(269 days)
Use the BCR-30-min BI™ and the RBIP-ST30™ together for monitoring performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). The BCR-30-min BI™ in conjunction with the RBIP-ST30™ provides final fluorescence results in 30 minutes.
The BCR-30-min BI™ is designed to be used with its readout accessory, the RBIP-ST30™ robotic processor, for validating and challenging performance of gravity displacement steam sterilization cycles at 250°F (121°C). The BCR-30-min BI™ consists of a strip (6.0 x 60 mm) of filter paper (Whatman GF/A) inoculated in the center with about 106 living spores of Geobacillus stearothermophilus ATCC No. 7953. The strip is packaged in a #30 blue glassine pouch (1 x 3 inch). The BCR-30-min BI™ should be placed in the center of the load or in the most difficult to sterilize area.
In the RBIP-ST30™, the spores of the BCR-30-min BI™ are first converted into Fspores™ and then they are incubated for 30 min at 55±2°C to allow germination of living Fspores™. The device utilizes the fact that F-spores™ are not fluorescent per se but produce intense fluorescence when germinated. Accordingly, the RBIP-ST30™ detects failure of a steam sterilization cycle when significant fluorescence is present. The RBIP-ST30™ is designed to automatically process the BCR-30-min BI™ to obtain a fluorescence reading within 30 minutes.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BCR-30-min BI™ and RBIP-ST30™ Readout Accessory.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria / Predicate Performance (3M Attest™ 1292 BI) | Reported Device Performance (BCR-30-min BI™) |
|---|---|---|
| Intended Use - Sterilization Method | Gravity displacement steam | Gravity displacement steam |
| Indications for Use (Common) | Monitoring gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). | Monitoring gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). |
| Organism (Species, Strain) | Geobacillus stearothermophilus from ATCC™ 7953 | Geobacillus stearothermophilus from ATCC™ 7953 |
| Viable Spore Population | About 10⁶ spores | About 10⁶ spores |
| D-Value | 1.5 - 2.2 min | 1.9 min |
| Z-Value | 10 - 13 °C | 15.5 °C |
| Survival Time | 7 - 10 min | 7.9 min |
| Kill Time | 16 - 23 min | 19 min |
| Incubation Temperature (for BI) | 60°C (for predicate BI) | 55±2 °C (for new device BI) |
| Reduced Incubation Time (Fluorescence result) | 180 min (with >97% correlation to 7-day visual readout) | 30 min (with >97% correlation to 7-day visual readout) |
| Shelf-life (BI) | 2 years | Six months |
| Readout Accessory Intended Use | Designed to incubate and automatically read BI for a final fluorescent result at 30 min (3M Attest 1492 BI - likely a typo and refers to 1292 BI). | Designed to incubate and automatically read BCR-30-min BI™ for a final fluorescent result at 30 min. |
| Readout Accessory Incubation Temperature | 56±2 °C | 55±2 °C |
| Basis of Rapid Readout | Fluorescence of BI medium | Fluorescence of F-spores™ |
| Method of Fluorescence Detection | UV LED, optical filters, sensing by photodiode | Blue LED, optical filters, detection, sensing by CCD array |
| Indicator of Adequate Sterilization Cycle | (-) on LCD Display. | Fluorescence below cut-off value. |
| Indicator of Possible Sterilization Cycle Failure | (+) on LCD Display. Audible Alarm. | Fluorescence above cut-off value. |
| Product Safety | UL/IEC 61010-1 | EN 61326-1 |
| EMC Compliance | FCC Part 15, Subpart B, Class A | FCC Part 15, Subpart B, Class A |
Summary of the Study and How the Device Meets Acceptance Criteria:
The study aims to demonstrate substantial equivalence of the BCR-30-min BI™ and RBIP-ST30™ Readout Accessory to legally marketed predicate devices. The acceptance criteria are largely defined by the performance characteristics of the predicate devices and relevant industry standards/guidance.
The device meets the acceptance criteria by showing comparable performance in critical areas such as spore population, resistance characteristics (D-Value, Z-Value, Survival Time, Kill Time), and alignment with established incubation protocols. Specifically, the new device achieves a fluorescence result in 30 minutes with greater than 97% correlation to the 7-day visual readout, which is a significant improvement in readout time compared to the predicate's 180 minutes, while still meeting the required performance standard. The readout accessory also demonstrates equivalent function and safety based on its intended use, incubation temperature, detection method, and compliance with safety and EMC standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for BCR-30-min BI™: Performance was determined using three (3) separate spore lots from independent spore cultures. The specific number of individual BI units tested per lot is not explicitly stated but implied to be sufficient for determining D-value, Z-value, survival, and kill times.
- Data Provenance: The document does not specify the country of origin. It indicates the study followed FDA guidance and international standards (ANSI/AAMI/ISO). It is a retrospective analysis in the sense that it compares to established predicate device data and standards, but the testing of the new device itself would have been prospective to generate the new data for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (biological indicator for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" here is objective: whether the spores are killed by sterilization or not, which is determined by their subsequent growth (or lack thereof) after incubation. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment is not directly applicable in this context. The ground truth for biological indicators is based on the biological viability of the spores when subjected to defined sterilization parameters and subsequent incubation.
4. Adjudication Method for the Test Set
Not applicable for this type of device. The outcome (fluorescence or lack thereof, and correlation to 7-day visual readout) is an objective, measurable endpoint based on biological processes, not subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret medical images or data, and an AI system may assist or replace them.
- The device in question is a biological indicator and a readout accessory for monitoring sterilization, not a diagnostic tool for human interpretation.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done for the device elements. The "Summary of a Comparative Validation of the BCR-30-min BI™" and subsequent sections detailing the RBIP-ST30™'s characteristics describe the performance of the biological indicator and its readout accessory in isolation as parts of the system.
- The performance of the BI was tested against industry standards and guidance, and the readout accessory's functionality was detailed. The entire system (BI + readout accessory) then provides the final result automatically. The "algorithm" here is the automated processing and fluorescence detection by the RBIP-ST30™, which is performed "standalone" without human intervention for result interpretation.
7. Type of Ground Truth Used
The ground truth used is primarily biological viability/non-viability of the Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is directly assessed by:
- Delayed Growth (7-day visual readout): The conventional method, where lack of growth after 7 days indicates successful sterilization (spores killed). The new device's rapid fluorescence result is correlated to this established 7-day method.
- Resistance Characteristics: Objective measurements like D-value, Z-value, survival time, and kill time, which are universally accepted metrics for BI performance.
8. Sample Size for the Training Set
- The document does not explicitly mention a distinct "training set" sample size. This suggests that a machine learning model, which typically requires a separate training set, may not be the primary component of this device.
- The device's function is based on detecting fluorescence as an indicator of spore germination. This is likely based on established biochemical principles and calibrated thresholds, rather than being "trained" on a large dataset of results. Thus, the concept of a "training set" in the context of predictive algorithms is not directly applicable here. The development would involve robust calibration and validation rather than a training/test split.
9. How the Ground Truth for the Training Set Was Established
- Since a distinct "training set" in the machine learning sense is not described, the ground truth establishment method for such a set is also not applicable or described.
- The "ground truth" for calibrating the device would be the known sterilization outcome (spore kill or survival) determined by traditional microbiological methods (e.g., 7-day visual growth after exposure to calibrated sterilization cycles with known efficacy). The device's fluorescence detection system would then be calibrated to correlate with these known outcomes.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
BCR Diagnostics, Inc. Boris Rotman, Ph.D. Vice President, CSO 145 S. 79th Street - Ste. 12 Chandler. AZ 85226
Re: K151482
Trade/Device Name: BCR-30-min BITM and RBIP-ST30™ Readout Accessory Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical/Physical Sterilization Indicator Regulatory Class: II Product Code: FRC Dated: January 27, 2016 Received: February 1, 2016
Dear Dr. Rotman:
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
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Page 2 - Dr. Rotman
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 (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/Resourcesfor You/Industry/default.htm. 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 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 Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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A.6 Statement of Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K151482 |
|---|---|
| Device Name |
BCR-30-min BI™ and RBIP-ST30™ Readout Accessory
Indications for Use (Describe)
lndications for Use (Desorite)
Use the BCR-30-min BI™ and the RBIP-ST30™ together for monitoring performance of gavity displacement steam
sterlization cycles of 30 minutes provides final fluorescence results in 30 minutes.
| 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) |
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510(k) Pre-market Notification Summarv K151482
Sponsor Information:
BCR Diagnostics, Inc. 145 S. 79th Street - Ste. 12 Chandler, AZ 85226
| Contact Person: | Boris Rotman, Ph.D., CSO. |
|---|---|
| Phone Number: | (480) 809-6156 |
| FAX Number: | (480) 809-6001 |
| email: | bcr@bcr.necoxmail.com |
| Date of Summary: | February 25, 2016 |
Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Biological Indicator Readout Accessory | |
| Trade/Proprietary Name: | BCR-30-min BI™ and RBIP-ST30™ Readout Accessory |
| Classification Name: | Chemical/Physical Sterilization Indicator |
| Regulation Number: | 21 CFR 880.2800 |
| Regulatory Class: | Class II |
| Product Code: | FRC |
Predicate Devices:
- 'Intended Use Predicate' for BCR-30-min BI™: 3M Attest™ 1292 Rapid Readout Biological Indicator for Steam, K090569.
- . 'Readout Predicate' for RBIP-ST30™: 3M Attest 490 Auto-reader, K103277.
Description of Device:
BCR-30-min ВГМ
The BCR-30-min BITM is designed to be used with its readout accessory, the RBIP-ST30™ robotic processor, for validating and challenging performance of gravity displacement steam sterilization cycles at 250°F (121°C).
The BCR-30-min BI™ consists of a strip (6.0 x 60 mm) of filter paper (Whatman GF/A) inoculated in the center with about 106 living spores of Geobacillus stearothermophilus ATCC No. 7953. The strip is packaged in a #30 blue glassine pouch (1 x 3 inch). The BCR-30-min BITM should be placed in the center of the load or in the most difficult to sterilize area.
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RBIP-ST30™ Readout Accessory
In the RBIP-ST30™, the spores of the BCR-30-min BI™ are first converted into Fspores™ and then they are incubated for 30 min at 55±2°C to allow germination of living Fspores™. The device utilizes the fact that F-spores™ are not fluorescent per se but produce intense fluorescence when germinated. Accordingly, the RBIP-ST30™ detects failure of a steam sterilization cycle when significant fluorescence is present.
The RBIP-ST30™ is designed to automatically process the BCR-30-min BI™ to obtain a fluorescence reading within 30 minutes. The fluorescence results at 30 minutes meet the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
Indications for Use:
Use the BCR-30-min BITM and the RBIP-ST30™ together for monitoring performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). The BCR-30-min BI™ in conjunction with the RBIP-ST30TM provides final fluorescence results in 30 minutes.
Substantial Equivalence of BCR-30-min BI™ to "Intended Use" Predicate Device 3M Attest™ 1292 Rapid Readout Biological Indicator (K090569):
Performance of the BCR-30-min BITM was determined using three (3) separate spore lots from independent spore cultures. A Summary of the Nonclinical Testing is shown in the table below.
| DEVICE CHARACTERISTICS | "INTENDED USE PREDICATE"3M Attest™ 1292 BI, K090569 | NEW DEVICEBCR-30-min BI™ |
|---|---|---|
| Intended use• Method of sterilization | Gravity displacement steam | Gravity displacement steam |
| Indications for Use | Use the 3M Attest 1292 RRBI and the 3M Attest 490 Auto-reader together for monitoring:1. Performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).2. Performance of vacuum assisted steam sterilization cycles at 270°F (132°C).The 3M Attest 1292 RRBI in conjunction with the 3M Attest 490 Auto-reader provide final fluorescence results in 180 minutes. | Use the BCR-30-min BI™ and the RBIP-ST30™ together for monitoring:1. Performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).The BCR-30-min BI™ in conjunction with the RBIP-ST30™ provide final fluorescence results in 30 minutes. |
| Organism• Spores, Species, Strain | Geobacillus stearothermophilus from ATCC™ 7953 | Geobacillus stearothermophilus from ATCC™ 7953 |
| Viable spore population | About 106 spores | About 106 spores |
| Carrier Material | Polyethylene terephthalate paper | Glass fiber paper |
Summary of a Comparative Validation of the BCR-30-min BITM
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| Resistance Characteristics* | ||
|---|---|---|
| • D-Value | 1.5-2.2 min | 1.9 min |
| • Z-Value | 10-13 °C | 15.5 °C |
| • Survival Time | 7-10 min | 7.9 min |
| • Kill Time | 16-23 min | 19 min |
| Incubation Temperature | 60°C | 55±2 °C |
| Reduced Incubation Time(>97% correlation to the 7-dayvisual readout result) | Fluorescence result in 180 min | Fluorescence result in 30 min |
| Shelf-life | 2 years | Six months |
*Resistance values for the predicate were obtained from the3M Attest™ 1292 brochure.
Testing of the BCR-30-min BI™ summarized above was conducted following the FDA guidance and standards below:
- . FDA's Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification 510(k) Submissions; October 4, 2007.
- . ANSI/AAMI/ISO 11138-1:2006/(R) 2010 Sterilization of health care products -Biological indicators - Part 1: General Requirements.
- . ANSI/AAMI/ISO 11138-3:2006/(R) 2010 Sterilization of health care products -Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization . and Chapter <55> Biological Indicators - Resistance Performance Tests.
The results of these tests show that the BCR-30-min BI™, when used with the RBIP-ST30™, complies with ANSVAAMI/ISO 11138-1:2006/(R) 2010 and ANSI/AAMI/ISO 11138-3:2006/(R) 2010, the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
Substantial Equivalence of RBIP-ST30™ to "Readout Predicate" Device 3M Attest 490 Auto-reader:
Since the RBIP-ST30™ is a required readout accessory of the BCR-30-min BT™, the performance of the RBIP-ST30™ was determined at each step during the validation of the BCR-30-min BI™. The table below shows the functionality and characteristics of the new device compared to the predicate.
| DEVICE CHARACTERISTICS | "READOUT PREDICATE"3M Attest 490 Auto-reader(K103277) | NEW DEVICERBIP-ST30TM |
|---|---|---|
| Intended use | The 3M Attest 490 Auto-reader isdesigned to incubate andautomatically read the 3M AttestTM1492 BI for a final fluorescent resultat 30 min. | The RBIP-ST30TM readoutaccessory is designed toincubate and automatically readthe BCR-30-min BITM for a finalfluorescent result at 30 min. |
| Incubation Temperature | $56\pm2$ °C | $55\pm2$ °C |
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| Basis of Rapid Readout | Fluorescence of BI medium | Fluorescence of F-spores™ |
|---|---|---|
| Method of FluorescenceDetection | UV LED, optical filters, sensing byphotodiode | Blue LED, optical filters,detection, sensing by CCD array |
| Indicator of AdequateSterilization Cycle | (-) on LCD Display. | Fluorescence below cut-offvalue |
| Indicator of PossibleSterilization Cycle Failure | (+) on LCD Display. Audible Alarm | Fluorescence above cut-offvalue |
| Incubation wells | 10—reader/incubation wells | 10—cartridge wells |
| Voltage Range | 100-240 Volts AC | 110 Volts |
| Product Safety | UL/IEC 61010-1 | EN 61326-1 |
| EMC Compliance | FCC Part 15, Subpart B, Class A | FCC Part 15, Subpart B, Class A |
Statement of Substantial Equivalence:
The RBIP-ST30™ was tested for safety by a certified Testing Laboratory to demonstrate compliance to EN 61326-1. All tests were conducted using measurement procedure from CISPR 16 as appropriate.
Based on the same intended use and similar performance data, the BCR-30-min BI™ and the RBIP-ST30™ readout accessory have been demonstrated to be substantially equivalent to, and therefore, as safe and effective as the legally marketed devices: 3M Attest™ 1292, Rapid Readout Biological Indicator for Steam (K090569), and 3M Attest 490 Auto-reader (K103277), respectively.
Conclusion
The BCR-30-min BI™ Biological Indicator and the RBIP-ST30™ readout accessory meet all applicable performance standards and are substantially equivalent to their predicate devices in terms of their intended use, physical properties and technological characteristics.
§ 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).