(28 days)
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No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing, which are often associated with AI/ML in medical devices. The description focuses on the device's function as an external pneumatic compression pump.
Yes
The device is described as an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT), which is a medical condition, making it a therapeutic device.
No
The VasoPress Pump is described as an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT), which is a preventative or therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "Pump Model No. VP500DM," which is a hardware component (an external pneumatic compression device).
Based on the provided information, the VasoPress Pump (Model VP500DM) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "lower the risk of deep vein thrombosis (DVT) in patients who may be at risk" using external pneumatic compression. This is a therapeutic and preventative function performed on the patient's body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description refers to a "Pump" and "garments," which are components of a physical therapy/medical device used externally.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition based on sample analysis.
- Using reagents or assays.
Therefore, the VasoPress Pump is a medical device used for external physical therapy/prevention, not an IVD.
N/A
Intended Use / Indications for Use
The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Product codes
JOW
Device Description
VasoPress DVT Supreme Mini, Pump Model No. VP500DM
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem, which features a stylized caduceus-like symbol with three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle. The emblem is black and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG - 6 2010
Compression Therapy Concepts c/o Leonard Nass, PhD, CBM Vice President 35 James Way Eatontown, NJ 07724
Re: K101915
VasoPress DVT Supreme Mini, Pump Model No. VP500DM Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 6, 2010 Received: July 9, 2010
Dear Mr. Nass:
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 intentate 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, Or w 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 1 1 . 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.
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.
1
Page 2 - Leonard Nass, PhD, CBM
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ina R. becher.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K101915
Indications for Use
AUG - 6 2010
510(k) Number (if known): K101915
VasoPress DVT Supreme Mini, Pump Model No. VP500DM Device Name:
Indications For Use:
The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
b. Schmer
Page 1 of
510(k) Number_KIO)915
Division of Cardiovascular Devices
(Division Sign-Off)