(123 days)
Not Found
No
The device description and performance studies focus on biological and enzymatic reactions detected by an auto-reader, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the summary.
No
The device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to treat or diagnose a disease in a patient.
No
Explanation: This device is a biological indicator used to monitor the effectiveness of sterilization cycles. It does not diagnose a medical condition in a patient but rather assesses the success of a separate process (sterilization).
No
The device is a biological indicator, which is a physical product containing spores and media, not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles." This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains a biological indicator (spores) and media. It detects the survival of these spores after a sterilization cycle. The detection of fluorescence or a color change indicates a failure in the sterilization process, not a condition in a patient.
- Lack of Patient Interaction: The device is used to test a sterilization process, not to analyze a sample taken from a patient.
- No Mention of Clinical Diagnosis: The text does not mention any use for diagnosing, treating, or preventing disease in humans.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
FRC
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-air-removal (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 ≥ 10^5 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
-
Performance Characteristics Testing:
- Viable Spore Population Assay: Assay to demonstrate the spore population of the BI meets specification of ≥ 10^5. Results: Pass
- Resistance Characteristics Testing: Resistance characteristics of the BI in the intended steam 132°C sterilization process and cycle using a resistometer must be: D-Value: ≥ 10 seconds; Z-Value: ≥ 10°C; Survival Time: ≥ 1 minute. Results: Pass
- Carrier and Primary Packaging Materials: Carrier and primary packaging materials must not have inhibitory effects on the growth of test organisms of the BI after sterilization. Results: Pass
- Holding Time Assessment: The 7 day holding time must have no effects on the performance of the subject BI. Results: Pass
- Growth Promotion and Media Suitability: The media of the biological indicator must support growth and recovery to be suitable. Results: Pass
- Reduced Incubation Time: Verification of 3 hour fluorescent and 48 hour biological readout per FDA's Validation of Reduced Incubation Protocol. Results: 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. Results: Pass
- 3M 390 Auto-Reader Compatibility Testing: Evaluation that the compatibility of the SporView Rapid Read Bl and 3M 390 Auto-Reader system such that the auto-reader reads and displays accurate results and alarms appropriately upon BI removal. Results: Pass
-
Shelf Life Testing: Verification of the viable spore population, resistance characteristics and media stability at the end of the shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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);
1
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
2
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 Road |
| Rush, NY 14543 | |
| (800) 722-1529 | |
| Official Contact: | Megan Skaar |
| Regulatory 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, 880.2800 |
| Predicate Device – 3M Attest 1292 Rapid Read Biological Indicator | |
| 880.2800 |
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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Image /page/4/Picture/0 description: The image shows the logo for Cantel Medical. The logo consists of a blue circular graphic on the left, followed by the words "CANTEL MEDICAL" in blue, sans-serif font. The graphic appears to be a stylized representation of waves or lines within a circle.
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 – SporView
Rapid Read BI | Predicate Device – 3M 1292
Rapid Read-Out BI
(K926364 and K090569) |
|-----------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Monitor 270°F (132°C)
prevacuum steam
sterilization cycles
for 4 minutes. | Monitor 270°F (132°C)
prevacuum steam
sterilization cycles and 250°F
(121°C) gravity steam
sterilization 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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Image /page/5/Picture/0 description: The image shows the logo for Cantel Medical. The logo consists of a blue circular graphic on the left, followed by the words "CANTEL MEDICAL" in blue sans-serif font. The graphic appears to be a stylized representation of waves or lines.
| 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 Spore | ||
| Population Assay | Assay to demonstrate the spore population of the BI | |
| meets specification of $≥ 105$ . | Pass | |
| Resistance | ||
| Characteristics Testing | Resistance characteristics of the BI in the intended | |
| steam 132°C sterilization process and cycle using a | ||
| resistometer must be: | ||
| D-Value: $≥$ 10 seconds | ||
| Z-Value: $≥$ 10°C | ||
| Survival Time: $≥$ 1 minute | Pass | |
| Carrier and Primary | ||
| Packaging | ||
| Materials | 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 | The 7 day holding time must have no effects on the | |
| performance of the subject BI. | Pass |
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Image /page/6/Picture/0 description: The image shows the logo for Cantel Medical. The logo consists of a blue circular graphic on the left, followed by the text "CANTEL MEDICAL" in blue. The text is in a sans-serif font and is horizontally aligned with the graphic.
| 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 Bl 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.
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.