WOUND PROTECTOR

K120061 · Covidien, Formerly US Surgical A Divison of Tyco H · GCJ · Mar 27, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120061
• Device Name: WOUND PROTECTOR
• Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The 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.

Device Story

Wound Protector is a sterile surgical device consisting of flexible interior and exterior rings connected by a cylindrical film. It is used by surgeons in the OR to retract surgical incisions atraumatically. The device provides access to the abdominal or thoracic cavity while protecting the wound edges from contamination. The surgeon inserts the device into the incision; the flexible rings allow for manual retraction and maintenance of the opening. This provides maximum exposure with minimal incision size, facilitating instrument access and specimen removal. The device is removed after the procedure. It benefits patients by reducing potential wound contamination and minimizing tissue trauma during surgery.

Clinical Evidence

Bench testing only. Testing included in-vitro and in-vivo evaluations: film tear resistance (ASTM D3787), film weld seam strength (ASTM D412), tensile/elongation strength of ring-to-film attachments, and ease of insertion/removal. Biocompatibility was evaluated per ISO 10993-1:2009. No clinical trials were conducted.

Technological Characteristics

Device consists of flexible interior and exterior rings connected by a cylindrical film. Materials evaluated per ISO 10993-1:2009. Performance standards include ASTM D3787 (film tear resistance) and ASTM D412 (weld seam strength). Mechanical operation via manual insertion and ring-based retraction.

Indications for Use

Indicated for patients undergoing abdominal or thoracic surgery requiring incision retraction and wound protection. Used in laparoscopic and open abdominal surgeries, as well as cardiac and general thoracic surgical procedures.

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

• Applied Medical, Alexis Wound Retractors (K041711)

Submission Summary (Full Text)

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#### Covidien (formerly registered as Tyco Healthcare, LP)

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#### 510(k) Summary of Safety and Effectiveness

SUBMITTER:

Covidien (formerly registered as Tyco Healthcare, LP) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: [phone]

CONTACT PERSON:

Joseph Canavan Senior Design Quality Engineer Covidien Phone: [phone] Fax: [phone]

DATE PREPARED: January 6, 2012

TRADE/PROPRIETARY NAME: Wound Protector

COMMON/USUAL NAME: Sterile Surgical Drape

CLASSIFICATION NAME: Surgical Drape and Drape Accessories per 21 CFR 878.4370

PREDICATE DEVICE: Applied Medical, Alexis ™ Wound Retractors (K041711) .

DEVICE DESCRIPTION:

Wound retraction device providing access and protection from wound contamination.

INTENDED USE: The 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.

TECHNOLOGICAL CHARACTERISTCS:

MATERIALS:

PERFORMANCE DATA:

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

The Wound Protector 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

All patient-contacting components of the Wound Protector are

accordance with ISO 10993-1: 2009, Biological Evaluation of

comprised of materials that have been evaluated in

medical devices -- Part 1: Evaluation and Testing.

- Film Penetration (Tear) Resistance (ASTM D3787) O
- Strength of Attachment between Film and Exterior Ring O (Tensile/Elongation)
- Strength of Attachment between Film and Interior Ring O (Tensile/Elongation)
- Film Weld Seam Strength (ASTM D412) 0
- Ease of Digital Insertion 0

retraction, and removal.

Traditional 510(k), Wound Protector

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# KI20061

## Covidien (formerly registered as Tyco Healthcare, LP)

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- Incision Retraction / Rolling O
- Ease of Use 0
- Instrument Access / Specimen Removal 0

.

- Specimen Manipulation 0
- Ease of Removal o
- Film Tear Resistance In-Vivo O
- Tissue Trauma O .

Traditional 510(k), Wound Protector

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

Covidien LLC % Mr. Joseph Canavan Senior Design Quality Engineer 60 Middleton Avenue North Haven, Connecticut 06472

Re: K120061

Trade/Device Name: Wound Protector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCI, KKX Dated: January 6, 2012 Received: January 9, 2012

MAR 2 7 2012

Dear Mr. Canavan:

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

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Page 2 - Mr. Joseph Canavan

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 (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 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,

Mark N. Malle

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Covidien (formerly registered as Tyco Healthcare, LP)

KI 20061 Indications for Use

510(k) Number (if known):

Device Name: Wound Protector

Indications for Use:

The 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.

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)

Niel RP Sedano for mxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K12006

Traditional 510(k), Wound Protector

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