(27 days)
Not Found
No
The description focuses on standard pneumatic compression technology and does not mention AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for medical conditions such as DVT prophylaxis, circulation enhancement, and edema, which are therapeutic applications.
No
Explanation: The device is designed to apply pneumatic compression to increase venous blood flow and prevent conditions like DVT and PE, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it consists of a controller, tubing sets, and garments, which are all hardware components. The performance studies also include testing of electrical safety, electromagnetic compatibility, and enclosure protection, further indicating it is a hardware device with embedded software.
Based on the provided information, the Kendall SCD 700 Sequential Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Kendall SCD 700 System applies external compression to the limbs. It does not analyze blood, tissue, or any other bodily fluid or substance.
- The intended use and device description clearly state its function is to apply pneumatic compression to increase blood flow and prevent DVT/PE. This is a mechanical intervention, not a diagnostic test performed on a sample.
Therefore, the Kendall SCD 700 Sequential Compression System falls under the category of a therapeutic or prophylactic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kendall SCD 700 Sequential Compression Controller is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SCD 700 Series") is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The System consists of the controller, the tubing sets (provided with the controller) and singlepatient use garments (purchased separately from this controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle has reached set pressure, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.
The use of the Kendall SCD 700 Series Compression System with Leg Sleeves is indicated for:
- Deep vein thrombosis and pulmonary embolism prophylaxis.
The use of the Kendall SCD 700 Series Compression System with Foot Cuffs 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.
Product codes
JOW
Device Description
The Kendall SCD™ 700 Sequential Compression controller is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's limbs for the prevention of DVT and PE. The controller delivers air though the tubing sets to the pair of disposable garments (one for each limb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs
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)
Testing was performed on the proposed Kendall SCD 700 Controller to compare it to the predicate device. Testing included Electric Safety testing according to IEC 60601-1 and UL60601-1, Electromagnetic Compatibility according to IEC 60601-1-2 and EN55011 and Enclosure Protection testing according to IEC 60529. In addition Design Verification and Validation testing was performed on General Controller Features, Compression Cycle Operation, Controller Alarm and Test Modes and Battery Operations. Results from the testing demonstrate that the modified device is substantially equivalent to the legally marketed predicate device.
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 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
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Covidien
15 Hampshire St
Mansfield, MA 02048 06856
Tel. No.: (508) 261-6325 | K102737 |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | OCT 19 2010 |
| CONTACT PERSON: | Melody Bi
Sr. Specialist, Regulatory Affairs | |
| DATE PREPARED: | Sept 17, 2010 | |
| TRADE/PROPRIETARY NAME: Kendall SCD™ 700 Sequential Compression Controller | | |
| COMMON/USUAL NAME: | Compressible Limb Sleeve Device | |
| CLASSIFICATION NAME: | Sleeve, Limb, Compressible | |
| PREDICATE DEVICE(S): | Kendall SCD Express™ Portable Compression System (PCS)
(K040511) | |
| DEVICE DESCRIPTION: | The Kendall SCD™ 700 Sequential Compression controller is an
intermittent pneumatic compression device for applying sequential,
gradient pressure to a patient's limbs for the prevention of DVT and
PE. The controller delivers air though the tubing sets to the pair of
disposable garments (one for each limb). | |
| INTENDED USE: | The Kendall SCD 700 Sequential Compression Controller is designed
to apply intermittent pneumatic compression to increase venous blood
flow in at-risk patients in order to help prevent deep vein thrombosis
and pulmonary embolism. | |
| TECHNOLOGICAL
CHARACTERISTICS: | The proposed Kendall SCD 700 Controller is identical to the
predicate device in terms of its intended use and mode of function. The
device will now be offered with improved features and robustness | |
| MATERIALS: | All components of the SCDTM 700 Sequential Compression System are
comprised of materials which are in accordance with ISO Standard
10993-1. | |
| PERFORMANCE DATA: | Testing was performed on the proposed Kendall SCD 700 Controller to
compare it to the predicate device. Testing included Electric Safety
testing according to IEC 60601-1 and UL60601-1, Electromagnetic
Compatibility according to IEC 60601-1-2 and EN55011 and
Enclosure Protection testing according to IEC 60529. In addition
Design Verification and Validation testing was performed on General
Controller Features, Compression Cycle Operation, Controller Alarm
and Test Modes and Battery Operations. Results from the testing
demonstrate that the modified device is substantially equivalent to the
legally marketed predicate device. | |
1
Image /page/1/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Covidien LLC c/o Melody Bi Ph.D. Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
OCT 1 9 2010
Re: K102737
Kendall SCD™ 700 Sequential Compression Controller Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: September 17, 2010 Received: September 22, 2010
Dear Dr. Bi:
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.
2
Page 2 - Melody Bi Ph.D.
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
OCT 1 9 2010
K102137 510(k) Number (if known):
Kendall SCD™ 700 Sequential Compression Controller Device Name:
Indications For Use:
The Kendall SCD 700 Sequential Compression System (hereby referenced as "Kendall SCD 700 Series") is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The System consists of the controller, the tubing sets (provided with the controller) and singlepatient use garments (purchased separately from this controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle has reached set pressure, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.
The use of the Kendall SCD 700 Series Compression System with Leg Sleeves is indicated for:
-
Deep vein thrombosis and pulmonary embolism prophylaxis. .
The use of the Kendall SCD 700 Series Compression System with Foot Cuffs 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.. .
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)
(Division Sign-Off)
Division of Cardiovascular Devices
| Covidien 510(k) Premarket Notification | 6102737 |
|---|---|
| Page 19 | TM Trademark |