The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.

The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator color changes from the start to the pass color. See reference colors on the bottle.

Device Description

The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink.

Modification for Which Clearance is Being Sought: There were no physical changes to the device and are no new indications for use. The labeling was modified to include an additional pass reference color and a gradient between the original and new pass reference colors to improve user interpretation of chemical indicator.

AI/ML Overview

The provided FDA 510(k) Premarket Notification summary describes a Chemical Indicator for the enspire CLCSPS (LCC015). The device is substantially equivalent to a predicate device (K240032). The key difference is a modification to the labeling to include an additional pass reference color and a gradient to improve user interpretation.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Users performed all critical tasks successfully	PASS

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

The document states "Users performed all critical tasks successfully" as the acceptance criteria for the Human Factors Study, and the result was "PASS". However, the sample size for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective).

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

The document mentions a "Human Factors Study" but does not specify the number of experts (users) involved in this study or their qualifications. The nature of the device (a chemical indicator for sterilization monitoring) suggests that "experts" in this context would likely be healthcare professionals or sterilization technicians who would use such indicators.

4. Adjudication Method for the Test Set

The document does not provide details on any specific adjudication method (e.g., 2+1, 3+1). For a human factors study, this would typically involve observing user performance and possibly qualitative feedback, rather than formal expert adjudication of results.

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

No MRMC comparative effectiveness study was done or reported. The study described is a Human Factors Study related to user interpretation of the chemical indicator's color change, not a comparative effectiveness study with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This device is a physical chemical indicator, not an algorithm or AI. Therefore, the concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not applicable. The device's function inherently involves human interpretation of a chemical reaction (color change).

7. Type of Ground Truth Used

For the Human Factors Study, the "ground truth" would implicitly be the correct interpretation of the chemical indicator's color change according to the established visual reference provided by the manufacturer. The acceptance criteria suggest that the ground truth was that users could correctly identify the "pass" condition based on the newly designed labeling.

8. Sample Size for the Training Set

Not applicable. This device is a physical chemical indicator, and there is no "training set" in the context of machine learning or algorithms. The device itself is designed based on known chemical reactions and visual communication principles. The human factors study evaluates the effectiveness of the labeling in conveying the correct interpretation to human users.

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

Not applicable. As there is no training set mentioned for the device itself (it's a physical indicator), this question is not relevant. The ground truth for the performance evaluation (Human Factors Study) is the correct interpretation of the indicator's state as defined by the manufacturer's specified color reference for a "pass" condition.

Summary

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December 3, 2024

STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060

Re: K243475

Trade/Device Name: Chemical Indicator for enspire CLCSPS (LCC015) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: JOJ Dated: November 8, 2024 Received: November 8, 2024

Dear Gregory Land:

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.

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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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices 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

Submission Number (if known)

K243475

Device Name

Chemical Indicator for enspire CLCSPS (LCC015)

Indications for Use (Describe)

The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.

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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510(k) Summary For Celerity Chemical Indicator for enspire 3000 CLCSPS K243475

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600

Contact:	Gregory Land
	Lead Regulatory Affairs Specialist
Telephone:	(440) 392-7424
Email:	greg_land@steris.com

Submission Date: December 2, 2024

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

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STERIS Special 510(k) PREMARKET NOTIFICATION - K243475 Celerity Chemical Indicator for enspire 3000 CLCSPS

1. Device Name

Trade Name:	Celerity Chemical Indicator for enspire 3000 CLCSPS
Models:	LCC015
Common Name:	Chemical Indicator.
Classification Name:	Physical/chemical sterilization process indicator
Classification	21 CFR 880.2800
Product Code	JOJ

2. Predicate Device

Celerity Chemical Indicator for enspire 3000 CLCSPS (K240032)

3. Device Description

Intended Use/Indications for Use: 4.

The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.

న్. Technological Characteristic Comparison

The proposed device and its predicate are physically identical and have the same Indications for Use. They differ only in the product labelling. The proposed device has additional graphics to aid the user in identifying Pass conditions.

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STERIS Special 510(k) PREMARKET NOTIFICATION – K243475 Celerity Chemical Indicator for enspire 3000 CLCSPS

Table 1
Feature	ProposedCelerity Chemical Indicatorfor enspire CLCSPS	Predicate K240032Celerity Chemical Indicatorfor enspire CLCSPS	Comparison
	The enspire 3000 ChemicalIndicator is a peracetic acidconcentration indicator forroutine monitoring of theliquid chemical sterilizationcycle of the enspire 3000employing S40 Sterilant.	The enspire 3000 ChemicalIndicator is a peracetic acidconcentration indicator forroutine monitoring of theliquid chemical sterilizationcycle of the enspire 3000employing S40 Sterilant.
Intendeduse	The unprocessed enspire 3000Chemical Indicator is blue.When exposed in the enspire3000 processor to aconcentration of >1820 ppm(mg/L) peracetic acid found inthe S40 use dilution during acontrolled 6-minute exposureat 45.5 - 60°C, the indicatorcolor changes from the start tothe pass color. See referencecolors on the bottle.	The unprocessed enspire3000 Chemical Indicator isblue. When exposed in theenspire 3000 processor to aconcentration of >1820 ppm(mg/L) peracetic acid foundin the S40 use dilution duringa controlled 6-minuteexposure at 45.5 - 60°C, theindicator color changes fromthe start to the pass color. Seereference colors on the bottle.	Identical
Devicedesign -components	Printed indicator ink printedonto polypropylene overlaidwith a clear, permeablelaminate	Printed indicator ink printedonto polypropylene overlaidwith a clear, permeablelaminate	Identical
Indicatoragent	Lissamine green B (activedye) and savinyl orange(background dye)	Lissamine green B (activedye) and savinyl orange(background dye)	Identical
Sterilization methodand cycles	Used in a liquid chemicalsterilant processing systememploying S40 SterilantConcentrate to form a usedilution concentration of≥1820 ppm (mg/L) peraceticacid and provide 6 minutesexposure at 45.5 – 60°C.	Used in a liquid chemicalsterilant processing systememploying S40 SterilantConcentrate to form a usedilution concentration of≥1820 ppm (mg/L) peraceticacid and provide 6 minutesexposure at 45.5 – 60°C.	Identical
Mechanism ofaction	Bleaching of lissamine greenB dye as a result of oxidation,resulting in a color change.	Bleaching of lissamine greenB dye as a result of oxidation,resulting in a color change.	Identical
Peraceticacid	> 1820 mg/L PAA	> 1820 mg/L PAA	Identical
Feature	ProposedCelerity Chemical Indicatorfor enspire CLCSPS	Predicate K240032Celerity Chemical Indicatorfor enspire CLCSPS	Comparison
concen-tration fortheendpointcolorchange
Disposable	Yes	Yes	Identical
Shelf-life	26 months;	26 months	Identical
Openbottle shelflife	6 months	6 months	Identical

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STERIS Special 510(k) PREMARKET NOTIFICATION - K243475 Celerity Chemical Indicator for enspire 3000 CLCSPS

6. Performance Testing

The following table summarizes the non-clinical testing that has demonstrated that the product is substantial equivalent to the predicate device (K240032).

Testing	Acceptance Criteria	Results
Human FactorsStudy	Users performed all critical tasks successfully	PASS

7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K240032), Class II (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).