(12 days)
Not Found
No
The document describes a biological indicator and an incubator that detects a fluorescent signal. There is no mention of AI or ML in the intended use, device description, or any other section.
No.
The 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 sterilization processes, not to diagnose a disease or 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 relies on a proprietary hardware reader (CELERITY 20 HP Incubator) to detect the result.
Based on the provided information, the CELERITY 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 monitoring is done in vitro (outside of a living organism) to assess the effectiveness of a sterilization process.
- Device Description: The description explicitly states 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 process of detecting a biological response (spore viability) in a controlled environment to assess the outcome of a process (sterilization) is characteristic of an IVD.
- Mechanism: The mechanism involves a biological indicator (spores) and a nutrient media in a vial, with a reaction that produces a fluorescent signal. This is a common format for biological indicators used in sterilization monitoring, which are considered IVDs.
While the device doesn't directly diagnose a disease in a patient, it is used in vitro to assess the effectiveness of a process (sterilization) that is critical for 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 to determine compatibility with potential recipients. In this case, the "specimen" is the biological indicator itself, and the information provided is about the effectiveness of the sterilization process, which directly impacts the safety of medical devices used on patients.
N/A
Intended Use / Indications for Use
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.
Product codes
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
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Summary of Performance Studies
Nonclinical Tests:
Study Type: Simulated Use
Sample Size: Not specified
Key Results: BI is inactivated when exposed in a worst-case cycle with a worst-case load. No growth of BI.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 13, 2018
STERIS Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5960 Heisley Road Mentor, Ohio 44060
Re: K181429
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: May 30, 2018 Received: June 1, 2018
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
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 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,
Elizabeth F. Claverie -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) K181429
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 20 HP Incubator, the CELERITY 20 HP Biological Indicator 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 K181429 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: Tony Piotrkowski Senior Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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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, K172752
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 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.
5. Summary of Technical Characteristics
A comparison of technical characteristics are summarized in Table 5-1.
5
| Feature | CELERITY 20 HP BI
K181429 | CELERITY 20 HP BI
Predicate (K172752) | Comparison |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | 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. | 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. | Identical |
| Indicator
organism | Geobacillus
stearothermophilus | 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 | $1.0 - 4.0 \times 10^6$ spore/BI | $1.0 - 4.0 \times 10^6$ spore/BI | Identical |
| 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 | Identical |
| Culture
Conditions | 55- 59°C, media included
in BI, 20-minute
incubation time. | 55- 59°C, media included
in BI, 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 |
| Process
indicator | VERIFY V-PRO
Chemical Indicator
(K140515); magenta to
yellow color change. | VERIFY V-PRO
Chemical Indicator
(K140515); magenta to
yellow color change. | Identical |
| Label | Single-ply on cap edge | Two-ply on top of cap | Same adhesive and
substrate, different format
and location |
| Shelf-life | Currently 7 months | Currently 7 months | Real Time Testing Ongoing |
Table 5-1. Summary of SCBI Physical Description and Technological Properties
6
K181429
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 | Result |
|---|---|---|
| Simulated Use | BI is inactivated when exposed in a worst-case cycle with a worst-case load | No growth of BI |
Conclusion 7.
The Celerity 20 HP 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, K172752 Class II (21 CFR 880.2800, Product code FRC).