(150 days)
Not Found
No
The summary describes a biological indicator and an incubator that detects a fluorescent signal. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on a chemical reaction and optical detection.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to treat or diagnose a medical condition in a patient.
No
The device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly states the product consists of physical components: Geobacillus stearothermophilus spores, nutrient media, and a plastic vial. It also mentions a proprietary reader (incubator) which is a hardware component.
Based on the provided information, the CELERITY 20 HP Biological Indicator is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is used for "routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities." This clearly indicates its use in a healthcare setting to assess the effectiveness of a sterilization process.
- Device Description: It "produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process." This describes a test performed in vitro (outside of the body) to determine a biological state (viability of spores) related to a healthcare process (sterilization).
- Mechanism: The description of the spore viability and the reaction with a fluorogenic substrate to produce a fluorescent moiety is a classic example of an in vitro biological test.
While the device doesn't directly diagnose a disease in a patient, it is used to monitor and qualify a critical process (sterilization) that directly impacts patient safety in a healthcare setting. This falls under the scope of IVDs, which include devices used to examine specimens derived from the human body or to provide information about a physiological state, pathological state, or state of health. In this case, the "specimen" is the biological indicator itself, and the information provided is about the effectiveness of the sterilization process, which is crucial for maintaining a state of health in the healthcare environment.
The fact that it is used in conjunction with an incubator to read a result further supports its classification as an IVD system.
N/A
Intended Use / Indications for Use
The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
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
healthcare facilities.
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)
BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle
- Acceptance Criteria: All BIs processed in full cycles will be negative for growth
- Conclusion: PASS
Reduced Incubation Time (RIT) Testing
- Acceptance Criteria: Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days
- Conclusion: PASS
Viable spore population
- Acceptance Criteria: 1.0 – 4.0 x 10^6 spore/SCBI
- Conclusion: PASS
Resistance
- Acceptance Criteria: D-value > 3 sec
- Conclusion: PASS
Survival Time
- Acceptance Criteria: Survival Time >= 4 sec
- Conclusion: PASS
Kill Time
- Acceptance Criteria: Kill Time
§ 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/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 9, 2018
Steris Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K172752
Trade/Device Name: CELERITY 20 HP Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: September 11,2017 Received: January 10, 2018
Dear Jennifer Nalepka:
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (ifknown)
K172752
Device Name CELERITY 20 HP Biological Indicator
Indications for Use (Describe)
The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.
Type of Use (Selectone orboth, as applicable)
D Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-CounterUse(21CFR801SubpartC)
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510(k)Summary For K172752 CELERITY 20 HP Biological Indicator
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Jennifer Nalepka Contact: Senior Regulatory Affairs Specialist
Telephone: (440) 392-7458 (440) 357-9198 Fax No: jennifer_nalepka@steris.com e-mail:
September 11, 2017 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator
1. Device Name
| Trade Name: | CELERITY 20 HP Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
2. Predicate Device
CELERITY 20 HP Biological Indicator. K171504 (previously named "VERIFY Assert VH2O2 Self-Contained Biological Indicator")-Note: The BI is identical to that provided in K171504 only the indications for use have been changed.
3. Description of Device
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
4. Intended Use/ Indications for Use
The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.
ട്. Summary of Technical Characteristics
A comparison of technical characteristics versus the predicate is summarized in Table 5-1.
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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator
| Table 5-1. SCBI Physical Description and Technological Properties vs the Predicate | |
|---|---|
| Device |
| Feature | CELERITY 20 HP BI (proposed) | CELERITY 20 HP BI Predicate (K171504) | Comparison |
|---|---|---|---|
| Intended Use | The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizer in healthcare facilities. |
When used in conjunction with the CELERITY Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes. | The CELERITY 20 HP Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizer in healthcare facilities.
When used in conjunction with the CELERITY Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes. | The proposed and predicate devices are identical. The Fast Non Lumen Cycle is a new cycle in the V-PRO maX 2 Low Temperature Sterilizer, which has been submitted in a separate premarketnotification.
The proposed indications for use include information about the incubator/reader and read time that are supported through testing in accordance with FDA guidance for BI 510(k). |
| Indicator organism | Geobacillus stearothermophilus | Geobacillus stearothermophilus | Same |
| Mechanism of action | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety. | Same |
| Accessories | Automated incubator / reader | Automated incubator / reader | Same |
| Viable spore population | $1.0 - 4.0 \times 10^6$ spore/BI | $1.0 - 4.0 \times 10^6$ spore/BI | Both contain greater than $10^6$ spores/BI. |
| Resistance characteristics | Resistance @ 9.1 mg/L H2O2:
• D-value > 3 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Resistance @ 9.1 mg/L H2O2:
• D-value > 3 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Same |
| Culture Conditions | 55-59°C, media included in BI, 20-minute incubation time. | 55-59°C, media included in BI, 20-minute incubation time. | RIT Testing and ISO 11138-1 media testing verifies performance |
| Primary Packaging | Direct inoculum on plastic vial, cap with recovery media. | Direct inoculum on plastic vial, cap with recovery media. | Same |
| Process indicator | VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change. | VERIFY V-PRO Chemical Indicator (K140515); magenta to yellow color change. | Same |
| Shelf-life | Currently 3 months | Currently 3 months | Real-time testing ongoing |
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Note: The BI is identical to that provided in K171504 only the indications for use have been changed.
6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
| Table 5-2. Summary of Non-clinical Testing | |||
|---|---|---|---|
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| BI Simulated Use in the V-PRO maX | ||
| 2 Sterilizer Fast Non Lumen Cycle | All BIs processed in full cycles will be | |
| negative for growth | PASS |
Performance testing of the predicate in V-PRO Sterilizers has been previously submitted in K171504. A summary of the testing can be found in Table 5-3.
| Table 5-3. Summary of Non-clinical Testing Previously Submitted in K171504. | ||
|---|---|---|
| Test | Acceptance Criteria | Conclusion |
| Reduced Incubation | ||
| Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the | |
| 20-minute results with the conventional incubation | ||
| time of 7 days | PASS | |
| Viable spore | ||
| population | $1.0 – 4.0 x 10^6$ spore/SCBI | PASS |
| Resistance | D-value > 3 sec | PASS |
| Survival Time | Survival Time $\geq$ 4 sec | PASS |
| Kill Time | Kill Time $\leq$ 6 min | PASS |
| Carrier growth | ||
| inhibition / media | ||
| growth promotion | Positive growth of less than 100 spores inoculated | |
| after primary packaging and media were subjected to | ||
| worst case VHP exposure | PASS | |
| Hold Time | Performance not affected if incubated within 72 hours | |
| of exposure to VHP sterilization | PASS | |
| Simulated Use | Demonstrate no growth when exposed to worst-case | |
| cycles | PASS |
7. Conclusion
Based on the intended use, technological characteristics and the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, the CELERITY 20 HP Biological Indicator (cleared in K171504) Class II (21 CFR 880.2800), product code FRC.