KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

K120944 · Covidien · JOW · May 31, 2012 · Cardiovascular

Device Facts

• Record ID: K120944
• Device Name: KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
• Applicant: Covidien
• Product Code: JOW · Cardiovascular
• Decision Date: May 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Intermittent pneumatic compression device; delivers gradient pressure to limbs via disposable garments (leg sleeves or foot cuffs) to increase venous blood flow. Controller measures limb refill time after compression cycle to determine timing of next cycle. Used in clinical or home settings; operated by patients or healthcare providers. Benefits include prevention of DVT and pulmonary embolism; management of edema, venous stasis, and extremity pain. System comprises controller, tubing, and single-patient use garments.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing, Use Failure Modes and Effects Analysis (UFMEA), and a Human Factors and Usability Study to validate safety and effectiveness for home environment operation.

Technological Characteristics

Intermittent pneumatic compression controller; gradient pressure delivery. Electrical safety per IEC 60601-1 and UL60601-1; EMC per IEC 60601-1-2. System includes controller, tubing, and disposable garments (leg sleeves/foot cuffs).

Indications for Use

Indicated for DVT and pulmonary embolism prophylaxis in at-risk patients. Leg sleeves indicated for DVT/PE prophylaxis. Foot cuffs indicated for circulation enhancement, DVT prophylaxis, acute/chronic edema, extremity pain from trauma/surgery, leg ulcers, and venous stasis/insufficiency. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Kendall SCDTM 700 Sequential Compression Controller (K102737)

Submission Summary (Full Text)

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K120944

## 510(k) Summary of Safety and Effectiveness

# MAY 3 1 2012

| SUBMITTER: | Covidien<br>15 Hampshire St<br>Mansfield, MA 02048<br>Tel. No.: [phone] |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Jennifer Sullivan<br>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<br>intermittent pneumatic compression device for applying sequential,<br>gradient pressure to a patient's limbs for the prevention of DVT and<br>PE. The controller delivers air though the tubing sets to the pair of<br>disposable garments (one for each limb). |
| INTENDED USE: | The Kendall SCDTM 700 Sequential Compression System (hereby<br>referenced as "Kendall SCDTM 700 Series") is designed to apply<br>intermittent pneumatic compression to increase venous blood flow in<br>at-risk patients in order to help prevent deep vein thrombosis and<br>pulmonary embolism. The Kendall SCDTM 700 Series is a<br>prescription device for use in a clinical setting or in the home. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The modified device has the same technological<br>characteristics as compared to the predicate device. |
| PERFORMANCE DATA: | A Use Failure Modes and Effects Analysis (UFMEA) was created to<br>adequately assess the risks related to the home user. Known and<br>potential hazards for operation of the Kendall SCDTM 700 Series<br>system were evaluated for risk and the severity of the failure effects<br>to the patient and servicing personnel and probability of occurrence<br>were categorized. The output of the UFMEA identified the need to<br>conduct validation testing.<br>A Human Factors and Usability Study was conducted to validate<br>usability of the Kendall SCDTM 700 Series system in the home<br>environment. The result of the Human Factors and Usability Study<br>substantiates the acceptability of the risks identified during the risk<br>assessment activities.<br>In addition, Electrical Safety testing according to IEC 60601-1 and<br>UL60601-1 and Electromagnetic Compatibility according to IEC<br>60601-1-2 were conducted. |

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#### 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

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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 [phone] or [phone] 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

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### Indications For Use

510(k) Number (if known):

Kendall SCD™ 700 Sequential Compression Controller Device Name:

K120944

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

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