3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK

K093199 · 3M Company · JOJ · Dec 4, 2009 · General Hospital

Device Facts

• Record ID: K093199
• Device Name: 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.

Device Story

Device is a chemical sterilization process indicator used to verify air removal efficiency in dynamic-air-removal steam sterilizers. It consists of a chemical indicator test sheet containing lead-free, steam-sensitive ink, positioned within a pack of porous sheets. During a sterilization cycle, the indicator ink pattern changes from yellow to a uniform dark brown/black. If air removal failure occurs (e.g., air leaks), the ink pattern shows lighter-colored areas, alerting the operator to the failure. Used in clinical settings by sterilization personnel to ensure sterilizer performance; provides immediate visual feedback for quality control of the sterilization process.

Clinical Evidence

No clinical data. Substantial equivalence is based on performance testing demonstrating the device functions equivalently to the predicate in testing air removal efficiency.

Technological Characteristics

Chemical indicator test sheet with lead-free, steam-sensitive ink printed on paper, enclosed in a pack of porous sheets. Operates via chemical color change (yellow to dark brown/black) in response to steam exposure and air removal conditions. Dimensions/form factor equivalent to AAMI ST79 Bowie-Dick towel pack requirements.

Indications for Use

Indicated for testing air removal efficiency in 132-134°C (270-273°F) dynamic-air-removal steam sterilizers.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• 3M™ Comply™ 1233 Bowie-Dick Type Test Pack (ATI Bowie-Dick Test Pack) (K841168)

Submission Summary (Full Text)

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#### 5.0 Premarket Notification (510(k)) Summary

### Sponsor Information:

DEC - 4 2009

K093199

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

| Contact Person: | Jizhong Jin |
|-----------------|-------------------------------|
| | Regulatory Affairs Specialist |
| Phone Number: | [phone] |
| FAX Number: | [phone] |

Date of Summary: October 7, 2009

#### Device Name and Classification:

Common or Usual Name: Sterilization process indicator

3M™ Comply™ Bowie-Dick Type Lead Free Test Pack Proprietary Name:

Classification Name: Indicator, Physical/Chemical Sterilization Process (21 CFR § 880.2800(b))

Performance Standards: N/A

## Predicate Device:

3M™ Comply™ 1233 Bowie-Dick Type Test Pack (ATI Bowie-Dick Test Pack)

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Special 510(k) Premarket Notification for 3MTM Comply TM Bowie-Dick Lead Free Test System

### Description of Device:

The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST79. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a lead-free steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.

#### Indications for Use:

The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.

### Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Information provided in this Special 510(k) submission shows that the 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is substantially equivalent to the predicate device 3M™ Comply™ 1233 Bowie-Dick Type Test Pack (ATI Bowie-Dick Test Pack), cleared under K841168 in terms of intended use, indications for use, composition, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

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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 stylized eagle or bird-like figure with flowing lines, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

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

## DEL - 4 2009

Mr. Jizhong Jin Regulatory Affairs Specialist 3M Company 3M Center, Building 275-5W-06 Saint Paul, Minnesota 55133-3275

Re: K093199

Trade/Device Name: 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack Regulation Number: 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 10, 2009 Received: November 13, 2009

Dear Mr. Jin:

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 Eederal Register.

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Page 2- Mr. Jin

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 (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anten Vimenton

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Special 510(k) Premarket Notification for 3M™ Comply™ Bowie-Dick Lead Free Test Systems

Indications for Use Statement 4.0

# Indications for Use

510(k) Number (if known):

Kogzi99

Device Name:

3M™ Comply™ Bowie-Dick Type Lead Free Test Pack

Indications For Use:

The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizbeth B. Clunie-Willis

(Division Sign-Off) Division of Anesthesiology, General Hoapital nfection Control, Dental Devices

510(k) Number: