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 Description

The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105) or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine pouch.

Operational Principles: 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.

The media containing the spore strip should be incubated at the organism's growth temperature. Media should be monitored daily for visible signs of growth and results recorded.

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.

AI/ML Overview

The provided document describes the NAMSA Biological Indicator Spore Strips and their performance, focusing on their substantial equivalence to predicate devices for assessing sterilization efficacy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state a table of acceptance criteria with numerical targets. Instead, it refers to compliance with recognized standards. The performance characteristics are established according to:

ANSI/AAMI/ISO 11138: This is a series of international standards for biological indicators.
USP (United States Pharmacopeia): This outlines pharmaceutical and medical device standards.

The performance is reported in the context of these standards for specific sterilization parameters:

Acceptance Criteria (Based on ANSI/AAMI/ISO 11138 and USP)	Reported Device Performance
*For Steam Sterilization (Single Species: Geobacillus stearothermophilus* ATCC® 7953):** - Efficacy for 121°C steam gravity displacement for 30 minutes. - Required resistance characteristics (e.g., D-value, Z-value, Survival/Kill Windows) must meet standard specifications. - Required Total Viable Spore Count. - Medium suitability for organism growth. - Holding time assessment must confirm stability. - Recovery protocols must be effective. - Reduced incubation time (24 hours with specific media) validation (if applicable).	Demonstrates efficacy in testing steam sterilization for Geobacillus stearothermophilus ATCC® 7953. - Testing performed for Total Viable Spore Count. - Testing performed for Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows. - Compliance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes. - Holding Time Assessment performed. - Recovery Protocols evaluated. - Medium Suitability evaluated. - Reduced incubation time of 24 hours for steam sterilization has been validated when used with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
*For Steam and Ethylene Oxide (EO) Sterilization (Dual Species: Geobacillus stearothermophilus* ATCC® 7953 and Bacillus atrophaeus ATCC® 9372):** - Efficacy for 121°C steam gravity displacement for 30 minutes. - Efficacy for ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes. - Required resistance characteristics (e.g., D-value, Z-value, Survival/Kill Windows) must meet standard specifications. - Required Total Viable Spore Count. - Medium suitability for organism growth. - Holding time assessment must confirm stability. - Recovery protocols must be effective. - Reduced incubation time (24 hours with specific media) validation (if applicable).	Demonstrates efficacy in testing steam and ethylene oxide sterilization for Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372. - Testing performed for Total Viable Spore Count. - Testing performed for Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows. - Compliance 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. - Holding Time Assessment performed. - Recovery Protocols evaluated. - Medium Suitability evaluated. - Reduced incubation time of 24 hours for steam sterilization has been validated when used with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
General Acceptance Criteria: - Total viable spore count within specified limits. - Carrier and Primary Packaging Materials Evaluation to ensure integrity and compatibility.	- Total Viable Spore Count testing was performed. - Carrier and Primary Packaging Materials Evaluation was performed.

The study described indicates that "testing was performed for steam for single specie spore strips and steam and Ethylene Oxide (EO) sterilization processes for dual species," validating the performance characteristics against these standards. The conclusion is that the device is "substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document states that "Multiple lots of NAMSA Biological Indicator Spore Strips were utilized" for testing. However, it does not provide a specific numerical sample size for the test set (e.g., how many strips per lot, how many lots).
Data Provenance: The document does not specify the country of origin of the data. It is a submission to the FDA in the US for a US-based company (NAMSA). The data is undoubtedly retrospective as it describes testing already performed to demonstrate device performance for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Biological indicator testing focuses on measurable biological and physical parameters (spore count, D-value, survival/kill) rather than human interpretation. Therefore, "experts" in the context of ground truth establishment as it applies to image interpretation or diagnostic test reading would not typically be relevant here. The ground truth is intrinsically tied to the viability of the spores after exposure to sterilization processes, assessed by laboratory culture methods.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods are typically employed in studies where human readers or multiple assessments are involved (e.g., radiology studies). For biological indicators, the outcome (growth/no growth, quantitative spore count) is a direct, objective measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., medical imaging AI). Biological indicators are laboratory-based tools with objective outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of an "algorithm." This device is a biological indicator, not a software algorithm. The "standalone performance" is the inherent performance of the spore strip itself as it responds to sterilization processes, which is what the testing describes.

7. The Type of Ground Truth Used:

The ground truth in this context is based on direct biological measurement and adherence to established physical/chemical parameters of sterilization. Specifically:
- Culture-based viability: Growth or no growth of spores after exposure to sterilization, assessed by incubating the strips in suitable media. This determines survival.
- Quantitative Spore Count: Measurable number of viable spores.
- Resistance Characteristics (D-value, Z-value, Survival/Kill Windows): These are quantitative measures directly derived from the resistance of the spores to specific sterilization conditions, which are established scientific benchmarks for biological indicators.
- Adherence to ANSI/AAMI/ISO 11138 and USP standards: These standards define the accepted performance criteria for effective sterilization monitors.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable in the context of this device. Biological indicators do not involve machine learning algorithms that require training sets. Their performance is inherent to their biological and physical composition and is validated through experimental testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no "training set" for a biological indicator. The ground truth for validating their performance is established through rigorous laboratory testing against defined sterilization cycles and using culture methods to confirm spore viability, all under the guidelines of recognized standards like ANSI/AAMI/ISO 11138 and USP.

Summary

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K113221

	510(k) Summary of NAMSA Biological Indicator Spore Strips	APR 27 2012
Submitter:	NAMSA6750 Wales RoadNorthwood, Ohio 43619P: 419.666.9455F: 419.666.1715E: info@namsa.com
Contacts:	Julie WheelerGeneral Manager, NAMSA Products419.662.4488jwheeler@namsa.comMichelle AdamskiQuality Assurance Specialist, NAMSA Products419.662.4829madamski@namsa.com
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:(Legally Marketed)	NAMSA Biological Indicator Spore Strips
Predicate Device510(k) Number:	K912796, K020026 and K050591
Description:	The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper stripinoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105)or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillusatrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassinepouch.
	Operational Principles: The NAMSA Biological Indicator Spore Strip (single species Geobacillusstearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC®7953 and Bacillus atrophaeus ATCC® 9372) is intended for use in testing the efficacy ofsteam sterilization for single species and steam and ethylene oxide sterilization for dualspecies.
	Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
	The media containing the spore strip should be incubated at the organism's growthtemperature. Media should be monitored daily for visible signs of growth and resultsrecorded.

NAMSA

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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.
	Total Viable Spore CountResistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows

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 (800) 638-2041 or (301) 796-7100 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.

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

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).