(73 days)
The NAMSA SCBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 121°C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
The activated SCBI should be incubated at 58-62°C for a minimum of 24 hours. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow and/or the presence of turbidity. The absence of growth indicates the exposure was effective.
1. Table of acceptance criteria and reported device performance:
The provided document does not explicitly state quantitative acceptance criteria or a dedicated section for "reported device performance." However, based on the testing descriptions and the nature of a biological indicator, the performance is implicitly linked to the successful demonstration of specific resistance characteristics and proper recovery.
| Acceptance Criteria (Implied) | Reported Device Performance/Testing Description |
|---|---|
| Viability of Spores | "Total Viable Spore Count" - This test is conducted to ensure the SCBIs contain a sufficient and consistent number of viable spores (Geobacillus stearothermophilus) to accurately monitor sterilization. Specific counts are generally specified by standards, but not detailed here. |
| Resistance to Sterilization Process | "Resistance Characteristic Studies including D value, z value, Survival/Kill Windows" - This demonstrates the SCBI's ability to resist specific steam sterilization cycles, quantifying its resistance (D-value) and the temperature coefficient (z-value) for demonstrating effectiveness. The survival/kill windows confirm that the SCBI shows growth when conditions are insufficient for sterility and no growth when conditions are sufficient. |
| Material Compatibility/Integrity | "Carrier and Primary Packaging Materials Evaluation" - This ensures the materials housing the spores and growth medium do not interfere with the sterilization process or the indicator's performance. |
| Stability Over Time (Shelf Life) | "Holding Time Assessment" - This likely refers to testing performed over the product's shelf life to ensure the SCBI maintains its performance characteristics. The document also states the device has "the same or similar shelf life" as the predicate. |
| Accurate and Timely Detection of Growth/No Growth | "Recovery Protocols Reduced Incubation Time Studies" & "Medium Suitability" - These tests ensure that surviving spores can be accurately and reliably recovered and grow within the specified incubation time (24 hours in this case), and that the growth medium supports this. The "color shift from purple to yellow and/or the presence of turbidity" indicates growth. |
| Monitoring Efficacy in Various Steam Processes | Stated for "pre-vacuum and gravity displacement 121°C steam processes" and "saturated steam processes of 132°C, 134°C and 135°C." The testing would have evaluated the performance at these specific temperatures and exposure times. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each test. It broadly states "multiple lots of NAMSA Steam Self-Contained Biological Indicators over the range of the shelf life" were used for the various tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission to the FDA, the testing was likely conducted in accordance with recognized FDA consensus standards and guidance documents, implying prospective studies for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device (biological indicator). The "ground truth" for a biological indicator is established by standard microbiological and sterilization testing methods, not by expert consensus on visual interpretation of results. The ground truth would be the known efficacy of the sterilization cycle itself, determined by validated physical and chemical parameters, against which the BI's performance is measured.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of images or clinical data, where there might be inter-reader variability. For biological indicators, the results (growth/no growth, D-value, Z-value) are objectively measured based on established microbiological and sterilization science principles.
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:
Not applicable. This device is a biological indicator, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a single-use, self-contained biological indicator. Its function is to provide a visual indication of sterilization efficacy (color change and/or turbidity), which is then interpreted by a human. There is no "algorithm only" component to assess.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for a biological indicator's performance is established by standardized microbiological methods and established sterilization parameters.
- For D-value and z-value determination: This involves exposing the BIs to precisely controlled sterilization cycles, often using resistance test equipment, to determine the exact time/temperature required to kill a certain percentage of spores. The "ground truth" is the mathematically derived logarithmic reduction of microorganisms based on kill-time studies.
- For survival/kill windows: The ground truth is determined by running cycles that are known (validated) to achieve sterility and cycles that are known (validated) to fail sterility. The BI's performance (growth/no growth) must align with these known outcomes.
- For total viable spore count: The ground truth is the actual number of viable spores determined by standard plate counting methods.
8. The sample size for the training set:
Not applicable. This device does not involve machine learning or AI, so there is no "training set." The performance is based on the intrinsic biological and physical properties of the indicator.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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510(k) Summary for NAMSA Steam Self-Contained Biological Indicators (SCBIs)
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The activated SCBI should be incubated at 58-62°C for a minimum of 24 hours. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow and/or the presence of turbidity. The absence of growth indicates the exposure was effective.
Statement of Similarity to Legally Marketed Predicate Device:
The NAMSA Steam Self-Contained Biological Indicators have the following similarities to the legally marketed predicate device:
- Same indication for use .
- Incorporation of the same or similar materials .
- Have the same or similar shelf life, and .
- . The same or similar materials for packaging
In summary, the data provided demonstrates substantial equivalence to the predicate device.
Description of Testing: Per FDA recognized consensus standards and guidance documents testing was performed for steam sterilization processes using multiple lots of NAMSA Steam Self-Contained Biological Indicators over the range of the shelf life.
- · Total Viable Spore Count
- Resistance Characteristic Studies including D value, z value, Survival/Kill . Windows
- Carrier and Primary Packaging Materials Evaluation .
- . Holding Time Assessment
- Recovery Protocols Reduced Incubation Time Studies �
- Medium Suitability .
Image /page/1/Picture/15 description: The image shows the word "NAMSA" in white letters against a black background. The letters are slightly distressed, with some areas appearing faded or broken. The letters are in a sans-serif font and are evenly spaced. There is a trademark symbol after the A.
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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 with three stripes forming its body and wing. The eagle is oriented towards the upper right corner of the image. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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 Association, Incorporation 6750 Wales Road Northwood, Ohio 43619
JAN 2 0 2012
Re: K113302
Trade/Device Name: NAMSA Steam Self-Contained Biological Indicator (SCBI) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 3, 2012 Received: January 4, 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 ( veperior 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 Compilance: "Theo; pread 107.97). 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 Tou may 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hh for
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: | K113302 |
|---|---|
| ---------------- | --------- |
NAMSA Steam Self-Contained Biological Indicator (SCBI) Device Name:
Indications for Use:
The NAMSA SCBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 121°C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
Exposure times at 121°C are 30 minutes and 3 minutes for exposures at 132°C, 134°C and 135°C. Reference the sterilizer user manual for specific exposure timeframes.
The NAMSA Steam SCBIs are placed into a sterilization load in a location that has been determined to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. The SCBI is removed after the cycle is complete and has cooled to a point where the SCBI can comfortably be handled. The SCBI is activated by pushing the sides with enough force to break the ampoule containing the growth medium. The activated SCBI is incubated at 58-62°C for 24 hours. A reduced incubation time of 24 hours has been validated.
Prescription Use (Part 21 CFR 801 SubpartD) AND/OR
Over-The-Counter Use X (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)
Elizabeth F. Claverie-Wills
(Division Sian-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K113302
§ 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).