and in human model systems. Test results show thatthe device is safe and effective for the intended use. Allcomponents which contact the fluid path or tissue arebiocompatible in accordance with ISO Standard 10993.

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KOZO879 page 2/2

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Image /page/2/Picture/2 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" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with a design that suggests flowing hair or fabric.

MAR 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Susan Turner, Ph.D. Director, Regulatory Affairs & Quality Assurance Integrated Vascular Systems, Inc. 743 North Pastoria Avenue Sunnyvale, California 94085

Re: K020879

Trade/Device Name: IVS Clip Closure System, Model 1002 and IVS Introducer Set Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: July 2, 2002 Received: July 2, 2002

Dear Dr. Turner:

This letter corrects our substantially equivalent letter of September 25, 2002 regarding the IVS Clip Closure System, which failed to include the IVS Introducer Set.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [{for the indications for use stated in the enclosure)] to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Susan Turner, Ph.D.

This letter will allow you to continue marketing your device as described in your Section 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Muriam C. Provost

to Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K 020879 Response to FDA request for additional information July 2, 2002

Indications For Use Statement Revised July 2, 2002

K020879 510(k) Number (if known)

The IVS Clip Closure System. Device Name

Indications For Use The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use Prescription Use (Per 21 CFR § 801.109) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _

CONFIDENTIAL Information of Integrated Vascular Systems, Inc.

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.