WOUND PROTECTOR/RETRACTOR

K020435 · Applied Medical Resources Corp. · KKX · Apr 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020435
• Device Name: WOUND PROTECTOR/RETRACTOR
• Applicant: Applied Medical Resources Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

Device Story

Wound retractor; disposable, single-use device. Comprised of molded plastic wound retractor ring and cylindrical elastic wound protecting sheath. Used in OR by surgeons during laparoscopic or open abdominal surgery. Surgeon marks incision site with template; inserts sheath with ring inside abdomen; attaches external ring to sheath. Device maintains atraumatic wound retraction; provides exposure; protects incision from contamination and instrument injury. Benefits include minimized incision size and reduced risk of wound contamination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: molded plastic ring, cylindrical elastic sheath. Form factor: four sizes (small, medium, large, extra-large) and two shapes (round, elliptical). Packaging: Tyvek/Mylar. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing laparoscopic or open abdominal surgery requiring incision retraction and protection against wound contamination.

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

• Dexterity Protractor (Protector Retractor and Protector Retractor with drape, K954824)

Submission Summary (Full Text)

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## APR 1 5 2002

510(k) SUMMARY

| 510(k) NUMBER: | PENDING K 020435 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone] |
| CONTACT PERSON: | Anil Bhalani<br>Vice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | February 6, 2002 |
| NAME OF DEVICE: | Wound Retractor |
| CLASSIFICATION NAME: | Drape, Surgical, General & Plastic Surgery.<br>(Regulation Number 21CFR 878.4370, Surgical drape and<br>drape accessories). |
| TRADE NAME: | Wound Retractors |
| PREDICATE DEVICE: | Dexterity Protractor (Protector Retractor and Protector<br>Retractor with drape, K954824), Medical Creative<br>Technologies, Inc. Colmar, PA. |

SUMMARY STATEMENT: The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

Applied's Wound Retractors come in-four sizes, small, medium-large and large and in two shapes, round and elliptical. The shape of a wound retractor is defined by its wound retracting ring. The Wound Retractor consists of a wound retractor ring and a wound protecting sheath. The wound retractor ring is molded from a plastic material. The wound protecting sheath is comprised of a cylindrical elastic sheath with a ring at one end. The Wound Retractor package also includes an incision template.

The Wound Retractor is simple to set up and easy to use. Using a sterile skin marker an incision line is marked at the surgery site. Once the incision is made the wound protecting sheath is placed in position through the incision with the ring inside the abdomen. The wound retractor ring is then placed on the abdomen and attached to the wound protecting sheath. Once securely in

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place, the Wound Retractor keeps the incision open or retracted during clinical procedure. The place, the wound or incision and or incision and protects its from contamination and injury from instruments during the surgical procedure.

The Wound Retractors is a disposable, single-use device and is packaged inside Tyvek/Mylar The would which is standard packaging material for medical products. The packaged product will then be packaged in an outer product carton in 1 to 10 pieces per carton.

The Wound Retractors is substantially equivalent to predicate devices in design methodology, principle of operation and clinical utility. The Wound Retractors introduces no new safety and effectiveness issues when used as instructed.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized symbol resembling three overlapping, abstract shapes that could be interpreted as wings or flowing elements.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2002

Mr. Anil Bhalani Applied Medical Resources Corporation 22872 Avenida Empressa Rancho Santa Margarita, California 92688

Re: K020435

.

Trade/Device Name: Applied Medical Resources Corporation Regulation Number: 878.4370 Regulation Name: Surgical Drape Regulatory Class: II Product Code: KKX Dated: February 6, 2002 Received: February 8, 2002

Dear Mr. Bhalani:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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## Page 2 - Mr. Bhalani

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); good manufacturing practice and if the (2) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = requirely as tectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy Ulatowski

Timethy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Wound Retractor's "Indications for Use" as required.

510(k) Number:

K020435

Wound Retractor Device Name:

Indications for Use: The Applied Wound Retractor is indicated for use to retract and protect an incision in the abdominal wall during both laparoscopic and open surgery. It is intended to allow the surgeon to access the abdominal cavity during surgery through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to protect against wound contamination during both laparoscopic and open surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The -Counter Use

(Optional Format 1-2-96)

Olin S. lin

(Division Sign-Off) Division of Dental, Infection C

Hospital Devices
K020435