CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT

K012621 · Clearmedical, Inc. · JOW · Feb 6, 2002 · Cardiovascular

Device Facts

• Record ID: K012621
• Device Name: CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
• 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 DVTs are intended as a single patient use accessory to a Huntleigh AC550 Flowtron pump. The role of the DVT is to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury and surgery, and increase arterial blood flow. The DVT Garments are used in coniunction with the Flowtron pump for non-ambulatory patients in a hospital environment.

Device Story

ClearMedical/Huntleigh DVT Garments are single-patient-use accessories for Huntleigh AC550 Flowtron pump systems. Garments feature inflatable bladders that provide pneumatic compression to calf and thigh; connected to pump via tubing system. Used in hospital environments for non-ambulatory patients to prevent deep vein thrombosis, manage post-surgical/injury pain and swelling, and improve arterial blood flow. Healthcare providers operate the system by attaching garments to the pump; pump cycles air to inflate bladders. Reprocessed devices are high-level disinfected.

Clinical Evidence

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

Technological Characteristics

Materials: latex-free, polyester-cotton fabric, molded polyethylene tubing, polypropylene snap-lock connector. Principle: pneumatic bladder inflation via external pump. Form factor: limb-worn garment. Connectivity: physical tubing connection to Flowtron pump. Infection control: high-level disinfection.

Indications for Use

Indicated for non-ambulatory patients in hospital settings to reduce deep vein thrombosis incidence, alleviate post-injury or post-surgical pain and swelling, and increase arterial blood flow.

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 DVT Garments (DVT 10, DVT 20, DVT 30 and DVT 40)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitter's name and Address: | ClearMedical, Inc.<br>1776 – 136th Place NE<br>Bellevue, WA 98005<br>Ph [phone]<br>Fax [phone] |
|-------------------------------|--------------------------------------------------------------------------------------------------------------|
| FDA Registration Number: | 3017110 |
| Contact Person: | Richard Radford<br>Director of Research and Product Development<br>[phone] |
| Date Summary Prepared: | August 8, 2001 |
| Trade or Proprietary Name: | ClearMedical/Huntleigh Deep Vein Thrombosis<br>(DVT) Garments |
| Common Name: | Deep Vein Thrombosis Garments |
| Classification Name: | Sleeve, Limb, Compressible (per 21 CFR<br>section 870.5800)/JOW |

### Equivalent Device

The ClearMedical/Huntleigh reprocessed Deep Vein Thrombosis (DVT) Garments are substantially equivalent to the Huntleigh DVT Garments (DVT 10, DVT 20, DVT 30 and DVT 40). 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 DVTs are accessory devices to a DVT System which is used for the prevention of deep vein thrombosis. The DVT Garment is designed with inflatable bladders that fill with air to provide compression to the calf and thigh. A connector tubing system attaches the DVT to the pump system.

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

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

#### Intended Use:

The ClearMedical/Huntleigh DVTs are intended as a single patient use accessory to a Huntleigh AC550 Flowtron pump. The role of the DVT is to reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury and surgery, and increase arterial blood flow. The DVT Garments are used in coniunction with the Flowtron pump for non-ambulatory patients in a hospital environment.

#### Technological Characteristics of ClearMedical and Predicate Devices:

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

Technological indicators of substantial equivalence were identified and included method 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 DVTs 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 ClearMedical/Huntleigh DVT 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 DVT Garments demonstrates substantial equivalence to the predicate devices, the Huntleigh DVT 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 features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

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: K012621

Trade Name: ClearMedical/Huntleigh Deep Vein Thrombosis (DVT) 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 f hat 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 or unry 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 Erth 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) I mo letter will and in yourse FDA finding of substantial equivalence of your device to a legally promated notification "caresults 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 Oiler general missimal 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,

signature

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

KO1262 510(K) NUMBER (IF KNOWN):

ClearMedical/Huntleigh Deep Vein Thrombosis (DVT) Garments DEVICE NAME:

DVT 10, DVT 20, DVT 30, DVT 40

## INDICATIONS FOR USE:

To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K012621

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use