Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)

K143317 · Currie Medical Specialties, Inc. · JOW · Jan 20, 2015 · Cardiovascular

Device Facts

• Record ID: K143317
• Device Name: Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
• Applicant: Currie Medical Specialties, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system. This submission is intended for use of the pump at pressure levels of 40 mm Hg.

Device Story

Pediatric calf compression sleeves; used with ALP 501 Pump System. Sleeves inflate to collapse veins, forcing blood toward heart; deflate to allow venous refill. Simulates natural muscle pumping action to prevent venous stasis, thrombosis, and embolism. Operated by clinicians in healthcare settings. Output is mechanical compression of the limb. Benefits patient by reducing DVT/PE risk. Device is a passive garment component; inflation/deflation cycles controlled by external pump.

Clinical Evidence

Bench testing only. Tests included bladder leak testing at 3 psi, bladder seal pull testing (>5 lbs force), velcro adhesion testing at 2 psi, and inflation-deflation timing at 40 mm Hg. Results demonstrated that design changes for pediatric sizing did not negatively impact performance or safety compared to the predicate.

Technological Characteristics

Intermittent pneumatic compression sleeve. Materials identical to predicate. Energy source: external pneumatic pump (ALP 501). Dimensions: pediatric sizing. Connectivity: pneumatic connection to pump. Sterilization: not specified.

Indications for Use

Indicated for pediatric patients requiring external compression therapy via the ALTERNATING LEG PRESSURE (ALP) SYSTEM to reduce the incidence of deep vein thrombosis and pulmonary embolism in the presence of risk factors for thrombosis formation.

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

• Healthcare Service & Supply Pump ALP 501 System (K955853)

Submission Summary (Full Text)

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Public Health Service

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

January 20, 2015

Currie Medical Specialties. Inc. Owen Bry Director of Quality Assurance 8758 Hellman Ave Rancho Cucamonga, CA 91730

Re: K143317

Trade/Device Name: Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 17, 2014 Received: November 19, 2014

Dear Mr. Bry.

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hilleman

for 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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SPECIALTIES. INC

#### INDICATIONS FOR USE

| Applicant: | Currie Medical Specialties, Inc. |
|---------------------------|-------------------------------------------------------------------|
| 510(k) Number (if known): | K143317 |
| Device Name: | Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) |
| Indications for Use: | |

The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric patients for whom external compression the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use | |
|--------------------|--|
| Per 21 CFR 801.109 | |

OR

Over-the-Counter_

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Image /page/3/Picture/0 description: The image shows the logo for Currie Medical Specialties, Inc. The logo consists of a green square with a blue circle in the center, and the text "Currie Medical Specialties, Inc." to the right of the square. The text is in a sans-serif font, and the words "Currie" and "Medical" are stacked on top of each other, with "Specialties, Inc." below.

# Section 11: 510(k) Summary

| Submitters Name and Address: | Currie Medical Specialties, Inc.<br>8758 Hellman Avenue<br>Rancho Cucamonga, CA 91730<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| FDA Registration Number: | 2023637 |
| Contact Person: | Owen J. Bry, Director of Quality Assurance |
| Date Summary Prepared: | 11/03/2014 |
| Trade or Proprietary Name(s): | Currie Medical ALP Pediatric Calf Compression Sleeves (all<br>sizes) |
| Common Name: | Compression sleeve limb |
| Product Code: | JOW |
| Panel: | Cardiovascular |
| Regulation Number: | 870.5800 |
| Classification: | Class II |
| Predicate Device(s): | K955853 – Healthcare Service & Supply Pump ALP 501 System |

#### Device Description:

Currie Medical Specialties (CMS) ALP® pediatric compression sleeves are compression devices, which when attached to the ALP® 501 Pump System, provide intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The inflation and deflation sequence is predicated by the ALP® 501 Pump System controller.

#### Intended Use:

The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.

This submission is intended for use of the pump at pressure levels of 40 mm Hg.

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### Indications for Use:

The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

## Technological characteristics of the CMS ALP Pediatric Calf Compression Sleeves:

The CMS ALP Pediatric Calf Compression Sleeves indications for use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance characteristics are identical and no different than the predicate device.

## Summary of Comparison Tests (Non-Clinical Tests):

Bench testing was conducted to ensure that the smaller sizing did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices (K955853).

Bench testing was conducted to demonstrate a bladder leak test where the bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by the design change. A bladder seal pull test was performed, where the bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals were intact and were not affected by the design change. A velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by the design change. Finally, an inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the design change did not affect the performance, or the safety and efficacy of the device.

#### Biocompatibility

Due to the materials used in the predicate and pediatric device(s) being identical to each other, biocompatibility of the CMS ALP® Pediatric Calf Compression sleeves is not affected.

#### Summary

The intended use and performance testing demonstrate that the Currie Medical ALP Pediatric Caff Compression Sleeves (all sizes) are substantially equivalent to the predicate device (K955853).