(57 days)
The ReNu Medical Reprocessed Aircast VenaFlow 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 vien thrombosis and resulting pulmonary embolism.
The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments. (All sizes)
Acceptance Criteria and Device Performance Study for ReNu Medical Reprocessed Aircast VenaFlow DVT garments
This document describes the acceptance criteria and the study conducted to demonstrate that the ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh, and Foot DVT garments meet these criteria, as presented in K121145.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bladder integrity (no leaks) | 100% verification of bladder integrity performed. Bladders pressurized to 52mmHg with no leaks detected. |
| Velcro adhesion intact at 52mmHg pressure | Velcro evaluated and found to have adhesion intact at 52mmHg pressure. |
| Biocompatibility unaffected by reprocessing | Reprocessing does not affect the biocompatibility of the device. (Stated as a characteristic, not a measured performance against a pre-defined threshold). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size for the bench testing. However, it mentions "100% verification of bladder integrity," which implies that all reprocessed Aircast VenaFlow DVT garments underwent leak testing.
- Sample Size for Test Set: Not explicitly stated as a number, but "100% verification" implies all reprocessed devices were tested for bladder integrity. The number of devices tested for Velcro adhesion is not specified but is part of the general "bench testing."
- Data Provenance: The data is generated from retrospective reprocessing of Aircast VenaFlow DVT garments by ReNu Medical, Inc. The country of origin of the data is implied to be the United States (specifically, Everett, WA, where ReNu Medical, Inc. is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This study does not involve human experts establishing ground truth for a test set in the conventional sense of clinical trials or image interpretation. The testing performed is physical bench testing. Therefore, this question is not applicable to the provided information.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (like 2+1, 3+1) typically applies to expert review of medical cases, often for establishing ground truth in clinical studies involving interpretation. Since this study is focused on physical bench testing of reprocessed medical devices, no adjudication method as described is applicable or mentioned. The testing involves objective measurements (pressure, leak detection, adhesion) rather than subjective expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study focuses on the physical performance and safety of a reprocessed medical device through bench testing, not on the interpretative performance of human readers, with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm-only performance study was done. This device is a physical medical garment, not an algorithm or AI system. The "performance" being evaluated is the physical functionality of the reprocessed device.
7. Type of Ground Truth Used
The "ground truth" for this study is based on objective physical measurements and standards for medical device functionality after reprocessing. Specifically:
- Bladder integrity: Verified by the absence of leaks when pressurized to 52mmHg.
- Velcro adhesion: Verified by the Velcro remaining intact at 52mmHg pressure.
- Biocompatibility: Stated as unaffected, implying adherence to a prior established biocompatibility profile of the original device. This is a characteristic that reprocessing aims not to alter, rather than a dynamic ground truth established for each reprocessed unit.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical garment, not a machine learning model or algorithm. Therefore, there is no "training set" in the context of AI or statistical model development. The manufacturing and reprocessing process can be considered analogous to a "training" phase where procedures are refined, but specific data for a "training set" as understood in AI is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no "training set" for an algorithm, there is no ground truth established for it in this context. The "ground truth" for the manufacturing and reprocessing process would be the design specifications and performance requirements for the original and reprocessed devices, established through engineering design, regulatory standards, and predicate device performance.
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Section 12: 510(k) Summary
JUN 1 2 2012
Submitters Name and Address:
ReNu Medical, Inc. 9800 Evergreen Way Everett, WA 98024 Phone: 425-353-1110 Fax: 425-353-9116
FDA Registration Number: 3034520
Contact Person: L. Bruce Pierson Chief Operating Officer
Date Summary Prepared: 02/20/12
Trade or Proprietary Name(s): ReNu Medical Reprocessed Aircast VenaFlow 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)
510k# K992454, VenaFlow System 30A Aircast VenaFlow DVT garments. (All Sizes). 510k# K031159 ReNu Medical Reprocessed Compression Sleeves different manufactures, types and sizes.
Device Description: The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments. (All sizes)
Indications for Use:
The ReNu Medical Reprocessed Aircast VenaFlow 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 vien thrombosis and resulting pulmonary embolism.
Technological characteristics of the ReNu Medical Reprocessed Aircast VenaFlow DVT garments:
The predicate devices and the ReNu Medical Aircast VenaFlow DVT garments are identical in intended use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance techniques and reprocessing methodology.
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K121145 Pg 2 of 2
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.
Bench testing is conducted to demonstrate leak testing of bladders and Velcro adhesion. 100% verification of bladder integrity is performed on the reprocessed Aircast VenaFlow DVT garments by implementing the leak test where the bladders are pressurized to 52mmHg. In addition the Velcro is evaluated to determine Velcro adhesion intact at this pressure.
Biocompatibility
Reprocessing does not affect the biocompatibility of the device.
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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 or bird symbol to the right of the text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged in a circular fashion around the bird symbol. The bird symbol is composed of three abstract human profiles facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 2 2012
ReNu Medical, Inc. c/o Mr. Bruce Pierson 9800 Evergreen Way Everett, WA 98204
Re: K121145
ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh, and Foot DVT. (All Sizes) Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: April 10, 2012 Received: April 16, 2012
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). and Cosmeter for (110) was 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 may be subject to additions, 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. Bruce Pierson
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.
cmg. Killam
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 4: Indications for Use
510(k) Number (if known):
Device Name: ReNu Medical Reprocessed Aircast VenaFlow Calf, Thigh and Foot DVT garments. (All Sizes)
Indications for Use:
The ReNu Medical Reprocessed Aircast VenaFlow 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 vien thrombosis and resulting pulmonary embolism.
Prescription Use XX (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (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 K21145
§ 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).