(156 days)
The VasoPress pump (VP500D) 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.
VasoPress DVT System, Pump Model VP500D
The provided document is a 510(k) premarket notification letter from the FDA for a medical device (VasoPress DVT System, Pump Model VP500D) that is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about acceptance criteria and specific study results proving the device meets those criteria.
The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but does not raise different questions of safety and effectiveness.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from this document.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
Information that can be extracted or inferred:
- Device Name: VasoPress DVT System, Pump Model VP500D
- Intended Use/Indications for Use: "The VasoPress pump (VP500D) 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."
- Regulatory Class: Class II (two)
- Product Code: JOW
- Regulation Number/Name: 21 CFR 870.5800 / Compressible Limb Sleeve
- Type of Approval: Substantial Equivalence via 510(k) premarket notification. This implies that the device's performance was compared to a predicate device's performance, but the details of that comparison are not included here.
- Standalone Performance: Since it's a pneumatic compression pump, its performance would inherently be "standalone" in the sense that it operates mechanically without human-in-the-loop interpretation like an AI diagnostic tool.
Information that CANNOT be extracted from this document:
- Table of acceptance criteria and reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics.
- Sample sizes used for the test set and data provenance: No test studies or their associated data are described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical studies with ground truth establishment are discussed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not an interpretative AI system.
- The type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device that involves a training set.
- How the ground truth for the training set was established: Not applicable.
Summary Table of Available Information (based on the limits of the provided document):
| Feature | Description / Data Point |
|---|---|
| Acceptance Criteria & Reported Performance | Not detailed in this document. The FDA has made a "substantial equivalence determination" based on comparison to a predicate device, meaning the device's technological characteristics and performance are considered equivalent for its intended use. Specific quantitative performance metrics or acceptance thresholds are not provided. |
| Sample size (test set) & data provenance | Not available in this document. |
| Number & qualifications of experts for ground truth (test set) | Not applicable for this type of device and document. |
| Adjudication method (test set) | Not applicable. |
| MRMC comparative effectiveness study (effect size human + AI vs. human only) | Not applicable. This is a pneumatic compression device, not an AI interpretive system. |
| Standalone performance (algorithm only) | Yes, the device ("VasoPress DVT System, Pump Model VP500D") is a standalone external pneumatic compression device. Its performance relates to its mechanical operation (e.g., pressure cycles, duration) as compared to a predicate, not an interpretive algorithm. The specific performance data for "standalone" operation is not detailed in this letter, beyond the FDA's statement of substantial equivalence. |
| Type of ground truth used | Not applicable in the context of ground truth for diagnostic imaging or similar AI systems. For a physical device, "ground truth" would relate to its physiological effect (e.g., actual reduction in DVT incidence), which would be assessed in clinical trials not detailed in this 510(k) summary. The basis for substantial equivalence is typically comparison to a predicate device, which implies the predicate's established safety and effectiveness forms the "ground truth" for the new device's regulatory pathway. |
| Sample size for training set | Not applicable, as this is not an AI/machine learning device. |
| How ground truth for training set was established | Not applicable. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the emblem. The emblem is black and the text is in a simple, sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 U 2006
Compression Therapy Concepts, Inc. c/o Mr. Leonard Nass 1750 Brielle Avenue, Suite B6 Wanamassa, NJ 07712
Re: K061814
VasoPress DVT System, Pump Model VP500D Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: October 23, 2006 Received: October 24, 2006
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 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. Iisting 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 such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duma R. Vochner
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
. . . . . . . . .
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
. . . . . . .
Device Name: VasoPress DVT System, Pump Model VP500D
、
Indications For Use:
The VasoPress pump (VP500D) 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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)
Duna R. Vochner
(Division Sigil-Off) (Division Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Sign-Seatle-Seat
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510(k) Number Korel8) 4
§ 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).