DVT60

K022786 · Huntleigh Healthcare, Inc. · JOW · Sep 19, 2002 · Cardiovascular

Device Facts

• Record ID: K022786
• Device Name: DVT60
• Applicant: Huntleigh Healthcare, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DVT60 sleeves are designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

Device Story

DVT60 is a single-chamber inflatable limb compression sleeve designed to fit around a patient's calf; used in conjunction with Huntleigh Flowtron Excel and Universal Pumps. Device functions by inflating to compress calf veins, expelling blood to promote circulation and overcome venous stasis. Used in clinical settings; operated by healthcare professionals. Output is mechanical compression of the limb; effect is increased venous blood flow velocity, aiding in DVT prevention. Extended width accommodates calf circumferences up to 28 inches.

Clinical Evidence

Bench testing only. Performance evaluated by fitting sleeves to subjects' calves and measuring venous blood flow velocity during compression. Results demonstrated that the DVT60 produces a similar increase in venous blood velocity and duration as the predicate device, effectively overcoming venous stasis.

Technological Characteristics

Single-chamber inflatable cuff; calf-worn; extended width for up to 28-inch circumference. Operates via pneumatic inflation from external Huntleigh Flowtron Excel or Universal Pumps. Materials and manufacturing methods identical to predicate DVT10.

Indications for Use

Indicated for the prevention of Deep Vein Thrombosis (DVT) by increasing venous blood flow in patients requiring limb compression therapy.

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 Healthcare DVT10(s) (K925717/A)

Submission Summary (Full Text)

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K022786

## 510(k) SUMMARY DVT60 Limb Compression Sleeves

| Company | Huntleigh Healthcare Inc<br>40 Christopher Way<br>Eatontown<br>New Jersey | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Contact | Audrey Witko<br>Phone<br>Fax | 732 578 9898<br>732 460 5809 |
| Summary<br>Preparation Date | 1ST August 2002 | |
| Trade Name | DVT60 | |
| Common Name | Limb Compression Sleeves | |
| Classification Name | Sleeve, Limb, Compression (JOW) | |
| Predicate Device | Huntleigh Healthcare DVT10(s) K925717/A | |
| Device Description | The DVT60 Compression Sleeves are single chamber<br>inflatable cuffs, designed to fit around a patient's<br>calf.<br>They are used with the Huntleigh Flowtron Excel and<br>Universal Pumps.<br>When inflated, they compress the veins in the calf<br>and expel blood out of the leg, promoting circulation<br>and overcoming stasis. | |
| Intended Use | DVT60 sleeves are designed to help prevent Deep<br>Vein Thrombosis (DVT), by increasing venous blood<br>flow. | |
| Summary of Technological Characteristics | | |

SEP 1 9 2002

The DVT60 compression sleeves have the same technological characteristics as the DVT10 predicate device.

The design characteristics, materials, and method of manufacture are the same,

When compared to the predicate device, the DVT60 sleeves are extended in width, so that are suitable to fit a patient's calf of up to 28 inches circumference.

HEALTH

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## Determination of Substantial Equivalence

The determination of Substantial Equivalence is based on non-clinical outcome, inflation performance testing. The sleeves are tested by fitting to a subject's calf and observing the increase in velocity of the blood flow in the veins during compression.

## Equivalence Testing Results

The sleeves are made from similar materials and compress a similar area of the patient's limb. The inflation sequence and pressures are the same.

The venous blood velocity increase and duration are similar to the predicate device. This increase in blood velocity overcomes venous stasis and so helps to prevent deep vein thrombosis, in the same manner as the predicate device.

Therefore, we propose that the clinical treatment that the patient receives will be equivalent.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2002

Huntleigh Healthcare, Inc. c/o Ms. Audrey Witko Vice President. Corporate & Clinical Affairs 40 Christopher Way Eatontown, NJ 07724

Re: K022786 Trade Name: DVT60 Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II (two) Product Code: JOW Dated: May 23, 2002 Received: August 22, 2002

Dear Ms. Witko:

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. Ilsting 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 - Ms. Audrey Witko

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.

V. Prem D. Zuckerman, M.D.

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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## INDICATIONS FOR USE STATEMENT DVT60 Limb Compression Sleeves

Ver/3-4/24/96

| Applicant: | Huntleigh Healthcare Inc. |
|---------------------------|---------------------------|
| 510(k) Number (if known): | Not known at present |
| Device Name: | DVT60 |
| Indications For Use: | |

The DVT60 Compression Sleeve is designed to help prevent Deep Vein
Thrombosis (DVT), by increasing venous blood flow.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <img alt="Checkbox" src="checkbox.png"/> </div> |
|------------------------------------------|-------------------------------------------------------|
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Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K022786 |
|---------------|---------|
|---------------|---------|

(Per 21 CFR 801.109)
(Optional Format 1-2-96)