(28 days)
No
The document describes a pneumatic compression system and its reprocessed sleeves, focusing on mechanical function and compatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is designed to increase venous blood flow in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism, which are medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is designed to apply pressure to a patient's leg to increase venous blood flow and prevent DVT and PE. It does not collect or analyze any physiological data to diagnose a condition.
No
The device description clearly states it is a "sleeve component of the pneumatic compression system" and describes physical components like bladders, tubing, and a valve system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "increase venous blood flow... in order to help prevent deep vein thrombosis and pulmonary embolism." This is a therapeutic and preventative function, not a diagnostic one.
- Device Description: The device description details a pneumatic compression system that applies pressure to the leg. This is a physical intervention, not a test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed 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.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
Product codes
JOW
Device Description
The Reprocessed Compression Sleeves are 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 Sleeves are compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubing to individual bladders within the sleeve. The controller 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 Reprocessed Compression Sleeves are for single-patient-use and are available in knee length (both Express and Comfort Sleeves) and thigh length (Express Sleeves only) 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 Sleeves were tested to demonstrate appropriate functional characteristics through bench top verification and cleaning validation. Testing included visual inspection, simulated use testing, leak testing and system compatibility 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)
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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
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
January 19, 2017
Covidien Nicole Genco Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K163620
Trade/Device Name: Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 21, 2016 Received: December 22, 2016
Dear Nicole Genco:
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 device
1
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 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. 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
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed SCD™ Express Compression Sleeves Reprocessed SCD™Comfort Compression Sleeves
Indications for Use (Describe)
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed 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.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
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/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a light blue vertical line running through the middle. 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: | Nicole Genco |
|---|---|
| Title: | Senior Regulatory Affairs Specialist |
| Telephone: | (508) 452-4128 |
| Date Prepared: | December 21, 2016 |
2. Device:
| Trade Names: | Reprocessed SCD™ Express Compression Sleeve
Reprocessed SCD™ Comfort Compression Sleeve |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Reprocessed Compression Sleeve |
| Classification Name: | Sleeve, Limb, Compressible |
| Regulation Number: | 21 CFR 870.5800 |
| Product Code: | JOW |
| Classification: | Class II |
3. Predicate Devices:
Covidien Reprocessed Compression Garments (K161105)
4. Device Description:
The Reprocessed Compression Sleeves are 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 Sleeves are compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubing to individual bladders within the sleeve. The controller 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 Reprocessed Compression Sleeves are for single-patient-use and are available in knee length (both Express and Comfort Sleeves) and thigh length (Express Sleeves only) configurations.
5
5. Indications for Use:
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in atrisk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in atrisk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
6. Technological Characteristics:
The Reprocessed Compression Sleeves 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 Sleeves were tested to demonstrate appropriate functional characteristics through bench top verification and cleaning validation. Testing included visual inspection, simulated use testing, leak testing and system compatibility verification. The manufacturing process includes visual and functional testing of all reprocessed products prior to release.
8. Conclusion:
Based on cleaning validation and functional testing, Covidien has demonstrated that the Reprocessed Compression Sleeves with one additional reprocessing cycle are substantially equivalent to the existing Reprocessed Compression Garment (K161105).