PULSTAR LOGIX PUMP

K141609 · Albahealth, LLC · JOW · Jul 15, 2014 · Cardiovascular

Device Facts

• Record ID: K141609
• Device Name: PULSTAR LOGIX PUMP
• Applicant: Albahealth, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Jul 15, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Patients at Risk for DVT: These include: a. Major orthopedic procedures e.g. knee surgery Major abdominal thoracic surgery including urogenital surgery Neurosurgery, subarachnoid hemorrhage and stroke Bedridden Medical patients b. Patients with chronic venous insufficiency

Device Story

Pulstar Logix Pump is a compression device designed to prevent deep vein thrombosis (DVT) and manage chronic venous insufficiency. It operates by delivering pneumatic compression to a limb sleeve, which promotes venous blood flow. The device is intended for use in clinical settings under the direction of a healthcare provider. By applying sequential or intermittent pressure, the pump reduces venous stasis, thereby lowering the risk of thrombus formation in at-risk patient populations. The healthcare provider sets the operational parameters, and the device functions to provide mechanical prophylaxis against DVT.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to existing legally marketed devices.

Technological Characteristics

Pneumatic compression pump system; utilizes limb sleeves for pressure application; intended for DVT prophylaxis; Class II device (21 CFR 870.5800).

Indications for Use

Indicated for patients at risk for DVT, including those undergoing major orthopedic, abdominal, thoracic, urogenital, or neurosurgery; patients with subarachnoid hemorrhage or stroke; bedridden medical patients; and patients with chronic venous insufficiency.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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July 15, 2014

Albahealth LLC Mr. Shane Bruce Quality Assurance and Compliance Manager 425 N Gateway Avenue Rockwood, TN 37854

Re: K141609

Trade/Device Name: Pulstar Logix Pump Regulation Number: 21 CFR 870.5800 Regulation Name: Compression limb sleeve Regulatory Class: Class II Product Code: JOW Dated: June 10, 2014 Received: June 16, 2014

Dear Mr. Shane Bruce:

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 commence 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 docs 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 that + 27 the I 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

Public Health Service

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

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Page 2 - Mr. Shane Bruce

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 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" (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 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,

MZ. Willmann

for

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141609

Device Name Pulstar Logix Pump

| Indications for Use (Describe) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patients at Risk for DVT: |
| These include: |
| a. Major orthopedic procedures e.g. knee surgery<br>Major abdominal thoracic surgery including urogenital surgery<br>Neurosurgery, subarachnoid hemorrhage and stroke<br>Bedridden Medical patients |
| b. Patients with chronic venous insufficiency |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

MZ Stillman

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