KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN

K012614 · Medical Instruments Technology, Inc. · JOW · May 1, 2002 · Cardiovascular

Device Facts

• Record ID: K012614
• Device Name: KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
• Applicant: Medical Instruments Technology, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: May 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.

Device Story

Reprocessed compression sleeves; used for bed-confined patients to aid circulation and prevent deep vein thrombosis/pulmonary embolism. Device consists of plastic or cloth covers containing one or more plastic or rubber bladders; connected via plastic tubing to an external compressor unit. Compressor inflates/deflates bladders to squeeze blood from limbs; cycle repeats to facilitate venous return. Operated by healthcare staff in clinical settings. Reprocessing involves cleaning and inspection of original manufacturer devices to ensure performance equivalence in pressure holding and release. Benefits include cost-effective reuse of compression therapy garments.

Clinical Evidence

Bench testing only. Comparison of physical characteristics (color, dimensions, damage) and performance characteristics (ability to hold and release pressure) between reprocessed devices and predicate devices demonstrated substantial equivalence. Biocompatibility data provided.

Technological Characteristics

Materials: plastic or cloth covers, plastic or rubber bladders. Sensing/Actuation: pneumatic inflation/deflation via external compressor. Form factor: adjustable leg, knee, and foot sleeves. Connectivity: mechanical connection to compressor. Sterilization: not specified. Software: none.

Indications for Use

Indicated for bed-confined patients to increase venous blood flow and prevent deep vein thrombosis and pulmonary embolism.

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 Sequential Compression Device (Tyco Healthcare Group LP)

Submission Summary (Full Text)

{0}------------------------------------------------

K012614

# MAY 0-1 2002 Medical Instruments Technology, Inc's Reprocessed Compression Sleeve Premarket Notification

**Medical Instruments Technology**Inc.

Quality Reprocessing and Surgical Cost Containment Systems

## Section 12: 510k Summary

#### Name of Submitter ,

Medical Instruments Technology, Inc. 385 North 3050 East Saint George, UT 84790 Tel: [phone] Fax: [phone]

Contact persons: Tom Haueter, RA/QA Manager Crystal Batcabe, Assistant RA/QA Manager

### Summary Prepared August 10, 2001

#### Device name and Classification: II.

Proprietary Name: N/A Common Name: Compression Sleeve, Sleeve, Limb, Compressible Classification: Class II per 21 CFR 870 5800 JOW

#### lli. Predicate Device:

MIT's reprocessed compressions sleeves are substantially equivalent to:

Kendall Sequential Compression Device, Tyco Healthcare Group LP, Mansfield, MA 02048

#### Description of Device IV.

Compression sleeves come in 3 adjustable sizes for the leg, one size for the knee and various sizes for the foot. They are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to squeeze the blood out of the foot or leg

385 North 3050 East St. George, Utah 86790 tust 888-673-4010 or 435-674-4010 fax: [phone]

ISO 9002 ceptified. FDA registered.

{1}------------------------------------------------

### Medical Instruments Technology, Inc's Reprocessed Compression Sleeve Premarket Notification

and deflates to allow the blood to flow back into the foot or leg. On many of the machines, air pressure can be adjusted to allow for the length and thickness of the leg. Below is a list of the brand names and models that MIT reprocesses. Although different manufacturers originally make the devices, the intended use of the devices is identical.

#### V. Intended Use:

The intended use of a compression sleeve is to aid in blood circulation in bed confined patients, to prevent deep vein thrombosis and pulmonary embolism.

#### VI. Technological Characteristics:

MIT's reprocessed compression sleeves have the same technological characteristics as the Kendall SCD's. The materials used in the manufacture of the garments are not changed during the reprocessing process. Additionally, MIT does not change any part of the SCD that might affect its function.

Testing by MIT has shown that the reprocessed devices are substantially equivalent to the predicate in performance.

#### VII. Blo-Compatibility:

MIT, Inc. has provided appropriate test data to demonstrate that no biocompatibility concerns exist with sequential compression devices reprocessed using MIT's procedures.

#### Substantial Equivalence: VIII.

Physical Characteristics: Color, dimensions, damage

MIT compared the reprocessed compression devices to the predicate device for the parameters above. In all cases the reprocessed devices were substantially equivalent to the new devices.

Performance Characteristics: Ability to hold pressure, ability to release pressure

MIT compared the reprocessed compression devices to the predicate devices (for the parameters above) and in all cases the devices were substantially equivalent.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 1 2002

Mr. John P. Batcabe R & D Manager Medical Instruments Technology, Inc. 385 North 3050 East St. George, UT 84790

Re: K012614

> Device Name: Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 29, 2002 Received: January 30, 2002

Dear Mr. Batcabe:

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.

{3}------------------------------------------------

### Page 2 - Mr. John P. Batcabe

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 vours,

J. D. Tulek

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| 510(k) Number (if known): | K012614 |
|---------------------------|---------------------------------|
| Device Name: | Reprocessed Compression Sleeves |

Indications For Use:

# Medical Instruments Technology, Inc's Reprocessed Compression Sleeve Premarket Notification

## Appendix 14: Indications for Use Statement

The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.

(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 K012614

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Pagc

(Optional Format 1-2-96)