(80 days)
Not Found
No
The device description and performance studies focus on biological and optical detection methods, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is a biological indicator used to monitor the effectiveness of steam sterilization cycles for medical instruments, not to directly treat or diagnose a medical condition in a patient.
No.
This device is a biological indicator used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly states the product consists of a biological organism and nutrient media, which are physical components, not software. It also mentions an incubator and reader, implying hardware is involved in the process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of steam sterilization cycles for medical devices. It does not involve testing a sample taken from the human body to diagnose a condition, monitor a treatment, or screen for a disease.
- Device Description: The device contains a biological organism and nutrient media to indicate whether a sterilization process was successful. It does not analyze human biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing human biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Being used in a clinical laboratory setting for patient testing
Instead, this device is a sterilization process indicator, specifically a biological indicator, used to ensure that medical devices are properly sterilized before use.
N/A
Intended Use / Indications for Use
The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:
- · Dynamic Air Removal 270°F (132°C) 4 minutes
- · Dynamic Air Removal 275°F (135°C) 3 minutes
- · Gravity 250°F (121°C) 30 minutes
- · Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the Incubator 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2.
- Study Type: Reduced Incubation Time (RIT) Testing
- Key Results: Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days (PASS).
- Study Type: Viable spore population
- Key Results: 2.3 - 2.5 x 10^6 spore/SCBI (Acceptance Criteria: 1.0 - 4.0 x 10^6 spore/SCBI).
- Study Type: Resistance
- Key Results: D121 >= 2.53 min, D132 >= 46 s, D135 >= 37 s (Acceptance Criteria: D121 >= 1.5 min, D132 >= 10 s, D135 >= 8 s).
- Study Type: Survival Time
- Key Results: 121 C >= 11.11 min, 132 C >= 3.42 min, 135 C >= 2.77 min (Acceptance Criteria: Meets the longer of FDA and ISO 11138-3 requirements).
- Study Type: Kill Time
- Key Results: 121 C
§ 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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February 12, 2018
STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K173634
Trade/Device Name: CELERITY 20 Steam Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 22, 2017 Received: November 24, 2017
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. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
CELERITY 20 Steam Biological Indicator
Indications for Use (Describe)
The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:
- · Dynamic Air Removal 270°F (132°C) 4 minutes
- · Dynamic Air Removal 275°F (135°C) 3 minutes
- · Gravity 250°F (121°C) 30 minutes
- · Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the 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 K173634 Celerity 20 Steam 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: Tony Piotrkowski Senior Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
Submission Date: January 17, 2018
Premarket Notification Number: K173634
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173634 Celerity 20 Steam Biological Indicator
Device Name 1.
| Trade Name: | Celerity 20 Steam Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR 880.2800, FRC) |
Predicate Device 2.
3M Attest Super Rapid Readout Biological Indicator, K121484
3. 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.
4. Intended Use/ Indications for Use
The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:
- · Dynamic Air Removal 270°F (132°C) 4 minutes
- · Dynamic Air Removal 275°F (135°C) 3 minutes
- · Gravity 250°F (121°C) 30 minutes
- · Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.
ട. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
5
| Feature | Celerity SCBI
(proposed) | Attest 1492V
(K121484) | Comparison |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | 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. | Use 3M Attest Super Rapid
Readout Biological
Indicator 1492V in
conjunction with the 3M
Attest Auto-reader 490 to
qualify or monitor dynamic
air removal (prevacuum)
steam sterilization cycles
of 4 minutes at 270 F (132
C) and 3 minutes at 275 F
(135 C).
The 3M Attest Super Rapid
Readout Biological
Indicator 1492V provides a
final fluorescent result in 1
hour. An optional visual
pH color change result is
observed in 48 hours. | Both are intended for
monitoring steam
sterilization cycles.
The Celerity BI is claiming
additional cycles compared
to the predicate. Simulated
use testing in sterilizers with
a load under pass and fail
conditions demonstrate
performance of the Celerity
BI in these additional 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 | 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 | Same mechanism |
| 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 x 106 spore/SCBI | Both proposed and predicate |
| Resistance | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | D132 ≥ 10 s
D135 ≥ 8 s | meet criteria of ISO 11138-3
and FDA guidance |
| Culture
Conditions | 55- 59 °C, media included
in SCBI, 20-minute
incubation time. | 55- 59 °C, media included
in SCBI, 60 minute
incubation time. | RIT Testing and ISO 11138
media testing verifies
performance |
| 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. Summary of SCBI Physical Description and Technological Properties
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION K173634 Celerity 20 Steam Biological Indicator
Summary of Nonclinical Tests 6.
Performance testing to demonstrate substantial equivalence to the predicate 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 40-minute results with the | ||
| conventional incubation time of 7 days | PASS | |
| Viable spore | ||
| population | 1.0 - 4.0 x 106 spore/SCBI | 2.3 - 2.5 x 106 |
| spore/SCBI | ||
| Resistance | D121 ≥ 1.5 min | |
| D132 ≥ 10 s | ||
| D135 ≥ 8 s | D121 ≥ 2.53 min | |
| D132 ≥ 46 s | ||
| D135 ≥ 37 s | ||
| Survival Time | Meets the longer of FDA and ISO 11138-3 | |
| requirements | 121 C ≥ 11.11 min | |
| 132 C ≥ 3.42 min | ||
| 135 C ≥ 2.77 min | ||
| Kill Time | Meets the shorter of FDA and ISO 11138-3 | |
| requirements | 121 C ≤ 31.81 min | |
| 132 C ≤ 8.62 min | ||
| 135 C ≤ 7.11 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 | |
| 72 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 |
Table 5-2. Summary of Non-clinical Testing
7. Conclusion
The Celerity 20 Steam Biological Indicator has met the established performance criteria. The conclusions drawn from the nonclinical tests performed demonstrate the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device, K121424 Class II (21 CFR 880.2800, Product code FRC).