ALEXIS ORTHOPAEDIC WOUND RETRACTOR

K100120 · Applied Medical Resources Corp. · KGW · Apr 2, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100120
• Device Name: ALEXIS ORTHOPAEDIC WOUND RETRACTOR
• Applicant: Applied Medical Resources Corp.
• Product Code: KGW · General, Plastic Surgery
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Orthopaedic wound retractors are sterile, single-use devices that are intended to access the musculoskeletal system through an atraumatically retracted wound. The predicate device(s) are cleared for access to internal spaces and for soft tissue retraction. Orthopaedic procedures fall in the latter category.

Device Story

Wound retractor; cylindrical flexible polymer film sheath with semi-rigid polymer ring at each end. Device inserted into incision; inner ring placed inside body cavity; outer ring remains outside. Rolling outer ring toward inner ring shortens retractor; anchors device; retracts wound; converts incision into round opening. Flexible membrane protects incised tissue. Used in open orthopaedic procedures to provide unimpeded access to internal spaces while protecting wound. Operated by surgeons. Sturdier sheath material accommodates orthopaedic instruments; some models feature asymmetric ring diameters.

Clinical Evidence

Bench testing only. No clinical data. Testing included wound retraction capability, resistance to tearing during instrument exchanges, durability (cycling test), and maximum allowable incision size.

Technological Characteristics

Sterile, single-use, flexible polymer membrane cylinder with semi-rigid polymer rings. Mechanical retraction via rolling outer ring. Sturdier sheath material compared to predicate. Asymmetric ring diameters available on some models.

Indications for Use

Indicated for accessing the musculoskeletal system through an atraumatically retracted wound.

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 Medical Alexis Wound Retractor (K062907)

Submission Summary (Full Text)

{0}------------------------------------------------

100120

APR - 2 2010

## 510(k) SUMMARY

Page 1 of ②

Applied Medical Resources Corporation 510(k) OWNERS NAME: 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 [phone] [phone] (FAX) CONTACT PERSON:

January 11, 2010

Wound retractor

Frans VandenBroek [e-mail]

DATE OF PREPARATION:

TRADE NAME:

ﺔ

COMMON NAME:

CLASSIFICATION NAME:

Surgical Drone and Drone Accessories

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

Alexis Orthopaedic Wound Retractor

PREDICATE DEVICE:

Applied Medical Alexis Wound Retractor

DEVICE DESCRIPTION: Wound retractors convert straight incisions into round openings that facilitate access to internal body cavities and spaces. APPLIED's wound retractors consist of a cylindrical flexible film sheath that has a semi-rigid polymer ring on each end. Retractors of this design are useful in open orthopaedic procedures that require unimpeded access while simultaneously protecting the wound.

INTENDED USE: Orthopaedic wound retractors are sterile, single-use devices that are intended to access the musculoskeletal system through an atraumatically retracted wound. The predicate device(s) are cleared for access to internal spaces and for soft tissue retraction. Orthopaedic procedures fall in the latter category.

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 is positioned inside a body cavity while the other remains outside the patient. Rolling down the outer ring towards the inner ring 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.

{1}------------------------------------------------

100120

Page 2 of (2)

The subject device is essentially equivalent to the predicate except that the sheath material is, sturdier to accommodate orthopaedic instruments. Further, whereas the diameters of the inner and outer rings of the predicate retractors are identical, some models of the orthopaedic retractor will feature an one ring smaller than the other.

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 of K062907. These tests include the device's:

- Ability to retract a wound .
- . Resistance to tearing during instrument exchanges
- Durability (cycling test) .

-

- Maximum allowable incision size .
These tests were performed on predicate and subject device and established substantial equivalence between the two.

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.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

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

Applied Medical Resources Corporation % Mr. Frans VandenBroek Vice President, Regulatory Affairs 22872 Avenida Empresa Rancho Santa Margarita, California 92688

APR -2 2010

Re: K100120

Trade/Device Name: Alexis Orthopaedic Wound Retractor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 11, 2010 Received: January 26, 2010

Dear Mr. VandenBroek:

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

{3}------------------------------------------------

Page 2 - Mr. Frans VandenBroek

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 (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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark A. Mckinnon

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

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE

K100120 510(k) Number (if known): Not yet assigned.

Device Name: Alexis Orthopaedic Wound Retractor

Indication for use: The Alexis Orthopaedic Wound Retractor is indicated for use to access the musculoskeletal system through an atraumatically retracted wound

Prescription Use X (Part 21 CFR 801 Subpart D)

产

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

\$\frac{\text{Niel RP. Roben}}{\text{(Division Sign-Off)}}\$ for a kn

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K100120

1-1