The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

Amputations (minor)
Angioplasty / stent failure
Arteriopathic wounds
Graft failure
Intermittent claudication
Ischemia
Night pain
Rest pain
Small vessel disease
Ulcers

Device Description

The BioArterial Plus Arterial Blood Flow Enhancement System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The AC-powered device for consists of a pump, inflatable garments, and interconnection tubina. In operation, the device is attached via interconnect tubina to sleeves or garments containing discrete inflatable chambers applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations. Garments are available in a unique anatomical configuration, providing a single inflation chamber for the foot, and a single inflation chamber for the calf. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners support a wide range of anatomy sizes. The device is intended for home use.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the "BioArterial Plus Arterial Blood Flow Enhancement System" based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
The product meets its specifications.	"Performance testing was performed and assures that the product meets its specifications."
Inflation cycle profiles (risetimes, cycle times, and inflation pressures) are similar to predicate devices.	"Bench testing was performed, comparing the inflation cycle profiles of the product to the predicate devices. The results of the testing demonstrate similar risetimes (time required to reach pressure), cycle times (total inflated and deflated times within a cycle), and inflation pressures."
The device is substantially equivalent to predicate devices, and does not raise any new questions of safety or effectiveness. (This is a regulatory acceptance criterion for 510(k) clearance).	"Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices in terms of features, functionality, and bench comparisonal testing, the manufacturer believes that the BioArterial Pius Arterial Blood Flow Enhancement System is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness." The FDA's 510(k) clearance letter (K072666) confirms this by stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Study Details from the Provided Document:

Sample size used for the test set and the data provenance:
The document does not specify a sample size or data provenance for human subject testing. The "Performance Data" section only mentions "bench testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring adjudication.
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. The device is an "Arterial Blood Flow Enhancement System" and not an AI-powered diagnostic or interpretive device that would involve human readers or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device (pump and garments) for enhancing blood flow, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the "ground truth" used was the specifications and performance profiles of the predicate devices. The testing aimed to show similarity to these established devices rather than a biological or clinical ground truth in the traditional sense.
The sample size for the training set:
This information is not applicable as there is no mention of a "training set" for an algorithm or AI model within this 510(k) submission. The performance assessment was based on bench testing of the physical device.
How the ground truth for the training set was established:
This information is not applicable for the reasons stated above (no training set for an algorithm).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for BIO Compression Systems Inc. The logo is composed of the letters "BIO" in large, bold font, with the words "COMPRESSION SYSTEMS INC." in a smaller font to the right of the "BIO". The logo is black and white, and it is surrounded by a series of vertical lines.

201-939-0716 Fax: 201-939-4503 800-888-0908 120 W. Commercial Avenue, Moonachie, NJ 07074

510(k) Summary Bio Arterial Plus Arterial Blood Flow Enhancement System 510(k) Number Ko72666

11/11/1

5 2097

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1. APPLICANT'S INFORMATION:
  Ron Motherwell Executive Vice President 201 939-0716 bH: FX: 201 939-4503 Internet: http://www.biocompression.com Medical Establishment Registration No.: 2424387
1. SUBMITTER'S INFORMATION
  James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 470218 Broadview Heights, OH 44141 PH/FX: 440 546.4936 Mobile: 724 713.2298 E-mail: coastalcg@earthlink.net Internet: http://www.coastalcg.com
1. Date: May 18, 2007
1. DEVICE INFORMAȚION

DEVICE NAME:	BioArterial Plus Arterial Blood Flow Enhancement System
Classification Panel:	Cardiovascular and Respiratory Devices
Classification Number:	870.5800
Product Nomenclature:	Compressible Limb Sleeve
Product Code(s):	JOW
Trade/Proprietary Name:	BioArterial Plus Arterial Blood Flow Enhancement System
Common Name:	BioArterial Plus Arterial Blood Flow Enhancement System
510(k) Submission Type: Traditional
Request for Confidentiality under 21 CFR §807.95: NO

1. DEVICE CLASSIFICATION:
  Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.

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6. PREDICATE DEVICE(s):

K061857 Model IC-1545-KT/-F Intermittent Circulator .
. K942530 ACI Medical Art-Assist Model AA-1000
K914461/K951683/K953648 Novamedix AV Impulse .

7. DEVICE DESCRIPTION:

The AC-powered device for consists of a pump, inflatable garments, and interconnection tubina. In operation, the device is attached via interconnect tubina to sleeves or garments containing discrete inflatable chambers applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations. Garments are available in a unique anatomical configuration, providing a single inflation chamber for the foot, and a single inflation chamber for the calf. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners support a wide range of anatomy sizes. The device is intended for home use.

1. INDICATIONS FOR USE:
  The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:
Amputations (minor)
. Angioplasty / stent failure
� Arteriopathic wounds
. Graft failure
. Intermittent claudication
� lschemia
� Night pain
◆ Rest pain
◆ Small vessel disease
◆ Ulcers

9. TECHNOLOGICAL CHARACTERISTICS:

The manufacturer believes that the technological characteristics of the BioArterial Plus Arterial Blood Flow Enhancement System are substantially similar to those of the predicate devices.

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10. PERFORMANCE DATA:

Performance testing was performed and assures that the product meets its specifications.

Bench testing was performed, comparing the inflation cycle profiles of the product to the predicate devices. The results of the testing demonstrate similar risetimes (time required to reach pressure), cycle times (total inflated and deflated times within a cycle), and inflation pressures.

11. STATEMENT OF SUBSTANTIAL EQUIVALENCE:

Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices in terms of features, functionality, and bench comparisonal testing, the manufacturer believes that the BioArterial Pius Arterial Blood Flow Enhancement System is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with its wings spread, positioned to the right. To the left of the bird, there is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2007

Bio Compression Systems, Inc. c/o Mr. Jay Y. Kogoma Intertek Testing Services NA, Inc. 2307 E Aurora Rd. Unit B7 Twinsburg, OH 44087

Re: K072666

BioArterial Plus. Arterial Blood Flow Enhancement System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 19, 2007 Received: September 21, 2007

Dear Mr. Kogoma:

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 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 device in the Federal Register.

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Page 2 - Mr. Jay Y. Kogoma

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 (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. This letter will allow you to begin 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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ourse B. backner

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

Enclosure

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510(k) Number (if known): K072666

Device Name: BioArterial Plus Arterial Blood Flow Enhancement System

Indications for Use:

The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

Amputations (minor)
Angioplasty / stent failure
Arteriopathic wounds
Graft failure
Intermittent claudication
Ischemia
...... Night pain
Rest pain
Small vessel disease
Ulcers

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use . (21 CFR801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ver R. lochmer

-----------Off) Cardiovascular Devices

Page 1 of

510(k) number K072666

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).