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.

Device Description

The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed 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 reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.

AI/ML Overview

The provided text describes the regulatory clearance for the VasoPress Reprocessed DVT Garment. This submission is for the reprocessing of an existing device, not the development of a new AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, ground truth establishment for AI training/test sets, expert adjudication, etc.) are not applicable to this document.

The acceptance criteria and performance testing described relate to the physical and functional integrity of the reprocessed medical device compared to new, unused garments, to demonstrate substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" where the information is absent or irrelevant to a physical reprocessing claim.

Acceptance Criteria and Device Performance for VasoPress Reprocessed DVT Garment

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Reprocessed Garments)	Reported Device Performance (compared to new, unused garments)
Bladder Fatiguing (worst-case simulated use)	Demonstrated robust performance after reprocessing.
Leak Testing of the Bladders	100% verification of bladder integrity. Bladders pressurized to 240mmHg for 30 seconds with allowed pressure drop not above 20 mmHg.
Inflation / Deflation Curve Analysis	Performance substantially equivalent to new, unused garments.
Velcro Adhesion Evaluation	Performed, (implied to be acceptable, as substantial equivalence was established).
Cleanliness (soil removal)	Validated cleaning process based on AAMI TIR30 standards.
End of Life Evaluation	100% verification during reprocessing cycle by leak testing.
Marking	Clearly marked with an indicator that it has been reprocessed.
Packaging	Packaged in an identical manner as new, unused garments.
Sterilization	Exposed to Ethylene Oxide (EO) gas wash (provided non-sterile).

2. Sample Size Used for the Test Set and Data Provenance

The text does not specify the exact sample sizes for each performance test (e.g., number of garments subjected to fatiguing, leak tests, etc.). It only states that "several performance tests were implemented" and "100% verification of bladder integrity is performed on reprocessed VasoPress garments."

Sample Size: Not explicitly stated for all tests, but "100% verification" implies a large sample for leak testing for every reprocessed garment.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal performance validations by the manufacturer, Compression Therapy Concepts, Inc., located in Eatontown, NJ, USA.
Retrospective or Prospective: Not explicitly stated, but typical of internal validation studies conducted before submission for regulatory approval.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a performance validation for a medical device's physical and functional properties after reprocessing, not an AI/ML diagnostic device requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not Applicable. This relates to human expert review for diagnostic classifications, not physical device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Not Applicable. This is a study type for evaluating the impact of an AI system on human reader performance, which is irrelevant for the physical performance validation of a reprocessed DVT garment.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not Applicable. This term usually applies to AI algorithms. The "standalone performance" here would be the physical testing of the garment itself, which was indeed done. The tests mentioned (fatiguing, leak, inflation/deflation, Velcro) are exactly the standalone, algorithm-only type of tests for a physical device.

7. The Type of Ground Truth Used

The ground truth for this submission is the functional and material equivalence to new, unused VasoPress DVT Garments. The performance of new garments serves as the benchmark against which the reprocessed garments are compared.

8. The Sample Size for the Training Set

Not Applicable. The concept of a "training set" is relevant for machine learning models. This submission is for a reprocessed medical device. The data used to establish the reprocessing parameters might be considered analogous to a training set in a broad sense, but the specific number is not provided. The performance testing is analogous to a "test set" for the reprocessed garments.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As above, the concept of ground truth for a "training set" is not directly applicable to this type of device. The "ground truth" for developing the reprocessing method would have been based on established engineering principles, material science, and regulatory standards (like AAMI TIR30 for cleaning) to ensure the reprocessed device performs like a new one.

Summary

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K112838
pg 1 of 2

SECTION 6: 510(k) SUMMARY

NOV 1 0 2011

Date of Preparation: September 28, 2011

Company Name / Contact:

Company: Compression Therapy Concepts. Inc. 35 James Wav Eatontown, NJ 07724-2272

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 Reprocessed DVT Garment Compressible Limb Sleeve 21 CFR § 870.5800 Cardiovascular JOW Class II

Predicate Device:

The VasoPress Reprocessed DVT Garments are substantially equivalent to devices in commercial distribution by Compression Therapy Concepts, Inc., 35 James Way, Eatontown, NJ 07724. Specifically the VasoPress DVT Leg Garments VP 501 (K991038) and VasoPress DVT Foot Garments VP 520 (K003828).

Device Description:

Indications for Use:

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K112838
pg 2 of 2

This is the same intended use as previously cleared for the VasoPress DVT Garments under K991038 and K003828.

Technological Characteristics:

The VasoPress Reprocessed 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.

Performance Testing:

To demonstrate robust performance of VasoPress DVT garments after reprocessing, several performance tests were implemented:

Bladder fatiguing (worst-case simulated use) .
Leak testing of the bladders .
Inflation / Deflation curve analysis of reprocessed versus new, unused . VasoPress garments
Velcro adhesion evaluation .

Each of the above evaluations were performed after reprocessing and compared to garments that were not reprocessed to establish substantial equivalence. A detailed summary of performance test data is provided in Section 12 to this 510(k). The data demonstrates that reprocessed garments perform in a substantially equivalent manner to new, unused garments.

100% verification of bladder integrity is performed on reprocessed VasoPress garments by implementing the leak test whereby the bladders are pressurized to 240mmHg (twice the amount deliverable by the garment's pump) and allowed to dwell for thirty (30) seconds without a drop in pressure above 20 mmHg. This 100% testing of reprocessed VasoPress garments demonstrates that every garment is functional prior to release and is consistent with the manner of testing for new, unused devices.

Summary of Reprocessing:

Reprocessed VasoPress garments are exposed to a validated cleaning process based upon requirements for soil removal defined in AAMI TIR30. All garments are evaluated for end of life via 100% verification during the reprocessing cycle by leak testing of the garment bladder. Reprocessed VasoPress garments are clearly marked with an indicator that it has been reprocessed and the garments are packaged in an identical manner as new, unused garments. Garments are exposed to an EO wash as a final processing step.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 0 2011

Compression Therapy Concepts, Inc. c/o Mr. Leonard Nass Vice President 35 James Way Eatontown, NJ 07724-2272

Re: K112838

VasoPress Reprocessed DVT Garment Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: September 27, 2011 Received: September 28, 2011

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

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Page 2 - Mr. Leonard Nass

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 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 (OS) 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/ucm11.5809.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 Pari 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,

/LL

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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K112838

INDICATIONS FOR USE

510(k) Number (if known): _K || 2 SBB

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use X (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

ion Sign-Off) on of Cardiovascular Devices

510(k) Number K112838

Page _1_of _1

Regulation Number and Section

§ 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).