NAMSA BIOLOGICAL INDICATOR SPORE STRIPS

K113221 · North American Science Assoc., Inc. · FRC · Apr 27, 2012 · General Hospital

Device Facts

• Record ID: K113221
• Device Name: NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
• Applicant: North American Science Assoc., Inc.
• Product Code: FRC · General Hospital
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species. Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.

Device Story

Device consists of filter paper strip inoculated with bacterial spores (Geobacillus stearothermophilus and/or Bacillus atrophaeus) inside glassine pouch. Used in clinical/hospital settings to monitor sterilization process efficacy. User places strip in sterilizer; after cycle, strip is transferred to growth media (e.g., Tryptic Soy Broth) and incubated. Growth (turbidity) indicates sterilization failure; absence of growth indicates successful sterilization. Provides objective verification of sterilization cycle performance, ensuring patient safety by confirming instruments are sterile before use.

Clinical Evidence

Bench testing only. Performance validated per ANSI/AAMI/ISO 11138 and USP standards. Testing included total viable spore count, resistance characteristics (D-value, Z-value, survival/kill windows), carrier/packaging evaluation, holding time assessment, recovery protocols, and medium suitability. Reduced incubation time (24 hours) for steam sterilization validated using Tryptic Soy Broth modified with Bromocresol Purple.

Technological Characteristics

Filter paper carrier inoculated with Geobacillus stearothermophilus (ATCC 7953) and/or Bacillus atrophaeus (ATCC 9372) spores. Packaged in 30# glassine pouch. Performance standards: ANSI/AAMI/ISO 11138 and USP. No electronic components or software.

Indications for Use

Indicated for testing the efficacy of steam sterilization (single or dual species) and ethylene oxide sterilization (dual species only).

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

• NAMSA Biological Indicator Spore Strips (K912796, K020026 and K050591)

Submission Summary (Full Text)

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K113221

| | 510(k) Summary of NAMSA Biological Indicator Spore Strips | APR 27 2012 | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|
| Submitter: | NAMSA<br>6750 Wales Road<br>Northwood, Ohio 43619<br>P: 419.666.9455<br>F: 419.666.1715<br>E: [e-mail] | | | |
| Contacts: | Julie Wheeler<br>General Manager, NAMSA Products<br>419.662.4488<br>[e-mail]<br>Michelle Adamski<br>Quality Assurance Specialist, NAMSA Products<br>419.662.4829<br>[e-mail] | | | |
| Prepared on: | October 28, 2011 | | | |
| Device Name: | NAMSA Biological Indicator Spore Strips | | | |
| Classification: | Class II Medical Device, FDA Product Code FRC, General Hospital | | | |
| Predicate Devices:<br>(Legally Marketed) | NAMSA Biological Indicator Spore Strips | | | |
| Predicate Device<br>510(k) Number: | K912796, K020026 and K050591 | | | |
| Description: | The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip<br>inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105)<br>or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus<br>atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine<br>pouch. | | | |
| | Operational Principles: The NAMSA Biological Indicator Spore Strip (single species Geobacillus<br>stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC®<br>7953 and Bacillus atrophaeus ATCC® 9372) is intended for use in testing the efficacy of<br>steam sterilization for single species and steam and ethylene oxide sterilization for dual<br>species. | | | |
| | Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138<br>and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600<br>mg/L, 60% RH and 55°C for 2 hours, 10 minutes. | | | |
| | The media containing the spore strip should be incubated at the organism's growth<br>temperature. Media should be monitored daily for visible signs of growth and results<br>recorded. | | | |

# NAMSA

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When standard media is utilized, incubate strips for a minimum of 7 days. Growth will be indicated by the presence of turbidity. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.

### Statement of Similarity to Legally Marketed Predicate Device:

The NAMSA Biological Indicator Spore Strip has the following similarities to the legally marketed Pre-amendment Biological Indicator Spore Strip:

- Same indication for use
- Incorporate the same materials .
- Have the same shelf life, and .
- The same materials for packaging .

In summary, the data provided demonstrates NAMSA Biological Indicator Spore Strip are substantially equivalent to the predicate device.

| Description of Testing: | Per FDA recognized consensus standards and guidance documents, testing was performed for steam for single specie spore strips and steam and Ethylene Oxide (EO) sterilization processes for dual species. Multiple lots of NAMSA Biological Indicator Spore Strips were utilized. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <ul><li>Total Viable Spore Count</li><li>Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows</li></ul> |

- Carrier and Primary Packaging Materials Evaluation .
- Holding Time Assessment .
- Recovery Protocols Reduced Incubation Time Studies .
- Medium Suitability .

Image /page/1/Picture/13 description: The image shows the word "NAMSA" in white font against a black background. The font is a sans-serif typeface, and the letters are bold. The letters are evenly spaced and aligned horizontally. The overall impression is clean and professional.

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## 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 a stylized symbol that resembles an abstract caduceus or a bird-like figure with three overlapping shapes.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Ms. Julie Wheeler General Manager North American Science Assoc, Incorporated 6750 Wales Road Northwood, Ohio 43619

# APR 2 7 2012

Re: K113221

Trade/Device Name: NAMSA Biological Indicator Spore Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: FRC Dated: April 16, 2012 Received: April 17, 2012

Dear Ms. Wheeler:

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.

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# Page 2- Ms Wheeler

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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### Indications for Use Statement

510(k) Number:

#### K113221

Device Name:

#### NAMSA Biological Indicator Spore Strip

Indications for Use:

The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus
stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.

Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.

A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.

Prescription Use (Part 21 CFR 801 SubpartD) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kummerle

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113221