(92 days)
Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for a fluorescent result within 20 minutes.
Celerity HP Incubator (Incubator) is an incubator/reader designed for use specifically with the Celerity 20 HP Biological Indicator (BI). The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus which is detected by an enzyme that cleaves the a substrate leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the BI is detected by the incubator/reader and indicates the presence of viable test microorganisms.
The provided text describes the acceptance criteria and the summary of performance testing for the Celerity HP Incubator (K190297). The information pertains to the device's adherence to safety and electromagnetic compatibility standards, and the proper function of its features, rather than a study involving human readers or a training set for an AI algorithm.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety - General | Conform with UL 61010-1 3rd Edition | PASS |
| Electrical Safety – Heating Equipment | Conform with UL 61010-2-010:2015 Ed.3 | PASS |
| Electromagnetic Compatibility | Conform with IEC 61326-1:2012 and FCC 47 CFR Part 15 | PASS |
| Alarm, LED and Print function Test | Demonstrate proper function of alarms, LED and print outputs | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of data or images, as this is a device for incubating and reading biological indicators. The performance tests are described as non-clinical and relate to the device's electrical safety, EMC, and functional aspects. No data provenance (country of origin, retrospective/prospective) is applicable or provided for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for this device relates to established engineering and safety standards (UL, IEC, FCC) and the functional operation of the incubator and its indicators. These are validated through standard technical testing, not expert consensus on medical images or pathology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or review of data (e.g., medical imaging), which is not the nature of the testing described for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done, as this device (Celerity HP Incubator) is an automated incubator/reader for biological indicators, not an AI-assisted diagnostic tool that involves human readers interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is inherently a standalone system. It automatically reads Celerity 20 HP Biological Indicators for a fluorescent result. The performance study refers to the device's ability to conform to electrical, safety, and functional standards, which are evaluated autonomously against set criteria. The "algorithm" in this context is the internal logic and detection mechanism of the incubator to determine a positive or negative result from the biological indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance tests are established international and national safety and electromagnetic compatibility standards (UL, IEC, FCC), as well as the functional specifications for the device's alarms, LEDs, and print outputs. A "PASS" conclusion indicates conformity with these predefined technical criteria. The performance testing also implies the accurate detection of fluorescence produced by the biological indicator, which is a chemical/biological truth based on microbial growth.
8. The sample size for the training set:
This information is not applicable. The device is not an AI algorithm that undergoes training on a dataset. Its functionality is based on direct physical and chemical detection principles.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no AI training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
May 14, 2019
Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K190297
Trade/Device Name: Celerity HP Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: April 16, 2019 Received: April 17, 2019
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,
David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Celerity HP Incubator
Indications for Use (Describe)
Use the Celerity HP Incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for a fluorescent result within 20 minutes.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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STERIS®
510(k) Summary For Celerity HP Incubator K190297
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
Telephone: (440) 392-7437 Fax No: e-mail: tony_piotrkowski@steris.com
February 8, 2019 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
| Trade Name: | Celerity HP Incubator |
|---|---|
| Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process(21 CFR 880.2800, FRC) |
2. Predicate Device
K171587 - VERIFY® Incubator for Assert™ |VH2O2 Self-Contained Biological Indicators (name changed to Celerity HP Incubator after clearance)
3. Reference Device
K173670 - Celerity 20 Steam Incubator
4. Description of Device
Celerity HP Incubator (Incubator) is an incubator/reader designed for use specifically with the Celerity 20 HP Biological Indicator (BI). The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus which is detected by an enzyme that cleaves the a substrate leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the BI is detected by the incubator/reader and indicates the presence of viable test microorganisms.
ട. Intended Use/ Indications for Use
Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 ℃ for a fluorescent result within 20 minutes.
6. Summary of Technical Characteristics
Comparisons of technical characteristics versus the predicate and reference devices are summarized in Tables 5-1 and 5-2 respectively.
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Table 5-1 Summary of Incubator Physical Description and Technological Properties vs Predicate
| Feature | VERIFY Incubator for AssertVH2O2 SCBI(predicate K171587) | Celerity HP Incubator(modified) | Comparison |
|---|---|---|---|
| Intended Use | Use the Celerity HP Incubator toincubate and automatically readVERIFY Assert VH2O2 Self-Contained Biological Indicators at57 °C for a fluorescent resultwithin 20 minutes. | Use the Celerity HP Incubator toincubate and automatically readCelerity HP Biological Indicatorsat 57 °C for a fluorescent resultwithin 20 minutes. | Sameindicationsfor use – thename of theincubatorhas changed. |
| Basis ofReadout | Photodiode detects fluorescenceproduced by enzymatic activitythat results from growingbiological indicator organisms | Photodiode detects fluorescenceproduced by enzymatic activitythat results from growingbiological indicator organisms | Same |
| IncubationTemperatureRange | 55 - 60 °C | 55 - 60 °C | Same |
| VoltageRange | 100-240 VAC with 12 VDCconversion. | 100-240 VAC with 12 VDCconversion. | Same |
| Test capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration – no calibrationby customer | Factory calibration – no calibrationby customer | Same |
| IncubationTime | 20 minutes | 20 minutes | Same |
| FluorescenceDetection | UV LEDs are used to excite thefluorescent molecule produced byenzyme cleavage of thefluorogenic substrate contained inthe SCBI's media. The emittedlight is detected by a photodiode. | UV LEDs are used to excite thefluorescent molecule produced byenzyme cleavage of thefluorogenic substrate contained inthe SCBI's media. The emittedlight is detected by a photodiode. | Same |
| Compliance | Electrical Safety and EMC Testing• IEC 61010-1 (2010) Third Ed• IEC 61010-2-010 (2013) ThirdEdElectromagnetic compatibility• USA Title 47, Code of FederalRegulations (2007) for:o Radiated Emissions (FCCPart 15, Subpart B, Class A)o Conducted Emissions (FCCPart 15, Subpart B, Class A)• IEC 61326:2013 -• EN 55011:2009, Inc. A1:2010• EN 61000-3-2:2006, Inc.A1:2009 and A2:2009EN 61000-3-3:2013 | Electrical Safety and EMC Testing• IEC 61010-1 (2010) Third Ed• IEC 61010-2-010 (2013) ThirdEdElectromagnetic compatibility• USA Title 47, Code of FederalRegulations (2007) for:o Radiated Emissions (FCCPart 15, Subpart B, Class A)o Conducted Emissions (FCCPart 15, Subpart B, Class A)• IEC 61326:2013 -• EN 55011:2009, Inc. A1:2010• EN 61000-3-2:2006, Inc.A1:2009 and A2:2009EN 61000-3-3:2013 | Same |
| Indication ofResults | Positive - audible alarm, visualLED lights and screenNegative - no alarm, visualindication with LED lights andLCD screenUser must acknowledge results | Positive - audible alarm, visualLED lights and screenNegative - no alarm, visualindication with LED lights andLCD screenUser must acknowledge results | Same |
| Feature | VERIFY Incubator for AssertVH2O2 SCBI(predicate K171587) | Celerity HP Incubator(modified) | Comparison |
| SystemOperation | The reader/incubator wells arearranged in 2 banks of 4 wells andpreset to 57℃. The measurementof fluorescence is initiated byplacement of a VERIFY AssertSCBI into any of the incubationwells and pressing the adjacent"ACTION" button.When an SCBI is placed into awell, the auto-reader detects itspresence. Upon pressing the buttonassociated with that well, ablinking yellow light indicates thatincubation is in process and theread initiated.A "positive" reading is interpretedas an indication of a potentialsterilization cycle failure. A"positive" finding is indicated tothe user by red light on the frontpanel adjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen. Thealarm must be muted by theoperator when a positive result isobtained. The LCD screenprovides instructions for the user toturn off the alarm for that specificSCBI.Should another BI become"positive", the alarm will soundagain and the above actions arerepeated.If the result is not positive at theend of the incubation time, theresult is negative. Negative resultsare identified by a green light onthe front panel adjacent to the wellwith the "negative" BI and by texton the LCD. | The reader/incubator wells arearranged in 2 banks of 4 wells andpreset to 57℃. The measurementof fluorescence is initiated byplacement of a VERIFY AssertSCBI into any of the incubationwells and pressing the adjacent"ACTION" button.When an SCBI is placed into awell, the auto-reader detects itspresence. Upon pressing the buttonassociated with that well, ablinking yellow light indicates thatincubation is in process and theread initiated.A "positive" reading is interpretedas an indication of a potentialsterilization cycle failure. A"positive" finding is indicated tothe user by red light on the frontpanel adjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen. Thealarm must be muted by theoperator when a positive result isobtained. The LCD screenprovides instructions for the user toturn off the alarm for that specificSCBI.Should another BI become"positive", the alarm will soundagain and the above actions arerepeated.If the result is not positive at theend of the incubation time, theresult is negative. Negative resultsare identified by a green light onthe front panel adjacent to the wellwith the "negative" BI and by texton the LCD. | Same |
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Table 5-2 Summary of Incubator Physical Description and Technological Properties vs. Reference Device
| Feature | Celerity Steam Incubator(Reference K173670) | Celerity HP Incubator(modified) | Comparison |
|---|---|---|---|
| Intended Use | Use the Celerity 20 SteamIncubator to incubate andautomatically read Celerity 20Steam Biological Indicators at 57°C for a fluorescent result within20 minutes. | Use the Celerity HP Incubator toincubate and automatically readCelerity HP Biological Indicatorsat 57 °C for a fluorescent resultwithin 20 minutes. | Sameoperatingtemperatureand readtime |
| Feature | Celerity Steam Incubator(Reference K173670) | Celerity HP Incubator(modified) | Comparison |
| Basis ofReadout | Photodiode detects fluorescenceproduced by enzymatic activitythat results from growingbiological indicator organisms | Photodiode detects fluorescenceproduced by enzymatic activitythat results from growingbiological indicator organisms | Same |
| IncubationTemperatureRange | 55 - 60 °C | 55 - 60 °C | Same |
| VoltageRange | 90 to 264 VAC with 12 VDCconversion. | 100-240 VAC with 12 VDCconversion. | Proposedwithin rangeof reference |
| Test capacity | 8 wells | 8 wells | Same |
| Calibration | Factory calibration – no calibrationby customer | Factory calibration – no calibrationby customer | Same |
| IncubationTime | 20 minutes | 20 minutes | Same |
| FluorescenceDetection | UV LEDs are used to excite thefluorescent molecule produced byenzyme cleavage of thefluorogenic substrate contained inthe SCBI's media. The emittedlight is detected by a photodiode. | UV LEDs are used to excite thefluorescent molecule produced byenzyme cleavage of thefluorogenic substrate contained inthe SCBI's media. The emittedlight is detected by a photodiode. | Same |
| Compliance | Electrical Safety and EMC TestingIEC 61010-1 (2010) Third Ed IEC 61010-2-010 (2013) Third Ed Electromagnetic compatibility USA Title 47, Code of Federal Regulations (2007) for: Radiated Emissions (FCC Part 15, Subpart B, Class A) Conducted Emissions (FCC Part 15, Subpart B, Class A) IEC 61326:2013 - EN 55011:2009, Inc. A1:2010 EN 61000-3-2:2006, Inc. A1:2009 and A2:2009 EN 61000-3-3:2013 | Electrical Safety and EMC TestingIEC 61010-1 (2010) Third Ed IEC 61010-2-010 (2013) Third Ed Electromagnetic compatibility USA Title 47, Code of Federal Regulations (2007) for: Radiated Emissions (FCC Part 15, Subpart B, Class A) Conducted Emissions (FCC Part 15, Subpart B, Class A) IEC 61326:2013 - EN 55011:2009, Inc. A1:2010 EN 61000-3-2:2006, Inc. A1:2009 and A2:2009 EN 61000-3-3:2013 | Same |
| Indication ofResults | Positive - audible alarm, visualLED lights and screenNegative - no alarm, visualindication with LED lights andLCD screenUser must acknowledge results | Positive – audible alarm, visualLED lights and screenNegative - no alarm, visualindication with LED lights andLCD screenUser must acknowledge results | Same |
| Feature | Celerity Steam Incubator(Reference K173670) | Celerity HP Incubator(modified) | Comparison |
| SystemOperation | The reader/incubator wells arearranged in 2 banks of 4 wells andpreset to 57℃. The measurementof fluorescence is initiated byplacement of a VERIFY AssertSCBI into any of the incubationwells and pressing the adjacent"ACTION" button.When an SCBI is placed into awell, the auto-reader detects itspresence. Upon pressing the buttonassociated with that well, ablinking yellow light indicates thatincubation is in process and theread initiated.A "positive" reading is interpretedas an indication of a potentialsterilization cycle failure. A"positive" finding is indicated tothe user by red light on the frontpanel adjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen. Thealarm must be muted by theoperator when a positive result isobtained. The LCD screenprovides instructions for the user toturn off the alarm for that specificSCBI.Should another BI become"positive", the alarm will soundagain and the above actions arerepeated.If the result is not positive at theend of the incubation time, theresult is negative. Negative resultsare identified by a green light onthe front panel adjacent to the wellwith the "negative" BI and by texton the LCD. | The reader/incubator wells arearranged in 2 banks of 4 wells andpreset to 57℃. The measurementof fluorescence is initiated byplacement of a VERIFY AssertSCBI into any of the incubationwells and pressing the adjacent"ACTION" button.When an SCBI is placed into awell, the auto-reader detects itspresence. Upon pressing the buttonassociated with that well, ablinking yellow light indicates thatincubation is in process and theread initiated.A "positive" reading is interpretedas an indication of a potentialsterilization cycle failure. A"positive" finding is indicated tothe user by red light on the frontpanel adjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen. Thealarm must be muted by theoperator when a positive result isobtained. The LCD screenprovides instructions for the user toturn off the alarm for that specificSCBI.Should another BI become"positive", the alarm will soundagain and the above actions arerepeated.If the result is not positive at theend of the incubation time, theresult is negative. Negative resultsare identified by a green light onthe front panel adjacent to the wellwith the "negative" BI and by texton the LCD. | Same |
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7. Summary of Nonclinical Tests
Performance testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown in Table 5-3 below.
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| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Electrical Safety -General | Conform with UL 61010-1 3rd Edition | PASS |
| Electrical Safety –Heating Equipment | Conform with UL 61010-2-010:2015 Ed.3 | PASS |
| ElectromagneticCompatability | Conform with IEC 61326-1:2012 and FCC 47CFR Part 15 | PASS |
| Alarm, LED andPrint function Test | Demonstrate proper function of alarms, LED andprint outputs | PASS |
Table 5-3. Summary of Non-clinical Testing
8. Conclusion
The Celerity HP Incubator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical test performed, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device, VERIFY® Incubator for Assert™ VH2O2 Self-Contained Biological Indicators, K171587, Class II (21 CFR 880.2800, Product code FRC).
§ 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).