ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE

K102582 · Devon Medical, Inc. · JOW · Oct 7, 2010 · Cardiovascular

Device Facts

• Record ID: K102582
• Device Name: ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
• Applicant: Devon Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The ArterioFlow 7500 is intended as an adjunctive 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 . The device is intended for home and hospital use.

Device Story

ArterioFlow 7500 is a sequential compression device for lower extremity blood circulation improvement. System components: pump, inflatable garments, tubing. Operation: bilateral/unilateral intermittent pneumatic compression applied to foot and calf. Input: digitally programmed pressure and treatment time settings. Output: cyclic pneumatic pressure. Usage: home or hospital setting; operated by patient or clinician. Benefit: helps prevent/reduce complications of poor circulation by increasing arterial blood flow. Clinician uses device to deliver prescribed therapy; output affects clinical management of ischemic conditions.

Clinical Evidence

Bench testing only. Performance tests included pressure calibration, cycle time performance, treatment time performance, arterial garment pressure performance, and garment tensile strength.

Technological Characteristics

Electrically generated compressed air source; tubing; inflatable garments with hook-and-loop fasteners. Digitally programmable pressure and treatment time. Conforms to UL 60601-1-2 and ISO 14971. Non-sterile, single-patient use garments.

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, and ulcers. Intended for home and hospital use.

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

• CircuFlow 5200 (K101523)
• BioArterial Plus (K072666)

Submission Summary (Full Text)

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# 510(K) SUMMARY

#### Submitter:

· Devon Medical, Inc.

#### Contact Person:

Ruth Wu, COO

1100 First Avenue, Suit 100

King of Prussia, PA 19406

800.571.3135 Phone:

484.636.3380 Fax:

## Common Classification & Proprietary Names:

| Common Names: | Sequential Compression Device |
|-------------------|-------------------------------|
| Proprietary Name: | ArterioFlow 7500 |

#### Date Prepared:

July 22, 2010

#### Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the ArterioFlow 7500.

| - - - - - - - - - - - -<br><br>Production Article<br>1995 - 1997 - 1997 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -<br>11:40 PM 11<br> | Submit Comments of Children Research Comments of the Comments of Children<br>- + 2435 × 12 × - - - | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----|--|
| . Imh SIPPVP | 870 5800 | IOW | |

#### Predicate Devices:

The ArterioFlow 7500 Sequential Compression Device is substantially equivalent to the following.

| Predicate Device | Manufacturer | 510(k)# |
|------------------|------------------------------|---------|
| CircuFlow 5200 | Devon Medical, Inc. | K101523 |
| BioArterial Plus | Bio Compression Systems Inc. | K072666 |

#### Device Description

The ArterioFlow 7500 is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complication of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.

The device for consists of a pump, inflatable garments, and tubing. In operation, the device is attached via tubing to garments containing inflatable chambers applied externally and bilaterally over the feet and calves. Maximum pressure and treatment times are digitally programmable. Quick connector fitting on the tubing prevent accidental and incorrect orientations. Garments are available in anatomical designs including a single inflation chamber for the foot and a single inflation chamber for the calf. Garments are non-sterile, intended for single patient use and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners allow for easy application and adopting a variety of sizes.

1402582

OCT. 7 2010

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## SECTION 5

#### Intended Use:

The ArterioFlow 7500 is intended as an adjunctive 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 .

The device is intended for home and hospital use.

## Technological Characteristics:

The manufacturer believes that the technological characteristic of the ArterioFlow 7500 are substantially similar to those of the predicate devices. The ArterioFlow 7500 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, like the predicates, pressure is applied cyclically for a specified period of time, according to the physician's prescription.

## Performance Testing

Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the ArterioFlow 7500 are substantially similar to those of the predicate devices.

| List of Performance Tests | |
|---------------------------|------------------------------------------|
| PQ-03 | Pressure Calibration for Pressure Sensor |
| PQ-04 | Cycle Time Performance |
| PQ-05 | Treatment Time Performance |
| PQ-06 | Pressure Performance of Arterial Garment |
| PQ-07 | Tensile Strength of Arterial Garment |

## Standards

The ArterioFlow 7500 conforms to the following standards: UL 60601-1-2 and ISO 14971

## Statement of Substantial Equivalence

The ArterioFlow 7500 is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.

## Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Inc, believes that the ArterioFlow 7500, is safe and effective and substantially equivalent to the predicate devices as described herein.

- Ischemia
- Night Pain
- Rest Pain
- Small vessel diseas
- Ulcers

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

DCT 7 2010

Devon Medical Inc. c/o Mr. Mark Job Regulatory Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K102582

ArterioFlow 7500 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 7, 2010 Received: September 8, 2010

Dear Mr. Mark Job:

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. 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

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Page 2 - Mr. Mark Job

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 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/ucm11.5809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Dmah R. Vahner

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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## SECTION 4

# INDICATIONS FOR USE STATEMENT

(102582 510(k) Number (if known):

Device Name: ArterioFlow 7500 Sequential Compression Device

The ArterioFlow 7500 is intended as an adjunctive 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 .

The device is intended for home and hospital use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write Below This line-continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

brune R. lehner
(D:vi:s

iovascular Devices ( arc

510(k) Number K102582