(113 days)
No
The device is a biological indicator that uses a chemical reaction and fluorescence detection to monitor sterilization. There is no mention of AI or ML in the description or performance studies.
No.
The device is a biological indicator used for monitoring and qualification testing of steam sterilization cycles, not for directly treating a medical condition or ailment.
No
Explanation: The device is a biological indicator used for monitoring and qualification testing of steam sterilization cycles, not for diagnosing medical conditions in patients. It assesses the effectiveness of a sterilization process.
No
The device is a biological indicator, which is a physical product containing biological material and media. It is not software.
Based on the provided information, the Celerity 20 STEAM Biological Indicator for IUSS is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for "monitoring and qualification testing" of steam sterilization cycles. This involves assessing the effectiveness of a process that impacts the safety of medical devices used on patients.
- Device Description: It contains a biological organism and nutrient media to "confirm the viability of the biological indicator at the end of a steam sterilization process." This is a test performed in vitro (outside of the body) to determine the effectiveness of the sterilization process.
- Mechanism: The device produces an "optical change (signal)" detected by a reader to indicate the viability of the organism. This is a diagnostic test to determine if the sterilization process was successful in killing the resistant spores.
- Performance Studies: The performance studies focus on the biological indicator's ability to accurately reflect the sterilization process (resistance, survival time, reduced incubation time alignment with conventional methods). This is consistent with the evaluation of an IVD.
- Predicate Device: The predicate device (3M Attest 1491 Super Rapid Readout Biological Indicator) is also a biological indicator used for monitoring sterilization, which are typically classified as IVDs.
While the device itself doesn't directly diagnose a patient's condition, it performs a test in vitro to assess the effectiveness of a process critical to patient safety (sterilization of medical devices). This falls under the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes.
When used in conjunction with the Celerity STEAM Incubator provides a fluorescent result within 20 minutes.
Product codes
FRC
Device Description
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native 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
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
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: D132 >= 10 s, D135 >= 8 s, PASS.
Survival Time: Meets FDA requirements, 132 C >= 1 min, 135 C >= 0.667 min.
Carrier growth inhibition / media growth promotion: Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure, PASS.
Hold Time: Performance not affected if incubated within 8 hours of exposure to steam sterilization, PASS.
Simulated Use: Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle, Abbreviated cycle - growth, Full cycle - no growth.
Shelf-life: Population, resistance, RIT and media must meet above criteria at each stability time point, PASS at 3 months (ongoing).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
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January 8, 2021
STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5976 Heislev Rd Mentor, Ohio 44060
Re: K202721
Trade/Device Name: Celerity 20 Steam Biological Indicator for IUSS Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 10, 2020 Received: December 11, 2020
Dear Anthony Piotrkowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202721
Device Name
Celerity 20 STEAM Biological Indicator for IUSS
Indications for Use (Describe) The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes.
When used in conjunction with the Celerity STEAM Incubator provides a fluorescent result within 20 minutes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary For Celerity 20 Steam Biological Indicator for IUSS
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: Tony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
Submission Date: January 8, 2021
Premarket Notification number: K202721
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | Celerity 20 Steam Biological Indicator for IUSS |
|---|---|
| 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
3M Attest 1491 Super Rapid Readout Biological Indicator, K103277
3. Reference Device
Celerity 20 Steam Biological Indicator, cleared under K173634 and modified under K181686
4. Description of Device
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
Intended Use/ Indications for Use ട്.
The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles:
- Gravity 270°F (132°C) 3 minutes ●
- Gravity 270°F (132°C) 10 minutes ●
- Gravity 275°F (135°C) 3 minutes ●
- Gravity 275°F (135°C) 10 minutes.
When used in conjunction with the Celerity STEAM Incubator, the Incubator provides a fluorescent result within 20 minutes.
5
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS
Summary of Technical Characteristics 6.
A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-1.
| | Celerity SCBI for IUSS
(proposed) | K103277 Attest 1491
(Predicate) | Comparison | Feature | Celerity SCBI for IUSS
(proposed) | K173634 Celerity 20
Steam BI (Reference) | Comparison |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | | Intended
Use | The Celerity 20 STEAM
Biological Indicator for
IUSS is used for monitoring
and qualification testing of
the following steam
sterilization cycles:
Gravity 270°F (132°C) 3
minutes
Gravity 270°F (132°C) 10
minutes
Gravity 275°F (135°C) 3
minutes
Gravity 275°F (135°C) 10
minutes.
When used in conjunction
with the Celerity STEAM
Incubator, the Incubator
provides a fluorescent result
within 20 minutes. | The Celerity 20 Steam
Biological Indicator (BI) is
for routine monitoring,
qualification testing and
product testing of the
following steam
sterilization processes:
270F, 4-minute dynamic
air removal; 275F, 3-
minute dynamic air
removal; 250 F, 30-minute
gravity; 270, 15-minutes
gravity.
When used in conjunction
with the Celerity 20 Steam
Incubator, the Celerity 20
Steam Biological Indicator
provides a fluorescent
result within 20 minutes. | Both are intended for
monitoring steam
sterilization cycles.
The Celerity BI for IUSS is
specifically for gravity IUSS
cycles. Testing is provided
in this 510(k) to demonstrate
suitable performance in
gravity IUSS cycles. |
| Intended
Use | The Celerity 20 STEAM
Biological Indicator for
IUSS is used for monitoring
and qualification testing of
the following steam
sterilization cycles:
Gravity 270°F (132°C) 3
minutes
Gravity 270°F (132°C) 10
minutes
Gravity 275°F (135°C) 3
minutes
Gravity 275°F (135°C) 10
minutes.
When used in conjunction
with the Celerity STEAM
Incubator, the Incubator
provides a fluorescent result
within 20 minutes. | Use 3M Attest 1491 Super
Rapid Read Biological
Indicator in conjunction
with the 3M Attest Auto-
reader 490 to monitor the
cycles below.
Gravity Displacement
IUSS (Flash):
270°F(132°C) 3 minutes;
270°F(132°C) 10 minutes;
275°F(135°C) 3 minutes;
275°F(135°C) 10 minutes.
The 3M Attest 1491 Super
Rapid Readout Biological
Indicator provides a final
fluorescent result in 30
minutes. An optional visual
pH color change result is
observed in 24 hours. | Both are intended for
monitoring the same steam
sterilization cycles.
The Celerity BI has a shorter
claimed readout time.
Reduced Incubation Time
(RIT) testing per the FDA
guidance demonstrates the
read time is appropriate. | Indicator
organism | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | Identical |
| Indicator
organism | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | Same criteria | 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 | Identical |
| 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 | Accessories | Automated incubator /
reader | Automated incubator /
reader | Both use the same reader |
| Accessories | Automated incubator /
reader | Automated incubator /
reader | RIT testing performed with
the proposed
incubator/reader. | Viable spore
population | 1.0 - 4.0 x 106 spore/SCBI | 1.0 - 4.0 x 106 spore/SCBI | Identical |
| Viable spore
population | 1.0 - 4.0 x 106 spore/SCBI | ≥ 1.0 x 106 spore/SCBI | Both proposed and predicate
meet criteria of the FDA | Resistance | D132 ≥ 10 s
D135 ≥ 8 s | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | Identical at the two
temperatures for which the
proposed device is indicated |
| Resistance | D132 ≥ 10 s
D135 ≥ 8 s | D132 ≥ 10 s
D135 ≥ 8 s | guidance on Biological
Indicator 510(k) | Culture
Conditions | 55- 59 °C, media included
in SCBI, 20-minute
incubation time. | 55- 59 °C, media included
in SCBI, 20-minute
incubation time. | Identical |
| Culture
Conditions | 55- 59 °C, media included
in SCBI, 20-minute
incubation time. | 55- 59 °C, media included
in SCBI, 30 minute
incubation time. | RIT Testing and ISO 11138
media testing verifies
performance | Primary
Packaging | Direct inoculum on plastic
vial, cap with recovery
media. | Direct inoculum on plastic
vial, cap with recovery
media. | Identical |
| Primary
Packaging | Direct inoculum on plastic
vial, cap with recovery
media. | Inoculated paper in plastic
vial with cap and glass
ampoule with recovery
media in capped vial. | Similar configuration.
Component testing per ISO
11138-1 Annex B
demonstrates packaging is
compatible with indicator
and sterilization process. | | | | |
Table 5-1. Proposed vs Predicate Physical Description and Technological Properties
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K202721 Celerity 20 Steam Biological Indicator for IUSS
A comparison of technical characteristics of the proposed device to the predicate are summarized in Table 5-2.
Table 5-2. Proposed vs Reference Physical Description and Technological Properties
7
7. Summary of Nonclinical Tests
Performance testing has been completed and is summarized in Table 5-2 below.
| 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 106 spore/SCBI | PASS |
| Resistance | $D_{132} ≥ 10 s$ | |
| $D_{135} ≥ 8 s$ | PASS | |
| Survival Time | Meets FDA requirements | $132 C ≥ 1 min$ |
| $135 C ≥ 0.667 min$ | ||
| Carrier growth | ||
| inhibition / media | ||
| growth promotion | Positive growth of less than 100 spores after | |
| primary packaging and media are subject to | ||
| worst case steam exposure | PASS | |
| Hold Time | Performance not affected if incubated within | |
| 8 hours of exposure to steam sterilization | PASS | |
| Simulated Use | Demonstrate growth when exposed to | |
| abbreviated cycle and all kill in a full cycle | Abbreviated cycle - growth | |
| Full cycle - no growth | ||
| Shelf-life | Population, resistance, RIT and media must | |
| meet above criteria at each stability time | ||
| point | PASS at 3 months | |
| (ongoing) |
Table 5-2. Summary of Non-clinical Testing
7. Conclusion
The conclusion drawn from the nonclinical tests performed demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K103277 Class II (21 CFR 880.2800, Product code FRC).