(451 days)
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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 description points to a standard pneumatic compression system.
Yes
The device is intended to "lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk," which is a therapeutic purpose.
No
The device is described as an external pneumatic compression system intended to lower the risk of DVT, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly mentions a "Pump Model VP 500 and Sleeve Model VP 501," which are hardware components of an external pneumatic compression system.
Based on the provided information, the Vaso Press system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk." This describes a therapeutic or preventative medical device that acts externally on the body.
- Device Description: The description mentions a "pump" and "sleeve," which are components of an external pneumatic compression system. This further supports the idea of an external, non-diagnostic device.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or assays.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Vaso Press system's function is to apply external pressure to the limbs, which is a physical intervention, not an in vitro analysis.
N/A
Intended Use / Indications for Use
The Vaso Press system is an external pneumatic compression system intended to lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk.
Product codes
JOW
Device Description
Vaso Press DVT System, Pump Model VP 500 and Sleeve Model VP 501
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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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
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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)
Not Found
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
510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
Name: Britt Corp. Address: 16 Crest Drive, colts Neck, NJ 07722 PO Box 547, Freehold, NJ 07728 Contact Person: J. James Britton Phone Number: (732) 817-1122 Fax Number: (732) 817-1123
510(k) Statement of Safety and Effectiveness
This statement regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
I certify that in my capacity as President of Britt Corp., I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission. including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
Signed:
Name:
Name: V. James Britton Position: President Date: March 9, 1999
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J. James Britton President Britt Corp PO Box 547 Freehold, NJ 07728
Re: K991038 Vaso Press DVT System, Models VP500, VP501 Requlatory Class: II (two) Product Code: JOW Dated: March 22, 2000 March 27, 2000 Received:
Dear Mr. Britton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws on requlations.
2
Page 2 - Mr. J. James Britton
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Brim E. Haimer
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K991038
Vaso Press DVT System, Pump Model VP 500 and Sleeve Model VP 501 Device Name:
Indications For Use:
The Vaso Press system is an external pneumatic compression system intended to lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Y Bere A. Kemper le
(Division Sign-Off)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K991039
(Optional Format 3-10-98)