ALEXIS WOUND RETRACTOR

K062907 · Applied Medical Resources · KGW · Jan 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062907
• Device Name: ALEXIS WOUND RETRACTOR
• Applicant: Applied Medical Resources
• Product Code: KGW · General, Plastic Surgery
• Decision Date: Jan 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Alexis Wound Retractor (large and extra large size only) is indicated for use to assist in non-urgent cesarean deliveries that are routine procedures . It is intended to provide incision retraction and to protect against open wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions. The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries. The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) : - Access the abdominal cavity during surgery through an atraumatically retracted incision. - Delivery maximum exposure of the abdominal cavity with minimum incision size. - Protect against wound contamination during laparoscopic and open surgery. - Seal off the incision opening to permit insufflating the peritoneum. - Convert the incision wound to an additional trocar port site. - Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

Device Story

Disposable, single-use surgical retractor; consists of flexible polymer membrane cylinder with semi-rigid polymer rings at each end. Used in OR by surgeons during cesarean sections and general/cardiac surgeries. Surgeon places internal ring inside abdomen; external ring is placed in traction and folded over itself until it contacts abdomen. Device maintains open incision; protects wound edges from contamination. Benefits include atraumatic retraction, improved exposure with minimal incision size, and reduced risk of wound contamination.

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 successfully.

Technological Characteristics

Flexible polymer membrane with semi-rigid polymer rings. Disposable, single-use. Sterilized via 100% ethylene oxide (EO) to SAL 10^-6. Complies with ANSI/AAMI/ISO 10993-7:1995 for sterilant residues. Mechanical properties verified via ASTM D 412 and ASTM D 624.

Indications for Use

Indicated for patients undergoing routine, non-urgent cesarean deliveries (large and extra-large sizes) requiring abdominal access, incision retraction, and protection against wound contamination. Also indicated for general surgical use to access abdominal or thoracic cavities, provide exposure, protect wounds, seal incisions for insufflation, or serve as a trocar port site.

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

• OB/Mobius (Apple Medical Corp.)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| 510(k) NUMBER: | K062907 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone] |
| CONTACT PERSON: | Cheryl Blake<br>Vice President, Regulatory Affairs and Quality Systems |
| DATE OF PREPARATION: | December 27, 2006 |
| NAME OF DEVICE: | Wound Retractor |
| CLASSIFICATION NAME: | Drape, Surgical, General & Plastic Surgery.<br>(Regulation Number 21CFR 878.4370, Surgical drape and drape<br>accessories).<br>Retractor, Manual Surgical<br>(Regulation number 878.4800 Manual surgical instruments for<br>general surgical use (retractor), and 884.4520 Obstetric-<br>gynecological general manual instruments. |
| TRADE NAME: | Alexis® Wound Retractors |
| PREDICATE DEVICE: | OB/Mobius<br>Apple Medical Corp.<br>28 Lord Road, Unit 135<br>Marlboro, MA 01752 |
| DESCRIPTION: | The Applied Wound Retractor consists of a flexible polymer<br>membrane formed into the shape of a cylinder. Attached to each<br>open end of the cylinder are two semi-rigid polymer rings. |

JAN 190 2007SUMMARY STATEMENT: The Applied Alexis Wound Retractor (large and extra large size only) is indicated for use to assist in non-urgent cesarean deliveries that are nutine procedures . It is intended to provide incision retraction and to protect against open wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

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 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 theath is placed in position through the incision with one ring inside the abdomen. The external ing is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Refractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects against wound contamination during the procedure,

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The Alexis Wound Retractor has been found 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 10°. 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 Bacillus Airophaeus 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 a circular seal with the Department of Health & Human Services logo. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUM." is arranged around the left side of the seal.

## 2007 JAN 9

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Cheryl Blake Vice President Regulatory Affairs Applied Medical Resources 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688

Re: K062907

Trade/Device Name: Alexis Wound Retractor Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: KNA and GAD Dated: December 29, 2006 Received: January 3, 2006

Dear Ms. Blake:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a black and white circular seal. The seal contains the letters "DA" in a bold, sans-serif font in the center. Above the letters, the numbers "1906-1996" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The seal is surrounded by a dotted border and some text that is difficult to read.

ationa Public .

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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 (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.

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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number: K062907

Device Name: Alexis Wound Retractor

Indication For Use:

The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) :

- l Access the abdominal cavity during surgery through an atraumatically retracted incision.
- 피 Delivery maximum exposure of the abdominal cavity with minimum incision size.
- 트 Protect against wound contamination during laparoscopic and open surgery.
- . Seal off the incision opening to permit insufflating the peritoneum.
- 트 Convert the incision wound to an additional trocar port site.
- 트 Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Nancy C. Brogdon

uctive. Abdominal, and 510(k) Numbe