PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM

K123308 · Albahealth, LLC · JOW · Feb 8, 2013 · Cardiovascular

Device Facts

• Record ID: K123308
• Device Name: PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
• Applicant: Albahealth, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 8, 2013
• Decision: SESE
• Submission Type: Traditional
• 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 Note: The indications for use of the Pulstar Logix Pneumatic Note. The indications is the same as predicate K770956B and K961405

Device Story

Pulstar Logix Intermittent Pneumatic Compression System; device applies external pneumatic compression to limbs to prevent DVT and manage venous insufficiency. System consists of controller unit and inflatable limb sleeves. Operates by inflating/deflating sleeves in cycles to promote venous blood flow. Used in clinical settings or home environments under physician prescription. Healthcare providers monitor patient usage and clinical status to assess DVT risk reduction. Benefits include mechanical prophylaxis against venous stasis.

Clinical Evidence

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

Technological Characteristics

Intermittent pneumatic compression system; consists of electronic controller and inflatable limb sleeves. Operates via pneumatic energy source. Class II device (21 CFR 870.5800).

Indications for Use

Indicated for patients at risk for deep vein thrombosis (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.

Predicate Devices

• K770956B
• K961405

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized depiction of an eagle or bird-like figure. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

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

Albahealth LLC c/o Mr. Patrick Frank 425 North Gateway Ave Rockwood TN 37854

Re: 510(k) Number: K123308 Trade/Device Name: Pulstar Logix Intermittent Pneumatic Compression System Regulation Number: 21 CFR § 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 19, 2012 Received: October 24, 2012

Dear Mr. Frank:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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### Page 2 -- Mr. Patrick Frank

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/1/Picture/6 description: The image shows the name "Bram D. Zuckerman" in a bold, sans-serif font. The first name, "Bram," is followed by the initial "D." which is followed by the last name "Zuckerman". The initial "D" and the last name "Zuckerman" are stylized with a decorative pattern.

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 Statement

210(14) Number (if known)

4477500 K123308

Device Name

Pulstar Logix Intermittent Pneumatic Compression System

Indications For 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

Note: The indications for use of the Pulstar Logix Pneumatic Note. The indications is the same as predicate K770956B and K961405

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801. 109) | X |
|-------------------------------------------|----------|
| | OR |
| Over-The-Counter Use | |
| (Division Sign Off) | |
| Division of Cardiovascular Devices. | |
| 510(k) Number | K123 308 |