(52 days)
Not Found
No
The description focuses on a mechanical device for pneumatic compression and does not mention any AI/ML components or functionalities.
Yes
The device is described as promoting blood flow and is indicated for conditions like circulation enhancement, deep vein thrombosis prophylaxis, and edema, all of which aim to treat or prevent medical conditions.
No
The device description indicates it "deliver[s] a set amount of pressure to the foot in order to promote blood flow," which is a therapeutic function, not a diagnostic one. Its intended uses also focus on prophylaxis and enhancement, not diagnosis. The performance studies focus on functional characteristics and biocompatibility, not diagnostic accuracy.
No
The device description explicitly states it is a "single patient use garment that connects to an intermittent pneumatic controller via a tubing set," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies pressure to the foot to promote blood flow and address various circulatory issues. This is a therapeutic or prophylactic function, not a diagnostic one.
- Device Description: The description confirms it's a garment that connects to a pneumatic controller to deliver pressure. This aligns with a physical therapy or medical device used for treatment or prevention, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and is indicated for:
- Circulation Enhancement
- Deep Vein Thrombosis Prophylaxis
- Edema – Acute
- Edema Chronic ●
- Extremity Pain Incident to Trauma or Surgery ●
- . Leg Ulcers
- Venous Stasis/ Venous Insufficiency o
Product codes
JOW
Device Description
The Reprocessed Kendall SCD™ Express Foot Cuff is a single patient use garment that connects to an intermittent pneumatic controller via a tubing set to deliver a set amount of pressure to the foot in order to promote blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Representative samples of the reprocessed foot cuffs were tested to demonstrate appropriate functional characteristics through bench top verification. Testing included; hook and loop simulated use, leak testing and system compatibility. Biocompatibility testing was conducted in accordance with ISO 10993-1. The cleaning process was validated in accordance with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and functional testing of all reprocessed products prior to release.
Key Metrics
Not Found
Predicate Device(s)
Kendall SCD™ Express Foot Cuff, K040511
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and conveys the department's focus on health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
Covidien Jennifer Sullivan Regulatory Affairs Manager 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K163055
Trade/Device Name: Reprocessed Kendall SCD Express Foot Cuff Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 31, 2016 Received: November 1, 2016
Dear Jennifer Sullivan:
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 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 (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.
1
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,
M.A. Hillemann
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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| Device Model | Device Name | Original
Manufacturer |
|--------------|--------------------------------------------------------|--------------------------|
| 5897R | Reprocessed Kendall SCDTM Express Foot Cuff – Regular | Covidien |
| 5898R | Reprocessed Kendall SCDTM Express Foot Cuff – Large | Covidien |
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510(k) Number (if known): K163055
Device Name:
Reprocessed Kendall SCD™ Express Foot Cuff
Indications for Use:
The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and is indicated for:
- Circulation Enhancement
- Deep Vein Thrombosis Prophylaxis
- Edema – Acute
- Edema Chronic ●
- Extremity Pain Incident to Trauma or Surgery ●
- . Leg Ulcers
- Venous Stasis/ Venous Insufficiency o
Prescription Use: X AND/OR Over-the-Counter Use: (Part 21 CFR 801 Subpart D) (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)
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Image /page/4/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a lighter blue cross shape inside, followed by the word "COVIDIEN" in a bold, dark blue font. The logo is simple and modern, with a focus on the company name.
510(k) SUMMARY
1. 510(k) Owner:
Covidien 15 Hampshire Street Mansfield, MA 02048
Contact: Jennifer Sullivan Title: Regulatory Affairs Manager Telephone: (508) 452-1659 Fax: (508) 452-1659 Email: jennifer.sullivan@medtronic.com Date Prepared: October 31, 2016
2. Device:
| Trade Name: | Reprocessed Kendall SCD™ Express Foot Cuff |
|---|---|
| Classification Name: | Sleeve, Limb, Compressible |
| Regulation Number: | 21 CFR 870.5800 |
| Product Code(s): | JOW |
| Classification: | Class 2 |
3. Predicate Devices:
Kendall SCD™ Express Foot Cuff, K040511
4. Device Description:
The Reprocessed Kendall SCD™ Express Foot Cuff is a single patient use garment that connects to an intermittent pneumatic controller via a tubing set to deliver a set amount of pressure to the foot in order to promote blood flow.
5. Intended use: The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and is indicated for:
- Circulation Enhancement ●
- Deep Vein Thrombosis Prophylaxis ●
- Edema – Acute
- . Edema - Chronic
- . Extremity Pain Incident to Trauma or Surgery
- . Leg Ulcers
- Venous Stasis/ Venous Insufficiency .
5
6. Technological Characteristics:
The Reprocessed Kendall SCD™ Express Foot Cuffs are identical to the predicate device in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation.
7. Performance Data:
Representative samples of the reprocessed foot cuffs were tested to demonstrate appropriate functional characteristics through bench top verification. Testing included; hook and loop simulated use, leak testing and system compatibility. Biocompatibility testing was conducted in accordance with ISO 10993-1. The cleaning process was validated in accordance with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and functional testing of all reprocessed products prior to release.
8. Conclusion:
Based on functional testing, Covidien has demonstrated that the Reprocessed Kendall SCD™ Express Foot Cuffs are substantially equivalent to the predicate device as described in this premarket notification.