Surgisleeve Wound Protector

K143091 · Covidien, LLC · GCJ · Nov 26, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K143091
• Device Name: Surgisleeve Wound Protector
• Applicant: Covidien, LLC
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 26, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• 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 thoracic and abdominal access; protects against wound contamination during surgery. Consists of cylindrical film with flexible interior and exterior rings for insertion, retraction, and removal. Large and extra-large models include a rigid circular retraction ring accessory to maintain maximum retraction. Used in OR by surgeons; provides atraumatic incision retraction and exposure. Benefits include reduced incision size and minimized wound contamination risk.

Clinical Evidence

Bench testing only. In-vitro testing included proximal ring rolling, film-to-ring attachment strength, film weld strength, and retraction ring compression force. In-vivo testing included digital proximal ring insertion, proximal ring rolling, retraction ring insertion/removal, and digital distal ring removal. Results demonstrate performance equivalent to the predicate.

Technological Characteristics

Cylindrical film with flexible interior/exterior rings; rigid circular retraction ring accessory for large/extra-large models. Materials comply with ISO 10993-1. Mechanical retraction principle.

Indications for Use

Indicated for patients undergoing laparoscopic, open, cardiac, or general surgical procedures requiring access to the abdominal or thoracic cavity. Used for atraumatic incision retraction and protection against wound contamination.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Surgisleeve™ Wound Protector (K140064)

Reference Devices

• Surgisleeve™ (K140014)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.

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

November 26, 2014

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

Re: K143091

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: October 27, 2014 Received: October 28, 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

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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 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/Resourcesfor You/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/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.

for

Sincerely yours,

# David-Krause -S

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

Enclosure

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### 5. Indications for Use

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | | |
| K143091 | | |
| Device Name | | |

Surgisleeve™ Wound Protector

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

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Image /page/3/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white square inside, followed by the word "COVIDIEN" in blue. The word "COVIDIEN" is in a sans-serif font and is slightly larger than the square logo.

## 510(k) Summary

This 510(k) summary of data used to demonstrate substantial equivalence is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR క్తి807.98

| NAME: | COVIDIEN |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| ADDRESS: | 60 Middletown Avenue<br>North Haven, Connecticut 06473 USA |
| CONTACT PERSON: | Michael Koczocik<br>Product Specialist, Regulatory Affairs |
| PHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| DATE PREPARRED: | October 27, 2014 |
| TRADE/PROPRIETARY NAME: | Surgisleeve™ |
| COMMON/USUAL NAME: | Wound Protector |
| CLASSIFICATION NAME: | Endoscope and Accessories per 21 CFR §<br>876.1500<br>Surgical Drape and Drape Accessories per 21<br>CFR § 878.4370 |
| PRODUCT CODE: | GCJ, KKX |
| CLASSIFICATION PANEL NAME: | Gastroenterology and Urology<br>General and Plastic Surgery, |
| FDA PANEL NUMBER: | 78, 79 |
| DEVICE CLASS: | Pursuant to 21 CFR § 876.1500 and 21 CFR §<br>878.4370 an endoscope and<br>accessories/surgical drape is a Class II device |
| PREDICATE DEVICE(S): | Surgisleeve™ Wound Protector K140064 |
| DEVICE DESCRIPTION: | Wound retraction device providing thoracic and<br>abdominal access and protection from wound<br>contamination |

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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 white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The square is positioned to the left of the word.

## 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.

SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED AND PREDICATE DEVICE(S)

Cylindrical Film is designed to retract an incision and provide protection from wound contamination. The interior and exterior rings are flexible to aid insertion, film retraction, and removal. The technological characteristics of the extra-large Surgisleeve™ remain the same as the 510(k) cleared Surgisleeve™ device (K140014). The retraction ring of the large and extra-large Surgisleeve™ Wound Protector is a rigid circular ring accessory that attaches to the exterior ring that aids in maintaining maximum retraction for both the large and extra-large device when necessary

The Surgisleeve™ Wound Protector's

MATERIALS:

All components of the Surgisleeve™ Wound Protector are comprised of materials which are in accordance with ISO 10993-1

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Image /page/5/Picture/0 description: The image shows the Covidien logo. The logo consists of a blue square with a white square inside, and the word "COVIDIEN" in blue text to the right of the square. The logo is simple and modern, and the colors are clean and professional.

## PERFORMANCE DATA:

In-vitro and in-vivo tests were performed to verify that the performance of the Surgisleeve™ Wound Protector with Retraction Ring is substantially equivalent to the predicate devices. To validate that the proposed device performs as intended to provide access into the body cavity and maintain maximum retraction, the following tests were performed:

- In-vitro proximal ring rolling .
- . In-vitro strength of attachment between film and proximal (exterior) and distal (interior) rings
- In-vitro film weld strength .
- In-vitro retraction ring compression ● force
- . In-vivo digital proximal ring insertion
- In-vivo proximal ring rolling
- In-vivo retraction ring insertion and ● removal
- . In-vivo digital distal ring removal

## CONCLUSION:

The results of the performance evaluation demonstrate that the Surgisleeve™ Wound Protector extra-large with Retraction ring performed substantially equivalent to the predicate device, Surgisleeve™ Wound Protector K140064.