(107 days)
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
Pulstar Logix Intermittent Pneumatic Compression System
This document is an FDA 510(k) clearance letter for the Pulstar Logix Intermittent Pneumatic Compression System. It does not contain information about a study proving the device meets acceptance criteria, an AI/ML component, or detailed performance data. Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for a study.
- Types of ground truth or training set details.
The letter explicitly states: "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... to legally marketed predicate devices..." This indicates the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria for an AI/ML algorithm.
The "Indications for Use Statement" only lists the medical conditions for which the device is intended. It does not provide any performance data or study results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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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
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) | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Division Sign Off) | |
| Division of Cardiovascular Devices. | |
| 510(k) Number | K123 308 |
§ 870.5800 Compressible limb sleeve.
(a)
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.(b)
Classification. Class II (performance standards).