(27 days)
The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
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The provided text is a 510(k) summary for a medical device (VasoGrad DVT Garment, Model-VG530). This type of document primarily focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria, performance metrics, and specific ground truth methodologies in the way a clinical trial report or a performance study would.
Therefore, the requested information elements related to detailed study design and acceptance criteria for demonstrating device performance (like specific accuracy metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not present in this document.
However, I can extract the following relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal "acceptance criteria" with quantitative targets (e.g., sensitivity > X%, specificity > Y%) or device performance metrics against such criteria. The FDA review determined that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is the primary "acceptance criterion" met for 510(k) clearance.
| Acceptance Criterion (Implied for 510(k)) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| Substantial Equivalence to Predicate Device | Device determined to be substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The 510(k) process typically relies on demonstrating equivalence through design, materials, and intended use, often supported by bench testing and sometimes limited clinical data, but not necessarily a large-scale, independent test set similar to diagnostic AI studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. This device is a physical, external pneumatic compression device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the context of device performance in a diagnostic sense. The "ground truth" for the 510(k) clearance is that the device's design, materials, and intended effect are substantially equivalent to a predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This device does not involve a machine learning training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT 1 9 2010
Compression Therapy Concepts, Inc. c/o Mr. Leonard Nass 35 James Way Eatontown, NJ 07724
Re: K102732
Trade/Device Name: VasoGrad DVT Garment, Model-VG530 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 21, 2010 Received: September 22, 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 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.
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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); 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/ReportalProblem/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,
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 Statement
OCT 1 9 2010
K102732 510(k) Number:
VasoGrad DVT Compression Garment Device Name:
Indications for Use:
The VasoGrad DVT Compression Garment is an external pneumatic compression device for use with VasoPress DVT Pumps, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
Prescription Use × (Per 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)
(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K102732
§ 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).