CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE

K012612 · Clearmedical, Inc. · JOW · Feb 6, 2002 · Cardiovascular

Device Facts

• Record ID: K012612
• Device Name: CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
• Applicant: Clearmedical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A-V Impulse System foot pump is safe and effective for the following indications. The proper duration for use of each indication is subject to the clinical judgment of the prescribing physician. Recommended Guidelines are as follows: Circulation Enhancement: For temporary impairments such as temporary trauma or disease conditions, continuous use until the condition is resolved. For chronic impairments, daily use depending on the severity of the patient's condition and activity. Deep Vein Thrombosis Prophylaxis: Continuous use until the patient is fully ambulatory and weight bearing (not just mobilized). Edema - Acute: Continuous use until edema is reduced. Edema -- Chronic: As required, but at least 4 hours per day. Extremity Pain Incident to Trauma or Surgery: Continuous use until severity of pain is reduced or physician recommends alternative therapy. Leg Ulcers: Continuous use until ulcer severity is reduced or physician recommends alternative therapy. Venous Stasis/ Venous Insufficiency: For temporary impairments such as temporary trauma or disease conditions, continuous use until condition is resolved. For chronic impairments, daily use depending on the severity of the patient's condition and activity level.

Device Story

Reprocessed limb sleeve (foot cover) used with A-V Impulse System Controller; non-invasive prophylaxis for DVT; reduces pain/swelling; increases arterial blood flow. Device features rigid sole to direct impulse against venous plantar plexus; anatomically shaped bladder collapses/empties plexus to send blood to right atrium. Used in hospital or home settings by adult patients. Healthcare providers monitor impulse pressure via controller; output affects clinical management of venous conditions. Device is latex-free; includes Velcro straps, vent holes, and polyethylene tubing. Reprocessed version is high-level disinfected.

Clinical Evidence

Bench testing only. No clinical data presented. Performance indicators included infection control methods, fit/attachment, bladder function, and velcro adhesion.

Technological Characteristics

Latex-free compressible limb sleeve; rigid sole; anatomically shaped bladder; polyethylene tubing; Velcro hook straps. High-level disinfected. Operates via pneumatic impulse directed to venous plantar plexus. Standalone component for use with external A-V Impulse System Controller.

Indications for Use

Indicated for adult patients requiring circulation enhancement, DVT prophylaxis, reduction of acute/chronic edema, management of extremity pain post-trauma/surgery, leg ulcer treatment, and management of venous stasis/insufficiency.

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

• Novamedix Arterial Venous Impulse (AVI) Foot Covers (Part Number 5065, 5075)

Submission Summary (Full Text)

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K012612

FEB 0 6 2002

## 510(k) Summary

3017110

August 8, 2001

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Submitter's name and Address:

ClearMedical, Inc. 1776 - 136th Place NE Bellevue, WA 98005 Ph [phone] Fax [phone]

FDA Registration Number:

Contact Person:

Richard Radford Director of Research and Product Development

Date Summary Prepared:

Trade or Proprietary Name:

ClearMedical/Novamedix AV Impulse (AVI)

Foot Covers: 5046 - Right Foot, Regular ImPad

5048 - Left Foot, Regular ImPad

5057 - Right Foot, Large ImPad

5059 - Left Foot, Large ImPad

5065 - Regular Impad Pair (containing 5046, 5048) 5075- Large Impad Pair (containing 5057, 5059)

Common Name:

Classification Name:

Sleeve, Limb, Compressible (per 21 CFR section 870.5800)/ JOW

## Equivalent Device

The ClearMedical/Novamedix reprocessed Arterial Venous Impulse (AVI) Foot Covers are substantially equivalent to the Novamedix Arterial Venous Impulse (AVI) Foot Covers distributed by Kendall (Part Number 5065, which is composed of Part Numbers 5046 and 5048, and Part Number 5075, which is composed of Part Numbers 5057 and 5059). This determination has been reached based on an evaluation and analysis of the predicate device's technical and promotional labeling and specific tests. For all established indicators of substantial

AVI Foot Cover

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## 510(k) Summary (Cont'd)

equivalence the ClearMedical devices demonstrated equality in safety and performance.

The ClearMedical/Novamedix reprocessed AVIs are a noninvasive prophylaxis for reducing the incidence of deep vein thrombosis. These AVIs are used by adult patients in hospital or home settings.

The AVIs are latex-free, cushioned throughout, and cover maximum foot surface area to distribute pressure evenly over the foot and minimize trauma to untreated areas. The right foot cover is designated with blue graphics, the left with red graphics.

The AVIs have a rigid sole that contains and directs the impulse (simulates the ground) aqainst the venous plantar plexus (network of veins at the sole of the foot). They also have an anatomically shaped bladder that completely covers the plantar plexus. Both the rigid sole and bladder ensure that the venous plantar plexus is completely flattened and stretched (causing the plantar plexus to collapse and empty, which sends a column of blood to the right atrium of the heart) during impulse pumping.

The AVIs have two Velcro hook straps to allow secure fastening, vent holes and a polyethylene tube.

#### Intended Use

The ClearMedical/Novamedix AVIs are used with an A-V Impulse System Controller (monitors impulse pressure to patient's feet) to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury and surgery, and increase arterial blood flow. Adult patients use them in hospital or home of environments.

## Technological Characteristics of ClearMedical/Novamedix AVIs Compared with the Novamedix AVIs

The predicate device and the ClearMedical/Novamedix AVIs contain bladders that inflate at the base of the foot, directing an impulse to the venous plantar plexus. Attached to the AVI is a connector tubing system that connects to the AVI pump. In form, the predicate device and the ClearMedical reprocessed device are substantially equivalent.

Technological indicators of substantial equivalence were identified and included methods of infection control, fit/attachment, bladder function, and velcro adhesion.

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## 510(k) Summary (Cont'd)

The predicate device is delivered to the customer labeled 'non-sterile' whereas the ClearMedical/Novamedix AVIs are delivered to the customer labeled "High Level-Disinfected." ClearMedical's infection control methods meet or exceed the CDC and APIC Guideline for Handwashing and Hospital Environmental Control, 1985, and APIC Guideline for Selection and Use of Disinfectants standards for this class of device.

Summary of the ClearMedical/Novamedix AVI Performance

Based on an assessment of bench tests and non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/ Novamedix AVIs demonstrates substantial equivalence to the predicate devices, the Novamedix AVIs.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a single staff and snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 0 6 2002

Mr. Richard Radford Director of Research and Product Development ClearMedical, Inc. 1776 136th Place NE Belluvue, WA 98005-2328

Re: K012612

Trade Name: ClearMedical/NovaMedix Arterial Venous Impulse (AVI) Foot Covers Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 16, 2002 Received: January 17, 2002

### Dear Mr. Radford:

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. Richard Radford

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Natha Tull

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

Enclosure

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# Statement of Indications for Use

Page 1 of 2

| 510(K) NUMBER (IF KNOWN): | K012612 |
|---------------------------|------------------------------------------------------------------|
| DEVICE NAME: | ClearMedical/Novamedix Reprocessed AVI Foot Cover (without pump) |

INDICATIONS FOR USE:

The A-V Impulse System foot pump is safe and effective for the following indications. The proper duration for use of each indication is subject to the clinical judgment of the prescribing physician.

Recommended Guidelines are as follows:

| Indication | Recommended Guidelines |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Circulation Enhancement | For temporary impairments such as temporary trauma or disease conditions, continuous use until the condition is resolved. For chronic impairments, daily use depending on the severity of the patient's condition and activity. |
| Deep Vein Thrombosis Prophylaxis | Continuous use until the patient is fully ambulatory and weight bearing (not just mobilized) |
| Edema - Acute | Continuous use until edema is reduced. |

(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K012612

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# Statement of Indications for Use

Page 2 of 2

510(K) NUMBER (IF KNOWN):

K012612

ClearMedical/Novamedix Reprocessed AVI Foot Cover (without pump) DEVICE NAME:

INDICATIONS FOR USE:

| Indication | Recommended Guidelines |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema -- Chronic | As required, but at least 4 hours per day. |
| Extremity Pain Incident to<br>Trauma or Surgery | Continuous use until severity of pain is<br>reduced or physician recommends<br>alternative therapy. |
| Leg Ulcers | Continuous use until ulcer severity is<br>reduced or physician recommends<br>alternative therapy. |
| Venous Stasis/<br>Venous Insufficiency | For temporary impairments such as<br>temporary trauma or disease conditions,<br>continuous use until condition is resolved.<br>For chronic impairments, daily use<br>depending on the severity of the patient's<br>condition and activity level. |

(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use_

**Division of Cardiovascular & Respiratory Devices**
**510(k) Number** K012612

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