CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR

K012616 · Clearmedical, Inc. · JOW · Feb 6, 2002 · Cardiovascular

Device Facts

• Record ID: K012616
• Device Name: CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR
• 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 ClearMedical/Huntleigh Foot Garments are intended as a single patient use accessory to a Huntleigh FP 5000 pump. The role of the Foot Garment is to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury and surgery, and increase arterial blood flow. The Foot Garment is used in conjunction with the FP 5000 pump for non-ambulatory patients in a hospital environment.

Device Story

ClearMedical/Huntleigh Foot Garments are single-patient-use accessories for the Huntleigh FP 5000 pump system. Device consists of inflatable polyester-cotton fabric bladder, velcro straps, and molded polyethylene tubing with polypropylene snap-lock connector. Used in hospital environments for non-ambulatory patients. Device connects to pump via tubing; pump inflates bladder to provide compression to feet. Compression action reduces deep vein thrombosis incidence, manages edema, alleviates pain, and improves circulation. Reprocessed device is high-level disinfected to meet CDC/APIC standards.

Clinical Evidence

Bench testing only. No clinical data provided. Performance assessment focused on infection control methods, fit/attachment, bladder function, velcro adhesion, and connector function to demonstrate equivalence to predicate.

Technological Characteristics

Latex-free polyester-cotton fabric garment with inflatable bladder. Components include velcro hook straps, molded polyethylene tubing, and polypropylene snap-lock connector. Operates via pneumatic inflation from external FP 5000 pump. High-level disinfection process used for reprocessing. No software or electronic components.

Indications for Use

Indicated for non-ambulatory patients requiring prevention of deep vein thrombosis, enhancement of venous and arterial circulation, prevention of venous stasis, assistance in healing cutaneous ulcers (including venous stasis ulcers), reduction of acute and chronic edema, reduction of lower limb pain due to trauma or surgery, and reduction of compartmental pressures.

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

• Huntleigh Foot Garments (FG200-LRG, FG200-STD, FG100-SM, FG100-R)

Submission Summary (Full Text)

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## 510(k) Summary

Submitter's name and Address:

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

FDA Registration Number:

3017110

Contact Person:

Richard Radford Director of Research and Product Development

Date Summary Prepared:

August 8, 2001

Trade or Proprietary Name:

Common Name:

Foot Garments

Classification Name:

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

ClearMedical/Huntleigh Foot Garments

## Equivalent Device

The ClearMedical/Huntleigh reprocessed Foot Garments are substantially equivalent to the following Huntleigh Foot Garments (FG200-LRG, FG200-STD, FG100-SM. FG100-R). This determination has been reached based on an evaluation and analysis of the predicate device's technical and promotional labeling and specific bench testing. For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance.

## Device Description:

The ClearMedical/Huntleigh Foot Garments are an accessory device to a Foot Garment System which is used for the prevention of deep vein thrombosis. The Foot Garment is designed with an inflatable bladder that fills with air to provide

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

compression to the feet. A connector tubing system attaches the Foot Garment to the pump system.

The Foot Garments are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, a vented bladder and molded polyethylene tubing with a polypropylene colder snap-lock connector.

#### Intended Use:

The ClearMedical/Huntleigh Foot Garments are intended as a single patient use accessory to a Huntleigh FP 5000 pump. The role of the Foot Garment is to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury and surgery, and increase arterial blood flow. The Foot Garment is used in conjunction with the FP 5000 pump for non-ambulatory patients in a hospital environment.

## Technological Characteristics of ClearMedical and Predicate Devices:

The predicate device and the ClearMedical/Huntleigh Foot Garments contain bladders that inflate with air to control circulation of a limb. Attached to the Garment is a connector tubing system that connects to the FP 5000 pump. In form, the predicate device and the ClearMedical reprocessed Foot Garments are substantially equivalent.

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

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

#### Summary of ClearMedical/Huntleigh Foot Garment 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/ Huntleigh Foot Garments demonstrates substantial equivalence to the predicate devices, the Huntleigh Foot Garments.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

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: K012616

Trade Name: ClearMedical/Huntleigh Foot Garments 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 I lease be actived a determination that your device complies with other requirements of the Act that I Drines Internations and regulations administered by other Federal agencies. You must or any I catales and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 6077; accems (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic rordlict 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) rms letter notification. The FDA finding of substantial equivalence of your device to a legally premium to modicate 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 Compliance at [phone] 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 O wision 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,

Bram 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

KO12616 510(K) NUMBER (IF KNOWN):

ClearMedical/Huntleigh Foot Garments (without pump) DEVICE NAME:

## INDICATIONS FOR USE:

Prevention of deep vein thrombosis.

Enhancement of venous and arterial circulation.

Prevention of venous stasis.

Assist in healing of cutaneous ulcers, including venous stasis ulcers.

Reduction of acute and chronic edema.

Reduction of lower limb pain due to trauma or surgery.

Reduction of compartmental pressures.

(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 K012616

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