Celerity Chemical Indicator for enspire 3000 CLCSPS

K240032 · STERIS Corporation · JOJ · Apr 17, 2024 · General Hospital

Device Facts

• Record ID: K240032
• Device Name: Celerity Chemical Indicator for enspire 3000 CLCSPS
• Applicant: STERIS Corporation
• Product Code: JOJ · General Hospital
• Decision Date: Apr 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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 Story

Chemical indicator strip for monitoring peracetic acid (PAA) concentration in enspire 3000 liquid chemical sterilization systems. Input: PAA concentration >1820 ppm during 6-minute cycle at 45.5–60°C. Principle: Oxidation-based bleaching of lissamine green B dye; color shifts from blue (start) to pink (pass). Output: Visual color change on strip. Used in clinical sterilization processing; interpreted by staff to verify sterilant efficacy. Benefits: Ensures sterilization cycle parameters met; prevents use of improperly processed instruments.

Clinical Evidence

Bench testing only. Studies included comparative sensitivity/specificity, analytic sensitivity/specificity, post-processing stability (inside/outside processor), blind studies, contaminant studies, temperature/light stability, and human factors. Results showed 100% accuracy (1.00 sensitivity/specificity) in pass/fail conditions. No clinical data required for this type of sterilization process indicator.

Technological Characteristics

Indicator strip: polypropylene substrate, screen-printed indicator ink (lissamine green B, savinyl orange), covered by clear polyether block amide laminate. Sensing principle: chemical oxidation/bleaching. Dimensions: strip form factor. Connectivity: none (standalone). Sterilization: N/A (device is a monitor).

Indications for Use

Indicated for routine monitoring of liquid chemical sterilization cycles in the enspire 3000 processor using S40 Sterilant. Intended for use by healthcare personnel in clinical settings.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• VERIFY® Chemical Indicator for S40 Sterilant (K173428)

Submission Summary (Full Text)

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April 17, 2024

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

Re: K240032

Trade/Device Name: Celerity Chemical Indicator for enspire 3000 CLCSPS Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 4, 2024 Received: March 6, 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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Stephen A. Digitally signed by Stephen A. Anisko -S Date: 2024.04.17 Anisko -S 17:21:46 -04'00'

for: Christopher Dugard 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

Submission Number (if known)

K240032

Device Name

Celerity Chemical Indicator for enspire 3000 CLCSPS

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.

The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mq/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.

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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Image /page/4/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is an image of several horizontal, wavy lines in blue, resembling water waves.

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

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone]

| Contact: | Gregory Land |
|------------|------------------------------------|
| | Lead Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Email: | [e-mail] |

| Submission Date: | April 15, 2024 |
|------------------|----------------|
|------------------|----------------|

510(k) number: K240032

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

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#### 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

VERIFY® Chemical Indicator for S40 Sterilant (K173428)

#### 3. 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.

#### 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.

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.

#### 5. Description of Technological Characteristics

The proposed device and predicate are physically identical and monitor the same Liquid Chemical Sterilant, S40. They differ only in the Liquid Chemical Sterilant Processing Systems in which they are intended.

The proposed device, like the predicate, indicates exposure to a targeted effective concentration of peracetic acid by a color change from blue through intermediate beige and then pink endpoint color when exposed for 6 minutes to concentrations of

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peracetic acid greater than 1820 ppm at 45.5 – 60°C during the liquid chemical sterilant processing system's standard cycle. Table 1 provides a side by side comparison of the proposed and predicate devices.

| Feature | Proposed Device<br>VERIFY Chemical<br>Indicator for enspire<br>CLCSPS K240032 | Predicate Device<br>VERIFY Chemical<br>Indicator for S40 Sterilant<br>K173428 | Comparison |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The enspire 3000 Chemical<br>Indicator is a peracetic acid<br>concentration indicator for<br>routine monitoring of the<br>liquid chemical sterilization<br>cycle of the enspire 3000<br>employing S40 Sterilant.<br>The unprocessed enspire 3000<br>Chemical Indicator is blue.<br>When exposed in the enspire<br>3000 processor to a<br>concentration of >1820 ppm<br>(mg/L) peracetic acid found in<br>the S40 use dilution during a<br>controlled 6-minute exposure<br>at 45.5 – 60°C, the indicator<br>color changes from the start to<br>the pass color. See reference<br>colors on the bottle. | The VERIFY® Chemical<br>Indicator for S40 Sterilant is a<br>peracetic acid concentration<br>indicator for routine<br>monitoring of STERIS<br>automated liquid chemical<br>sterilant processing systems<br>that employ S40 Sterilant<br>Concentrate in a controlled<br>cycle.<br>The unprocessed VERIFY®<br>Chemical Indicator for S40<br>Sterilant is blue. When<br>exposed in a STERIS<br>automated liquid chemical<br>sterilant processor to a<br>concentration of >1820 ppm<br>(mg/L) peracetic acid found in<br>the S40 use dilution during a<br>controlled 6-minute exposure<br>at 45.5 – 60°C, the indicator<br>changes color from blue<br>through an intermediate beige<br>and then to the endpoint color,<br>pink. The indicator may<br>become more pink when<br>exposed to higher peracetic<br>acid concentrations in S40<br>sterilant use dilution. | Similar.<br>Proposed<br>device is to<br>be used with<br>the same<br>sterilant at<br>the same<br>MEC but in a<br>different<br>processor |
| Feature | Proposed Device<br>VERIFY Chemical<br>Indicator for enspire<br>CLCSPS K240032 | Predicate Device<br>VERIFY Chemical<br>Indicator for S40 Sterilant<br>K173428 | Comparison |
| Device design<br>-components | Printed indicator ink printed<br>onto polypropylene overlaid<br>with a clear, permeable<br>laminate | Printed indicator ink printed<br>onto polypropylene overlaid<br>with a clear, permeable<br>laminate | Identical |
| Indicator<br>agent | Lissamine green B (active<br>dye) and savinyl orange<br>(background dye) | Lissamine green B (active<br>dye) and savinyl orange<br>(background dye) | Identical |
| Sterilization<br>method and<br>cycles | Used in a liquid chemical<br>sterilant processing system<br>employing S40 Sterilant<br>Concentrate to form a use<br>dilution concentration of<br>≥1820 ppm (mg/L) peracetic<br>acid and provide 6 minutes<br>exposure at 45.5 - 60°C. | Used in a liquid chemical<br>sterilant processing system<br>employing S40 Sterilant<br>Concentrate to form a use<br>dilution concentration of<br>≥1820 ppm (mg/L) peracetic<br>acid and provide 6 minutes<br>exposure at 45.5 - 60°C. | Identical |
| Mechanism of<br>action | Bleaching of lissamine green<br>B dye as a result of oxidation,<br>resulting in a color change. | Bleaching of lissamine green<br>B dye as a result of oxidation,<br>resulting in a color change. | Identical |
| Peracetic acid<br>concentration<br>for the<br>endpoint color<br>change | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 26 months; | 24 months | Similar |
| Open bottle<br>shelf life | 6 months | 6 months | Identical |
| Intended<br>Processor | Enspire 3000 CLCSPS | System 1E LCSPS & System<br>1E Endo LCSPS | Similar |
| Processor<br>Basin | 10.8 L | 10.8 L | Identical |
| Sterilant Type | Peracetic Acid | Peracetic Acid | Identical |
| Sterilant<br>Source | STERIS S40 Sterilant<br>Concentrate | STERIS S40 Sterilant<br>Concentrate | Identical |
| Feature | Proposed Device<br>VERIFY Chemical<br>Indicator for enspire<br>CLCSPS K240032 | Predicate Device<br>VERIFY Chemical<br>Indicator for S40 Sterilant<br>K173428 | Comparison |
| S40 Nominal<br>Dose and<br>Concentration | 67.73 mL<br>35 % PAA | 67.73 mL<br>35 % PAA | Identical |
| | 2187 mg/L (PAA in use<br>dilution) | 2187 mg/L (PAA in use<br>dilution) | |
| S40 End of<br>Shelf-Life<br>Dose and<br>Concentration | ≥ 61.4 mL<br>≥ 31.5% PAA<br>2022 mg/L (PAA in use<br>dilution) | ≥ 61.4 mL<br>≥ 31.5% PAA<br>2022 mg/L (PAA in use<br>dilution) | Identical |
| Exposure time | 6-minutes | 6-minutes | Identical |

### Table 1: Comparison Table of Proposed and Predicate Devices

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#### 6. Performance Testing

Table 2 summarizes the non-clinical testing performed for the proposed device that has demonstrated that the product is safe and effective.

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| Testing | Acceptance Criteria | Results |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Non-Reactive Ink<br>Suitability Study | 100% of indicator text ink shows no smearing,<br>no discoloration and no fading | PASS |
| Comparative<br>Sensitivity,<br>Comparative<br>Specificity, Analytic<br>Sensitivity and<br>Analytic Specificity<br>Study | A minimum of 75% of indicator from each lot<br>• to show a PASS result when exposed to Pass<br>cycle<br>100% of indicators to show a FAIL result<br>• when exposed to the Fail cycle<br>100% of indicators show no delamination<br>• affecting the color change<br>100% of indicators show no deformation<br>• | PASS |
| Post-Processing<br>Stability (Outside<br>Processor) Study | A minimum of 75% of indicator from each lot<br>• to show a PASS result when exposed to Pass<br>cycle at each time point<br>100% of indicators to show a FAIL result<br>• when exposed to the Fail cycle at each time<br>point | PASS |
| Post-Processing<br>Stability (Inside<br>Processor) Study | A minimum of 75% of indicator from each lot<br>• to show a PASS result when exposed to Pass<br>cycle at each time point<br>100% of indicators to show a FAIL result<br>• when exposed to the Fail cycle at each time<br>point<br>100% CI from each lot correctly interpreted<br>• by inexperienced reader | PASS |
| Blind Study | A minimum of 75% of indicator from each lot<br>• to show a PASS result when exposed to Pass<br>cycle<br>100% of indicators to show a FAIL result<br>• when exposed to the Fail cycle<br>100% CI from each lot correctly interpreted<br>• by inexperienced reader | PASS |
| Contaminants Study | 100% of indicators to show a FAIL result<br>• when exposed to the Fail cycle | PASS |
| Exposure to<br>Temperature<br>Extremes Study | CI start color to remain unchanged after<br>• exposure to three freeze/thaw cycles before<br>processing.<br>≥75% CI from each lot to show a PASS result.<br>• 100% of indicators to show a FAIL result<br>• when exposed to the Fail cycle. | PASS |

| Table 2: Summary of Performance Testing | | | | |
|-----------------------------------------|--|--|--|--|
|-----------------------------------------|--|--|--|--|

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| Testing | Acceptance Criteria | Results |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Light Stability Study | CI start color to remain unchanged after exposure to fluorescent light before processing. ≥75% of indicator from each lot to show a PASS result when exposed to Pass cycle. 100% of indicators to show a FAIL result when exposed to the Fail cycle. | PASS |
| Open Bottle Stability<br>Study | ≥75% of indicator from each lot to show a PASS result when exposed to Pass cycle. 100% of indicators to show a FAIL result when exposed to the Fail cycle. | PASS |
| Shelf Life Study | ≥75% of indicator from each lot to show a PASS result when exposed to Pass cycle. 100% of indicators to show a FAIL result when exposed to the Fail cycle. | PASS |
| Human Factors<br>Study | Users complete all critical tasks | PASS |

Table 3: Provides a comparison of the Sensitivity and Specificity testing performed on the proposed and predicate devices.

| Table 3: Sensitivity and Specificity comparison Table | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | Proposed Device<br>VERIFY Chemical Indicator for<br>enspire CLCSPS K240032 | Predicate Device<br>VERIFY Chemical Indicator<br>for S40 Sterilant K173428 |
| Number Lots tested | 3 | 3 |
| Pass<br>Condition | ≥2200 mg/L PAA<br>100% PASS | Approximately 2390 mg/L PAA<br>100% PASS |
| Fail<br>Condition | 1750 - 1820 mg/L PAA<br>100% FAIL | 1750 - 1820 mg/L PAA<br>100% FAIL |
| Fail<br>Condition | 0 mg/L PAA<br>100% FAIL | 0 mg/L PAA<br>100% FAIL |
| Study Conclusion | The proposed device met the acceptance criteria for Comparative Sensitivity (=1.00), Comparative Specificity (=1.00), Analytic Specificity (100% FAIL) and | Comparative Sensitivity and Specificity values of 1.00 demonstrated the ability of the |

Table 3: Sensitivity and Specificity comparison Table

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| Accuracy (100% PASS in Pass<br>condition and 100% FAIL in Fail<br>condition), when tested in the | processed CI strip to provide<br>reliable results. |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| enspire 3000 CLCSPS (Eclipse<br>EPS) using the S40 Sterilant<br>Concentrate. | Predicate device demonstrated<br>Analytic Specificity by<br>exhibiting no observable color<br>change when exposed to all<br>components of the processor<br>cycle except the diluted PAA<br>concentrate solution. |

#### 7. 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 safely and effectively as the legally marketed predicate device (K173428), Class II (21 CFR 880.2800), product code JOJ.