The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.

Device Description

The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments. (All sizes)

AI/ML Overview

This document describes the 510(k) submission for the ReNu Medical Reprocessed Vaso Press CTC DVT garments. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a new device.

Therefore, much of the requested information about a study proving the device meets acceptance criteria cannot be extracted because such a study, with defined acceptance criteria and detailed performance metrics, is not present in the provided text. The submission relies on "bench testing" to ensure reprocessing doesn't compromise performance compared to predicate devices.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Reprocessing does not affect the biocompatibility of the device.
Overall Performance (post-reprocessing)	Bench testing conducted to ensure that reprocessing did not compromise the performance of the device in a manner that is substantially equivalent to that of the predicate devices.
Intended Use	Identical to predicate device.
Fundamental Scientific Technology	Identical to predicate device.
Overall Design	Identical to predicate device.
Materials	Identical to predicate device.
Energy Source	Identical to predicate device.
Mode of Operation	Identical to predicate device.
Performance Techniques	Identical to predicate device.
Reprocessing Methodology	Identical to predicate device.

Missing Information: Specific quantitative acceptance criteria (e.g., pressure output ranges, cycle life, material strength after reprocessing) are not provided. The performance is described qualitatively as "not compromised" and "substantially equivalent."

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

Sample Size for Test Set: Not specified. The document mentions "bench testing" but does not detail the number of units tested.
Data Provenance: Not specified. The testing was conducted by ReNu Medical, Inc., but the location or whether the data is retrospective or prospective is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable as the submission describes bench testing for substantial equivalence, not a clinical study requiring expert-established ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

This information is not applicable for the type of bench testing described.

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

An MRMC comparative effectiveness study was not done. This submission is for reprocessed medical devices, not an AI-powered diagnostic or assistive device.

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

This information is not applicable. This is not an algorithmic or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is the performance of the original, new, legally marketed predicate devices. The reprocessed device is compared against the performance characteristics of these predicate devices to demonstrate substantial equivalence, particularly that reprocessing did not degrade these characteristics.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable as there is no training set for this type of device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "K093658 pg 1 of 2" written in black ink on a white background. The text appears to be handwritten. The text "K093658" is larger than the text "pg 1 of 2". The text "pg 1 of 2" indicates that this is page 1 of a 2-page document.

510(k) Summary

Submitters Name and Address: ReNu Medical, Inc. 9800 Evergreen Way Everett, WA 98024 Phone: 425-353-1110 Fax: 425-353-9116

JAN 1 4 2010

FDA Registration Number: 3034520

Contact Person: L. Bruce Pierson Chief Operating Officer

Date Summary Prepared: 01/06/10

Trade or Proprietary Name(s): ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments. (All sizes)

Common Name: Sleeve, limb, compression

Product Code: JOW

Panel: Cardiovascular 870.5800

Classification: Class II

Equivalent Device(s)

The ReNu Medical Reprocessed ALP DVT garments. 510k# K051227 ReNu Medical Reprocessed many different manufacturers types/sizes DVT garments 510k# K031159

Device Description:

The ReNu Medical Reprocessed Vaso Press CTC calf, thigh and foot DVT garments. (All sizes)

Indications for Use:

The ReNu Medical Reprocessed Vaso Press CTS Calf, Thigh and foot DVT garments are to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of alphanumeric characters and some additional text. The alphanumeric part reads 'K093658', and next to it, there is 'Pg 2 of 2'. The text is written in black ink on a white background, and the handwriting style is cursive.

Technological characteristics of the ReNu Medical Reprocessed Vaso Press CTC DVT garments:

The predicate devices and the ReNu Medical Vaso Press CTC DVT garments are identical in intended use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance techniques and reprocessing methodology.

Summary of Comparison Tests

Bench testing was conducted to ensure that reprocessing did not compromise the performance of the device in a manner that is substantially equivalent to that of the predicate devices.

Biocompatibility

Reprocessing does not affect the biocompatibility of the device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 4 2010

ReNu Medical, Inc. c/o Mr. Bruce Pierson, COO 9800 Evergreen Way Everett, WA 98204

Re: K093658

ReNu Medical Reprocessed Vaso Press CTC Calf, Thigh and Foot DVT garments. (ALL Sizes) Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: November 20, 2009 Received: November 25, 2009

Dear Mr. Pierson:

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Bruce Pierson, COO

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

sma R. Viher

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K093658

Indications for Use

510(k) Number (if known): K093658

Device Name: ReNu Medical Reprocessed Vaso Press CTC Calf, Thigh and Foot DVT garments. (All Sizes)

Indications for Use:

Prescription Use XX (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)

R.V. Luner

Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_Kog3(e5) 5

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).