The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, product code STS-05R, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372. product code STNS-65R) is intended for use in testing the efficacy of chemiclave sterilization.

Performance characteristics are established for exposure at 132ºC for 20 minutes in a MDT Harvey Chemiclave model EC5500 chemiclave sterilizer. Vapo-Steril Solution is the sterilant utilized in the MDT Harvey Chemiclave sterilizer. The solution was cleared under 510(k) number K984270. The validation load used for evaluation of the device performance characteristics consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg.

A reduced incubation time of 72 hours for chemiclave sterilization at 132°C has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple and incubated at 58° - 62°C.

Device Description

The Biological Indicator Spore Strips are typically used in a dental office but may be used by other small healthcare offices which utilize chemiclave processes to sterilize instruments. The spore strips are utilized to verify the chemiclave exposures were effective at killing the Geobacillus stearothermophilus bacterial spores present on the strips in high volume.

Modification to K113221 are to include chemiclave sterilization at 132°C for 20 minutes in a Harvey model EC5500. The predicate device was not specific to sterilizer type or model number but rather is legally marketed for use in monitoring the chemiclave process. Specificity of the chemiclave model in no way affects the safety or effectiveness of the device.

NAMSA Biological Indicator Spore Strips are easy to use; simply place the spore strips in the most difficult area to sterilize and process the load as normal. After exposure, remove the spore strips and aseptically transfer to growth medium and incubated. After incubation if no signs of bacterial growth are present, the sterilization cycle was effect.

The spore strips may be aseptically transferred to standard media such as Tryptic Soy Broth (TSB) and incubated for a minimum of 7 days. Growth will be indicated by the presence of turbidity. Conversely, the strips may be cultured using TSB which has been modified with a pH indicator (Bromocresol Purple) for a reduced incubation time of 72 hours. Growth will be indicated by a change in color of the media from purple to yellow and/or presence of turbidity.

Biological Indicator Spore Strips consist of a 1.25" x 0.25" filter paper strip which has been inoculated with either single species (Geobacillus stearothermophilus ATCC® 7953 at a population level of 105 per strip), or dual species (Geobacillus stearothermophilus ATCC® 7953 at a population level of 105 and Bacillus atrophaeus ATCC® 9372 at a population level of 106 per strip). The spore strips are individually packaged in a 30# glassine pouch.

AI/ML Overview

This document describes the NAMSA Biological Indicator Spore Strip, a device intended to test the efficacy of chemiclave sterilization. However, the provided text does not contain a typical acceptance criteria table with reported device performance metrics in the format usually associated with AI/ML device studies. Instead, it outlines the technological characteristics of the device and a list of testing performed to demonstrate substantial equivalence to a predicate device.

Given the nature of this submission (a 510(k) for a biological indicator, not an AI/ML device), the "acceptance criteria" discussed are primarily about meeting performance characteristics analogous to existing predicate devices, rather than predefined statistical thresholds for a new analytical algorithm.

Here's an attempt to extract the relevant information based on the provided text, reformatted to fit the request where possible, keeping in mind the device is a biological indicator, not an AI algorithm.

1. Table of Acceptance Criteria (Technological Characteristics) and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device and the new device's ability to demonstrate substantial equivalence in key performance characteristics. The document presents a comparison of the new device's technological characteristics against the predicate device.

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (NAMSA Spore Strip)
Product Type	Biological Indicator	Biological Indicator
Intended Use	Chemiclave at 132°C	Chemiclave 132°C for 20 minutes, Harvey Model EC5500
Construction	Paper spore strip in glassine	Paper spore strip in glassine
Organism	G. stearothermophilus, ATCC® 7953	G. stearothermophilus, ATCC® 7953
Viable Spore Population	10^5^/strip	10^5^/strip (single species) or 10^5^ G. stearothermophilus and 10^6^ B. atrophaeus (dual species)
Certified Resistance Characteristics	Dvalue at 132°C: 1.0 to 3.0 Minutes; Survival: 5 min; Kill: 15 min	Dvalue at 132°C: 1.0 to 3.0 Minutes; Survival: 5 min; Kill: 15 min
Incubation Temperature	60°±2°C	60°±2°C
Readout Time in Modified Culture Medium	72 hours	72 hours
Shelf Life	Minimum of 18 Months	18 Months

Study Proving Acceptance Criteria is Met:

The document describes a series of studies designed to demonstrate that the NAMSA Biological Indicator Spore Strip is substantially equivalent to the predicate device and performs as intended. These include:

Survival-Kill Window Verification: Demonstrated equivalence with the predicate device at the manufacturer's certified chemiclave resistance characteristics (5-minute survival, 15-minute kill). This was also verified at the end of the device's shelf life.
Population Evaluation: Confirmed equivalent population levels to the predicate device.
Readout Time Evaluation: Confirmed equivalent reduced incubation times to the predicate device.
Resistance Characterization (D-value Determination and Verification): Determined D-values at 124°C, 132°C, and 140°C using the Fraction Negative Method. Verified D-values using expired Vapo-Steril solution to account for its full shelf life.
Load/Chamber Evaluation Studies: Verified device performance in a full chamber with a standard load (stainless steel dental instruments in a wrapped tray with a mass of 1 kg) to confirm no negative influence on sterilization conditions.
Quantitative Determination of Pre-Exposure Phase Lethality: Quantified spores killed prior to the exposure phase across various load conditions and temperature extremes.
Carrier and Primary Packaging Material Evaluation: Assessed inhibitory properties and degradative changes of materials.
Holding Time Assessment: Verified that the Biological Indicators (BIs) were not negatively impacted if left at room temperature for 96 hours post-exposure prior to incubation.
Recovery Protocols - Reduced Incubation Time (RIT): Determined that the 72-hour RIT claim remains valid even with a 96-hour delay in incubation post-exposure.

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

The document does not explicitly state the specific sample sizes (number of biological indicators or test runs) for each individual test or for a single "test set" in the context of an algorithm. However, testing involved:

Evaluation of "NAMSA's Biological Indicator Spore Strips" for population and readout time.
"Three lots of the device" were evaluated for D-values with expired Vapo-Steril solution.
"Standard chemiclave sterilizer" at "standard 132°C cycle for 20 minutes."
"Validation load...consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg."
"BI's not processed...immediately following exposure are not negatively impacted" if left at room temperature for 96 hours.

The provenance of data is not explicitly stated in terms of country of origin, but all testing appears to be conducted by NAMSA (North American Science Assoc., Inc.) to support their 510(k) submission to the US FDA. The studies are prospective in nature, as they involve performing specific tests on the device under defined conditions.

3. Number of Experts and Qualifications for Ground Truth

This type of submission for a biological indicator does not typically involve human experts establishing "ground truth" for a test set in the way an AI/ML diagnostic device does. The ground truth for biological indicators is established through objective biological and physical measurements:

Bacterial spore population counts: Measured via standard microbiological techniques.
Survival/kill determination: Based on the presence or absence of bacterial growth after incubation, which is an objective observation (turbidity or color change).
D-value calculations: Derived mathematically from experimental data on spore survival at different exposure times.
Sterilization efficacy: Determined by the physical/chemical process itself and validated by the BI's response.

Therefore, the concept of "number of experts used to establish ground truth" and their "qualifications" is not directly applicable in the same way it would be for medical image interpretation or similar diagnostic tasks. The "experts" in this context would be the microbiologists and engineers who designed and executed the validated test methods.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for a biological indicator is based on objective biological and physical measurements rather than expert human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML diagnostic device that would be used by human readers. Its purpose is to indicate the success of a sterilization process.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical biological indicator, not an algorithm. Its performance is inherent in its biological and physical properties.

7. Type of Ground Truth Used

The ground truth used is based on:

Biological viability: Growth or no growth of Geobacillus stearothermophilus spores.
Quantitative microbiology: Spore population counts and D-value calculations.
Physical sterilization parameters: Exposure time, temperature, and sterilant concentration, which are controlled experimental variables against which the BI's performance is measured.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses training data. The device's performance is based on its inherent physical and biological characteristics, which are then validated through empirical testing, not learned from a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.

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

September 9, 2014

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

Re: K141244

Trade/Device Name: NAMSA Biological Indicator Spore Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator/Biological Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: August 8, 2014 Received: August 12, 2014

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.

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

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri S. Purohitsheth -S Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH 2014.09.09 17:28:18 -04'00'

Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K141244

Device Name NAMSA Biological Indicator Spore Strip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image features the word "NAMSA" in a bold, sans-serif font. The letters are white, contrasting against a dark blue background. A small trademark symbol is located to the right of the letter A.

PEOPLE > SCIENCE > SOLUT

USA CorporateHeadquarters	California	Ohio
6750 Wales Rd	9 Morgan	6750 Wales Rd
Northwood, Ohio 43619	Irvine, California 92618	Northwood, Ohio 43619
T 866.666.9455 (tollfree)	T 949.951.3110	T 866.666.9455
F 419.662.4386	F 949.951.3280	F 419.662.4386

510(k) Summary

ഗ്ര

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 and Regulatory Affairs Manager, NAMSA Products419.662.4829madamski@namsa.com
Prepared on:	April 4, 2014
Device Trade Name:	NAMSA Biological Indicator Spore Strips
Common Name:	Indicator/Biological Sterilization Process Indicator
Classification Name:	Class II Medical Device, FDA Product Code FRC, General Hospital (21 CFR 880.2800)
Predicate Device:(Legally Marketed)	Raven Bacterial Spore Strips
Predicate Device 510(k) Numbers:	K912796, K020026 and K050591
Description:	The Biological Indicator Spore Strips are typically used in a dental office but may be usedby other small healthcare offices which utilize chemiclave processes to sterilizeinstruments. The spore strips are utilized to verify the chemiclave exposures wereeffective at killing the Geobacillus stearothermophilus bacterial spores present on thestrips in high volume.Modification to K113221 are to include chemiclave sterilization at 132°C for 20 minutes ina Harvey model EC5500. The predicate device was not specific to sterilizer type or modelnumber but rather is legally marketed for use in monitoring the chemiclave process.Specificity of the chemiclave model in no way affects the safety or effectiveness of the

device.

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

Intended Use:

The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, product code STS-05R, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372, product code STNS-65R) is intended for use in testing the efficacy of chemiclave sterilization.

Performance characteristics are established for exposure at 132℃ for 20 minutes in a MDT Harvey Chemiclave model EC5500 chemiclave sterilizer. Vapo-Steril Solution is the sterilant utilized in the MDT Harvey Chemiclave sterilizer. The solution was FDA cleared under 510(k) number K984270. The validation load used for evaluation of the device performance characteristics consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg.

A reduced incubation time of 72 hours for chemiclave sterilization at 132℃ has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple and incubated at 58° - 62°C.

Summary of Technological Characteristics:

The NAMSA Biological Indicator Spore Strip has the following similarities related to the technological characteristics of those legally marketed under 510(k) numbers K912796, K020026 and K050591:

	New Device	Predicate Device
Technological Characteristic	NAMSA Spore Strip	Raven Bacterial Spore Strip
Product Type	Biological Indicator	Biological Indicator
Intended Use	Chemiclave 132°C for 20 minutes,Harvey Model EC5500	Chemiclave at 132°C
Design/Materials
Construction	Paper spore strip in glassine	Paper spore strip in glassine
Organism	G. stearothermophilus , ATCC® 7953	G. stearothermophilus , ATCC® 7953

{5}------------------------------------------------

Viable Spore Population	105/strip	105/strip
Certified ResistanceCharacteristics	Dvalue at 132°C: 1.0 to 3.0 MinutesSurvival - Kill Windows at 132 °C:5 minute Survival, 15 Minute Kill	Dvalue at 132°C: 1.0 to 3.0 MinutesSurvival - Kill Windows at 132 °C:5 minute Survival, 15 Minute Kill
Incubation Temperature	60°±2°C	60°±2°C
Readout Timein Modified Culture Medium(TSB with Bromocresol purple)	72 hours	72 hours
Shelf Life	18 Months	Minimum of 18 Months

The technological characteristics of the NAMSA Bl spore strip are very similar to those of the predicate device in terms of design, materials, performance and principles of operation. The NAMSA Bl spore strips have a more specific intended use by inclusion of the specific cycle and conditions; along with more defined resistance characteristics through a certified Dyalue associated with the specific intended use conditions.

Description of Testing:

In accordance with FDA recognized consensus standards and quidance documents applicable for chemiclave sterilization processes and based on the label claims of the following tests were performed to verify the performance of NAMSA Biological Indicator Spore Strip was substantially equivalent to the predicate device.

Survival-Kill Window
- o The certified chemiclave resistance characteristics of the predicate device, survival time of 5 minutes and kill time of 15 minutes, was verified in conjunction with NAMSA's device to demonstrate equivalence.
Population
- 0 NAMSA's Biological Indicator Spore Strips were evaluated to confirm equivalent population levels to the predicate device
Readout Time ●
- NAMSA's Biological Indicator Spore Strips were evaluated to confirm equivalent reduced o incubation times to the predicate device

The following studies were performed to characterize the performance of NAMSA Biological Indicator Spore Strips for use in the stated chemiclave sterilization cycle:

. Resistance Characterization
- Chemiclave Dvalue Determination at 124 °C,132 °C, 140 °C o
  - Dvalues at each of the temperatures were determined using the Fraction Negative Method. NAMSA determined that the temperature range can vary from 124 °- 140°C in a standard chemiclave sterilizer when ran at the standard 132℃ cycle for 20 minutes.
- Chemiclave Dvalue Verifications at 124 °C.132°C. 140°C Using Expired Vapo-Steril Solution O To ensure that the resistance characteristics of NAMSA's device were addressed for the Vapo-Steril solution at the full extent of the Vapo-Steril solution's claimed shelf life. NAMSA evaluated the Dvalues for three lots of the device over the full temperature range at the end of the shelf life the Vapo-Steril solution.

{6}------------------------------------------------

റ Verification of Survival-Kill Windows at End of Device Shelf Life The certified chemiclave resistance characteristics of the predicate device, survival time of 5 minutes and kill time of 15 minutes, were verified with NAMSA's device at the end of the shelf life to demonstrate the device performs as expected beyond the end of the shelf life.
Load/Chamber Evaluation Studies
- Claimed Sterilization Cycles O

To verify that the sterilization load would not negatively influence the effective sterilization chamber conditions and performance of the device. NAMSA conducted a study to verify the performance of the subject device in a full chamber. The validation load used for evaluation of the device performance characteristics consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg.

Quantitative Determination of the Pre-Exposure Phase Lethality of the Chemiclave Process o The study quantified the number of spores killed prior to initiation of the exposure phase (pre exposure) across the possible range of load conditions and temperature extremes.
Carrier and Primary Packaging Material Evaluation The suitability of the carrier and primary packaging materials for the intended sterilization processes was determined through evaluation of the inhibitory properties on growth of Geobacillus stearothermophilus after sterilization. Neither the primary carrier or packaging material high levels of absorption of sterilant or degradative changes during the chemiclave sterilization process.
. Holding Time Assessment

The intent of the study was to verify that Bls not processed (transferred to growth medium and incubated) immediately following exposure are not negatively impacted. The Bls are not impacted if left at room temperature for 96 hours prior to transfer to growth medium.

. Recovery Protocols - Reduced Incubation Time (RIT)
- Determination of Reduced Incubation for Chemiclave Sterilization Process (Modified TSB) with O Delayed Incubation Post-Exposure The 72 hour RIT claim for chemiclave sterilization was determined to be still valid even when the

Spore Strips are held for 96 hours post-exposure prior to transferring to growth medium.

In summary, the data provided demonstrates NAMSA Biological Indicator Spore Strip is substantially equivalent to the predicate device. The test results support a determination of substantial equivalence to the legally marketed predicate device, as well as demonstrate the NAMSA Biological Indicator Spore Strip is as safe, as effective, and performs as well as or better than the predicate device.

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).