ALEXIS WOUND RETRACTOR

K031889 · Applied Medical Resources Corp. · KKX · Sep 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031889
• Device Name: ALEXIS WOUND RETRACTOR
• Applicant: Applied Medical Resources Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Applied Alexis Wound Retractor 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. - Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: - Seal off the incision opening to permit insufflating the peritoneum. - Convert the incision wound to an additional trocar port site.

Device Story

Alexis Wound Retractor is a disposable, single-use surgical device; consists of flexible polymer membrane cylinder with semi-rigid polymer rings at each end. Surgeon places device through abdominal incision; internal ring positioned inside abdomen; external ring folded over itself to create traction against abdominal wall. Device maintains atraumatic retraction; provides maximum exposure with minimal incision size; protects incision from contamination/injury. Small/medium models feature iris valve to seal incision for peritoneal insufflation or to accommodate trocar placement. Used in OR by surgeons. Benefits include reduced wound contamination and improved surgical access.

Clinical Evidence

Bench testing only. Materials tested for biocompatibility per ISO 10993-1. Mechanical testing performed for tensile strength and elongation (ASTM D 412) and tear strength (ASTM D 624). Functional performance testing completed.

Technological Characteristics

Flexible polymer membrane cylinder with semi-rigid molded plastic rings. Disposable, single-use. Sterilized via 100% ethylene oxide (EO) per ANSI/AAMI/ISO 10993-7:1995. Materials meet ASTM D 412 and ASTM D 624 standards.

Indications for Use

Indicated for patients undergoing laparoscopic or open abdominal surgery requiring incision retraction and protection. Smaller models are indicated for sealing incisions for peritoneal insufflation and converting incision sites to trocar ports.

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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## 510(k) SUMMARY

| 510(k) NUMBER: | K031889 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone] |
| CONTACT PERSON: | Mary Jo Stegwell<br>Vice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | September 12, 2003 |
| 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: | AlexisTM Wound Retractors |
| PREDICATE DEVICE: | Dexterity Protractor (Protector Retractor and Protector<br>Retractor with drape, K954824), Medical Creative<br>Technologies, Inc. Colmar, PA. |
| DESCRIPTION | The Applied Wound Retractor consists of a flexible<br>polymer membrane formed into the shape of a cylinder.<br>Attached to each open end of the cylinder are two semi-<br>rigid polymer rings. |

SUMMARY STATEMENT: The Applied Alexis Wound Retractor is indicated for use in retracting and protecting an abdominal incision during laparoscopic or open surgery. It is intended to allow the surgeon to access the abdominal cavity through an atraumatically retracted wound that provides maximum exposure with minimum incision size. Further, once positioned in the abdominal wall, the Alexis Wound Retractor is intended to protect against wound contamination. To perform these functions, Alexis Wound Retractors are constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template.

The device will be manufactured in four sizes, small, medium-large and large. The small and medium products will have two additional indications. These models have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar. The procedure may

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then be returned to fully laparoscopic and an additional trocar may be placed through the incision site.

The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting sheath is placed in position through the incision with one ring inside the abdomen. The external ring is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Retractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects it from contamination and injury from instruments during the procedure.

The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices. The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation. (ASTM D 412) and Tear Strength (ASTM D 624). Functional performance testing has been completed and has passed the required testing.

The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.

The Applied Wound Retractor is sterilized using 100% EO. Applied's 100% EO sterilization cycle provides a sterility assurance level of 106. Sterilization for Applied Medical's EO cycle uses three half-cycle validation runs, which incorporate biological indicators and temperature monitors distributed throughout the load to verify gas penetration and profile temperature distribution. Spore strip biological indicators of B. subtillis var. niger with a population of 10° are used to monitor routine finished product sterilization loads. Sterilant residue levels will be in compliance with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices which is 20 mg ethylene oxide and 12 mg ethylene chlorohydrin.

The Alexis Wound Retractor is substantially equivalent to predicate devices in design methodology, principle of operation and clinical utility. The device introduces no new safety or 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird, represented by three curved lines that suggest wings and a body. The logo is black and white.

Public Health Service

SEP 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary J. Stegwell Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K031889

Trade/Device Name: Alexis™ Wound Retractors Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 13, 2003 Received: July 1, 2003

Dear Ms. Stegwell:

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.

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Page 2 - Ms. Stegwell

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); 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.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental 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 Alexis Wound Retractor's "Indications for Use" as required.

510(k) Number:

K03/886

Alexis Wound Retractor Device Name:

Indications for Use: The Applied Alexis Wound Retractor 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.
- · Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

- · Scal off the incision opening to permit insufflating the peritoneum.
- · Convert the incision wound to an additional trocar port site.

Suzer Kums

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031889

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)