SURGISLEEVE WOUND PROTECTOR

K140064 · Covidien · KKX · Mar 12, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140064
• Device Name: SURGISLEEVE WOUND PROTECTOR
• Applicant: Covidien
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Mar 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Device Story

Wound retraction device providing abdominal and thoracic cavity access; protects against wound contamination during surgery. Consists of cylindrical film with flexible interior and exterior rings; rings facilitate insertion, retraction, and removal. Used in OR by surgeons; provides atraumatic retraction to maximize exposure through minimal incision size. Benefits include reduced risk of wound contamination and improved surgical access. Device is purely mechanical; no electronic or software components.

Clinical Evidence

Bench testing only. In-vitro testing included film penetration resistance, attachment strength between film and rings, and weld seam strength. In-vivo testing evaluated ring insertion/rolling, instrument insertion/removal, specimen removal, and thoracic use. No clinical human trial data presented.

Technological Characteristics

Cylindrical film wound retractor with flexible interior and exterior rings. Materials evaluated per ISO 10993-1:2009. Mechanical retraction principle. No energy source, connectivity, or software.

Indications for Use

Indicated for patients undergoing laparoscopic, open, cardiac, or general surgical procedures requiring abdominal or thoracic cavity access and soft tissue retraction. No specific age or gender contraindications stated.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Applied Medical, Alexis™ Wound Retractors (K041711)
• Covidien Surgisleeve™ Wound Protector (K120061)

Submission Summary (Full Text)

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Surgisleeve™ Wound Protector XS

| K140064 | |
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## 510(k) Summary

| SUBMITTER: | Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473 USA<br>Tel. No.: [phone] |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Michael Koczocik<br>Product Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | January 2014 |
| TRADE/PROPRIETARY NAME: | Surgisleeve™ Wound Protector |
| Product Code(s) | GCJ<br>KKX |
| COMMON/USUAL NAME: | Wound Protector |
| CLASSIFICATION NAME: | Endoscope and accessories per 21 CFR 876.1500<br>Surgical Drape and Drape Accessories per 21 CFR 878.4370 |
| PREDICATE DEVICE(S): | Applied Medical, Alexis™ Wound Retractors (K041711),<br>Covidien Surgisleeve™ Wound Protector (K120061) |
| DEVICE DESCRIPTION: | Wound retraction device providing abdominal access and<br>Protection from wound contamination |
| INTENDED USE: | The Surgisleeve™ Wound Protector is indicated for use to access the<br>abdominal cavity during surgery through an atraumatically retracted<br>incision, deliver maximum exposure of the abdominal cavity with<br>minimum incision size, and protect against wound contamination<br>during laparoscopic and open surgery. Additionally, the small size<br>Wound Protector is indicated for use to access the thoracic cavity<br>during cardiac and general surgical procedures through an<br>atraumatically retracted incision. The extra-small Wound Protector is<br>also indicated for use to access the thoracic cavity and other soft<br>tissue retraction during cardiac and general surgical procedures<br>through an atraumatically retracted incision. |
| TECHNOLOGICAL<br>CHARACTERISTICS | The Surgisleeve™ Wound Protector Cylindrical Film is designed to<br>retract an incision and provide protection from wound contamination.<br>The interior and exterior rings are flexible to aid insertion, film<br>retraction, and removal. |
| MATERIALS: | The Surgisleeve™ Wound Protector is comprised of materials that<br>have been evaluated in accordance with ISO 10993-1:2009, Biological<br>Evaluation of medical devices - Part 1: Evaluation and Testing. |

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### Surgisleeve™ Wound Protector XS

PERFORMANCE DATA:

In-vitro and in-vivo testing to support the intended use of this device includes:

- Film Penetration Resistance .
- Strength of Attachment Between Film and Proximal Ring, Distal . Ring
- Film Weld Seam Strength .
- . In-Vivo Use:
- . Ring Insertion and Rolling,
- Instrument Insertion and Removal, .
- . Specimen removal,
- . Thoracic use,
- . Thoracic use specimen removal,
- . Digital ring removal

CONCLUSION:

The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector (subject device) performed substantially equivalent to the predicate devices, the Alexis™ wound retractor (K041711) and the Covidien Surgisleeve™ wound protector (K120061).

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#### 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

## March 12, 2014

Covidien Mr. Michael Koczocik Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K140064

Trade/Device Name: Surgisleeve" Wound Protector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, KKX Dated: January 10, 2014 Received: January 10, 2014

Dear Mr. Koczocik:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Image /page/2/Picture/11 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

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Page 2 - Mr. Michael Koczocik

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Surgisleeve™ Wound Protector XS

#### Indications for Use

510(k) Number (if known): K140064

Device Name: Surgisleeve™ Wound Protector

Indications for Use:

The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Prescription Use X (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)

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for BSA

(Division Sign-Off) Division of Surgical devices 510(k) Number: K140064