(57 days)
Not Found
No
The device description and performance studies focus on the reprocessing of garments and mechanical testing, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism."
No
Explanation: The device is described as a "non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism," indicating a preventative or therapeutic function rather than a diagnostic one. There is no mention of it being used to detect or diagnose a condition.
No
The device description and performance studies clearly indicate a physical garment with bladders and Velcro, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent deep vein thrombosis (DVT) and pulmonary embolism through a non-invasive therapeutic method. This involves applying external pressure to the limbs.
- Device Description: The device is described as garments (calf, thigh, foot) used for DVT prevention.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).
The device is a therapeutic device that applies physical pressure to the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The ReNu Medical Reprocessed Aircast VenaFlow calf, thigh and foot DVT garments. (All sizes)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Calf, Thigh and Foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients in both the home and institutional settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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.
2
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.
3
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
4
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