(28 days)
Not Found
No
The device description and performance studies focus on a biological indicator and an incubator detecting a fluorescent signal, with no mention of AI or ML.
No.
The device is a biological indicator used to monitor the effectiveness of steam sterilization cycles, not to 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Celerity 20 Steam Biological Indicator is used to monitor the effectiveness of steam sterilization cycles for medical devices and other materials. It does this by detecting the viability of a resistant microorganism after the sterilization process.
- No Human Samples: The device does not interact with or analyze samples taken from a human body. Its purpose is to assess the sterilization process itself, not to diagnose or monitor a patient's health.
Therefore, while it's a medical device used in healthcare settings, it falls under the category of sterilization process indicators rather than in vitro diagnostics.
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 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 below.
Table 5-2. Summary of Non-clinical Testing
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Simulated Use | Demonstrate no growth when exposed to a full cycle | Full cycle - no growth |
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).
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STERIS Corporation Tony Piotrkowski Senior Regulatory Affairs Manager 5960 Heisley Rd Mentor, Ohio 44060
Re: K181686
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: June 25, 2018 Received: June 26, 2018
Dear Tony 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
1
manufacturing practice requirements as set forth in the quality systems (OS) 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/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.
Clarence W. Murray lii III -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
Indications for Use
510(k) Number (if known) K181686
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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510(k) Summary For 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: July 18, 2018
Premarket Notification Number: K181686
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| 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) |
2. Predicate Device
Celerity 20 Steam Biological Indicator, K173634
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 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.
5
5. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
| Feature | Celerity 20 Steam SCBI
(modified) | Celerity 20 Steam SCBI
Predicate (K173634) | Comparison |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended
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. | 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. | Identical |
| Indicator
organism | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | 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 | Identical |
| Accessories | Automated incubator / reader | Automated incubator / reader | Identical |
| Viable spore
population | 1.0 - 4.0 x 106 spore/SCBI | 1.0 - 4.0 x 106 spore/SCBI | Identical |
| Resistance | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | Identical |
| Survival
Time | Meets the longer of FDA and
ISO 11138-3 requirements | Meets the longer of FDA and
ISO 11138-3 requirements | Identical |
| Kill Time | Meets the shorter of FDA and
ISO 11138-3 requirements | Meets the shorter of FDA and
ISO 11138-3 requirements | Identical |
| Hold time | Up to 72 h | Up to 72 h | Identical |
| Carrier
growth
inhibition /
media
growth | Positive growth of less than
100 spores after primary
packaging and media are
subject to worst case steam
exposure | Positive growth of less than
100 spores after primary
packaging and media are
subject to worst case steam
exposure | Identical |
| Feature | Celerity 20 Steam SCBI
(modified) | Celerity 20 Steam SCBI
Predicate (K173634) | Comparison |
| 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 |
| Primary
Packaging | Direct inoculum on plastic
vial, cap with recovery media. | Direct inoculum on plastic
vial, cap with recovery media. | Identical |
| Shelf Life | 10 months | 10 months | Shelf-life testing is
ongoing |
| Cap label | Single-ply label on cap edge
Process indicator on label | Two-ply label on cap top
Process indicator on label | Same adhesive,
process indicator ink
and substrate different
format and location |
Table 5-1. Summary of SCBI Physical Description and Technological Properties
6
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.
Table 5-2. Summary of Non-clinical Testing
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Simulated Use | Demonstrate no growth when exposed to a | |
| full cycle | Full cycle - no growth |
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, K173634 Class II (21 CFR 880.2800, Product code FRC).