· STERRAD® 100S Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
· Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes

The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

Device Description

Biological Indicator: 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.

Challenge Pack: The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator* for a final determination of viability within 20 minutes of incubation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Celerity 20 HP Biological Indicator and Celerity 20 HP Challenge Pack, based on the provided document.

CELERITY 20 HP Biological Indicator

Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle	All BIs processed in full cycles will be negative for growth	PASS
Recoverable Population after exposure to STERRAD ALLClear	Recoverable Population of 50 – 300% of the label claim	PASS

Sample Size and Data Provenance: The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing demonstrated that the subject device met its acceptance criteria."
Number of Experts and Qualifications: Not applicable for this type of device (biological indicator testing for sterilization).
Adjudication Method: Not applicable for this type of device. The determination of "negative for growth" or "recoverable population" is based on objective microbiological assays.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an objective indicator, not subject to human reader interpretation in the context of diagnostic imaging.
Standalone (Algorithm Only) Performance: The document describes the Celerity 20 HP BI as a standalone device whose performance is assessed through its growth characteristics after exposure to sterilization cycles. The "fluorescent result within 20 minutes" when used with the Celerity HP Incubator is the objective output of the system.
Type of Ground Truth Used: The ground truth is based on the biological viability of Geobacillus stearothermophilus spores after exposure to sterilization, and the quantitative recovery of these spores. This is a direct measure of microbial survival/kill.
Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set in that sense. The device is a biological indicator with inherent characteristics that are tested.
How Ground Truth for Training Set was Established: Not applicable.

CELERITY 20 HP Challenge Pack

Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Simulated Use	Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions	PASS
Cycle-Specific Testing	The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions.	PASS

Sample Size and Data Provenance: Similar to the Biological Indicator, the document does not explicitly state the sample size used for the test set or the data provenance. It states "Performance testing demonstrated that the subject device met its acceptance criteria."
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable. The results are based on the objective outcome of the biological indicator and chemical indicator within the pack after a sterilization cycle.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone (Algorithm Only) Performance: The CELERITY 20 HP Challenge Pack's performance is intrinsically standalone, as it's a physical pack designed to present a challenge to the sterilization process. Its outcome is determined by the biological and chemical indicators it contains.
Type of Ground Truth Used: The ground truth is established by assessing the biological (spore kill/survival) and chemical (color change) indicators within the pack after exposure to standardized sterilization conditions, particularly under "worst-case sterilization conditions" and against a "biological model."
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

Overall Note: This document describes the 510(k) submission for a traditional biological indicator and challenge pack, not an AI/ML powered device. Therefore, many of the requested points related to AI/ML study methodologies (experts, adjudication, MRMC, training sets) are not applicable to this submission. The focus is on the physical and biological performance characteristics of the indicator and pack.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 3, 2019

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K183294

Trade/Device Name: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 26, 2018 Received: November 27, 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 mav, 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 avare 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.html; 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.

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

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Indications for Use

510(k) Number (if known)

K183294

Device Name

Celerity 20 HP Biological Indicator

Indications for Use (Describe)

The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 and s2 Low Temperature Sterilization Systems.

· STERRAD® 100S Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
· Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

51 0(k) Number (if known)

K183294

Device Name

CELERITY 20 HP Challenge Pack

Indications for Use (Describe)

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

Type of Use (Select one or both, as applicable)

□ Prescription Use(Part 21CFR801Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary For CELERITY 20 HP Biological Indicator And CELERITY 20 HP Challenge Pack

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

Tony Piotrkowski Contact: Director Regulatory Affairs

Telephone: (440) 392-7437 Fax No: (440) 357-9198 tony_piotrkowski@steris.com e-mail:

Submission Date: January 2, 2019

Premarket Notification Number: K183294

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

Device Name 1.

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(a), FRC]

2. Predicate Device Biological Indicator

CELERITY 20 HP Biological Indicator, K172752 (modified under K181429)

3. Description of Device - Biological Indicator

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 - Biological Indicator

The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX2 and s2 Low Temperature Sterilization Systems.
· STERRAD® 100S Sterilizer (Default Cycle)
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
· Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

Technical Characteristics Comparison Table – Biological Indicator 5.

	CELERITY 20 HP BI	CELERITY 20 HP BI
Feature	K183294 (proposed)	Predicate (K172752)	Comparison
Intended Use	The Celerity 20 HPBiological Indicator isintended for routinemonitoring of the followingsterilizer cycles:Lumen, Non Lumen,Fast Non Lumen, Fastand Flexible Cycles ofthe V-PRO: 1, 1 Plus,maX, maX2 and s2 LowTemperatureSterilization Systems. STERRAD® 100SSterilizer (Default Cycle) Standard and AdvancedCycles of theSTERRAD® NXSterilizer with or withoutALLClear Standard, Flex Scope,Express and DUOCycles of theSTERRAD® 100NXSterilizer with or withoutALLClear When used in conjunctionwith the Celerity HPIncubator, the Celerity 20 HPBI provides a fluorescentresult within 20 minutes.	The CELERITY BiologicalIndicator is used for routinemonitoring, andqualification of the NonLumen, Flexible, Lumenand Fast Non Lumen Cyclesof the V-PRO 1, 1 Plus,maX, 60 and maX 2 LowTemperature Sterilizers inhealthcare facilities.When used in conjunctionwith the VERIFYCELERITY 20 HPIncubator, the CELERITY20 HP Biological Indicatorprovides a fluorescent resultwithin 20 minutes.	The Fast Cycle is a newcycle in the V-PRO s2Low TemperatureSterilizer, which hasbeen submitted in aseparate premarketnotification.Testing to supportclaims in sterilizers withALLClear is included inthis submission.Indications forSTERRAD sterilizerswere cleared underK172474.
Indicatororganism	Geobacillusstearothermophilus	Geobacillusstearothermophilus	Same
Mechanismof action	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety.	An enzyme, which isproduced by the organism,reacts with a fluorogenicsubstrate within the definednutrient media to produce afluorescent moiety.	Same
Accessories	CELERITY HP Incubator*(K171587)	CELERITY HP Incubator*(K171587)	Same
Viable sporepopulation	1.0 - 4.0 x 106 spore/BI	1.0 – 4.0 x 106 spore/BI	Same
Resistancecharacteristics	Resistance @ 9.1 mg/LH2O2:D-value > 6 sec Survival Time ≥ 4 sec Kill Time ≤ 7 min	Resistance @ 9.1 mg/LH2O2:D-value > 3 sec Survival Time ≥ 4 sec Kill Time ≤ 6 min	Increased minimum D-value specification,within the range of thepredicate device.
Feature	CELERITY 20 HP BIK183294 (proposed)	CELERITY 20 HP BIPredicate (K172752)	Comparison
Culture Conditions	55- 59°C, media included inBI, 20-minute incubationtime.	55- 59°C, media included inBI, 20-minute incubationtime.	Same
Primary Packaging	Direct inoculum on plasticvial, cap with recoverymedia.	Direct inoculum on plasticvial, cap with recoverymedia.	Same
Process indicator	VERIFY V-PRO ChemicalIndicator (K140515);magenta to yellow colorchange.	VERIFY V-PRO ChemicalIndicator (K140515);magenta to yellow colorchange.	Same
Shelf-life	Currently 10 monthsTarget of 13 months	Currently 10 monthsTarget of 13 months	Real-time testingongoing

Table 5-1. BI Physical Description and Technological Properties vs the Predicate Device

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

Summary of Nonclinical Performance Tests – Biological Indicator 6.

Performance testing demonstrated that the subject device met its acceptance criteria and the results are summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
BI Simulated Use in the V-PRO maX2 Sterilizer Fast Non Lumen Cycle	All BIs processed in full cycles will benegative for growth	PASS
Recoverable Population afterexposure to STERRAD ALLClear	Recoverable Population of 50 – 300%of the label claim	PASS

Table 5-2. Summary of Non-clinical Testing

Device Name – Challenge Pack 7.

Trade Name:	CELERITY 20 HP Challenge Pack
Common/usual Name:	Biological Indicator Challenge Pack
Device Classification:	Class II
Classification Name:	Sterilization Process Indicator(21 CFR 880.2800, FRC)

8. Predicate Device - Challenge Pack

CELERITY 20 HP Challenge Pack K173488 (NOTE: The proposed and predicate devices are identical)

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9. Description of Device - Challenge Pack

The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.

The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator* for a final determination of viability within 20 minutes of incubation.

10. Intended Use/ Indications for Use - Challenge Pack

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.

11. Technical Characteristics Comparison Table - Challenge Pack

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indicator and CELERITY 20 HP Challenge Pack

Feature	CELERITY packK183294 (Proposed)	CELERITY pack(K173488) Predicate	Comparison
IntendedUse /Indicationfor Use	The CELERITY 20 HPChallenge Pack is intended forqualification testing of the V-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.The Challenge Pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load isnot included.The challenge pack is notintended for routinemonitoring of the V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of thesterilizers.	The CELERITY 20 HPChallenge Pack is intendedfor qualification testing of theV-PRO LowTemperature SterilizationSystem following installation,relocation, malfunctions ormajor repairs and for routinerequalification testing.The Challenge Pack is placedin an otherwise emptysterilizer chamber; a hospital-defined challenge load isnot included.The challenge pack is notintended for routinemonitoring of the V-PROSterilizers. It has been testedand validated solely for use inperiodic testing of thesterilizers.	Same
GeneralDesign	Sealed sterilization pouchcontaining SCBI, CI andbarrier material.	Sealed sterilization pouchcontaining SCBI, CI andbarrier material.	Same
BiologicalIndicator	Celerity 20 HP BiologicalIndicator	Celerity 20 HP BiologicalIndicator	Same
ChemicalIndicator	VERIFY HPU ChemicalIndicator	VERIFY HPU ChemicalIndicator	Same
Means todistinguishprocessedpack fromunprocessed	Proposed device's internalindicator is visible through thepack.	Proposed device's internalindicator is visible throughthe pack.	Same
Requiredaccessories	CELERITY HP Incubator*(K171587)	CELERITY HP Incubator*(K171587)	Same

Table 5-3. Summary of Pack Physical Description and Technological Properties

12. Summary of Nonclinical Performance Tests – Challenge Pack

Performance testing demonstrated that the subject device met its acceptance criteria and the results are summarized in Table 5-4 below.

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION CELERITY 20 HP Biological Indictor and CELERITY 20 HP Challenge Pack

Test	Acceptance Criteria	Conclusion
Simulated Use	Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions	PASS
Cycle-Specific Testing	The pack provides an equivalent or greater challengeto the claimed cycle than the biological model underworst-case conditions.	PASS

Table 5-4. Summary of Non-Clinical Testing

13. Conclusion

Based on the intended use, technological characteristics and the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, the CELERITY 20 HP Biological Indicator (cleared in K172752) Class II (21 CFR 880.2800, product code FRC).

The CELERITY 20 HP Challenge Pack has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, K173488, Class II (21 CFR 880.2800, Product code FRC).

The Celerity HP Incubator was cleared in K171587 under the name "VERIFY Incubator for Assert VH2O2 SCBI"

Regulation Number and Section

§ 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).