(73 days)
Not Found
No
The summary describes a reprocessed medical device (compression sleeves) and its intended use with a pump system. There is no mention of AI, ML, or any computational processing beyond the basic function of the pump.
Yes
The device is described as applying sequential compression to the lower limbs to prevent deep vein thrombosis, which is a medical condition, making it a therapeutic intervention.
No
The device, Medline ReNewal Reprocessed Compression Limb Sleeves, is designed to apply sequential compression to the lower limbs to prevent deep vein thrombosis. Its intended use is prophylactic (preventative), not diagnostic. It does not identify or detect disease.
No
The device description clearly states it is a physical product (limb sleeves made of materials) and is used with a pump system, indicating hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Medline ReNewal Reprocessed Compression Limb Sleeves are used externally on the body to apply physical compression. They do not analyze any samples taken from the body.
- Intended Use: The intended use is to prevent deep vein thrombosis through physical compression, not to diagnose or monitor a condition based on laboratory analysis.
The provided information clearly describes a physical therapy/medical device used for external application, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
Product codes
JOW
Device Description
Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs (leg and foot)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles. Testing included:
• bioburden testing;
• biocompatibility testing (cytotoxicity, irritation, sensitization);
• cleaning process validation;
• equipment qualification; and
• visual inspection.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 3, 2021
Surgical Instrument Service and Savings (dba Medline ReNewal) Richard Wynkoop VP Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K143166
Trade/Device Name: Medline ReNewal Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW
Dear Richard Wynkoop:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 16, 2015. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Nicole Gillette, OHT2: Office of Cardiovascular Devices, 240 - 402 - 6630, Nicole.Gillette@fda.hhs.gov.
Sincerely.
Nicole M. Gillette -S
Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Surgical Instrument Service and Savings (dba Medline Renewal) Richard Wynkoop VP Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K143166
Trade/Device Name: Medline Renewal Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 15, 2014 Received: December 17, 2014
Dear Richard Wynkoop,
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 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
2
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Willemen
for 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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Indications for Use
510(k) Number (if known) K143166
Device Name
Medline ReNewal Reprocessed Compression Limb Sleeves
Indications for Use (Describe)
Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the text is the Medline logo, which features the word "MEDLINE" in blue with a stylized blue symbol.
Special 510(K) Medline ReNewal Reprocessed Compression Limb Sleeves
7.0 510(k) Summary
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon
Richard D. Wynkoop
Director, Regulatory Affairs
VP, QA/RA
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com
E: rwynkoop@medline.com |
| Date Prepared | January 15, 2014 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Compression Limb
Sleeves
Common Name:, Compression Limb Sleeves |
| Classification | Sleeve, limb, compressible
§ 870.5800
Class II
Product Code: JOW |
| Predicate
Device | K012658 - Surgical Instrument Service and Savings, Inc. Reprocessed
Compression Limb Sleeves |
| Device
Description | Medline ReNewal Reprocessed Compression Limb Sleeves are used with a
pump system to apply sequential compression to the lower limbs (leg and
foot). They are made of a variety of materials and come in various sizes.
They are originally manufactured as single use devices. |
| Indications for
Use | Medline ReNewal Reprocessed Compression Limb Sleeves are designed
to be used with a pump system to apply sequential compression to the
lower limbs to prevent deep vein thrombosis. |
| Technological
Characteristics | The technological characteristics of the devices are identical to the
predicate devices. There has been no change to the fundamental scientific
technology of the devices. |
| Performance
Testing | The functional characteristics of the proposed devices have been evaluated
and found to be equivalent to the predicate devices after the specified
number of reprocessing cycles. Testing included:
• bioburden testing;
• biocompatibility testing (cytotoxicity, irritation, sensitization);
• cleaning process validation;
• equipment qualification; and
• visual inspection. |
5
Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
| Conclusion | Based on the information provided, the modified Medline ReNewal Reprocessed Compression Limb Sleeves are substantially equivalent to the predicate device. |
|---|---|
| ------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------ |