(107 days)
K770956B, K961405
K770956B,K961405
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is for an intermittent pneumatic compression system, which is a mechanical device.
Yes
The device is intended for patients at risk for DVT, which is a medical condition, and it provides intermittent pneumatic compression, indicating a therapeutic function.
No
The device description states it is an "Intermittent Pneumatic Compression System," which is a therapeutic device used to prevent DVT, not to diagnose it.
No
The device description explicitly states "Pulstar Logix Intermittent Pneumatic Compression System," which is a hardware system used for DVT prevention. The summary does not mention any software-only component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used on patients to prevent DVT, which is a physical intervention. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
- Device Description: The description "Intermittent Pneumatic Compression System" indicates a physical device that applies pressure to the limbs. This is consistent with a therapeutic or preventative medical device, not a diagnostic one.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the Pulstar Logix Intermittent Pneumatic Compression System is a medical device used for the prevention of DVT, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
JOW
Device Description
Pulstar Logix Intermittent Pneumatic Compression System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K770956B, K961405
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 (800) 638-2041 or (301) 796-7100 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
2
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 |