The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

Device Description

The Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label (PI) is to be affixed to the outside of a pack by means of the adhesive back. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:

Lumen, Non Lumen, Flexible, Fast Non Lumen Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® ● System, including those systems with ALLClear Technology.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Class II medical device, the Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PCC078). This document primarily focuses on demonstrating substantial equivalence to a predicate device and extending the indications for use.

Based on the provided text, the device is a chemical indicator, not an AI/ML powered device. Therefore, a study proving the device meets AI/ML specific acceptance criteria as you've requested is not applicable here. The information you've asked for regarding acceptance criteria, sample size for test/training sets, expert involvement, and ground truth establishment typically applies to the evaluation of AI/ML models in diagnostic or predictive applications.

However, I can extract information related to the performance evaluation of this chemical indicator, which serves a similar purpose of demonstrating its effectiveness as intended.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this chemical indicator are based on its ability to demonstrate a visible color change from magenta to orange/yellow or lighter when exposed to specific sterilization cycles. The performance is gauged by its visual change and adherence under these conditions.

Acceptance Criteria (Implied)	Reported Device Performance
Visible color change from magenta to orange/yellow or lighter	The device is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter. This is the core claim for its function. The submission asserts that the device conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1 Process Indicator, which implies it meets the performance standards for color change under defined sterilization conditions.
Adheres to packs during sterilization	Testing from K231490 (reference device) demonstrated that the VERIFY V24 Self-Contained Biological Indicator (SCBI) label remained adhered to the vial. The document states that this testing is applicable to the subject device because it has the same adhesive and is adhered to plastic of a pouch similar to the reference device adhering to a plastic SCBI vial. This implies the subject device also meets the adherence requirement.
Performance in specific V-PRO cycles (Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast, Specialty)	The device's intended use specifies these cycles, indicating expected performance within them. The submission extends the indication to the "Specialty" cycle based on testing from the reference device (K231490), noting that the subject device is cleared for use in the V-PRO maX 2 Fast Non Lumen Cycle which has identical preconditioning and exposure phases to the Specialty Cycle. This implies successful performance in the Specialty cycle.
Performance in specific ASP STERRAD cycles (Standard, Advanced, Express, Flex, Duo) including ALLClear Technology	The device's intended use specifies these cycles, indicating expected performance within them. No specific new test data is provided for these cycles in this submission, as the modification focuses on the V-PRO "Specialty" cycle. The continued inclusion implies prior documentation or equivalence for these cycles.
Endpoint stability (15 months)	The comparison table states the "Endpoint stability" for both the predicate and modified device is "15 months," indicating this is a maintained performance characteristic. No new study details are provided on how this was re-verified for the modified device in this specific submission, but it's listed as a "Same" characteristic.
Conformance to ANSI/AAMI/ISO 11140-1:2014 for VH2O2 Type 1 Process Indicator	The document explicitly states that the device Conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1 Process Indicator. This is a crucial, overarching acceptance criterion, signifying compliance with established standards for chemical indicators. This standard dictates specific performance attributes like color change kinetics, resistance to over-processing, and storage stability.

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

Sample Size for Test Set: The document does not explicitly state the sample size (number of indicators) used for the testing. It refers to testing previously submitted as part of K231490 for a reference device (VERIFY V24 Self-Contained Biological Indicator). The current submission leverages the equivalence of materials (indicator ink, substrate, adhesive) and the similarity of the V-PRO cycles to claim applicability of the previous testing.
Data Provenance: Not explicitly stated regarding country of origin. The testing supporting the extended indication (Specialty Cycle) is retrospective, as it refers to data from a previously cleared device (K231490) rather than a new, dedicated prospective study for the Celerity™ label.

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

This question is not applicable for this type of device. Chemical indicators do not involve human interpretation like medical images that require experts to establish ground truth. Their "ground truth" is their physical chemical reaction (color change) in response to a specific sterilization process. The compliance with standards like ANSI/AAMI/ISO 11140-1:2014 verifies their performance.

4. Adjudication Method for the Test Set

Not applicable. This device doesn't involve subjective human interpretation of outputs that would require an adjudication method. The outcome is a clear physical change (color).

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

Not applicable. This is a chemical indicator, not an AI-assisted diagnostic tool. No human "readers" or AI are involved in interpreting its output beyond confirming a color change.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical chemical indicator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for a chemical indicator is the defined sterilization process parameters (e.g., specific concentrations of VH2O2, exposure times, temperature), and the physical-chemical reaction of the indicator itself when exposed to those parameters. Compliance with international standards (ANSI/AAMI/ISO 11140-1:2014) serves as the primary validation for this ground truth, indicating the device performs as a "Type 1 Process Indicator" (meaning it reacts to the presence of the agent). For the new indication, the ground truth is established by the V-PRO Specialty Cycle parameters and the observed, expected color change of the indicator within these parameters, leveraging prior testing equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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October 27, 2023

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

Re: K233187

Trade/Device Name: Celerity Vaporized VH202 Process Indicator Adhesive Label (PCC078) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 28, 2023 Received: September 28, 2023

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.

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K233187

Device Name

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

Indications for Use (Describe)

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary For K233187 Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

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

Contact: Tony Piotrkowski Director, Regulatory Affairs

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

Summary Date: October 17, 2023

Premarket Notification Number: K233187

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

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K233187 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label

1. Device Name

Trade Name:	Celerity™ Vaporized VH2O2 Process IndicatorAdhesive Label
Device Class:	Class II
Common/usual Name:	Chemical Indicator
Classification Name:	Physical/chemical process indicator
Classification Number:	21 CFR 880.2800
Product Code:	JOJ

2. Predicate Device

Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label K192020

Feature	Celerity™ Vaporized $VH2O2$ ProcessIndicator Adhesive Label (PredicateDevice/K192020)	Celerity™ Vaporized $VH2O2$ ProcessIndicator Adhesive Label (ModifiedDevice)	Comparison
Intended Use /Indications for Use	The Celerity™ Vaporized $VH2O2$ ProcessIndicator Adhesive Label is a Type 1vaporized hydrogen peroxide sterilizationprocess indicator. It is designed todistinguish between processed andunprocessed units, when affixed to packs tobe sterilized, through a visible change frommagenta to orange/yellow or lighter, whenthe pack has been exposed to the:Lumen, Non Lumen, Flexible, Fast NonLumen or Fast sterilization cycle of a V-PRO® Low Temperature SterilizationSystem, or Standard, Advanced, Express, Flex orDuo cycles of an ASP STERRAD®System, including those systems withALLClear Technology.	The Celerity™ Vaporized $VH2O2$ ProcessIndicator Adhesive Label is a Type 1vaporized hydrogen peroxide sterilizationprocess indicator. It is designed todistinguish between processed andunprocessed units, when affixed to packs tobe sterilized, through a visible change frommagenta to orange/yellow or lighter, whenthe pack has been exposed to the:Lumen, Non Lumen, Flexible, Fast NonLumen, Fast or Specialty sterilizationcycle of a V-PRO® Low TemperatureSterilization System, or Standard, Advanced, Express, Flex orDuo cycles of an ASP STERRAD®System, including those systems withALLClear Technology.	Addedindication foruse in theSpecialtyCycle which isthe subject ofthissubmission
Device design -components	Indicator Ink printed onto spun-bondedpolyolefin with an adhesive and a glassinebacking	Indicator Ink printed onto spun-bondedpolyolefin with an adhesive and a glassinebacking	Same
Indicator agent	Non-transferable indicator ink ofproprietary formulation which changescolor when exposed to $VH2O2$	Non-transferable indicator ink ofproprietary formulation which changescolor when exposed to $VH2O2$	Same
Sterilization methodand cycles	Vaporized Hydrogen Peroxide in the V-PRO1, V-PRO 1 Plus, V-PRO maX, V-PRO 60,V-PRO maX 2, V-PRO s 2 LowTemperature Sterilizers and ASP STERRAD100S, NX and 100NX System, includingthose systems with ALLClear Technology.	Vaporized Hydrogen Peroxide in the V-PRO1, V-PRO 1 Plus, V-PRO maX, V-PRO 60,V-PRO maX 2, V-PRO s 2 LowTemperature Sterilizers and ASP STERRAD100S, NX and 100NX System, includingthose systems with ALLClear Technology.	Same
Endpointspecifications	No Endpoint Specifications (Type 1 ProcessIndicator)	No Endpoint Specifications (Type 1 ProcessIndicator)	Same
Endpoint stability	15 months	15 months	Same

Table 1. Device Comparison Table for Modified Label and Predicate

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K233187 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label

Feature	Celerity™ Vaporized VH2O2 ProcessIndicator Adhesive Label (PredicateDevice/K192020)	Celerity™ Vaporized VH2O2 ProcessIndicator Adhesive Label (ModifiedDevice)	Comparison
Recommendedstorage conditions	5-25°C/41-77°F, away from direct light. Donot store indicator labels near heat,moisture, oxidizing agents, acids/alkalis orcleaning/disinfecting agents.	5-25°C/41-77°F, away from direct light. Donot store indicator labels near heat,moisture, oxidizing agents, acids/alkalis orcleaning/disinfecting agents.	Same
Specification	Conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1Process Indicator	Conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1Process Indicator	Same

3. Reference Device

K231490 VERIFY V24 Self-Contained Biological Indicator (SCBI)

4. Description of Device

Lumen, Non Lumen, Flexible, Fast Non Lumen Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® ● System, including those systems with ALLClear Technology.

న. Intended Use/Indications for Use

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

6. Summary of Nonclinical Tests

Testing was submitted as part of K231490 to demonstrate that the VERIFY V24 Self-Contained Biological Indicator (SCBI) label remained adhered to the vial and had appropriate color change in the Specialty Cycle and this testing is also applicable to the Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label for the following reasons:

The subject device has the same indicator ink as the reference vial indicator ● label of the VERIFY V24 SCBI

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The subject device has the same substrate as the reference vial indicator label of the VERIFY V24 SCBI
The subject device has the same adhesive as the reference vial indicator label of the VERIFY V24 SCBI
The subject device is used to monitor the same cycle (Specialty) as the reference ● vial indicator label of the VERIFY V24 SCBI
The subject device is cleared for use in the V-PRO maX 2 Fast Non Lumen ● Cycle which has identical preconditioning and exposure phases to the Specialty Cycle.
. The subject device is adhered to plastic of a pouch and the reference vial indicator label of the VERIFY V24 SCBI adheres to the plastic SCBI vial.

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device K192020, Class II (21 CFR 880.2800), product code JOJ.

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).