(26 days)
Not Found
No
The device is a chemical indicator strip that changes color based on chemical exposure. There is no mention of software, algorithms, or data processing that would suggest AI/ML is involved. The modification is a labeling change to improve user interpretation of the color change.
No
Explanation: The device is a chemical indicator used to monitor the peracetic acid concentration in a liquid chemical sterilization cycle. It is not applied to a patient for diagnosis, treatment, or prevention of disease.
No
The 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 is a physical chemical indicator strip with ink and laminate, not a software program.
Based on the provided information, the enspire 3000 Chemical Indicator is not an In Vitro Diagnostic (IVD) device.
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 human or animal to diagnose a condition, monitor treatment, or screen for disease.
- 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 IVD Characteristics: The description lacks any mention of analyzing biological samples, diagnosing conditions, or providing information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The enspire 3000 Chemical Indicator does not fit this definition.
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.
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.
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
Human Factors Study: Users performed all critical tasks successfully.
Key Metrics
Not Found
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).
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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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
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.
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.
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
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.
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.
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.
6
STERIS Special 510(k) PREMARKET NOTIFICATION – K243475 Celerity Chemical Indicator for enspire 3000 CLCSPS
| Table 1 | |||
|---|---|---|---|
| Feature | Proposed | ||
| Celerity Chemical Indicator | |||
| for enspire CLCSPS | Predicate K240032 | ||
| Celerity Chemical Indicator | |||
| for enspire CLCSPS | Comparison | ||
| 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 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. | |||
| Intended | |||
| use | 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 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. | Identical | ||
| Device | |||
| design - | |||
| component | |||
| s | 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 | ||
| Sterilizatio | |||
| n 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 | ||
| Mechanis | |||
| m 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 | > 1820 mg/L PAA | > 1820 mg/L PAA | Identical |
| Feature | Proposed | ||
| Celerity Chemical Indicator | |||
| for enspire CLCSPS | Predicate K240032 | ||
| Celerity Chemical Indicator | |||
| for enspire CLCSPS | Comparison | ||
| concen- | |||
| tration for | |||
| the | |||
| endpoint | |||
| color | |||
| change | |||
| Disposable | Yes | Yes | Identical |
| Shelf-life | 26 months; | 26 months | Identical |
| Open | |||
| bottle shelf | |||
| life | 6 months | 6 months | Identical |
7
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 Factors | ||
| Study | 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.