ARTASSIST AND VENASSIST

K131146 · Aci Medical, LLC · JOW · Feb 10, 2014 · Cardiovascular

Device Facts

• Record ID: K131146
• Device Name: ARTASSIST AND VENASSIST
• Applicant: Aci Medical, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

Device Story

ArtAssist is a pneumatic compression device designed to increase limb blood flow. System consists of a pump controller (housing, air pump, reservoir, power supply, pressure/timing regulation, safety circuitry), tubing set, and limb cuffs with air bladders. Device applies rapid, timed pneumatic compression to limb soft tissues, emptying veins and reducing venous pressure to increase driving pressure for blood flow. Used in clinical settings to manage arterial insufficiency and related conditions. Healthcare providers operate the device to deliver therapy; output is the physical compression of the limb, which improves perfusion and aids in managing ischemic conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by laboratory pressure/timing performance graphs and compliance with safety (UL 60601-1) and EMC (IEC 60601-1-2) standards, demonstrating equivalent performance to the predicate device.

Technological Characteristics

Pneumatic compression device; microcontroller-based electronic pressure and timing regulation. Components include air pump, reservoir, tubing, and limb cuffs with air bladders. Safety/EMC compliance per UL 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring pneumatic limb compression due to conditions including intermittent claudication, rest pain, diabetic foot, ischemic neuritis, arterial ulcers, gangrene, poor runoff, or when surgery is contraindicated or pending.

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

• ArtAssist (K942530)

Submission Summary (Full Text)

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

FEB 1 0 2014

Image /page/0/Picture/1 description: The image shows the logo for ACI Medical. The logo has the text "ACI MEDICAL" in bold, with the words "innovate, engineer, deliver" in a smaller font underneath. The logo is surrounded by a curved line on the left and right sides.

ACI Medical, LLC 1857 Diamond St. San Marcos, CA 92078 USA Tel. [phone] Fax [phone] [e-mail]

# 510(k) SUMMARY

K131146

510(k) owner's name: ACI Medical, LLC 1857 Diamond St. San Marcos, CA 92078 Tel. [phone] Fax [phone] Contact name: Ed Arkans Prepared: February 7, 2014

- Trade name ArtAssist .
- Common name Compressible limb sleeve or Pneumatic compression . device
- . Classification name - Compressible limb sleeve (21 CFR 870.5800, Product Code JOW)

The legally marketed devices to which our firm is claiming equivalence is the ArtAssist device (K942530).

## Device description

The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequences. There is a pump controller that contains a housing, an air pump, an air reservoir, electrical power supply, pressure regulation, timing regulation and safety circuitry. A set of limb cuffs contains air bladders that fill and apply pressure. A tubing set delivers the air from the pump controller to the limb cuffs.

The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.

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

#### Intended use of the device

Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

### Summary of the technological characteristics

The device has the same technological characteristics as the predicate device except that it has been modified to include changes in the control mechanism from mechanical pressure regulation to electronic type and from discrete electronics to microcontroller based.

### Performance data

Pressure/timing graphs obtained in the laboratory demonstrate substantial equivalence to the predicate device. The device has been tested to safety requirements (UL 60601-1) and EMC requirements (IEC 60601-1-2)

### Conclusions drawn from testing

The laboratory test results demonstrate that the device performs as well as the predicate device since it applies equivalent pressures and timing and is therefore as effective as the predicate device. The risk analysis, safety and EMC tests performed demonstrate the device is substantially equivalent to the predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 10, 2014

ACI Medical, LLC c/o Mr. Ed Arkans 1857 Diamond St. San Marcos, CA 92078

Re: K131146

Trade Name: ArtAssist Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 24, 2013 Received: December 27, 2013

Dear Mr. Arkans:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Mr. Ed Arkans

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Hillenbrand

for

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

Enclosure

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

## Indications for Use Statement

Device Name: ArtAssist 510(k) number: K131146

Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

Prescription Use:_ YES (Part 21 CFR 801 Subpart D)

M. Azbilliem