(104 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Celerity Chemical Indicator for enspire 3000 CLCSPS, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Reactive Ink Suitability Study | 100% of indicator text ink shows no smearing, no discoloration and no fading | PASS |
| Comparative Sensitivity | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle | PASS (100% PASS) |
| Comparative Specificity | 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS (100% FAIL) |
| Analytic Sensitivity | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle | PASS (100% PASS) |
| Analytic Specificity | 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS (100% FAIL) |
| Post-Processing Stability (Outside Processor) Study | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle at each time point; 100% of indicators to show a FAIL result when exposed to the Fail cycle at each time point | PASS |
| Post-Processing Stability (Inside Processor) Study | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle at each time point; 100% of indicators to show a FAIL result when exposed to the Fail cycle at each time point; 100% CI from each lot correctly interpreted by inexperienced reader | PASS |
| Blind Study | A minimum of 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; 100% CI from each lot correctly interpreted by inexperienced reader | PASS |
| Contaminants Study | 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| Exposure to Temperature Extremes Study | CI start color to remain unchanged after exposure to three freeze/thaw cycles before processing; ≥75% CI from each lot to show a PASS result; 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| 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 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 Study | Users complete all critical tasks | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity, and Analytic Specificity studies (and likely many other studies based on the acceptance criteria phrase "each lot"), 3 lots of the proposed device were tested.
- The exact number of individual indicators within each lot used for testing is not explicitly stated. However, the acceptance criteria are given as percentages of indicators ("minimum of 75% of indicator from each lot" or "100% of indicators").
- Data Provenance: The document does not specify the country of origin of the data. The studies are non-clinical performance testing, meaning they are laboratory or engineering-based tests, not human subject studies. They are presumably prospective for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: For the "Post-Processing Stability (Inside Processor) Study" and the "Blind Study," it mentions "inexperienced reader." This implies at least one, and likely more, inexperienced readers were used. It does not state how many experts, if any, were used alongside or to establish ground truth for these readings beyond the "inexperienced reader."
- Qualifications of Experts: The document specifies "inexperienced reader" for certain studies. It does not provide further qualifications for these readers or for any experts involved in establishing ground truth for other tests. For most of the chemical indicator tests, the "ground truth" is intrinsically defined by the chemical conditions (concentration of peracetic acid, temperature, time) to which the indicator is exposed.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for reconciling interpretations from multiple readers. For tests involving "inexperienced readers," it simply states whether "100% CI from each lot correctly interpreted." This suggests a binary outcome (correct/incorrect) without detail on reconciliation if there were multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance testing is for a chemical indicator, not a diagnostic imaging device that typically uses MRMC studies. The "Human Factors Study" is mentioned, indicating usability assessment, but not an MRMC study related to diagnostic accuracy improvement.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- This device is a chemical indicator, which is a physical material that changes color based on chemical exposure. It is not an algorithm or software. Therefore, the concept of a "standalone algorithm" study does not apply. Its performance is inherent to the material and its chemical reaction, which is then visually interpreted.
7. Type of Ground Truth Used
- The ground truth for this device is based on defined chemical conditions (e.g., concentration of peracetic acid, exposure time, temperature). For "Pass Conditions" and "Fail Conditions," specific mg/L of peracetic acid (PAA) are used as the reference standard (e.g., ≥2200 mg/L PAA for Pass, 1750-1820 mg/L PAA and 0 mg/L PAA for Fail). This is a highly controlled and objective measure of the chemical environment.
8. Sample Size for the Training Set
- This device is a passive chemical indicator, not an AI/ML algorithm. Therefore, there is no training set in the typical sense used for machine learning models. The device's color change mechanism is based on established chemical principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's design and verification is based on fundamental chemistry and engineering principles for chemical indicators.
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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 (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: 2024.04.17 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)
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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510(k) Summary For Celerity Chemical Indicator for enspire 3000 CLCSPS
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: | 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 DeviceVERIFY ChemicalIndicator for enspireCLCSPS K240032 | Predicate DeviceVERIFY ChemicalIndicator for S40 SterilantK173428 | Comparison |
|---|---|---|---|
| Intended use | The enspire 3000 ChemicalIndicator is a peracetic acidconcentration indicator forroutine monitoring of theliquid chemical sterilizationcycle of the enspire 3000employing S40 Sterilant.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 VERIFY® ChemicalIndicator for S40 Sterilant is aperacetic acid concentrationindicator for routinemonitoring of STERISautomated liquid chemicalsterilant processing systemsthat employ S40 SterilantConcentrate in a controlledcycle.The unprocessed VERIFY®Chemical Indicator for S40Sterilant is blue. Whenexposed in a STERISautomated liquid chemicalsterilant 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 indicatorchanges color from bluethrough an intermediate beigeand then to the endpoint color,pink. The indicator maybecome more pink whenexposed to higher peraceticacid concentrations in S40sterilant use dilution. | Similar.Proposeddevice is tobe used withthe samesterilant atthe sameMEC but in adifferentprocessor |
| Feature | Proposed DeviceVERIFY ChemicalIndicator for enspireCLCSPS K240032 | Predicate DeviceVERIFY ChemicalIndicator for S40 SterilantK173428 | Comparison |
| Device design-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 |
| Sterilizationmethod andcycles | 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 |
| Peracetic acidconcentrationfor theendpoint colorchange | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 26 months; | 24 months | Similar |
| Open bottleshelf life | 6 months | 6 months | Identical |
| IntendedProcessor | Enspire 3000 CLCSPS | System 1E LCSPS & System1E Endo LCSPS | Similar |
| ProcessorBasin | 10.8 L | 10.8 L | Identical |
| Sterilant Type | Peracetic Acid | Peracetic Acid | Identical |
| SterilantSource | STERIS S40 SterilantConcentrate | STERIS S40 SterilantConcentrate | Identical |
| Feature | Proposed DeviceVERIFY ChemicalIndicator for enspireCLCSPS K240032 | Predicate DeviceVERIFY ChemicalIndicator for S40 SterilantK173428 | Comparison |
| S40 NominalDose andConcentration | 67.73 mL35 % PAA | 67.73 mL35 % PAA | Identical |
| 2187 mg/L (PAA in usedilution) | 2187 mg/L (PAA in usedilution) | ||
| S40 End ofShelf-LifeDose andConcentration | ≥ 61.4 mL≥ 31.5% PAA2022 mg/L (PAA in usedilution) | ≥ 61.4 mL≥ 31.5% PAA2022 mg/L (PAA in usedilution) | 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 InkSuitability Study | 100% of indicator text ink shows no smearing,no discoloration and no fading | PASS |
| ComparativeSensitivity,ComparativeSpecificity, AnalyticSensitivity andAnalytic SpecificityStudy | A minimum of 75% of indicator from each lot• to show a PASS result when exposed to Passcycle100% of indicators to show a FAIL result• when exposed to the Fail cycle100% of indicators show no delamination• affecting the color change100% of indicators show no deformation• | PASS |
| Post-ProcessingStability (OutsideProcessor) Study | A minimum of 75% of indicator from each lot• to show a PASS result when exposed to Passcycle at each time point100% of indicators to show a FAIL result• when exposed to the Fail cycle at each timepoint | PASS |
| Post-ProcessingStability (InsideProcessor) Study | A minimum of 75% of indicator from each lot• to show a PASS result when exposed to Passcycle at each time point100% of indicators to show a FAIL result• when exposed to the Fail cycle at each timepoint100% CI from each lot correctly interpreted• by inexperienced reader | PASS |
| Blind Study | A minimum of 75% of indicator from each lot• to show a PASS result when exposed to Passcycle100% of indicators to show a FAIL result• when exposed to the Fail cycle100% CI from each lot correctly interpreted• by inexperienced reader | PASS |
| Contaminants Study | 100% of indicators to show a FAIL result• when exposed to the Fail cycle | PASS |
| Exposure toTemperatureExtremes Study | CI start color to remain unchanged after• exposure to three freeze/thaw cycles beforeprocessing.≥75% CI from each lot to show a PASS result.• 100% of indicators to show a FAIL result• 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 StabilityStudy | ≥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 FactorsStudy | 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 DeviceVERIFY Chemical Indicator forenspire CLCSPS K240032 | Predicate DeviceVERIFY Chemical Indicatorfor S40 Sterilant K173428 | |
| Number Lots tested | 3 | 3 |
| PassCondition | ≥2200 mg/L PAA100% PASS | Approximately 2390 mg/L PAA100% PASS |
| FailCondition | 1750 - 1820 mg/L PAA100% FAIL | 1750 - 1820 mg/L PAA100% FAIL |
| FailCondition | 0 mg/L PAA100% FAIL | 0 mg/L PAA100% 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 Passcondition and 100% FAIL in Failcondition), when tested in the | processed CI strip to providereliable results. |
|---|---|
| enspire 3000 CLCSPS (EclipseEPS) using the S40 SterilantConcentrate. | Predicate device demonstratedAnalytic Specificity byexhibiting no observable colorchange when exposed to allcomponents of the processorcycle except the diluted PAAconcentrate 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.
§ 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).