ALEXIS LAPAROSCOPIC SYSTEM

K093296 · Applied Medical Resources Corp. · KGW · Nov 5, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K093296
• Device Name: ALEXIS LAPAROSCOPIC SYSTEM
• Applicant: Applied Medical Resources Corp.
• Product Code: KGW · General, Plastic Surgery
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Alexis Laparoscopic System 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. - Seal off the incision opening to permit insufflation of 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

Alexis Laparoscopic System consists of flexible polymer membrane cylinder with semi-rigid polymer rings at each end; inner ring placed inside body cavity, outer ring remains outside. Surgeon rotates outer ring inward to shorten retractor, anchor device, and retract wound into round opening. System includes snap-on silicone cap to seal wound opening, allowing peritoneal insufflation; cap accommodates 12mm trocar to convert retractor into additional port site. Used by surgeons in OR during laparoscopic or open surgery to provide exposure, protect wound from contamination, and maintain pneumoperitoneum. Benefits include atraumatic retraction, reduced incision size, and secondary access port.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing compared subject device to predicate (K041711) regarding leak rates, ring retention strength, maximum retraction, and sealing integrity during trocar manipulation.

Technological Characteristics

Flexible polymer membrane; semi-rigid polymer rings; silicone snap-on cap. Mechanical retraction via ring rotation. Provides wound protection and insufflation seal. Accommodates 12mm trocar. No energy source. Non-powered, manual surgical accessory.

Indications for Use

Indicated for patients undergoing laparoscopic or open abdominal, thoracic, or general surgical procedures requiring soft tissue retraction, wound protection, or insufflation access.

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

• Applied Alexis Wound Retractor (K041711)

Submission Summary (Full Text)

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# 14093296 510(k) SUMMARY

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#### SUBMITTED BY:

Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 [phone] [phone] (FAX)

NOV - 5 2009

CONTACT PERSON:

Frans VandenBroek Vice President, Regulatory Affairs [e-mail]

DATE OF PREPARATION:

Alexis Laparoscopic System

Wound Retractor

July 22, 2009

COMMON NAME:

TRADE NAME:

CLASSIFICATION NAME:

Surgical Drape and Drape Accessories, General & Plastic Surgery (21CFR 878.4370, Product Code KKX)

PREDICATE DEVICE:

Applied Alexis Wound Retractor, K041711

DEVICE DESCRIPTION: Wound retractors convert straight incisions into semi round openings that facilitate access to internal body cavities and operative sites. These retractors are particularly useful in open or laparoscopic procedures that require removal of large quantities of tissue.

Image /page/0/Picture/15 description: The image shows a petri dish. The dish is circular and appears to contain some type of substance, possibly a culture medium. A portion of the dish is obscured by a dark, horizontal band, which may be due to lighting or an obstruction in the image.

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0.93296

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INTENDED USE: The Alexis Laparoscopic System 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.
- Seal off the incision opening to permit insufflation of 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.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The predicate and subject wound retractors share a common construction. Each consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. One ring (the inner ring) is positioned inside a body cavity while the other (outer ring) remains outside the patient.

Rotating the outer ring inward - similar to rolling up a shirt sleeve - shortens the retractor and anchors the device in the patient. It also retracts the wound and converts the incision into a round opening. The flexible membrane that connects the rings protects the incised tissue throughout the procedure.

The subject device has a snap-on silicone cap that closes and seals the wound opening. This allows the body cavity to be insufflated and the procedure to be completed under laparoscopic conditions. The center of the cap is designed to accommodate a 12mm trocar which effectively converts the wound retractor into a trocar port site.

For a more detailed description of retractor features, please see section 8.

DISCUSSION OF NONCLINICAL TESTS SUBMITTED: There are no recognized standards that specify performance of wound retractors of this type. For that reason. APPLIED created test protocols specifically designed to confirm safety and efficacy of the subject device relative to the predicate device (K041711). These tests include comparison of:

- The leak rate of the device when the retracted wound is closed. .
- . The leak rate of the device when the retracted wound is closed and when a trocar is in place.
- Force required to fasten and to detach the cap. .
- Retention strength of inner (green) ring. .
- Maximum retraction of wound.
- Sealing integrity during manipulation of trocars. .
- Potential for trocars that are placed through the cap to inflict undue stress on wound. .
- Flammability evaluation of cap material. .

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93296

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Several of these tests were performed on both predicate and subject devices. A discussion of the test methods and results are in Section 15.

CONCLUSIONS DRAWN FROM TESTING: APPLIED's functional and performance testing has demonstrated that the subject device is substantially equivalent or superior to its predicate device and introduces no new safety and effectiveness issues when used as instructed. The subject device gives surgeons a secondary method for sealing a wound that has been retracted and can also serve as an additional port site while still maintaining pneumoperitoneum.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Applied Medical Resources Corp % Underwriters Laboratories, Inc. Morten Simon Christensen 455 E. Trimble Road San Jose, California 95131

NOV - 5 2009

Re: K093296

Trade/Device Name: Alexis Laparoscopic System Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories Regulatory Class: II Product Code: KKX Dated: October 19, 2009 Received: October 21, 2009

Dear Morten Simon Christensen:

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 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 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.

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#### Page 2 – Morten Simon Christensen

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/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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Mikkelsen

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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## INDICATIONS FOR USE

## 510(k) Number (if known): Not you assigned. K 0 9 3 2 96

Device Name: Alexis Laparoscopic System

Indication for use: The Alexis Laparoscopic System 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. .
- Seal off the incision opening to permit insufflation of 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neitke of for mxm

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093296