TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N

K061308 · Cardinal Health 200, Inc. · FYA · Jun 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061308
• Device Name: TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N
• Applicant: Cardinal Health 200, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Jun 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The gown is a single use disposable device intended for repackaging and sterilization before use. This single use product is a disposable non-sterile surgical gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide the Validation and Routine Control under following ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health, Inc. The exception for sterilization is that the SMS polyolefin reinforced gown, cannot under go steam sterilization. sterilization may damage the impervious Steam reinforcement on the gown. Ethylene Oxide is the only method of sterilization for this gown.

Device Story

Surgical gowns composed of SMS polyolefin, spunlace (wood pulp/polyester), or breathable monolithic film laminates; designed for use by operating room personnel during surgical procedures. Devices are provided non-sterile; intended for repackaging and sterilization by the user via moist heat or ethylene oxide (except poly-reinforced models, which require ethylene oxide only). Gowns act as physical barriers to protect both patient and staff from cross-contamination of microorganisms, fluids, and particulates. Single-use, disposable design.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1, including cytotoxicity, sensitization, and primary skin irritation. Materials tested in accordance with industry-recognized methods and found acceptable for intended use.

Technological Characteristics

Materials: SMS polyolefin, spunlace (wood pulp/polyester blend), breathable monolithic film, polyolefin-based film reinforcement. Construction: Single or multi-layer non-woven fabrics. Sterilization: Compatible with moist heat (ANSI/AMMI/ISO 11134) and ethylene oxide (ANSI/AMMI/ISO 11135), with specific limitations for poly-reinforced models (Ethylene Oxide only).

Indications for Use

Indicated for use by operating room personnel during surgical procedures to provide a barrier against the transfer of microorganisms, body fluids, and particulate material between the patient and the personnel.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Submission Summary (Full Text)

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K06/308

Image /page/0/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of the text "CardinalHealth" in a simple, sans-serif font. Above the text, there is a stylized graphic of three curved lines that converge at a point, resembling a bird in flight or a stylized checkmark.

JUN - 5 2006

Cardinal Health Inc. 1500 Waukegan Road McGaw Park, Illinois 60085 847.473.1500 FAX: [phone]

## SMDA REQUIREMENTS

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Convertors® SMS Polyolefin Gowns, Breathable, Surgical Gowns, Breathable Surgical Gowns and O. R. Surgical Gowns

| Manufacturer: | Cardinal Health Inc.<br>One Butterfield Trail<br>El Paso, Texas 79906 |
|-----------------------------|-----------------------------------------------------------------------|
| Regulatory Affairs Contact: | Lavenia Ford<br>1500 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |

Telephone:

Date Summary Prepared:

Common Name:

Classification:

Predicate Device:

Description:

Class II per 21CFR § 878.4040

April 24, 2006

Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns and O. R Surgical Gowns

Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns with

Breathable sleeves, Breathable Surgical Gowns and Optima Surgical Gowns

SMS polyolefin, the standard, fabric and poly-reinforced gowns are

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K061308

comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

The Breathable Surgical Gown with Breathable sleeves consists of an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt non-woven (SMS) with polyolefin-based film reinforcement.

The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.

The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.

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K061308

Image /page/2/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that converge at a point, resembling a bird in flight or a stylized medical symbol. The text "CardinalHealth" is written in a simple, sans-serif font, with the two words joined together.

Cardinal Health Inc. 1500 Waukegan Road McGaw Park, Illinois 60085 847.473.1500 FAX: [phone]

### SMDA REQUIREMENTS (continued)

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Convertors® SMS Polyolefin Gowns, Breathable, Surgical Gowns, Breathable Surgical Gowns and O. R. Surgical Gowns

- Intended Use: Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.

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| Substantial<br>Equivalence: | The Convertors® non-sterile gowns are<br>substantially equivalent to the Convertors®<br>SMS Polyolefin Gowns, Breathable Surgical<br>Gowns, Breathable Surgical Gowns and O. R.<br>Surgical Gowns have the same intended use<br>as the current SMS Polyolefin Gowns,<br>Breathable Surgical Gowns, Breathable<br>Surgical Gowns and O. R. Surgical Gowns. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - the intended use is the same |
| | - the performance attributes are the same |
| Summary of Testing | All materials used in the fabrication of this<br>Convertors® SMS Polyolefin Gowns,<br>Breathable Surgical Gowns, Breathable<br>Surgical Gowns and O. R. Surgical Gowns<br>have the same intended use that includes the<br>same indication for use as the current SMS<br>Polyolefin Gowns, Breathable Surgical Gowns,<br>Breathable Surgical Gowns and O. R. Surgical<br>Gowns were evaluated through biological<br>qualification safety tests as outlined in ISO<br>10993 Part-1 "Biological Evaluation of Medical<br>Devices". The biocompatibility tests performed<br>were cytotoxicity, sensitization, and primary<br>skin irritation. These materials also were<br>tested in accordance with industry recognized<br>test methods and were found to be acceptable<br>for the intended use. |

.

:

:

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black, and the text is also in black against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2006

Ms. Lavenia Ford Manager, Regulatory Affairs Cardinal Health 200 Incorporated 1500 Waukegan Road McGaw Park, Illinois 60685

Re: K061308

Trade/Device Name: Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns Breathable Surgical Gowns and O.R. Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 24, 2006 Received: May 10, 2006

Dear Ms. Ford:

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. Ford

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 [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/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

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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REVISED

Image /page/6/Picture/1 description: The image shows the logo for Cardinal Health. The logo is in black and features the company name in a simple, sans-serif font. The word "Cardinal" is connected to the word "Health".

Cardinal Health Inc. 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847,473,1500 F6X- 847 785 2461

510(k) Number (if known): _ _ _ _ _ 06 /30 / 30 8

K061308

. Device Name:

Indications For Use:

Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns Breathable Surgical Gowns and O. R. Surgical Gowns

Convertors@Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The gown is a single use disposable device intended for repackaging and sterilization before use.

This single use product is a disposable non-sterile surgical gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide the Validation and Routine Control under following ANSVAMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health, Inc.

The exception for sterilization is that the SMS polyolefin reinforced gown, cannot under go steam sterilization. sterilization may damage the impervious Steam reinforcement on the gown. Ethylene Oxide is the only method of sterilization for this gown.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

on of Anasthesiology, General Hospital. Jon Control, Dental Devices

40 K061308