(104 days)
Not Found
No
The device is a chemical indicator strip that changes color based on chemical concentration and temperature, with no mention of computational analysis or learning algorithms.
No.
The device is a chemical indicator used to monitor the concentration of peracetic acid in a sterilization cycle, not to diagnose, treat, cure, or prevent disease.
No
This device is a chemical indicator used to monitor the concentration of peracetic acid in a sterilization cycle, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a physical chemical indicator strip with ink printed on a polypropylene strip and a laminate covering, indicating it is a hardware device.
Based on the provided information, the enspire 3000 Chemical Indicator is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the concentration of peracetic acid in a liquid chemical sterilization cycle. This is a quality control measure for a sterilization process, not a test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device is a chemical indicator strip that changes color based on exposure to a chemical (peracetic acid). It does not involve the analysis of biological specimens.
- Lack of Biological Sample Analysis: IVDs are designed to analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health. This device does not interact with or analyze any biological samples.
Therefore, the enspire 3000 Chemical Indicator falls under the category of a sterilization process indicator, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
JOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed as summarized in Table 2:
- Non-Reactive Ink Suitability Study: 100% of indicator text ink shows no smearing, no discoloration and no fading. Results: PASS.
- Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity and Analytic Specificity 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% of indicators show no delamination affecting the color change; 100% of indicators show no deformation. Results: PASS.
- 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. Results: 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. Results: 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. Results: PASS.
- Contaminants Study: 100% of indicators to show a FAIL result when exposed to the Fail cycle. Results: 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. Results: 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. Results: 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. Results: 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. Results: PASS.
- Human Factors Study: Users complete all critical tasks. Results: PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity and Analytic Specificity Study was performed.
- Number of Lots tested: 3
- Pass Condition: >=2200 mg/L PAA 100% PASS (Proposed device); Approximately 2390 mg/L PAA 100% PASS (Predicate device).
- Fail Condition: 1750 - 1820 mg/L PAA 100% FAIL (Both devices); 0 mg/L PAA 100% FAIL (Both devices).
- Study Conclusion: The proposed device met the acceptance criteria for Comparative Sensitivity (=1.00), Comparative Specificity (=1.00), Analytic Specificity (100% FAIL) and Accuracy (100% PASS in Pass condition and 100% FAIL in Fail condition), when tested in the enspire 3000 CLCSPS (Eclipse EPS) using the S40 Sterilant Concentrate.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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"
1
(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
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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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: (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
5
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
6
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
VERIFY Chemical
Indicator for enspire
CLCSPS K240032 | Predicate Device
VERIFY Chemical
Indicator for S40 Sterilant
K173428 | Comparison |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The VERIFY® Chemical
Indicator for S40 Sterilant is a
peracetic acid concentration
indicator for routine
monitoring of STERIS
automated liquid chemical
sterilant processing systems
that employ S40 Sterilant
Concentrate in a controlled
cycle.
The unprocessed VERIFY®
Chemical Indicator for S40
Sterilant is blue. When
exposed in a STERIS
automated liquid chemical
sterilant 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
changes color from blue
through an intermediate beige
and then to the endpoint color,
pink. The indicator may
become more pink when
exposed to higher peracetic
acid concentrations in S40
sterilant use dilution. | Similar.
Proposed
device is to
be used with
the same
sterilant at
the same
MEC but in a
different
processor |
| Feature | Proposed Device
VERIFY Chemical
Indicator for enspire
CLCSPS K240032 | Predicate Device
VERIFY Chemical
Indicator for S40 Sterilant
K173428 | Comparison |
| Device design
-components | Printed indicator ink printed
onto polypropylene overlaid
with a clear, permeable
laminate | Printed indicator ink printed
onto polypropylene overlaid
with a clear, permeable
laminate | Identical |
| Indicator
agent | Lissamine green B (active
dye) and savinyl orange
(background dye) | Lissamine green B (active
dye) and savinyl orange
(background dye) | Identical |
| Sterilization
method and
cycles | Used in a liquid chemical
sterilant processing system
employing S40 Sterilant
Concentrate to form a use
dilution concentration of
≥1820 ppm (mg/L) peracetic
acid and provide 6 minutes
exposure at 45.5 - 60°C. | Used in a liquid chemical
sterilant processing system
employing S40 Sterilant
Concentrate to form a use
dilution concentration of
≥1820 ppm (mg/L) peracetic
acid and provide 6 minutes
exposure at 45.5 - 60°C. | Identical |
| Mechanism of
action | Bleaching of lissamine green
B dye as a result of oxidation,
resulting in a color change. | Bleaching of lissamine green
B dye as a result of oxidation,
resulting in a color change. | Identical |
| Peracetic acid
concentration
for the
endpoint color
change | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Disposable | Yes | Yes | Identical |
| Shelf-life | 26 months; | 24 months | Similar |
| Open bottle
shelf life | 6 months | 6 months | Identical |
| Intended
Processor | Enspire 3000 CLCSPS | System 1E LCSPS & System
1E Endo LCSPS | Similar |
| Processor
Basin | 10.8 L | 10.8 L | Identical |
| Sterilant Type | Peracetic Acid | Peracetic Acid | Identical |
| Sterilant
Source | STERIS S40 Sterilant
Concentrate | STERIS S40 Sterilant
Concentrate | Identical |
| Feature | Proposed Device
VERIFY Chemical
Indicator for enspire
CLCSPS K240032 | Predicate Device
VERIFY Chemical
Indicator for S40 Sterilant
K173428 | Comparison |
| S40 Nominal
Dose and
Concentration | 67.73 mL
35 % PAA | 67.73 mL
35 % PAA | Identical |
| | 2187 mg/L (PAA in use
dilution) | 2187 mg/L (PAA in use
dilution) | |
| S40 End of
Shelf-Life
Dose and
Concentration | ≥ 61.4 mL
≥ 31.5% PAA
2022 mg/L (PAA in use
dilution) | ≥ 61.4 mL
≥ 31.5% PAA
2022 mg/L (PAA in use
dilution) | Identical |
| Exposure time | 6-minutes | 6-minutes | Identical |
Table 1: Comparison Table of Proposed and Predicate Devices
7
8
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.
9
| Testing | Acceptance Criteria | Results |
|---|---|---|
| Non-Reactive Ink | ||
| Suitability Study | 100% of indicator text ink shows no smearing, | |
| no discoloration and no fading | PASS | |
| Comparative | ||
| Sensitivity, | ||
| Comparative | ||
| Specificity, Analytic | ||
| Sensitivity and | ||
| Analytic Specificity | ||
| 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% of indicators show no delamination | ||
| • affecting the color change | ||
| 100% of indicators show no deformation | ||
| • | PASS | |
| 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 |
| Table 2: Summary of Performance Testing | ||||
|---|---|---|---|---|
| ----------------------------------------- | -- | -- | -- | -- |
10
| 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 | ||
| 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 |
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 | ||
| VERIFY Chemical Indicator for | ||
| enspire CLCSPS K240032 | Predicate Device | |
| VERIFY Chemical Indicator | ||
| for S40 Sterilant K173428 | ||
| Number Lots tested | 3 | 3 |
| Pass | ||
| Condition | ≥2200 mg/L PAA | |
| 100% PASS | Approximately 2390 mg/L PAA | |
| 100% PASS | ||
| Fail | ||
| Condition | 1750 - 1820 mg/L PAA | |
| 100% FAIL | 1750 - 1820 mg/L PAA | |
| 100% FAIL | ||
| Fail | ||
| Condition | 0 mg/L PAA | |
| 100% FAIL | 0 mg/L PAA | |
| 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
11
| Accuracy (100% PASS in Pass
condition and 100% FAIL in Fail
condition), when tested in the | processed CI strip to provide
reliable results. |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| enspire 3000 CLCSPS (Eclipse
EPS) using the S40 Sterilant
Concentrate. | Predicate device demonstrated
Analytic Specificity by
exhibiting no observable color
change when exposed to all
components of the processor
cycle except the diluted PAA
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.