Use the ConFirm 20 Minute Incubator to incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

Device Description

The ConFirm 20 Minute Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The Bl is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

AI/ML Overview

While the provided text describes the "ConFirm 20 Minute Incubator" and its 510(k) submission, it explicitly states under the "Summary of Non-Clinical Testing" section that "Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2." Following this, Table 2 only contains "Regression Testing" with an acceptance criterion of "No unresolved anomalies" and a result of "PASS."

This document does NOT contain a study that proves the device meets specific performance acceptance criteria for its intended function (automatically reading biological indicators with a certain accuracy, sensitivity, or specificity). It primarily highlights that the "ConFirm 20 Minute Incubator" is substantially equivalent to a predicate device (Celerity Incubator K223715) based on technological characteristics and that regression testing passed.

Therefore, I cannot fulfill the request to describe a study proving the device meets performance acceptance criteria for reading biological indicators, as that information is not present in the provided text. The document focuses on regulatory equivalence rather than detailed performance study results.

However, based on the information provided, I can infer and state what is present and what is absent from the document regarding acceptance criteria and performance studies:

**Analysis of Acceptance Criteria and Device Performance (Based only on provided text):**

The provided 510(k) summary for the "ConFirm 20 Minute Incubator" (K233681) does not detail specific performance acceptance criteria related to its ability to accurately incubate and read biological indicators (e.g., sensitivity, specificity, accuracy rates). Instead, the evaluation focuses on demonstrating substantial equivalence to a predicate device (Celerity Incubator K223715) and passing regression testing.

The only explicit "acceptance criteria" and "result" provided in the "Summary of Non-Clinical Testing" (Table 2) are for Regression Testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Performance
Regression Testing	No unresolved anomalies	PASS

2. Sample Size Used for the Test Set and Data Provenance:

Not specified. The document does not provide details on sample size for any performance testing related to the incubation and reading of biological indicators. The "Regression Testing" mentioned in Table 2 is a general software/system testing term and does not imply a specific sample size for a clinical or performance study of the device's primary function.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable/Not specified. The document does not describe any study involving expert readers or establishment of ground truth in the context of device performance in reading biological indicators. The assessment relies on a comparison to a predicate device and internal regression testing.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. As no multi-reader or similar performance study is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done according to the provided text. The device is an incubator/reader for biological indicators, not an AI-assisted diagnostic tool that would typically involve a multi-reader study with human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study was done:

Not specified/Not applicable in the typical AI sense. While the device "automatically read[s]" results, the document does not present a standalone performance study with metrics like sensitivity, specificity, or accuracy for this automated reading function. The evaluation focuses on substantial equivalence to a predicate.

7. The Type of Ground Truth Used:

Not specified. For the "Regression Testing," the ground truth would likely be defined by expected system behavior or documented requirements. For the primary function of reading biological indicators, the inherent ground truth would be the actual viability of the microorganisms within the biological indicator, often determined by traditional microbiological culture methods (which are not mentioned here as part of a performance study).

8. The Sample Size for the Training Set:

Not applicable. The device is an incubator and reader for biological indicators, not an AI/ML device that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As the device is not an AI/ML device with a training set, this information is not relevant or provided.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence to a legally marketed predicate device (Celerity Incubator) and passing internal regression testing. It does not present detailed performance studies with specific statistical metrics (e.g., accuracy, sensitivity, specificity) for the device's core function of interpreting biological indicators, nor does it discuss clinical studies, human readers, or AI algorithms in the context of diagnostic performance.

Summary

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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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 15, 2023

Steris Corporation Logan Persons Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K233681

Trade/Device Name: ConFirm 20 Minute Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 16, 2023 Received: November 16, 2023

Dear Logan Persons:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233681

Device Name ConFirm 20 Minute Incubator

Indications for Use (Describe)

Use the ConFirm 20 Minute Incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

510(k) Summary For ConFirm 20 Minute Incubator K233681

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Mr. Logan Persons Regulatory Affairs Specialist Tel: 440-392-7325 Fax: 440-357-9198 Logan persons@steris.com

Summary Date: December 15, 2023

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1. Device Name

Trade Name:	ConFirm 20 Minute Incubator
Device Classification:	II
Common Name:	Incubator
Classification Name:	Indicator, Biological Sterilization Process
Classification Panel:	General Hospital and Personal Use Devices Panel
Classification Number:	21 CFR 880.2800
Product Code	FRC

2. Predicate Device

K223715 - Celerity Incubator

Reference Device K173634 - ConFirm Biological Indicator (cleared as CELERITY 20 Steam Biological Indicator)

3. Device Description

Indications for Use 4.

ડ. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

Feature	Modified DeviceConFirm 20 MinuteIncubator	Predicate DeviceCelerity Indicator(K223715)	Comparison
Indicationsfor Use	Use the ConFirm 20	Use the Celerity Incubator	Same, only
Feature	Modified DeviceConFirm 20 MinuteIncubator	Predicate DeviceCelerity Indicator(K223715)	Comparison
	Minute Incubator toincubate and automaticallyread ConFirm Rapid 20Minute Biological	to incubate andautomatically read STERISCelerity BiologicalIndicators for Steam andVaporized HydrogenPeroxide sterilization at55°C - 60°C for afluorescent result.	change isbranding ofincubator andBI with whichit is used
Basis ofReadout	Photodiode detectsfluorescence produced byenzymatic activity thatresults from viablebiological indicatororganisms.	Photodiode detectsfluorescence produced byenzymatic activity thatresults from viablebiological indicatororganisms.	Same
IncubationTemperature Range	55 - 60 °C	55 - 60 °C	Same
VoltageRange	100-240 VAC with 12VDC conversion	100-240 VAC with 12VDC conversion	Same
TestCapacity	8 wells	8 wells	Same
Calibration	Factory calibration – nocalibration by customer	Factory calibration – nocalibration by customer	Same
IncubationTime	20 minutes	5 minutes or 20 minutesdepending on BiologicalIndicator	Similar, the 5-minute BI isnot beingrebranded.
FluorescenceDetection	UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the BI'smedia. The emitted light isdetected by a photodiode.	UV LEDs are used toexcite the fluorescentmolecule produced byenzyme cleavage of thefluorogenic substratecontained in the BI'smedia. The emitted light isdetected by a photodiode.	Same
Indication ofResults	Positive – audible alarm,visual LED lights and	Positive – audible alarm,visual LED lights and	Same
Feature	Modified DeviceConFirm 20 MinuteIncubator	Predicate DeviceCelerity Indicator(K223715)	Comparison
	screenNegative - optional alarm,visual indication with LEDlights and LCD screenUser must acknowledgeresults	screenNegative - optional alarm,visual indication with LEDlights and LCD screenUser must acknowledgeresults
SystemOperation	The reader/incubator wellsare arranged in 2 banks of4 wells and preset to 59°C.The user scans the barcodeon the label of an activatedBI using the system'sbarcode scanner and placesit into an open well. Thesystem detects the well theBI was placed into andbegins measurement offluorescence; a blinkingyellow light indicates theincubation is in processand the read initiated. TheSystem uses informationfrom the barcode to applythe appropriate algorithmto the well. A "positive"reading is interpreted as anindication of a potentialsterilization cycle failure.A “positive” finding isindicated to the user by redlight on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCDscreen. The alarm must bemuted by the operatorwhen a positive result isobtained. The LCD screenprovides instructions forthe user to turn off thealarm for that specific BI.	The reader/incubator wellsare arranged in 2 banks of4 wells and preset to 59°C.The user scans the barcodeon the label of an activatedBI using the system'sbarcode scanner and placesit into an open well. Thesystem detects the well theBI was placed into andbegins measurement offluorescence; a blinkingyellow light indicates theincubation is in processand the read initiated. TheSystem uses informationfrom the barcode to applythe appropriate algorithmto the well. A "positive"reading is interpreted as anindication of a potentialsterilization cycle failure.A “positive” finding isindicated to the user by redlight on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCDscreen. The alarm must bemuted by the operatorwhen a positive result isobtained. The LCD screenprovides instructions forthe user to turn off thealarm for that specific BI.	Same
Feature	Modified DeviceConFirm 20 MinuteIncubator	Predicate DeviceCelerity Indicator(K223715)	Comparison
	Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.If the result is not positiveat the end of the incubationtime, the result is negative.Negative results areidentified by a green lighton the front panel adjacentto the well with the"negative" BI and by texton the LCD. In addition, anoptional alarm is availablefor negative results.	Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.If the result is not positiveat the end of the incubationtime, the result is negative.Negative results areidentified by a green lighton the front panel adjacentto the well with the"negative" BI and by texton the LCD. In addition, anoptional alarm is availablefor negative results.

Table 1. Technological Characteristics Comparison Table to predicate device

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6. Summary of Non-Clinical Testing

Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.

Table 2. Performance Testing

Test	Acceptance Criteria	Result
RegressionTesting	No unresolved anomalies	PASS

7. Conclusion

The ConFirm 20 Minute Incubator 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 (K223715), Class II (21 CFR 880.2800), product code FRC.

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).