STS RANGE , MODELS STS20,STS30,STS40

K012008 · Huntleigh Healthcare, Inc. · JOW · Sep 21, 2001 · Cardiovascular

Device Facts

• Record ID: K012008
• Device Name: STS RANGE , MODELS STS20,STS30,STS40
• Applicant: Huntleigh Healthcare, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Sep 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

Device Story

STS compression sleeves are three-chamber graduated, sequential compression devices used with the Huntleigh AC600 Flowtron Universal pump. The sleeves are applied to a patient's limb to provide external compression. Unlike predicate devices that use separate tubes for each chamber, the STS system uses a single tube into the lower chamber; gradient inflation of middle and upper chambers is achieved via internal bleed channels and orifices. The device is intended to increase venous blood flow to help prevent DVT. Healthcare providers use the system in clinical settings to manage patient risk. The output is the mechanical compression of the limb, which mimics the effect of the predicate device to provide equivalent clinical treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence was determined through non-clinical inflation performance testing, comparing pressure/time cycle results of the subject device against the predicate device when fitted to subject limbs.

Technological Characteristics

Three-chamber graduated sequential compression sleeve. Materials: PVC laminate sheets, polyester foam patient-contact layer. Inflation principle: Single-tube input to lower chamber with internal bleed channels and orifices for gradient inflation of upper chambers. Connectivity: Connects to Huntleigh AC600 Flowtron Universal pump. Form factor: Knee-length (STS20) and thigh-length (STS30, STS40) sleeves.

Indications for Use

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

• Kendall SCD Therapeutic System (K890938)

Reference Devices

• Huntleigh AC600 Flowtron Universal pump (K010744)

Submission Summary (Full Text)

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K012008

SEP 2 1 2001

Image /page/0/Picture/2 description: The image shows the logo for Huntleigh Healthcare. The logo consists of the word "Huntleigh" in a serif font, with the word "HEALTHCARE" in a smaller serif font directly below it. Above the text is a symbol that resembles a stylized building or structure, composed of several horizontal bars with a vertical gap in the center.

# 510(k) SUMMARY

## STS Compression Sleeves

| Company | Huntleigh Healthcare Inc<br>40 Christopher Way<br>Eatontown<br>New Jersey |
|--------------------------|-------------------------------------------------------------------------------------------|
| Contact | Audrey Witko<br>Phone [phone]<br>Fax [phone] |
| Summary Preparation Date | 19 June 2001 |
| Trade Name | STS20 Knee Length Size<br>STS30 Thigh Length Medium Size<br>STS40 Thigh Length Large Size |
| Common Name | Gradient, Sequential Compression Sleeves |
| Classification Name | Sleeve, Limb, Compression (JOW) |
| Predicate Device | Kendall SCD Therapeutic System K890938 |

#### Device Description

The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744)

#### Intended Use

The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

## Summary of Technological Characteristics

The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb.

On the predicate device, separate tubes individually inflate the three chambers. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere.

On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves.

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The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.

### Determination of Substantial Equivalence

The determination of Substantial Equivalence is based on non-clinical, inflation performance testing. The sleeves are tested by fitting to a subject's limbs and the pressure/time cycle results compared.

## 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 in each chamber are similar.

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

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right.

SEP 2 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Audrey Witko Huntleigh Healthcare, Inc. 40 Christopher Way Eatontown, NJ 07724

Re: K012008

Trade Name: STS Range Models STS20, STS30, and STS40 Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II (two) Product Code: JOW Dated: June 27, 2001 Received: June 27, 2001

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, 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 - 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.

signature

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## STS Compression Sleeves

| Ver/3 - 4/24/96 | |
|---------------------------------------------------------------------------------------------------------|------------------------------|
| Applicant: | Huntleigh Healthcare Inc. |
| 510(k) Number (if known): | Not known at present K012008 |
| Device Name: | STS |
| Indications For Use: | |
| The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow. | |

Division of Cardiovascular & Respiratory Devices
510(k) Number K012006

(PLEASE DO NOT WRITE BELOW THIS LIME – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)