(269 days)
Not Found
No
The device description and performance studies focus on biological and mechanical processes (spore germination, fluorescence detection, robotic processing) and do not mention any AI or ML components. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
This device is designed to monitor the performance of steam sterilization cycles for medical instruments, not to directly treat a patient or a disease.
Yes
The device detects the failure of a steam sterilization cycle by identifying the presence of viable spores through fluorescence, which is a form of diagnostic testing for the efficacy of the sterilization process.
No
The device description clearly outlines physical components (filter paper strip, glassine pouch) and a robotic processor (RBIP-ST30™) that performs physical actions (converting spores, incubation, detecting fluorescence). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "monitoring performance of gravity displacement steam sterilization cycles." This is a quality control process for medical devices or other items being sterilized, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device consists of a biological indicator (spores) and a processor to detect the viability of those spores after a sterilization cycle. This process is evaluating the effectiveness of the sterilization equipment, not diagnosing a condition in a patient.
- Anatomical Site and Patient Age Range: These are listed as "Not Applicable," which is consistent with a device not used for patient diagnosis.
- Performance Studies: The performance studies focus on the ability of the device to accurately indicate the success or failure of a sterilization cycle, using metrics like D-Value, Z-Value, Survival Time, and Kill Time. These are relevant to sterilization efficacy, not diagnostic accuracy in a patient.
- Predicate Devices: The predicate devices listed are also biological indicators and auto-readers used for monitoring sterilization cycles, further supporting that this device falls within the category of sterilization process indicators, not IVDs.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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-ST30TM provides final fluorescence results in 30 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
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.
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.
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)
Performance of the BCR-30-min BITM was determined using three (3) separate spore lots from independent spore cultures. Testing of the BCR-30-min BI™ was conducted following: 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 Biological Indicators for Sterilization; and Chapter Biological Indicators - Resistance Performance Tests.
Key results:
D-Value: 1.9 min
Z-Value: 15.5 °C
Survival Time: 7.9 min
Kill Time: 19 min
Reduced Incubation Time (>97% correlation to the 7-day visual readout result): Fluorescence result in 30 min
Shelf-life: Six months
Safety testing for the RBIP-ST30™ was conducted per EN 61326-1. All tests were conducted using measurement procedure from CISPR 16 as appropriate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be moving forward.
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
1
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
2
A.6 Statement of Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Office of Chief Information Officer
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"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."
FORM FDA 3881 (8/14)
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PSC Publishing Services (1011) 443-6780 - EF
============================================================================================================================================================================== ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Image /page/3/Picture/0 description: The image shows the logo for BCR Diagnostics. The letters "BCR" are stacked on top of each other in a bold, sans-serif font. The word "Diagnostics" is written in a smaller, italicized font to the right of the letters "BCR". The logo is simple and professional.
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.
4
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 DEVICE
BCR-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:
- Performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
- 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: - 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
5
| 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-day | ||
| visual 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 Biological Indicators for Sterilization . and Chapter 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 DEVICE
RBIP-ST30TM |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The 3M Attest 490 Auto-reader is
designed to incubate and
automatically read the 3M AttestTM
1492 BI for a final fluorescent result
at 30 min. | The RBIP-ST30TM readout
accessory is designed to
incubate and automatically read
the BCR-30-min BITM for a final
fluorescent result at 30 min. |
| Incubation Temperature | $56\pm2$ °C | $55\pm2$ °C |
6
| 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 | ||
| 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.