The Gator ClipSeal Plug (GATOR) is a flexible polymer plug used to seal against blood loss through the hemostatic valve of 12F - 24F introducer sheaths. The GATOR can be used with 0.035" or 0.038" guidewires.

AI/ML Overview

This document contains a 510(k) summary for a medical device called the "Gator™ ClipSeal Plug." It is a traditional 510(k) submission, confirming substantial equivalence to a predicate device. This type of submission relies on bench testing and possibly animal studies (though not explicitly stated here) to demonstrate performance characteristics and safety, not clinical studies with human participants. Therefore, the device is not an AI/ML device, and many of the requested categories are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state a table of acceptance criteria or specific quantitative performance metrics for the Gator™ ClipSeal Plug, as would typically be found in a more detailed test report. Instead, it relies on the concept of "substantial equivalence" to a predicate device (K073620 Guardian Hemostasis Valve).

The summary states: "Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions." This implies that the device performed comparably to the predicate without introducing new risks or underperforming.

Without specific performance data, we can infer the acceptance criteria and performance are related to maintaining a hemostatic seal around guidewires of specific sizes, consistent with its intended use.

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Ability to maintain a hemostatic seal with 12F - 24F introducer sheaths around 0.035" or 0.038" guidewires, consistent with predicate device.	"Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions." This indicates the device successfully met its intended function without issues.
Biocompatibility of materials (not explicitly stated as an AC but implied by "biomaterial assessments").	Tested and found acceptable (implied by "biomaterial assessments").

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

The document does not specify a "test set" in the context of a clinical study or a labeled dataset for an AI model. This device is not an AI device. The "verification testing" mentioned would typically involve bench testing using a representative number of devices and conditions. The sample size for such tests is not provided in this summary. The data provenance would be from internal laboratory testing conducted by Vascular Solutions, Inc.

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

Not applicable. As noted above, this device is not an AI/ML device and does not involve a "test set" requiring expert ground truth labeling in the way an AI model would. Performance is established through physical and mechanical testing against design specifications and comparison to the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" requiring adjudication by experts for this type of device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of an AI algorithm is not relevant. Its performance is inherent in its design and materials.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance would be established through engineering specifications, material standards, and objective physical measurements during verification testing (e.g., flow rates, sealing integrity under pressure, durability tests). The comparison to the predicate device also forms a key part of the "truth" by demonstrating equivalent performance.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML device, and therefore, it does not have a "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth" established for it in the context of machine learning.

Summary

{0}------------------------------------------------

K092563

510(k) Summary

Date Prepared: October 21, 2009

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812

Contact Person

NOV - 4 2009

Loucinda Bjorklund Sr. Regulatory Affairs Associate Tel: 763-656-4300; Fax: 763-656-4253 Email: Ibjorklund@vascularsolutions.com

General Information

Trade Name	Gator™ ClipSeal Plug
Common / Usual Name	Hemostatic plug
Classification Name	870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fittingClass II
Predicate Device	K073620 Guardian Hemostasis Valve (Zerusa Limited)

Device Description

Intended Use / Indications

The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.

Substantial Equivalence and Summary of Studies

The Gator ClipSeal Plug is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services. The seal features an eagle with its wings spread, and the words "Department of Health & Human Services - USA" are written around the eagle. The image is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

NOV - 4 2009

Vascular Solutions, Inc. Ms. Loucinda Bjorklund Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

Re: K092563

Vascular Solutions Gator ClipSeal Plug Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: August 19, 2009 Received: August 20, 2009

Dear Ms. Bjorklund:

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 application (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

{2}------------------------------------------------

Page 2 - Ms. Loucinda Bjorklund

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements, as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duna R. Vudner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K092563

Device Name:

Gator™ ClipSeal Plug

Indications for Use:

The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801 S

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

una R. V. Unn

Ivision Sign-Off) (Division Sign-off)
Division of Cardiovascular Devices

510(k) Number Kog

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.