Reprocessed Kendall SCD Express Foot Cuff

K163055 · Covidien · JOW · Dec 23, 2016 · Cardiovascular

Device Facts

• Record ID: K163055
• Device Name: Reprocessed Kendall SCD Express Foot Cuff
• Applicant: Covidien
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and 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

Device Story

Reprocessed Kendall SCD Express Foot Cuff is a single-patient-use garment; connects to intermittent pneumatic controller via tubing set. Device delivers set pressure to foot to promote blood flow. Used in clinical settings; operated by healthcare providers. Output is mechanical compression of foot; affects clinical decision-making by providing DVT prophylaxis and circulation support. Benefits patient by reducing risk of venous stasis and associated complications.

Clinical Evidence

Bench testing only. Testing included functional verification (hook and loop simulated use, leak testing, system compatibility), biocompatibility testing per ISO 10993-1, and validation of the cleaning process per AAMI TIR 30:2011. Manufacturing includes 100% visual and functional testing.

Technological Characteristics

Compressible limb sleeve; identical to predicate in design and materials. Operates via connection to intermittent pneumatic controller. Biocompatibility per ISO 10993-1. Cleaning validated per AAMI TIR 30:2011.

Indications for Use

Indicated for patients requiring circulation enhancement, DVT prophylaxis, management of acute or chronic edema, relief of extremity pain incident to trauma or surgery, treatment of leg ulcers, and management of venous stasis/insufficiency.

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 SCD™ Express Foot Cuff (K040511)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 23, 2016

Covidien Jennifer Sullivan Regulatory Affairs Manager 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K163055

Trade/Device Name: Reprocessed Kendall SCD Express Foot Cuff Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 31, 2016 Received: November 1, 2016

Dear Jennifer 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 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 of medical devicerelated 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillemann

for

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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| Device Model | Device Name | Original<br>Manufacturer |
|--------------|--------------------------------------------------------|--------------------------|
| 5897R | Reprocessed Kendall SCDTM Express Foot Cuff – Regular | Covidien |
| 5898R | Reprocessed Kendall SCDTM Express Foot Cuff – Large | Covidien |

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510(k) Number (if known): K163055

Device Name:

Reprocessed Kendall SCD™ Express Foot Cuff

Indications for Use:

The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and 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 o

Prescription Use: X AND/OR Over-the-Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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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 lighter blue cross shape inside, followed by the word "COVIDIEN" in a bold, dark blue font. The logo is simple and modern, with a focus on the company name.

#### 510(k) SUMMARY

#### 1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048

Contact: Jennifer Sullivan Title: Regulatory Affairs Manager Telephone: [phone] Fax: [phone] Email: [e-mail] Date Prepared: October 31, 2016

# 2. Device:

| Trade Name: | Reprocessed Kendall SCD™ Express Foot Cuff |
|----------------------|--------------------------------------------|
| Classification Name: | Sleeve, Limb, Compressible |
| Regulation Number: | 21 CFR 870.5800 |
| Product Code(s): | JOW |
| Classification: | Class 2 |

# 3. Predicate Devices:

Kendall SCD™ Express Foot Cuff, K040511

# 4. Device Description:

The Reprocessed Kendall SCD™ Express Foot Cuff is a single patient use garment that connects to an intermittent pneumatic controller via a tubing set to deliver a set amount of pressure to the foot in order to promote blood flow.

# 5. Intended use: The Reprocessed Kendall SCD™ Express Foot Cuff is intended to be used with an intermittent pneumatic device and 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 .

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# 6. Technological Characteristics:

The Reprocessed Kendall SCD™ Express Foot Cuffs 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 foot cuffs were tested to demonstrate appropriate functional characteristics through bench top verification. Testing included; hook and loop simulated use, leak testing and system compatibility. Biocompatibility testing was conducted in accordance with ISO 10993-1. The cleaning process was validated in accordance with AAMI TIR 30:2011 requirements. 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 Reprocessed Kendall SCD™ Express Foot Cuffs are substantially equivalent to the predicate device as described in this premarket notification.