(123 days)
The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.
The SporView Rapid Read Biological Indicator is a self-contained biological indicator designed to be used with the 3M Attest 390 auto-reader to qualify or routinely challenge dynamic-airremoval (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C). The SporView Rapid Read Biological Indicator is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap. Similar to the predicate device, 3M's 1292 Rapid Read-Out Biological Indicator cleared under 510(k)s K090569 and K926364, the subject device contains ≥ 105 viable spore population of G. stearothermophilus. It utilizes the a-glucosidase system, which is generated naturally within growing G. stearothermophilus. A successful steam sterilization cycle will result in no growth of G. stearothermophilus. A failure in the sterilization cycle creates a fluorescence change, which is detected upon incubation in the 3M 390 Attest Auto-reader. This provides an enzymatic result in 3 hours to indicate a steam sterilization process failure. The biological indicator will also detect the presence of G. stearothermophilus organism by a visual color change reaction. Biochemical activity of the orqanism will produce acid by-products that cause the media to change color after 48 hours. A visual pH color change after 48 hours also indicates a steam sterilization process failure.
This document describes the SporView Rapid Read Biological Indicator, a device designed to monitor the effectiveness of steam sterilization cycles.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Viable Spore Population Assay | Spore population of the BI meets specification of $\ge 10^5$. | Pass |
| Resistance Characteristics Testing | Steam 132°C:D-Value: $\ge$ 10 secondsZ-Value: $\ge$ 10°CSurvival Time: $\ge$ 1 minute (Calculated as D-value x (Log10[viable spore population] - 2] per FDA guidance) | Pass |
| Carrier and Primary Packaging Materials | Must not have inhibitory effects on the growth of test organisms of the BI after sterilization. | Pass |
| Holding Time Assessment | 7-day holding time must have no effects on the performance of the subject BI. | Pass |
| Growth Promotion and Media Suitability | The media of the biological indicator must support growth and recovery to be suitable. | Pass |
| Reduced Incubation Time | Verification of 3-hour fluorescent and 48-hour biological readout per FDA's Validation of Reduced Incubation Protocol. | Pass |
| Verification of Full and Fractional Cycle | Partial kill achieved after a fractional cycle and full biological inactivation after a full cycle in a marketed sterilizer. | Pass |
| 3M 390 Auto-Reader Compatibility Testing | Evaluation that the compatibility of the SporView Rapid Read BI and 3M 390 Auto-Reader system such that the auto-reader reads and displays accurate results and alarms appropriately upon BI removal. | Pass |
| Shelf Life Testing | Verification of the viable spore population, resistance characteristics, and media stability at the end of the shelf life. | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test in the "Performance Characteristics Testing" section. However, the testing was conducted by Medivators in accordance with FDA Guidance on Biological Indicators to demonstrate that the device meets or exceeds acceptance criteria. The data provenance is implied to be from laboratory testing conducted by the manufacturer, Medivators (Crosstex/SPSmedical). The type of data is non-clinical performance data. There is no information regarding country of origin or whether the data is retrospective or prospective, although typically, pre-market submissions involve prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for a biological indicator would be based on the known state of sterilization (e.g., whether a sterilization cycle was effective or not) and the measurable biological response of the indicator (e.g., spore growth or no growth). This is determined by the experimental setup rather than expert consensus on individual results.
4. Adjudication method for the test set:
Not applicable. The "ground truth" for the performance of a biological indicator in these types of tests is typically objective (e.g., based on known sterilization parameters and direct observation of microbial growth/killing), rather than requiring adjudication among human experts.
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 for sterilization monitoring, not an AI-assisted diagnostic or interpretation tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a biological indicator itself, which is then read by an auto-reader (3M Attest 390 Auto-Reader). The performance evaluated is the indicator's ability to accurately reflect sterilization efficacy, confirmed by its interaction with the auto-reader. There is no "algorithm only" performance reported in the sense of a software-based diagnostic.
7. The type of ground truth used:
The ground truth used for these tests is based on objective biological and physical measurements related to sterilization efficacy. This includes:
- Spore viability: Direct counts of viable spores.
- Resistance characteristics (D-value, Z-value, Survival Time): Determined by exposing the biological indicators to precisely controlled steam sterilization conditions and observing the killing kinetics of the spores.
- Growth promotion: Observing the ability of the media to support the growth of G. stearothermophilus.
- Fractional and full cycle inactivation: Observing partial kill after a fractional cycle and complete inactivation after a full cycle in a marketed sterilizer.
8. The sample size for the training set:
Not applicable as this is not an AI/machine learning device that requires a training set. The "training set" concept is traditionally associated with statistical models or machine learning algorithms that learn from data.
9. How the ground truth for the training set was established:
Not applicable for the reasons stated in point 8.
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December 12, 2017
Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar Regulatory Affairs Specialist 6789 West Henrietta Road Rush, New York 14543
Re: K172432
Trade/Device Name: SporView Rapid Read Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: October 31, 2017 Received: November 1, 2017
Dear Megan Skaar:
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.
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172432
Device Name SporView® Rapid Read Biological Indicator
Indications for Use (Describe)
The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PSC Publishing Services (301) 443-6740
EF
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K172432 - 510(k) Summary
| Manufacturer: | Crosstex/SPSmedical, a Cantel Medical Company |
|---|---|
| Address: | 6789 W. Henrietta RoadRush, NY 14543(800) 722-1529 |
| Official Contact: | Megan SkaarRegulatory Affairs Specialist, Cantel Medical |
| Date: | 9 August 2017 |
| Trade Name: | SporView Rapid Read Biological Indicator |
| Common Name: | Biological Indicator |
| Classification Name: | Indicator, Biological Sterilization Process |
| Product Code: | FRC |
| Device Class: | II |
| Regulation No: | Subject Device – SporView Rapid Read Biological indicator, 880.2800Predicate Device – 3M Attest 1292 Rapid Read Biological Indicator880.2800 |
1. Device Description
The SporView Rapid Read Biological Indicator is a self-contained biological indicator designed to be used with the 3M Attest 390 auto-reader to qualify or routinely challenge dynamic-airremoval (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C).
The SporView Rapid Read Biological Indicator is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.
Similar to the predicate device, 3M's 1292 Rapid Read-Out Biological Indicator cleared under 510(k)s K090569 and K926364, the subject device contains ≥ 105 viable spore population of G. stearothermophilus. It utilizes the a-glucosidase system, which is generated naturally within growing G. stearothermophilus. A successful steam sterilization cycle will result in no growth of G. stearothermophilus. A failure in the sterilization cycle creates a fluorescence change, which is detected upon incubation in the 3M 390 Attest Auto-reader. This provides an enzymatic result in
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3 hours to indicate a steam sterilization process failure. The biological indicator will also detect the presence of G. stearothermophilus organism by a visual color change reaction. Biochemical activity of the orqanism will produce acid by-products that cause the media to change color after 48 hours. A visual pH color change after 48 hours also indicates a steam sterilization process failure.
2. Indications for Use
The SporView Rapid Read Biological Indicator is intended to be used with the 3M Attest 390 Auto-Reader to monitor the effectiveness of dynamic-air-removal (pre-vacuum) steam sterilization cycles of 4 minutes at 132°C.
The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.
3. Comparison of Technological Characteristics with the Predicate Device
The subject device – SporView Rapid Read Biological Indicator and its predicate device – 1292 Rapid Read-Out Biological Indicator are substantially equivalent in that they both have the same intended use, fundamental technology and general performance. Both the subject device and the 3M 1292 Rapid Read Indicator have a spore carrier inoculated with the same organism. G. stearothermophilus. The subject and predicate Bls both utilize a a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus organisms.
Table 05.1 below provides a detailed comparison between the subject and predicate device -
| Important Elements | Subject Device – SporViewRapid Read BI | Predicate Device – 3M 1292Rapid Read-Out BI(K926364 and K090569) |
|---|---|---|
| Intended Use | Monitor 270°F (132°C)prevacuum steamsterilization cyclesfor 4 minutes. | Monitor 270°F (132°C)prevacuum steamsterilization cycles and 250°F(121°C) gravity steamsterilization cycles. |
| Product Code | FRC | FRC |
| FDA Regulation | 21 CFR§ 880.2800 | 21 CFR§ 880.2800 |
| Biological Indicator Design | Self-Contained Steam BI | Self-Contained Steam BI |
| Organism | > 90% genetic similarity to G.stearothermophilus ATCC™strain 7953 | > 90% genetic similarity to G.stearothermophilus ATCC™strain 7953 |
| Viable Spore Population | ≥ 1.0 x 105 | ≥ 1.0 x 105 |
| Table 05.1 - Predicate Device Comparison Table | ||||||
|---|---|---|---|---|---|---|
| -- | ------------------------------------------------ | -- | -- | -- | -- | -- |
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| BI Components | Vial, cap, cap filter, base plug, glass ampoule and spore carrier | Vial, cap, cap filter, base plug, glass ampoule and spore carrier |
|---|---|---|
| Incubation Temperature | 60±2°C | 60±2°C |
| Incubation Duration | 3 hours | 3 hours |
| Growth Medium | Purple to yellow | Purple to yellow |
| D-Value | Steam 132°C: ≥ 10.0 seconds | Steam 132°C: ≥ 10.0 seconds |
| Z-Value | Steam 132°C: ≥ 10°C | Steam 132°C: ≥ 10°C |
| Minimum Survival Time & Calculation | Steam 132°C: ≥ 1 minute; D-value x (Log10[viable spore population] - 2] per FDA guidance (2.10 min average) | Steam 132°C: ≥ 1 minute; D-value x (Log10[viable spore population] - 2] per FDA guidance |
| Maximum Kill Time Calculation | D-value x (Log10[viable spore population] + 4] per FDA guidance (4.98 min average) | D-value x (Log10[viable spore population] + 4] per FDA guidance |
4. Summary of Non-Clinical Performance Data
Medivators has conducted the following testing in accordance with the FDA Guidance on Biological Indicators to demonstrate that the SporView Rapid Readout BI meets or exceeds acceptance criteria. Please refer to the table below for a brief description of the subject device testing –
- Performance Characteristics Testing: .
| Performance Testing | Details and Acceptance Criteria | Results |
|---|---|---|
| Viable SporePopulation Assay | Assay to demonstrate the spore population of the BImeets specification of $≥ 105$ . | Pass |
| ResistanceCharacteristics Testing | Resistance characteristics of the BI in the intendedsteam 132°C sterilization process and cycle using aresistometer must be:D-Value: $≥$ 10 secondsZ-Value: $≥$ 10°CSurvival Time: $≥$ 1 minute | Pass |
| Carrier and PrimaryPackagingMaterials | Carrier and primary packaging materials must not haveinhibitory effects on the growth of test organisms of theBI after sterilization. | Pass |
| Holding TimeAssessment | The 7 day holding time must have no effects on theperformance of the subject BI. | Pass |
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| Growth Promotion andMedia Suitability | The media of the biological indicator must supportgrowth and recovery to be suitable. | Pass |
|---|---|---|
| Reduced IncubationTime | Verification of 3 hour fluorescent and 48 hourbiological readout per FDA's Validation of ReducedIncubation Protocol. | Pass |
| Verification of Full andFractional Cycle | Partial kill achieved after a fractional cycle and fullbiological inactivation after a full cycle in a marketedsterilizer. | Pass |
| 3M 390 Auto-ReaderCompatibility Testing | Evaluation that the compatibility of the SporView RapidRead Bl and 3M 390 Auto-Reader system such thatthe auto-reader reads and displays accurate resultsand alarms appropriately upon BI removal. | Pass |
- Shelf Life Testing: Verification of the viable spore population, resistance characteristics . and media stability at the end of the shelf life.
5. Conclusion
The subject device effectively monitors dynamic-air-removal (pre-vacuum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator is substantially equivalent to predicate device 3M 1292 Rapid Read-Out Biological Indicator originally cleared in 510(k) K090569.
§ 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).