REPROCESSED RESTEP COMPRESSION SLEEVES

K101087 · Ascent Heatlhcare Solutions · JOW · Jul 16, 2010 · Cardiovascular

Device Facts

• Record ID: K101087
• Device Name: REPROCESSED RESTEP COMPRESSION SLEEVES
• Applicant: Ascent Heatlhcare Solutions
• Product Code: JOW · Cardiovascular
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.

Device Story

Reprocessed Restep Compression Sleeves are single-chamber pneumatic garments used as part of the Restep DVT System. The sleeves connect to an electronically controlled pump unit that uses solenoid valves to provide intermittent pneumatic compression to the limbs. This compression stimulates blood flow in deep veins to prevent DVT. The device is used in clinical settings (orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery) and is operated by healthcare professionals. Reprocessing involves cleaning, decontamination, and functional testing of used sleeves to ensure they perform as originally intended.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of the reprocessing process, and functional testing of sleeve components to ensure performance equivalent to the original device.

Technological Characteristics

Single-chamber pneumatic compression garments. Materials and mechanical design are identical to the predicate Restep sleeves. The device functions via pneumatic actuation from an external pump unit. Reprocessing includes removal of visible soil and decontamination.

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT) undergoing orthopedic, trauma, urologic, neurologic, critical care, general medicine, obstetric, or general surgery procedures.

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

• Restep DVT System (K090308)

Submission Summary (Full Text)

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K101087 pg 1 of 2

# SECTION 5: 510(k) SUMMARY

、

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | JUL 1 6 2010 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Contact: | Amanda Babcock<br>Sr. Regulatory Affairs Specialist<br>480.763.5300 (o)<br>863.904.2312 (f)<br>[e-mail] | |
| Date of preparation: | April 15, 2010 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Restep Compression<br>Sleeves<br>Common or Usual Name: Compression Sleeve<br>Classification Name: Compressible Limb Sleeve | |
| Predicate Devices<br>K090308 | 510(k) Title<br>Restep DVT System | Manufacturer<br>Stortford Medical LLC |
| Device description: | The Restep Deep Vein Thrombosis (DVT) System, consists of<br>the Restep pump and compatible leg and foot compression<br>garments. The system is a lightweight, portable, prescriptive<br>pneumatic compression device that helps to stimulate blood flow<br>in the deep veins of the legs through the use of pneumatically<br>controlled single chamber pressure cuffs, actuated by an<br>electronically controlled pump unit and solenoid valves. | |
| | Note: Only the compression sleeves (garments) are the subject<br>of this submission, the pump is not included in the scope of this<br>submission. | |
| Indications for Use: | Intermittent Pneumatic Compression (IPC) is indicated for use<br>for the prevention of deep vein thrombosis due to the presence<br>of risk factors for thrombus formation during orthopedic, trauma,<br>urologic, neurology, critical care, general medicine, obstetrics,<br>and general surgery. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Compression Sleeves are identical to the predicate devices.<br><br>The mechanism of action of Reprocessed Compression Sleeves<br>is identical to the predicate devices in that the same standard<br>mechanical design, size, and materials are utilized. There are<br>no changes to the claims, intended use, clinical applications,<br>patient population, performance specifications, or method of | |

.

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K101087 pg 2 of 2

Ascent Healthcare Solutions' In addition, operation. reprocessing of Compression Sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations.

Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves. This included the following tests:

- Biocompatibility .
- Validation of reprocessing ●
- Function test(s) ●

Performance testing t demonstrates that Reprocessed Compression Sleeves perform as originally intended.

Conclusion: Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Restep Compression Sleeves) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line drawing. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular fashion around the bird.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

July 1 6 2010

Ms. Amanda Babcock Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

Re: K101087

Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: April 15, 2010 Received: April 19, 2010

Dear Ms. Babcock:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Amanda Babcock

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dona R. Vahner

ABram D. Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101087

## SECTION 4: INDICATIONS FOR USE STATEMENT

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

Device Name: Reprocessed Restep Compression Sleeves

#### Indications For Use:

Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.

Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vohmer.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Kio 1087

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. Page 4 - Ms. Amanda Babcock

## K101087

## Applicant: Ascent Healthcare Solutions 10232 S 51st Street Phoenix, AZ 85044 Contact Individual: Amanda Babcock, Senior Regulatory Affairs Specialist Ph: [phone] Fax: [phone] Email: [e-mail]

Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve

Device Name: Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves

| Manufacturer | Models |
|--------------|---------------------------------------|
| Restep | RCG-10 Calf Garment (up to 22") |
| Restep | RCG-30 Thigh Garment (up to 32") |
| Restep | RCG-60 Bariatric Garment (up to 27") |
| Restep | RCG-210 Foot Garment (universal size) |

#### Indications for Use (IFU)

Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.