(50 days)
Not Found
No
The summary describes reprocessed DVT garments and bench testing for substantial equivalence, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" states that the device is a "non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism."
No
The device is described as a non-invasive therapeutic method to prevent deep vein thrombosis and pulmonary embolism, not for diagnosing them.
No
The device description explicitly states it is "DVT garments," which are physical, hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism." It's a garment that applies pressure to the limbs.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device works externally on the body.
Therefore, based on the provided information, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The ReNu Medical Reprocessed Vaso Press CTC 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.
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
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
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:
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 vien thrombosis and resulting pulmonary embolism.
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