(108 days)
Not Found
Not Found
No
The summary describes a standard pneumatic compression device and makes no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk," indicating a therapeutic purpose.
No
The device 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. It does not mention analyzing patient data to identify or characterize a disease or condition.
No
The device description explicitly states it is an "external pneumatic compression device," which is a hardware component, and it is used with "VasoPress Sequential Garments," which are also hardware. The summary does not mention any software-only functionality.
Based on the provided information, the VasoPress Sequential DVT Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The VasoPress Sequential DVT Pump is described as an "external pneumatic compression device" used to "lower the risk of deep vein thrombosis (DVT)". This is a physical therapy/prevention device that acts externally on the body.
- Lack of IVD Characteristics: The description does not mention analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, the VasoPress Sequential DVT Pump falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential 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
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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
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903. New Hampshire Avenue Document Control Room -WO66-G6 Silver Spring, MD 20993-0002
Mr. Leonard Nass Compression Therapy Concepts, Inc. 35 James Way Eatontown, NJ 07724
JAN 2 0 201
Re: K102940
Trade/Device Name: VasoPress Sequential DVT Pump, Model-VP500DS Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 29, 2010 Received: October 4, 2010
Dear Mr. Nass:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosine) to regally mannet date of the Medical Device American Frank Food. Drug commerce prof to May 20, 1978, the enaonance with the provisions of the Federal Food, Drug. devices that have been receise in assee approval of a premarket approval application (PMA). and Cosment AC (ACI) that to hot require approvisions provisions of the Act. The You may, therefore, manset the doctor, beloject of the manual registrator, listing of the read general controls provisions of the fiel labeling, and prohibitions against mistranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Thease note: ODTCP 8000 at 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 11 your device is Classified (soc above) Existing major regulations affecting your device can be may be subject to additional Controls: "Entring may .
found in the Code of Federal Regulations, Title 21, Partis the Faderal Register found in the Code of Poderning your device in the Federal Register.
1
Page 2 Mr. Leonard Nass
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/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,
David R. Richter
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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Image /page/2/Picture/0 description: The image shows a logo for Compression Therapy Concepts, abbreviated as CTC. The letters CTC are large and bold, with "Compression Therapy Concepts" written in smaller font above the letters. The letters are black and the background is white.
Indications for Use Statement
JAN 2 0 2011
K102940 510(k) Number:
Device Name: VasoPress Sequential DVT Pump
Indications for Use:
The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
AND/OR Over-the-Counter Use Prescription Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anna R. V. A. A. A.
(Division Sign-Off) (Division Sign Sign Sin
510(k) Number_K102946
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