(28 days)
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
The VasoPress DVT Leg Garment (sterile) consists of a brushed nylon outer material bonded to a foam inner liner bonded to an inner lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The devices are terminally sterilized with Ethylene Oxide (EO) gas.
The provided text describes the acceptance criteria and performance testing for the VasoPress DVT Garment (sterile). It does not contain information about a study proving the device meets the acceptance criteria in the context of clinical effectiveness or performance against a ground truth. Instead, the performance testing focuses on manufacturing quality control.
Here's the breakdown of the information that can be extracted:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bladder integrity: pressurize to 120 mmHg | Bladders are pressurized to 120 |
| Dwell for 30 seconds | Dwell for thirty (30) seconds |
| Drop in pressure not above 20 mmHg | No drop in pressure above 20 mmHg |
(Note: The reported performance is a statement of the test methodology and expected outcome rather than specific numerical results from a study.)
2. Sample Size Used for the Test Set and Data Provenance
The document states "100% verification of bladder integrity via leak test." This implies a sample size of 100% of manufactured devices for this specific test.
Data Provenance: The data provenance is not explicitly mentioned as coming from a specific country or being retrospective/prospective in a clinical research sense. It relates to manufacturing quality control checks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance testing described is a technical test of bladder integrity, not a clinical assessment requiring expert interpretation or ground truth establishment in the traditional sense of a medical device study (e.g., image analysis, diagnosis).
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is a pass/fail technical test, not a subjective assessment requiring consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in the provided text. The document focuses on manufacturing and technological equivalence.
6. Standalone Performance Study
No, a standalone (algorithm-only without human-in-the-loop performance) study was not done. This device is a physical, pneumatic compression device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this performance test is the physical property of bladder integrity per the specified pressure and leak parameters. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. The device is a physical product, and the performance testing described relates to manufacturing quality, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and performance testing.
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K122179 pg 1 of 2
SECTION 6: 510(k) SUMMARY
AUG 20 2012
Date of Preparation: July 20, 2012
Company Name / Contact:
Company: Compression Therapy Concepts, Inc. 555 Industrial Way West Eatontown, NJ 07724-2298
Contact:
Leonard Nass Phone: (732) 544-0800 Fax: (732) 544-0850 LNass@ctcdvt.com
Establishment Registration Number: 2249552
Device Identification:
Proprietary Name: Common Used Name: Classification Reference: Classification Panel: Device Product Code: Proposed Regulatory Class:
VasoPress DVT Garment (sterile) Compressible Limb Sleeve 21 CFR § 870.5800 Cardiovascular JOW Class II
Predicate Device:
The VasoPress DVT Garments (sterile) are substantially equivalent to devices in commercial distribution by Compression Therapy Concepts, Inc., 555 Industrial Way West, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038, K112838) and VasoPress DVT Foot Garments VP 520 (K003828, K112838).
Device Description:
The VasoPress DVT Leg Garment (sterile) consists of a brushed nylon outer material bonded to a foam inner liner bonded to an inner lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The devices are terminally sterilized with Ethylene Oxide (EO) gas.
Intended Use:
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
This is the same intended use as previously cleared for the VasoPress DVT Garments under K991038, K003828, and K112838.
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Technological Characteristics:
The sterile VasoPress DVT Garments have the same technological characteristics as the predicate devices. The materials used in the garments are identical and the mode of operation is unchanged.
PerformanceTesting:
The sterile VasoPress DVT Garments have the same performance testing requirements as the predicate devices. This includes 100% verification of bladder integrity via leak test where the bladders are pressurized to 120 mmHg and allowed to dwell for thirty (30) seconds without a drop in pressure above 20 mmHg. EO sterilization is performed at temperatures and pressures which will not impact bladder integrity.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three curved shapes that resemble a stylized caduceus, a symbol often associated with healthcare. The text is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 200 2012
Compression Therapy Concepts, Inc. c/o Mr. Leonard Nass 35 James Way Eatontown, NJ 07724-2272
Re: K122179
Trade/Device Name: VasoPress DVT Garment (Sterile) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 20, 2012 Received: July 23, 2012
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.
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
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Page 2 - Mr. Leonard Nass
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,
Cm&thillabe
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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SECTION 5: DEVICE INDICATIONS FOR USE
510(k) Number (if known):
Device Name: VasoPress DVT Garment (Sterile)
Indications for Use:
The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
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)
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K122179
Page 1 of 1
§ 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).