(121 days)
Not Found
No
The description focuses on the mechanical function of the compression garment and its compatibility with a pneumatic controller. There is no mention of AI or ML in the intended use, device description, or performance studies. The controller's software is described as delivering and monitoring pressure based on predetermined criteria, which is a standard control system function, not indicative of AI/ML.
Yes
The device is intended to prevent deep vein thrombosis and pulmonary embolism, which are medical conditions, by increasing venous blood flow.
No
The device description clearly states its purpose is to "apply circumferential pressure to a patient's leg... to aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)." This is a therapeutic and preventative function, not a diagnostic one.
No
The device is a physical garment component of a pneumatic compression system, not a software-only device.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a compression garment used with an intermittent pneumatic device. Its function is to apply external pressure to the leg to increase blood flow and prevent blood clots.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. It is a physical therapy/mechanical device applied externally.
Therefore, based on the provided information, the Reprocessed Compression Garment falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Compression Garments (Large and X-Large Sizes)
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.
Compression Garments (Small and Medium Sizes)
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Reprocessed Compression Garment is the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Garment is compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubinq to individual bladders within the garment. The controller's software delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.
The modified reprocessed compressible garment is for single-patient-use and is available in knee length and thigh length confiqurations.
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. 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2016
Covidien Wing Ng Director, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K161105
Trade/Device Name: Reprocessed Compression Garments Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 11, 2016 Received: July 14, 2016
Dear Wing Ng:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Reprocessed Single-Use Device Models Included in Clearance:
| Device Model | Device Name | Original
Manufacturer |
|--------------|------------------------------------------------------|--------------------------|
| 9529R | Reprocessed Express Sleeve - Knee Length
Medium | Covidien |
| 9789R | Reprocessed Express Sleeve - Knee Length
Large | Covidien |
| 9790R | Reprocessed Express Sleeve - Knee Length X-
Large | Covidien |
| 9545R | Reprocessed Express Sleeve - Thigh Length
Small | Covidien |
| 9530R | Reprocessed Express Sleeve - Thigh Length
Medium | Covidien |
| 9780R | Reprocessed Express Sleeve - Thigh Length
Large | Covidien |
| 74021R | Reprocessed Comfort Sleeve - Knee Length
Small | Covidien |
| 74022R | Reprocessed Comfort Sleeve - Knee Length
Medium | Covidien |
| 74023R | Reprocessed Comfort Sleeve - Knee Length
Large | Covidien |
3
510(k) Number (if known): To Be Determined K161105
Device Name: Reprocessed Compression Garment
Indications for Use:
Compression Garments (Large and X-Large Sizes)
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.
Compression Garments (Small and Medium Sizes)
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.
Prescription Use X (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)
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Image /page/4/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a lighter blue vertical stripe and a white square in the center. To the right of the square is the word "COVIDIEN" in blue sans-serif font.
510(K) SUMMARY
1. 510(k) Owner:
Covidien 15 Hampshire Street Mansfield, MA 02048
| Contact: | Mr. Wing Ng |
|---|---|
| Title: | Director, Regulatory Affairs |
| Telephone: | (508) 261 – 6596 |
| Fax: | (508) 261 – 6596 |
| Date Prepared: | April 18, 2016 |
2. Device:
Trade Names: SCD™ Express Compression Sleeve SCD™ Comfort Compression Sleeve Common Name: Compression Garment Classification Name: Sleeve, Limb, Compressible Regulation Number: 21 CFR 876.5800 Product Code: JOW Classification: Class II
3. Predicate Devices:
Covidien Reprocessed Compression Garments (K140813)
4. Device Description:
The Reprocessed Compression Garment is the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Garment is compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubinq to individual bladders within the garment. The controller's software delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.
5
The modified reprocessed compressible garment is for single-patient-use and is available in knee length and thigh length confiqurations.
5. Intended Use:
Compression Garments (Large and X-Large Sizes)
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.
Compression Garments (Small and Medium Sizes)
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.
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. 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 modified Reprocessed Compression Garment is substantially equivalent to the existing Reprocessed Compression Garment (K140813).