SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES

K052691 · Suretek Medical · JOW · May 17, 2006 · Cardiovascular

Device Facts

• Record ID: K052691
• Device Name: SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
• Applicant: Suretek Medical
• Product Code: JOW · Cardiovascular
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Device Story

SureTek Reprocessed Compression Sleeves are inflatable vinyl bladders lined with non-woven fabric; designed to apply intermittent pneumatic pressure to foot, calf, or thigh. Device connects to compatible external pump controllers via pneumatic tubing; secured to patient limbs using hook-and-loop fasteners. Used in clinical settings to increase venous return and prevent DVT. Reprocessing involves decontamination and sterilization of previously used sleeves; device materials, dimensions, and operating principles remain identical to original manufacturer specifications. Healthcare providers operate the pump system to deliver pressure cycles; output is mechanical compression of the limb. Benefits include DVT prophylaxis through improved blood flow.

Clinical Evidence

Bench testing only. Testing included validation of cleaning processes for decontamination under worst-case conditions, sterility validation per ISO 11135, and biocompatibility/residual testing per ISO 10993. Packaging performance was verified against ISO 11607, EN868-1, and ASTM standards (F88-00, F2906-04, D4169-04a, F1980-02).

Technological Characteristics

Inflatable vinyl bladder with non-woven fabric lining; hook-and-loop fasteners. Pneumatic actuation via external pump controller. Sterile (ethylene oxide). Conforms to ISO 10993 (biocompatibility), ISO 11135 (sterilization), and ISO 11607 (packaging).

Indications for Use

Indicated for patients requiring intermittent compression of lower extremities to increase venous return and prevent Deep Vein Thrombosis (DVT).

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

• Flowtron (K022786, K010744)
• SCD (K992079, K964425)
• Impad (K992079, K964425)
• Plexipulse (K981311)
• VasoPress (K003828)
• Alternating Leg Pressure, ALP (K000303)
• Venaflow (K992454, K023800)
• pulStar (K961405)
• Reprocessed Compression Sleeves (K012597)
• Reprocessed Compression Garment (K012403)

Submission Summary (Full Text)

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K052691
MAY 17 2006

· ·

## SureTek Medical 510(k) Summary

| Submitter | SureTek Medical | 25-B Maple Creek Circle Greenville, SC 29607 | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|------------------|
| Contact | Mike Sammon, Ph.D. | 864-299-9743 | |
| Date | 9/25/05 | | |
| Product | SureTek Reprocessed Compression Sleeve | | |
| Classification | Code:JOW Regulation: 21 CFR 870.5800 Name: Compressible Limb Sleeve | | |
| Predicate<br>Devices | Manufacturer/Reprocessor | Tradename(s) | 510(k)'s |
| | Huntleigh Healthcare | Flowtron* | K022786, K010744 |
| | Kendall (Tyco Healthcare) | SCD*, Impad* | K992079, K964425 |
| | Kinetic Concepts | Plexipulse* | K981311 |
| | Compression Therapy | VasoPress* | K003828 |
| | Currie Medical | Alternating Leg Pressure, ALP* | K000303 |
| | Aircast | Venaflow* | K992454, K023800 |
| | Alba Health | pulStar* | K961405 |
| | SterilMed | Reprocessed Compression Sleeves | K012597 |
| | Vanguard Medical Concepts | Reprocessed Compression Garment | K012403 |
| Device<br>Design and<br>Description | Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf<br>or thigh in order to increase venous return and prevent pooling of blood associated with the<br>formation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s)<br>lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connection<br>with a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loop<br>fasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are available<br>in a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessed<br>sleeves have identical technological characteristics as the predicate devices, i.e. device materials,<br>dimensions, operating principle and system compatibility are unchanged during reprocessing.<br>SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile. | | |
| Intended Use | SureTek Compression Sleeves are intended for use with a compatible pump controller for<br>intermittent compression of the lower extremities so as to increase venous return as a prophylaxis<br>to Deep Vein Thrombosis. | | |
| Testing and<br>Standards | • Bench testing of devices following the maximum number of use and reprocessing cycles found<br>their performance to be substantially equivalent to new, unused devices.<br>• SureTek cleaning process is validated to be effective for decontamination of grossly<br>contaminated instruments under worst case operational conditions.<br>• Product packaging conforms to all relevant requirements of ISO 11607 Packaging for<br>terminally sterilized medical devices, with performance qualifications tested according to<br>EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02.<br>• Product sterility and process validation conform to the relevant requirements of ISO 11135<br>Medical Devices – Validation and routine control of ethylene oxide sterilization.<br>• Products conform to the relevant requirements of ISO 10993 Biological Evaluation of Medical<br>Devices for ethylene oxide residuals and biocompatibility of device materials.. | | |
| Substantial<br>Equivalence | Product testing and comparisons of specifications determines that SureTek Reprocessed<br>Compression Sleeves are substantially equivalent to their predicate devices with respect to device<br>intended use and performance, as well as product packaging, labeling and safety. | | |

^* The listed product tradenames are registered trademarks of their respective manufacturers.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

SureTek Medical c/o Mike Sammon, Ph.D. CEO President 44 Bellwood Farms Greenville, SC 29607

Re: K052691

SureTek Reprocessed Compression Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 1, 2006 Received: April 5, 2006

Dear Dr. Sammon:

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 - Mike Sammon, Ph.D.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Dunia R. Vochner

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

## 510(k) Number (if known): _K052691

Device Name: SureTek Reprocessed Compression Sleeve

| Manufacturer | Model Number | Manufacturer | Model Number |
|------------------|--------------|---------------------|--------------|
| Huntleigh | DVT10 | Compression Therapy | VP 501M |
| Huntleigh | DVT20 | Compression Therapy | VP 501L |
| Huntleigh | DVT60 | Compression Therapy | VP 501B |
| Huntleigh | DVT30 | Compression Therapy | VP 530M |
| Huntleigh | DVT40 | Compression Therapy | VP 530L |
| Huntleigh | FG100 | Compression Therapy | VP 520 |
| Huntleigh | FG200 | Currie Medical | ALP 1 |
| Kendall | 5329 | Currie Medical | ALP 2 |
| Kendall | 5489 | Currie Medical | ALP 5 |
| Kendall | 5345 | Currie Medical | ALP 3 |
| Kendall | 5330 | Currie Medical | ALP 4 |
| Kendall | 5480 | Currie Medical | PVA 1 |
| Kendall | 5065 | Currie Medical | PVA 2 |
| Kendall | 5075 | Aircast | 3010 |
| Kinetic Concepts | 28900000 | Aircast | 3012 |
| Kinetic Concepts | 28900001 | Aircast | 3014 |
| Alba Healthcare | 51558-01 | Aircast | 3015 |
| Alba Healthcare | 51558-02 | Aircast | 3016 |

Indications for Use: SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vockner

II Sign-Siovascular Device

510(k) number K052691