(105 days)
Not Found
No
The description focuses on the mechanical function of the compression garments and their compatibility with a pneumatic controller, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to increase venous blood flow to help prevent deep vein thrombosis and pulmonary embolism, which are therapeutic medical conditions.
No
The device is described as a reprocessed compression garment intended to apply pressure to a patient's leg to aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), not to diagnose a condition.
No
The device description explicitly states that the device is a "compressible limb sleeve component" and mentions "tubing connected to each bladder of the sleeve," indicating it is a physical hardware component.
Based on the provided information, 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 that the Reprocessed Compression Garments are a component of a pneumatic compression system that applies pressure to a patient's leg to increase blood flow and prevent DVT and PE. This is a physical intervention applied externally to the body.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
The device is a therapeutic device used externally on the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended use for following codes: 9529(R), 9530(R), 9545(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
Intended use for following codes: 9780(R), 9789(R), 9790(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Reprocessed Compression Garments are the compressible limb sleeve component of a pneumatic compression system intended to apply pressure to a patient's leg to aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Garments are compatible with the OEM pneumatic compression controller. The controller provides air to the sleeves through tubing connected to each bladder of the sleeve for the purposes of delivering pneumatic pressure to the limb. The controller software monitors the pressure in the bladders and releases the pressure by venting the air from the sleeve bladders through a valve system.
The proposed reprocessed device is for single-patient-use and will be available in knee and thigh configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of the Reprocessed Compression Garments were tested to demonstrate appropriate functional characteristics through bench top verification and process validation. Visual inspection, leak testing, reliability testing and biocompatibility performance data were used to demonstrate the device function. Testing was performed to validate the cleaning process in line with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and functional testing of all reprocessed products prior to release.
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
JUL 15 2014
COVIDIEN
TRADITIONAL 510(K) SUMMARY
1. 510(k) Owner:
Applicant:
Telephone: Fax:
Covidien 15 Hampshire Street Mansfield, MA 02048 (508) 452 - 4135 (508) 452 - 1640
Contact: Title: Date Prepared: Daniel Campion Director Regulatory Affairs 3/28/2014
2. Device:
| Trade Name: | |
|---|---|
| Classification Name: | |
| Regulation Number: | |
| Product Code(s): | |
| Classification: |
Covidien Reprocessed Compression Garments Sleeve, Limb Compressible 21 CFR 870.5800 JOW Class II
3. Predicate Device:
The Reprocessed Compression Garments are substantially equivalent in intended use and operation to the predicate Compression Garments (K051805 and K781357).
4. Device Description:
The Reprocessed Compression Garments are the compressible limb sleeve component of a pneumatic compression system intended to apply pressure to a patient's leg to aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Garments are compatible with the OEM pneumatic compression controller. The controller provides air to the sleeves through tubing connected to each bladder of the sleeve for the purposes of delivering pneumatic pressure to the limb. The controller software monitors the pressure in the bladders and releases the pressure by venting the air from the sleeve bladders through a valve system.
The proposed reprocessed device is for single-patient-use and will be available in knee and thigh configurations.
5. Intended Use:
Intended use for following codes: 9529(R), 9530(R), 9545(R),
The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
1
Intended use for following codes: 9780(R), 9789(R), 9790(R),
The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
6. Technological Characteristics:
The Reprocessed Compression Garments 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 Compression Garments were tested to demonstrate appropriate functional characteristics through bench top verification and process validation. Visual inspection, leak testing, reliability testing and biocompatibility performance data were used to demonstrate the device function. Testing was performed to validate the cleaning process in line 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 the performance and cleaning results Covidien concludes that the Reprocessed Compression Garments are safe, effective, and substantially equivalent to the predicate device as described in this premarket notification submission
2
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
July 15, 2014
Covidien Mr. Daniel Campion Director Regulatory Affairs 15 Hampshire Street Mansfield, MA 02048 US
Re: K140813
Trade/Device Name: Reprocessed Kendall SCD Express Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: June 18, 2014 Received: June 20, 2014
Dear Mr. Campion:
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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
3
Page 2 - Mr. Daniel Campion
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers. International and Consumer Assistance 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.
MA Zilleben
for
for 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 Statement
510(k) Number (if known): K140813
Device Name: Covidien Reprocessed Compression Garments
Indications for Use:
Intended use for following codes: 9529(R), 9530(R), 9545(R), The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
Intended use for following codes: 9780(R), 9789(R), 9790(R),
The Reprocessed Compression Garments are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
M.A. Hillemann