(63 days)
Not Found
No
The description focuses on standard pneumatic compression technology and does not mention any AI or ML components. The "Not Found" entries for AI/ML mentions and training/test data descriptions further support this.
Yes
The device is designed to apply intermittent pneumatic compression to increase venous blood flow to prevent deep vein thrombosis and pulmonary embolism, and is indicated for conditions like DVT prophylaxis, circulation enhancement, edema, extremity pain, leg ulcers, and venous stasis, all of which are therapeutic purposes.
No
Explanation: The Kendall SCDTM 700 system is designed to prevent deep vein thrombosis and pulmonary embolism by applying intermittent pneumatic compression to increase venous blood flow. It is a therapeutic device, not one that identifies or diagnoses a disease or condition. While it measures limb refill time, this is for controlling the compression cycle, not for diagnostic purposes.
No
The device description explicitly states the system consists of a controller, tubing sets, and garments, which are all hardware components.
Based on the provided text, the Kendall SCDTM 700 Sequential Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Kendall SCDTM 700 Function: The description clearly states that the Kendall SCDTM 700 system applies intermittent pneumatic compression to the patient's limbs to increase venous blood flow. It is a physical therapy/medical device that acts externally on the body.
- No Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the Kendall SCDTM 700 Sequential Compression System falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kendall SCDTM 700 Sequential Compression System (hereby referenced as "Kendall SCDTM 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 Kendall SCDTM 700 Series is a prescription device for use in a clinical setting or in the home.
The use of the Kendall SCDTM 700 Series Compression System with Leg Sleeves is indicated for:
- Deep vein thrombosis and pulmonary embolism prophylaxis. .
The use of the Kendall SCDTM 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 (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Kendall SCDTM 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).
The System consists of the controller, the tubing sets (provided with the controller) and single-patient 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.
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
clinical setting or in the home.
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)
A Use Failure Modes and Effects Analysis (UFMEA) was created to adequately assess the risks related to the home user. Known and potential hazards for operation of the Kendall SCDTM 700 Series system were evaluated for risk and the severity of the failure effects to the patient and servicing personnel and probability of occurrence were categorized. The output of the UFMEA identified the need to conduct validation testing.
A Human Factors and Usability Study was conducted to validate usability of the Kendall SCDTM 700 Series system in the home environment. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.
In addition, Electrical Safety testing according to IEC 60601-1 and UL60601-1 and Electromagnetic Compatibility according to IEC 60601-1-2 were conducted.
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
510(k) Summary of Safety and Effectiveness
MAY 3 1 2012
| SUBMITTER: | Covidien
15 Hampshire St
Mansfield, MA 02048
Tel. No.: (508) 452-1659 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Jennifer Sullivan
Sr. Regulatory Affairs Specialist |
| DATE PREPARED: | March 28, 2012 |
| TRADE/PROPRIETARY NAME: | Kendall SCDTM 700 Sequential Compression Controller |
| COMMON/USUAL NAME: | Compressible Limb Sleeve Device |
| CLASSIFICATION NAME: | Sleeve, Limb, Compressible |
| PREDICATE DEVICE(S): | Kendall SCDTM 700 Sequential Compression Controller (K102737) |
| DEVICE DESCRIPTION: | The Kendall SCDTM 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 SCDTM 700 Sequential Compression System (hereby
referenced as "Kendall SCDTM 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 Kendall SCDTM 700 Series is a
prescription device for use in a clinical setting or in the home. |
| TECHNOLOGICAL
CHARACTERISTICS: | The modified device has the same technological
characteristics as compared to the predicate device. |
| PERFORMANCE DATA: | A Use Failure Modes and Effects Analysis (UFMEA) was created to
adequately assess the risks related to the home user. Known and
potential hazards for operation of the Kendall SCDTM 700 Series
system were evaluated for risk and the severity of the failure effects
to the patient and servicing personnel and probability of occurrence
were categorized. The output of the UFMEA identified the need to
conduct validation testing.
A Human Factors and Usability Study was conducted to validate
usability of the Kendall SCDTM 700 Series system in the home
environment. The result of the Human Factors and Usability Study
substantiates the acceptability of the risks identified during the risk
assessment activities.
In addition, Electrical Safety testing according to IEC 60601-1 and
UL60601-1 and Electromagnetic Compatibility according to IEC
60601-1-2 were conducted. |
1
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
MAY 3 1 2012
Covidien c/o Ms. Jennifer Sullivan Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfiled. MA 02048
Re: K120944
Trade/Device Name: Kendall SCD™ 700 Sequential Compression Controller Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW Dated: March 28, 2012 Received: March 29, 2012
Dear Ms. 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
2
Page 2 - Ms. Jennifer Sullivan
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-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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
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 Kendall SCD™ 700 Series is a prescription device for use in a clinical setting or in the home.
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 | |
| 510(k) Number | K120944 |
Covidien 510(k) Premarket Notification
Page 16 TMTrademark
KI20944