REPROCESSED COMPRESSION SLEEVES

K100909 · Ascent Healthcare Solutions · JOW · Jul 23, 2010 · Cardiovascular

Device Facts

• Record ID: K100909
• Device Name: REPROCESSED COMPRESSION SLEEVES
• Applicant: Ascent Healthcare Solutions
• Product Code: JOW · Cardiovascular
• Decision Date: Jul 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Device Story

Reprocessed Compression Sleeves are limb garments used as part of an external intermittent or sequential compression system. The system comprises a control unit (pump), inflatable limb sleeves, and conduit tubing. The device functions by applying mechanical pressure to the limb to enhance blood circulation and prevent DVT. Ascent Healthcare Solutions reprocesses used sleeves by removing visible soil and decontaminating them. Each sleeve undergoes functional testing prior to packaging. The device is intended for clinical use, operated by healthcare professionals. The output is mechanical compression of the limb, which aids in post-operative recovery and DVT prevention.

Clinical Evidence

No clinical data. Evidence consists of bench and laboratory testing, including biocompatibility, validation of the reprocessing procedure, and functional testing of components.

Technological Characteristics

Mechanical compression sleeve consisting of inflatable chambers and conduit tubing. Identical in design, materials, and size to original predicate devices. Reprocessing involves removal of adherent visible soil and decontamination. Functional testing performed on each unit.

Indications for Use

Indicated for patients requiring deep vein thrombosis (DVT) prophylaxis, reduction of post-operative pain and swelling, enhanced blood circulation, and improved wound healing time. Used in conjunction with an external inflation system.

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

• K060049
• K060091
• K053316
• K051438
• K012403
• K024087
• K024074
• K021654
• K011192

Submission Summary (Full Text)

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K100909 pg 1 of 2

# SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | JUL 23 2010 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Contact: | Ramona Kulik<br>Regulatory Affairs Engineer<br>480.763.5300 (o)<br>480.763.2952 (f)<br>[e-mail] | |
| Date of preparation: | March 31, 2010 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression Sleeves<br>Common or Usual Name: Compression Sleeve<br>Classification Name: Compressible Limb Sleeve | |
| Predicate Devices<br>K060049 | 510(k) Title | Reprocessor |
| | Reprocessed Compression Sleeves | Alliance Medical<br>Corporation |
| K060091 | Reprocessed Compression Sleeves | Alliance Medical<br>Corporation |
| K053316 | Vanguard Reprocessed<br>Compression Garments | Vanguard Medical<br>Concepts |
| K051438 | Vanguard Reprocessed<br>Compression Garments (Hill-Rom) | Vanguard Medical<br>Concepts |
| K012403 | Vanguard Reprocessed<br>Compression Garments | Vanguard Medical<br>Concepts |
| K024087 | Reprocessed Compression Sleeves | Alliance Medical<br>Corporation |
| K024074 | Reprocessed Compression Sleeves | Alliance Medical<br>Corporation |
| K021654 | Reprocessed Compression Sleeves | Alliance Medical<br>Corporation |
| K011192 | Reprocessed Compression Sleeves | Alliance Medical<br>Corporation |

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K100909 pg 2 of 2

Indications for Use: When coupled with an appropriate inflation system. compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Device Description: Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.

Technological The design, materials, and intended use of Reprocessed characteristics: Compression Sleeves are identical to the predicate devices. The mechanism of action of Reprocessed Compression Sleeves is identical to the predicate devices in that the same standard mechanical design, size, and materials are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Ascent Healthcare Solutions' 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 demonstrates · that · Reprocessed Compression Sleeves perform as originally intended.

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

Conclusion:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUL 2 3 2010

Ms. Ramona Kulik Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044

Re: K100909

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: July 9, 2010 Received: July 10, 2010

Dear Ms. Kulik:

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. Isting 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. 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

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#### Page 2 - Ms. Ramona Kulik

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/CDRHOffices/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,

una R. L. Auner

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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## Page 3 - Ms. Ramona Kulik

#### K100909

Applicant: Ascent Healthcare Solutions 10232 S 51st Street Phoenix, AZ 85044 Contact Individual: Ramona Kulik, Regulatory Affairs Engineer Ph: [phone] Fax: [phone] Email: [e-mail]

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JUL 2 3 2010

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

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

| Manufacturer | Foot | Calf | Thigh |
|-----------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Kendall | 5065, 5075, 5107,<br>5897, 5898, 5046,<br>5048, 5057, 5059 | 5329, 5329-M, 5489,<br>5489-M, 9529, 9789 | 5330, 5330-M, 5345,<br>5345-M, 5480, 5480-<br>M, 9530, 9545, 9780 |
| Healthcare Services and<br>Supply | PVA-1, PVA-2 | ALP-1, ALP-2, ALP-<br>2XL | ALP-3, ALP-3(S),<br>ALP-4 |
| Hill-Rom | P3808 | P3801, P3801-L,<br>P3802, P3802-L,<br>P3803, P3803-L,<br>P3804, P3804-L,<br>P3841, P3842, P3843 | P3805, P3805-L,<br>P3806, P3806-L,<br>P3807, P3807-L |
| Huntleigh Healthcare | FG-100, FG-100(2),<br>FG-100R, FG-100R(2),<br>FG-200, FG-200(2),<br>FG-200R, FG-200R(2) | DVT-10, DVT-10(S),<br>DVT-20, DVT-60,<br>L501-M | DVT-30, DVT-30(S),<br>DVT-40, |
| Compression Therapy<br>Concepts | VP520, VP520L, | VP501L, VP501M,<br>VP501P, | VP530B, VP530L,<br>VP530M |
| Kinetic Concepts Inc | 235340 | 112453 | 112452 |
| Microtek | V3012, V3014, V3022, V3026, V3030 | | |
| Aircast Inc. | 3016, 3016-5, 3016-PL | 3010, 3010-5, 3010-<br>PL, 3012, 3012-5,<br>3012-PL, | 3015, 3015-5, 3015-PL |

#### Indications for Use (IFU)

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

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K100909

# SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ¿¡ 00 90 9

#### Device Name: Reprocessed Compression Sleeves

#### Indications For Use:

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

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)

smna 12. vi. Annes

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_King 969