The femoral compression device is used to provide compression of the femoral artery for hemostasis management after catheterization. The device is comprised of an arch with an attached sterile pneumatic pressure dome, connector tube, stopcock and belt locks. A woven belt is used to secure the device onto the patient. In use, the belt is placed under and around the patient's hips and the arch is placed over the patient's groin with the dome atop the puncture site. The belt is attached to the arch via the adjustable belt locks and is tightened. A pneumatic pump and manometer are attached to the stopcock connector. The user controls the mechanical pressure applied to the puncture site by increasing or decreasing air pressure applied to the dome. The arch and belt absorb and distribute the opposing force from the dome. Vanguard receives previously used compression devices from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.

AI/ML Overview

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the "Vanguard Reprocessed Femoral Compression Device." The core of the submission is to demonstrate that the reprocessed device is substantially equivalent to the original equipment manufacturer (OEM) device.

Here's an analysis based on your request, keeping in mind that this document refers to physical device testing, not an AI/algorithm-based system:

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

The document does not explicitly list a table of quantifiable acceptance criteria with corresponding performance metrics in the format typically seen for algorithms. Instead, it states that the reprocessed device undergoes "Decontamination and cleaning, sterilization validations and functional/performance and biocompatibility testing." The conclusion is that these tests demonstrate the reprocessed devices "perform as intended and are safe and effective."

Given the context of a physical medical device, the "acceptance criteria" can be inferred as:

Decontamination and Cleaning: The device must be adequately cleaned of biological and other contaminants after a single use. (Performance: "Decontamination and cleaning... demonstrates that the reprocessed devices perform as intended")
Sterilization: The device must be effectively sterilized to remove viable microorganisms for safe reuse. (Performance: "Sterilization validations... demonstrates that the reprocessed devices perform as intended")
Functional/Performance: The reprocessed device must function identically and maintain the same performance characteristics as the original OEM device. This would include aspects like pneumatic pressure integrity, structural integrity, and proper operation of all components (e.g., belt locks, dome, connector tube). (Performance: "Functional/performance... testing demonstrates that the reprocessed devices perform as intended and are safe and effective. The Vanguard reprocessed compression device is essentially identical to the currently marketed OEM compression device. No changes are made to the currently marketed device's specifications and they possess the same technological characteristics.")
Biocompatibility: The materials of the reprocessed device, after reprocessing, must remain biocompatible and not pose new risks to patients. (Performance: "Biocompatibility... testing demonstrates that the reprocessed devices perform as intended and are safe and effective.")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the test set used for decontamination, cleaning, sterilization, functional/performance, or biocompatibility validation. It also does not specify the provenance (country of origin, retrospective or prospective) of any data beyond the fact that Vanguard receives "previously used compression devices from healthcare facilities." This implies the devices being reprocessed come from real-world use, but the testing itself would likely be conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes a physical medical device reprocessing and not an AI or algorithm-based system requiring expert-established ground truth. The "ground truth" here is the physical state and performance of the device itself, assessed through standardized engineering, microbiological, and chemical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3. Physical device testing relies on objective measurements against established specifications, not human adjudication of subjective assessments.

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 as the document describes a physical medical device and not an AI-based system.

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

This information is not applicable as the document describes a physical medical device and not an AI-based system.

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

As explained in point 3, the concept of "ground truth" in the AI/algorithm sense is not applicable here. For this physical device, the "ground truth" or reference for evaluating the reprocessed device's performance would be:

Original OEM device specifications: The reprocessed device must meet the same specifications as the new, unused OEM device.
Industry standards/guidelines: For cleaning, sterilization, and biocompatibility, the tests would be conducted against recognized standards (e.g., ISO for sterilization).
Functional integrity: The device must operate as designed, which is an objective measurement of mechanical and pneumatic function.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device and not an AI-based system that uses a training set.

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

This information is not applicable as the document describes a physical medical device and not an AI-based system that uses a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three parallel lines forming a serpentine shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2004

Vanguard Medical Concepts, Inc. c/o Ms. Heather Crawford Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815

Re: K011832 - Supplemental Validation Submission Vanguard Reprocessed Femoral Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular Regulatory Class: II (2) Product Code: NMF Dated: September 18, 2001 Received: September 24, 2001

Dear Ms. Crawford:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on December 21, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

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Page 2 - K011832

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120 (DOEB). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

B. Bimmima for

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

Enclosures

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Attachment 1

USCI ® C.R. Bard®, Inc. / RADI Medical Systems AB Model Number: 017500

OEM Trade Name: FemoStop® Femoral Compression System

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Indications for Use

510(k) Number:

Device Name: Yanguard Reprocessed Femoral Compression Device

Indications for Use:

The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Y. Oele Mch
Division of Cardiovascular & Respiratory Devices
510(k) Number K011832

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K011832

DEC 21 2001

510(k) Summary of Safety & Effectiveness

Submitter	Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815
Contact	Mr. Mike Sammon, Ph.D.Director, Research and Development(863) 683-8680, extension 228(801) 327-3339 (facsimile)mikes@safe-reuse.com
Date	June 14, 2001
Device	Trade Names: Vanguard Reprocessed Femoral Compression Device ⇒ USCI® C. R. Bard®, Inc., RADI Medical Systems AB FemoStop® Femoral Compression SystemCommon Name: Femoral compression device, groin compressorClassification: 21 CFR 870.4450 - Vascular Clamp – Class IIProduct Code DXC
PredicateDevice	USCI® C. R. Bard®, Inc., RADI Medical Systems AB FemoStop® FemoralCompression System legally marketed under 510(k) premarket notificationK983471
Indications forUse	The femoral compression system is indicated for the compression of thefemoral artery or vein following catheterization.
Contra-indications	Femoral compression presents a significant risk for deep vein thrombosis inpatients with severe peripheral vascular disease. Femoral artery or vein graftsare also at significant risk for damage with use of this device.
	Continued on next page

USCI and Bard are registered trademarks of C.R. Bard, Inc. FemoStop is a registered trademark of RADI Medical Systems AB

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510(k) Summary of Safety & Effectiveness, Continued

DeviceDescription	The femoral compression device is used to provide compression of thefemoral artery for hemostasis management after catheterization. The deviceis comprised of an arch with an attached sterile pneumatic pressure dome,connector tube, stopcock and belt locks. A woven belt is used to secure thedevice onto the patient.
	In use, the belt is placed under and around the patient's hips and the arch isplaced over the patient's groin with the dome atop the puncture site. The beltis attached to the arch via the adjustable belt locks and is tightened. Apneumatic pump and manometer are attached to the stopcock connector. Theuser controls the mechanical pressure applied to the puncture site byincreasing or decreasing air pressure applied to the dome. The arch and beltabsorb and distribute the opposing force from the dome.
	Vanguard receives previously used compression devices from healthcarefacilities; cleans, inspects, tests, repackages and sterilizes the devices; andreturns them to the healthcare facility.
TechnologicalCharacteristics	The Vanguard reprocessed compression device is essentially identical tothe currently marketed OEM compression device. No changes are made tothe currently marketed device's specifications and they possess the sametechnological characteristics. Biocompatibility and performance/functionaltesting demonstrate that the devices are equivalent and continue to be safe andeffective for their intended use.
Test Data	Decontamination and cleaning, sterilization validations andfunctional/performance and biocompatibility testing demonstrates that thereprocessed devices perform as intended and are safe and effective.
Conclusion	Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the Vanguardreprocessed femoral compression device is substantially equivalent to thepredicate device, the OEM compression device, USCI® C. R. Bard®, Inc.,RADI Medical Systems AB FemoStop® Femoral Compression System,under the Federal Food, Drug and Cosmetic Act.

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).