The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX 2, 60, and s2 Low Temperature Sterilization Systems.

· 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.

Device Description

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

AI/ML Overview

The STERIS CELERITY HP Indicator Tape is a chemical indicator designed to distinguish between processed and unprocessed units in various low-temperature sterilization systems using vaporized hydrogen peroxide (VHP).

1. Table of Acceptance Criteria and Reported Device Performance:

Testing	Acceptance Criteria	Reported Device Performance
Simulated Use Testing	• Complete color change in full cycle • Incomplete color change in partial cycle • Remain adhered after worst-case cycle	• Complete color change in full cycle • Incomplete color change in partial cycle • Remains adhered after worst-case cycle
ISO 11140-1 Testing	Meets requirement of Type 1 VHP Indicator	Meets requirement of Type 1 VHP Indicator
Light Stability	Ink performs as intended when exposed to light for labeled period	Ink performs as intended when exposed to light for labeled period
Endpoint Stability	Endpoint color remains stable for labeled period	Endpoint color remains stable for labeled period
Shelf Life	Meets all performance requirements at labeled shelf-life	Meets all performance requirements at labeled shelf-life (Note: Real-time testing is ongoing; currently, a 5-month shelf-life is reported).

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of indicator tapes per cycle, number of cycles tested). However, it mentions that "Performance testing was completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design." This suggests that standard testing methodologies, which typically include specific sample size requirements, were followed.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a premarket notification (510(k)) for a medical device to be marketed in the US, the studies were likely conducted to meet US regulatory requirements.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not provided in the document. For chemical indicators like the CELERITY HP Indicator Tape, the "ground truth" for successful processing is typically defined by the objective color change criteria specified by the manufacturer and validated against known sterilization conditions (full cycle vs. partial cycle). The interpretation of the color change might be assessed by trained personnel rather than "experts" in the traditional sense, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For a chemical indicator, the color change itself is a direct visual output. Adjudication, if any, would likely involve confirmation that the observed color change aligns with the expected outcome (e.g., full color change for a successful cycle, incomplete for a partial cycle). However, the specific method (e.g., consensus among multiple observers) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret complex data, and the AI's impact on their performance is measured. The CELERITY HP Indicator Tape is a passive chemical indicator with a direct visual output, making an MRMC study irrelevant to its evaluation.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The performance testing (Simulated Use Testing, ISO 11140-1 Testing, Light Stability, Endpoint Stability, Shelf Life) described in the document evaluates the intrinsic behavior and response of the CELERITY HP Indicator Tape itself, independent of human interpretation or assistance beyond observing the color change. The device's performance is determined by its physical and chemical properties and its reaction to sterilization conditions.

7. Type of Ground Truth Used:

The ground truth used for the performance testing is based on:

Known Sterilization Conditions: The indicators are exposed to "full cycle" and "partial cycle" conditions within specified sterilization systems. A full cycle represents effective sterilization, while a partial cycle represents an insufficient process.
Adherence to Standards: The "Meets requirement of Type 1 VHP Indicator" for ISO 11140-1 Testing implies that the ground truth for this aspect is defined by the objective performance criteria outlined in the ISO 11140-1 standard for Class 1 chemical indicators. These standards specify how the indicator should react to critical process variables.
Stability over Time: For light stability and endpoint stability, the ground truth is the expectation that the ink's performance and the endpoint color remain consistent for the labeled period under specified environmental conditions.

8. Sample Size for the Training Set:

This information is not applicable and is not provided in the document. The CELERITY HP Indicator Tape is a chemical indicator, not an AI/ML algorithm that requires a training set. Its design and behavior are based on chemical formulations and physical characteristics, not on learned patterns from a dataset.

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

This information is not applicable, as there is no "training set" for this type of device.

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 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.

April 10, 2024

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

Re: K240760

Trade/Device Name: CELERITY HP Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: March 20, 2024 Received: March 20, 2024

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 (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, Stephen A. Digitally signed by Stephen A. Anisko -S Date: 2024.04.10 Anisko -S 11:42:33 -04'00'

For: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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OHT4: Office of Surgical 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) K240760

Device Name CELERITY HP Indicator Tape

Indications for Use (Describe)

The tape may be used in the following sterilization cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX 2, 60, and s2 Low Temperature Sterilization Systems.

· 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.

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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K240760 510(k) Summary for CELERITY HP Indicator Tape

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski@steris.com

Anthony Piotrkowski

Submission Date: April 10, 2024

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

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1. Predicate Device

Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:

VERIFY VH2O2 Indicator Tape Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K231488

2. Device Description

3. Indications for Use:

The tape may be used in the following sterilization cycles:

. Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
. 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.

4. Technological Characteristics

The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change.

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Feature	Proposed: CELERITY HP Indicator Tape	Predicate: VERIFY VH2O2 IndicatorTape (K231488)	Comparison
Intended Use/ Indicationsfor Use	The Indicator Tape is intended to secure itemswrapped in synthetic wrap materials until usedand to distinguish between processed andunprocessed units through a color changefrom the start color (pink/magenta) to orange,yellow or lighter. The Indicator Tape is alsointended to be used as an external processindicator when applied to synthetic wrapmaterials and/or Tyvek pouches.	The Indicator Tape is intended to secure itemswrapped in synthetic wrap materials until usedand to distinguish between processed andunprocessed units through a color changefrom the start color (pink) to peach, yellow orlighter. The Indicator Tape is also intended tobe used as an external process indicator whenapplied to synthetic wrap materials and/orTyvek pouches.	Similar, a slightchange to thestart and endcolor descriptorto match colordescription ofother Celeritychemicalindicators and
	The tape may be used in the followingsterilization cycles:• Lumen, Non Lumen, Fast Non Lumen,Fast, Flexible, and Specialty Cycles of theV-PRO: 1, 1 Plus, maX, maX 2, 60, ands2 Low Temperature SterilizationSystems.• Standard and Advanced Cycles of theSTERRAD® NX Sterilizer with orwithout ALLClear• Standard, Flex Scope, Express and DUOCycles of the STERRAD® 100NXSterilizer with or without ALLClear	The tape may be used in the followingsterilization cycles:• Lumen, Non Lumen, Fast Non Lumen,Fast, Flexible, and Specialty Cycles of theV-PRO: 1, 1 Plus, maX, maX 2, 60, ands2 Low Temperature SterilizationSystems.• STERRAD® 100S Sterilizer (DefaultCycle)• Standard and Advanced Cycles of theSTERRAD® NX Sterilizer with orwithout ALLClear• Standard, Flex Scope, Express and DUOCycles of the STERRAD® 100NXSterilizer with or without ALLClear	removal of theSTERRAD100S DefaultCycle
ChemicalIndicatorAgent andPerformanceSpecification	The indicator agent is a vaporized hydrogenperoxide reactive ink that meets therequirement specified in ANSI/AAMI/ISO11140-1:2014 for a Type 1 Process Indicatorfor a vaporized hydrogen peroxide process	The indicator agent is a vaporized hydrogenperoxide reactive ink that meets therequirement specified in ANSI/AAMI/ISO11140-1:2014 for a Type 1 Process Indicatorfor a vaporized hydrogen peroxide process	Identical
DeviceDesign	Tape: 3/4" wide by 60 yards long crepe(masking) tape which is wound around a 3"core. A hydrogen peroxide reactive ink is laiddown on the non-adhesive surface. The ink isprotected from transfer to the adhesive via acoating.	Tape: 3/4" wide by 60 yards long crepe(masking) tape which is wound around a 3"core. A hydrogen peroxide reactive ink is laiddown on the non-adhesive surface. The ink isprotected from transfer to the adhesive via acoating.	Identical
Shelf Life	5 months - real-time testing is ongoing	Tape 24 months	real-timetesting isongoing
PerformanceLimitations(taken frominstructionsfor use)	Do not overlap the tape onto itself as this mayprevent the underlying layer from beingappropriately exposed to hydrogen peroxideresulting in a failed indicator response.	Do not overlap the tape onto itself as this mayprevent the underlying layer from beingappropriately exposed to hydrogen peroxideresulting in a failed indicator response.	Identical

Table 1 Comparison of CI Physical Description and Technological Properties

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STERIS Traditional 510(k) PREMARKET NOTIFICATION K240760 CELERITY HP Indicator Tape

5. Performance Testing

Performance testing was completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design.

Testing	Acceptance Criteria	Study Result
Simulated UseTesting	• Complete color change in full cycle• Incomplete color change in partial cycle• Remain adhered after worst-case cycle	• Complete color change in full cycle• Incomplete color change in partial cycle• Remains adhered after worst-case cycle
ISO 11140-1 Testing	Meets requirement of Type 1 VHP Indicator	Meets requirement of Type 1 VHP Indicator
Light Stability	Ink performs as intended when exposed tolight for labeled period	Ink performs as intended when exposed tolight for labeled period
Endpoint Stability	Endpoint color remains stable for labeledperiod	Endpoint color remains stable for labeledperiod
Shelf Life	Meets all performance requirements atlabeled shelf-life	Meets all performance requirements at labeledshelf-life

Table 2. Verification Results Summary
---------------------------------------	--

The results of the performed testing demonstrate that the CELERITY HP Indicator Tape performs as intended.

6. Conclusion

The conclusion drawn from the non-clinical testing demonstrates that the subject device, CELERITY HP Indicator Tape, submitted under K240760, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K231488.

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).