BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM

K072666 · Bio Compression Systems, Inc. · JOW · Nov 5, 2007 · Cardiovascular

Device Facts

• Record ID: K072666
• Device Name: BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
• Applicant: Bio Compression Systems, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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

Device Story

BioArterial Plus is an AC-powered intermittent pneumatic compression system for home use. It consists of a pump, interconnect tubing, and non-sterile, single-patient-use inflatable garments. Garments feature discrete chambers for foot and calf application. Unique connector fittings prevent incorrect assembly. Operation involves applying bilateral or unilateral compression to feet and calves to enhance arterial blood flow. The device is intended as an adjunct therapy for patients with lower extremity ischemic disease. Patients or caregivers operate the device at home. By increasing blood circulation, the system aims to prevent or reduce complications associated with poor circulation, such as ulcers and rest pain. Healthcare providers prescribe the device to manage ischemic symptoms and improve patient outcomes.

Clinical Evidence

Bench testing only. Testing compared inflation cycle profiles (risetimes, cycle times, and inflation pressures) of the subject device against predicate devices to ensure performance specifications were met.

Technological Characteristics

AC-powered pneumatic pump; inflatable limb garments with discrete foot and calf chambers; hook-and-loop fasteners; unique connector fittings for safety. Non-sterile, single-patient-use. Operates via intermittent compression cycles.

Indications for Use

Indicated for patients with lower extremity ischemic disease, including those with minor amputations, angioplasty/stent failure, arteriopathic wounds, graft failure, intermittent claudication, ischemia, night pain, rest pain, small vessel disease, or ulcers.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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

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: [phone] 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

- 2. 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: [phone] E-mail: [e-mail] Internet: http://www.coastalcg.com

- 3. Date: May 18, 2007
- 4. 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 | |

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

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

# 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 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.

- 8. 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.

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

#### 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.

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

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.

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

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