(136 days)
No
The device description and performance studies focus on biological and optical detection methods, with no mention of AI or ML.
No.
This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to directly treat or diagnose a medical condition.
No
The device is a biological indicator used to monitor the effectiveness of sterilizer cycles by detecting the presence of spores. It does not diagnose medical conditions or diseases.
No
The device description clearly states it is a biological indicator consisting of spores, nutrient media, and a plastic vial, which are physical components, not software. It also mentions an optical change detected by a proprietary reader and an incubator, further indicating hardware components are involved.
Based on the provided information, the Celerity 20 HP Biological Indicator (BI) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "routine monitoring of the following sterilizer cycles." This is a quality control function for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains bacterial spores and nutrient media to assess the effectiveness of a sterilization process. It produces a signal based on the viability of the spores after exposure to the sterilant. This is a measure of the sterilization process's efficacy, not a diagnostic measurement of a patient's health.
- Lack of Patient Interaction: The device is used within the sterilizer and incubated in a separate reader. It does not interact with a patient or a patient sample.
- Performance Studies: The performance studies focus on the device's ability to accurately indicate whether the sterilization process was successful (growth/no growth of spores) and the speed of the result. These are not studies evaluating diagnostic accuracy (sensitivity, specificity, etc.) in relation to a patient's condition.
In summary, the Celerity 20 HP Biological Indicator is a quality control tool used to monitor the effectiveness of sterilization equipment, not a device used to diagnose or monitor a patient's health condition using in vitro methods.
N/A
Intended Use / Indications for Use
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature. Sterilization Systems.
• STERRAD® 100S Sterilizer (Default Cycle)
• Standard and Advanced Cycles of the STERRAD® NX Sterilizer ●
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX ● Sterilizer
When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The subject device 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 Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), 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. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.
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 testing to demonstrate substantial equivalence to the predicate in STERRAD Sterilizers has been completed and is summarized in Table 5-3 below.
Test: BI Half Cycle Performance Evaluation in the STERRAD Sterilizer Cycles; Acceptance Criteria: All BIs processed in half cycle will be negative for growth.; Conclusion: PASS
Test: BI Growth Inhibition Following Exposure to STERRAD Sterilizer Cycles; Acceptance Criteria: All BIs inoculated with low numbers of Geobacillus stearothermophilus spores will demonstrate growth.; Conclusion: PASS
Test: BI Simulated Use in the STERRAD Sterilizer Cycles; Acceptance Criteria: All BIs processed in full cycles will be negative for growth.; Conclusion: PASS
Performance testing to demonstrate substantial equivalence to the predicate in V-PRO Sterilizers has been previously submitted in K171504. A summary of the testing can be found in Table 5-4.
Test: 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
Test: Viable spore population; Acceptance Criteria: 1.0 - 4.0 x 10^6 spore/SCBI; Conclusion: PASS
Test: Resistance; Acceptance Criteria: D-value > 3 sec; Conclusion: PASS
Test: Survival Time; Acceptance Criteria: Survival Time >= 4 sec; Conclusion: PASS
Test: 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters FDA in a black square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in bold black letters. The word "ADMINISTRATION" is on the second line.
January 26, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K172474
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: November 16, 2017 Received: November 17, 2017
Dear Mr. Piotrkowski:
This letter corrects our substantially equivalent letter of December 29, 2017.
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
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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.
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 medical devices and radiation-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/CDRHLeam). 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172474
Device Name
CELERITY 20 HP Biological Indicator
Indications for Use (Describe)
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
· Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems.
· STERRAD® 100S Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer
· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer
When used in conjunction with the Celerity HP Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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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3
STERIS®
510(k) Summary For 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
Contact: Anthony Piotrkowski Senior Manager Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com
Submission Date: December 5, 2017
Premarket Notification Number: K172474
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | CELERITY 20 HP Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
2. Predicate Device
VERIFY® V24 Self-Contained Biological Indicator, K140708
Reference Devices
3M Attest™ Rapid Readout Biological Indicator 1295, K160546
3. Description of Device
The subject device 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 Incubator (originally named "VERIFY Incubator for Assert | VH2O2 | Self Contained Biological Indicator" in K171587), 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. The BI is identical to that submitted in K171504. The current premarket notification is for the addition of claims in STERRAD sterilization cycles.
Intended Use/ Indications for Use 4.
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems.
- . STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX Sterilizer ●
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX ● Sterilizer
5
When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.
ડાં Summary of Technical Characteristics
A comparison of technical characteristics versus the predicate is summarized in Table 5-1 and versus the reference device in Table 5-2.
Table 5-1 BI Physical Description and Technological Properties vs the Predicate Device
| Feature | Celerity VH2O2 BI
(proposed) K172474 | VERIFY V24 SCBI
Predicate (K140708) | Comparison | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Celerity 20 HP
Biological Indicator (BI)
is intended for routine
monitoring of the
following sterilizer
cycles:
• Lumen, Non Lumen,
and Flexible Cycles of
the V-PRO® Low
Temperature
Sterilization Systems.
• STERRAD® 100S
Sterilizer (Default
Cycle)
• Standard and
Advanced Cycles of
the STERRAD® NX
Sterilizer
• Standard, FLEX,
Express and DUO
Cycles of the
STERRAD® 100NX
Sterilizer
When used in conjunction
with the Celerity HP
Incubator, the Incubator
for the Celerity 20 HP BI
provides a fluorescent
result within 20 minutes. | The VERIFY® V24 Self
Contained Biological
Indicator is intended for
routine monitoring of the
following sterilization
cycles in healthcare
facilities:
• Lumen, Non Lumen
and Flexible cycles of
V-PRO® Low
Temperature
Sterilization Systems
• Default Cycle of the
STERRAD 100S
Sterilizer
• Default Cycle of the
STERRAD 200
Sterilizer
• Standard and
Advanced Cycles of
the STERRAD NX
Sterilizer
• Express, Standard and
Flex Scope Cycles of
the STERRAD 100
NX Sterilizer | The intended cycles for the
proposed and predicate are
the same with the following
exceptions:
• Use of the proposed
device in the Default
Cycle of the STERRAD
200 Sterilizer - the
STERRAD 200 Sterilizer
is no longer on the
market.
• Use of the predicate
device in the Duo Cycle
of the STERRAD 100NX
- the Duo Cycle had not
yet been cleared for use
when the predicate was
submitted for clearance.
• V-PRO sterilizer claims
were cleared in K171504
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 | |
| | Celerity VH2O2 BI | VERIFY V24 SCBI | | |
| Feature | (proposed) K172474 | Predicate (K140708) | Comparison | |
| 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. | Visual detection of growth
based on media color
change in the presence of
surviving indicator
organisms. | Both devices indicate
survival of indicator
organisms after sterilization.
The mechanism of the
proposed device is more
similar to the reference
device (see table 5-2).
Resistance testing and
simulated use testing
demonstrate appropriate
monitoring of indicated
sterilization cycles. | |
| Accessories | Automated incubator /
reader | None | This accessory is more
similar to the reference
device (see table 5-2) than to
the predicate device.
RIT testing and simulated
use testing demonstrate
appropriate monitoring of
indicated sterilization
cycles. | |
| Viable spore
population | 1.0 - 4.0 x 106 spore/BI | 2.0 - 3.4 x 106 spore/BI | Both contain greater than
106 spores/BI. | |
| Resistance
characteristics | Resistance @ 9.1 mg/L
H2O2:
• D-value > 3 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Resistance @ 2.7 mg/L
H2O2:
• D-value 4.0 - 8.0 sec
• Survival Time 4 - 30 sec
• Kill Time ≤ 16 min | Resistance testing for
proposed device at a higher
H2O2 concentration.
Simulated use testing
verifies suitability for use in
claimed cycles. | |
| Culture
Conditions | 55- 59°C, media included
in BI, 20-minute
incubation time. | 55- 59°C, media included
in SCBI, 24h 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, glass ampule with
recovery media. | Similar configuration.
Component testing per ISO
11138-1 Annex B
demonstrates packaging is
compatible with indicator
and sterilization process. | |
| 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 chemical indicator on
both BI. | |
| Shelf-life | Currently 3 months
Target of 13 months | 18 months | Real-time testing ongoing | |
| Feature | Celerity VH2O2 BI
(proposed) K172474 | Attest 1295
Reference (K160546) | Comparison | |
| Intended Use | The Celerity 20 HP
Biological Indicator (BI)
is intended for routine
monitoring of the
following sterilizer
cycles:
• Lumen, Non Lumen,
and Flexible Cycles of
the V-PRO® Low
Temperature
Sterilization Systems.
• STERRAD® 100S
Sterilizer (Default
Cycle)
• Standard and
Advanced Cycles of
the STERRAD® NX
Sterilizer
• Standard, FLEX,
Express and DUO
Cycles of the
STERRAD® 100NX
Sterilizer
When used in conjunction
with the Celerity HP
Incubator, the Incubator
for the Celerity 20 HP BI
provides a fluorescent
result within 20 minutes. | Use the 3M™ Attest™
Rapid Readout Biological
Indicator 1295 in
conjunction with the 3M
Attest™ Auto reader 490H
as a standard method of
routine monitoring of
vaporized hydrogen
peroxide sterilization
processes in the Amsco®
V-PRO® maX Low
Temperature Sterilization
System (Lumen, Non
Lumen, and Flexible
cycles), and in
STERRAD® 100S,
STERRAD® NX
(Standard and Advanced
cycles) and 100NX
(Standard, Flex, Express
and Duo cycles) systems. | Intended cycles for both
reference and proposed
devices include the same
STERRAD cycles.
Both require an automated
incubator/reader for results.
V-PRO sterilizer claims for
the proposed device were
cleared under K171504. | |
| 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 mechanism of action | |
| | Accessories | Automated incubator /
reader | Automated incubator /
reader | This accessory is similar to
the reference. RIT testing
and simulated use testing
demonstrate appropriate
monitoring of indicated
sterilization cycles. |
| Viable spore
population | | $1.0 - 4.0 \times 10^6$ spore/BI | $\ge 1.0 \times 10^6$ spore/BI | Both contain greater than
$10^6$ spore/BI |
| Feature | | Celerity VH2O2 BI
(proposed) K172474 | Attest 1295
Reference (K160546) | Comparison |
| Resistance
characteristics | | Resistance @ 9.1 mg/L
H2O2:
• D-value > 3 sec
• Survival Time ≥ 4 sec
• Kill Time ≤ 6 min | Resistance @ 10 mg/L
H2O2:
• D-value > 1 sec
• Survival Time ≥ 5 sec
• Kill Time = 7 min | Resistance values are similar
for both devices. Simulated
use testing verifies
suitability for use in claimed
cycles. |
| Culture
Conditions | 55- 59°C, media included
in BI, 20-minute
incubation time. | 60 +/- 2°C; media
included in SCBI, 4-hour
incubation time. | RIT Testing and ISO 11138-1
media testing verifies
performance. | |
| Primary
Packaging | Direct inoculum on plastic
vial, cap with recovery
media. | Inoculation on plastic disc
within vial, ampoule of
recovery medium. | Similar configuration.
Component testing per ISO
11138-1 Annex B
demonstrates packaging is
compatible with indicator
organism and sterilization
process. | |
| Process
indicator | VERIFY V-PRO
Chemical Indicator
(K140515); magenta to
yellow color change. | H2O2 sensitive ink:
appears blue until
processed, then appears
pink | Both contain a VH2O2 CI to
distinguish processed BI
from unprocessed BI. | |
| Shelf-life | Currently 3 months
Target of 13 months | 18 months | Real-time testing ongoing | |
6
Note: The BI is identical to that provided in K171504 only the name and indications have been changed.
7
Table 5-2 BI Physical Description and Technological Properties vs the Reference Device
8
6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate in STERRAD Sterilizers has been completed and is summarized in Table 5-3 below.
| Table 5-3. Summary of Non-clinical Testing | ||
|---|---|---|
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| BI Half Cycle Performance | ||
| Evaluation in the STERRAD | ||
| Sterilizer Cycles | All BIs processed in half cycle will be | |
| negative for growth. | PASS | |
| BI Growth Inhibition Following | ||
| Exposure to STERRAD Sterilizer | ||
| Cycles | All BIs inoculated with low numbers of | |
| Geobacillus stearothermophilus spores | ||
| will demonstrate growth. | PASS | |
| BI Simulated Use in the STERRAD | ||
| Sterilizer Cycles | All BIs processed in full cycles will be | |
| negative for growth. | PASS |
Performance testing to demonstrate substantial equivalence to the predicate in V-PRO Sterilizers has been previously submitted in K171504. A summary of the testing can be found in Table 5-4.
| Table 5-4. 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 |
9
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Viable spore | ||
| population | 1.0 - 4.0 x 106 spore/SCBI | PASS |
| Resistance | D-value > 3 sec | PASS |
| Survival Time | Survival Time ≥ 4 sec | PASS |
| Kill Time | Kill Time ≤ 6 min | PASS |
| Carrier growth | ||
| inhibition / media | ||
| growth promotion | Positive growth of less than 100 spores after | |
| primary packaging and media are subject 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
The Celerity 20 HP Biological Indicator has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as the legally marketed pril book device, VERIFY V24 Self-Contained Biological Indicator cleared in K140708, (21 CFR 880.2800, Product code FRC).