(99 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to sterilization variables. There is no mention of AI/ML in the description, intended use, or performance studies.
No.
This device is a chemical indicator used to monitor the effectiveness of sterilization processes, not to treat or prevent a disease or condition in a patient.
No
The device is a chemical indicator used for routine monitoring of sterilization cycles to ensure critical variables (time, temperature, sterilant concentration) are met, not for diagnosing a medical condition in a patient.
No
The device is a chemical indicator strip with ink printed on a polypropylene strip, which is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring sterilization cycles of medical devices using vaporized hydrogen peroxide. This is a process control for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a chemical indicator that changes color based on exposure to sterilization parameters (time, temperature, sterilant concentration). It does not interact with or analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays designed for biological analysis
The device is clearly designed to assess the effectiveness of a sterilization process, which is a quality control measure for medical devices, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
Product codes (comma separated list FDA assigned to the subject device)
QKM
Device Description
The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for multivariable indicator claims.
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)
Performance testing was conducted to verify that the proposed Celerity CI meets the requirements for multivariable chemical indicator using the Type 4 vaporized hydrogen peroxide sterilization indicator requirements defined in ANSI/AAMI/ISO 11140-1:2014. In addition, ongoing endpoint color stability testing has demonstrated stability throughout 15 months, so the labeling has been updated to reflect this.
Multivariable CI Performance Testing:
Purpose: Demonstrates that the indicator reacts to all critical variables (time, temperature and sterilant concentration) of the sterilization process.
Acceptance Criteria: Pass testing per Table 8 of ISO 11140-1:2014, Fail testing per Table 8 of ISO 11140-1:2014
Study Result: Pass. All CI show a complete color change, Pass. All CI show an incomplete color change.
Endpoint color stability:
Purpose: Demonstrates that the processed indicator color does not significantly change over the labeled time period.
Acceptance Criteria: Color remains stable
Study Result: Pass. Color stable up to 15 months.
Simulated Use Testing (Leveraged from K192020):
Purpose: Demonstrates that the indicator performs as expected in a commercial sterilizer with worst-case load.
Acceptance Criteria: Complete color change in a full cycle. Incomplete color change in an abbreviated cycle.
Study Result: Pass. Complete color change in a full cycle. Incomplete color change in an abbreviated cycle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
January 7, 2022
Steris Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060
Re: K213262
Trade/Device Name: CELERITY HP Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: December 7, 2021 Received: December 8, 2021
Dear Anthony Piotrkowski:
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 (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 located 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.
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
1
542 of the Act); 21 CFR 1000-1050.
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213262
Device Name Celerity™ HP Chemical Indicator
Indications for Use (Describe)
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
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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3
STI
510(k) Summary For CELERITY HP Chemical Indicator (CI)
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Manufacturing Facility
Albert Browne Ltd., a subsidiary of STERIS Corporation Rayns Way Watermead Business Park Syston Leicester LE7 1PF UNITED KINGDOM
| Contact: | Anthony Piotrkowski |
|---|---|
| Director, Regulatory Affairs | |
| Telephone: (440) 392-7437 | |
| Fax No: (440) 357-9198 | |
| Tony_piotrkowski@steris.com |
| Submission Date: | January 6, 2022 |
|---|---|
| ------------------ | ----------------- |
K213262 510K number:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)
1. Predicate Device
| Trade Name: | 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E |
|--------------------------|-------------------------------------------------------------------------------------|
| Common/Usual Name: | Chemical Indicator Classification: |
| | Class II |
| Classification Name: | Physical/chemical sterilization processindicator |
| 510(k) Submitter/Holder: | 3M Corporation |
| 510(k) Number: | K203284 |
2. Device Description
The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for multivariable indicator claims.
3. Indications for Use
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
- Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® . System, including those systems with ALLClear Technology.
4. Technological Characteristics
The proposed and predicate devices are chemical indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are similar and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change.
5
STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)
| Feature | Proposed: Celerity™ HP | Predicate: K203284, 3M Attest | Comparison |
|---|---|---|---|
| Chemical Indicator | Tri-Metric Chemical Indicator | ||
| Intended Use / | |||
| Indications for | |||
| Use | The Celerity™ HP Chemical | ||
| Indicator is a vaporized hydrogen | |||
| peroxide multivariable chemical | |||
| indicator. It is designed for | |||
| routine monitoring of the | |||
| following cycles: | |||
| • Lumen, Non Lumen, | |||
| Flexible, Fast Non Lumen or | |||
| Fast sterilization cycle of a V- | |||
| PRO® Low Temperature | |||
| Sterilization System, or | |||
| • Standard, Advanced, Express, | |||
| Flex or Duo cycles of an ASP | |||
| STERRAD® System, including | |||
| those systems with ALLClear | |||
| Technology. | Use the 3MTM Attest™ Vaporized | ||
| Hydrogen Peroxide Tri-Metric Chemical | |||
| Indicator 1348/1348E for pack control | |||
| monitoring of the following hydrogen | |||
| peroxide sterilization sterilizers and | |||
| cycles: STERRAD® 100S System, | |||
| STERRAD® NX® System (Standard and | |||
| Advanced cycles), STERRAD® NX® | |||
| System with AllClear™ Technology | |||
| (Standard and Advanced cycles), | |||
| STERRAD® 100NX® System (Standard, | |||
| Flex, Express and Duo cycles) | |||
| STERRAD® 100NX® System with | |||
| AllClear™ Technology (Standard, Flex, | |||
| Express and Duo cycles) vaporized | |||
| hydrogen peroxide sterilizers and | |||
| STERIS® V-PRO® 1 (Lumen cycle), | |||
| STERIS® V-PRO® 1 Plus (Lumen and | |||
| Non-Lumen cycles) and STERIS® V- | |||
| PRO® maX Low Temperature | |||
| Sterilization System (Lumen, Non- | |||
| Lumen and Flexible cycles), STERIS® | |||
| V-PRO® 60 Temperature Sterilization | |||
| System (Lumen, Non-Lumen and | |||
| Flexible cycles), STERIS® V-PRO® | |||
| maX 2 Temperature Sterilization System | |||
| (Lumen, Non-Lumen, Flexible, and Fast | |||
| Non-lumen cycles), STERIS® V- PRO® | |||
| s2 Low Temperature Sterilization | |||
| System (Lumen, Non- Lumen, Flexible, | |||
| and Fast cycles) | Both predicate and subject | ||
| indicators are used for | |||
| monitoring the same | |||
| STERRAD and V-PRO | |||
| sterilization cycles. | |||
| Device design | Indicator Ink printed | ||
| onto polypropylene. | The 3MTM Attest™ Vaporized | ||
| Hydrogen Peroxide Tri-Metric | |||
| Chemical Indicator 1348/1348E is a | |||
| chemical indicator consisting of a non- | |||
| cellulose based coated indicator strip | |||
| sensitive to vaporized hydrogen | |||
| peroxide, contained in a film laminate | Both proposed and predicate | ||
| devices have a VH2O2 | |||
| reactive ink on a non- | |||
| cellulosic substrate that | |||
| demonstrates a color change | |||
| when exposed to VH2O2. | |||
| Indicator agent | Proprietary | Proprietary | Both proposed and |
| predicate devices have a | |||
| VH2O2 reactive ink that | |||
| demonstrates a color | |||
| change when exposed to | |||
| VH2O2. | |||
| Critical | |||
| parameters | 4.7 mg/L - VH2O2 | ||
| 29 second - exposure time | |||
| 50 °C - exposure Temperature | 5.1 mg/L - VH2O2 | ||
| 1 minute - exposure time | |||
| 50 °C - exposure Temperature | Both proposed and | ||
| predicate devices only | |||
| react when all the variables | |||
| are reached. | |||
| Color change | Magenta to orange/yellow or | ||
| lighter yellow | Blue to pink with a moving dye front | Both proposed and | |
| predicate devices use color | |||
| changes that are the same | |||
| as other cleared devices. | |||
| Endpoint | |||
| stability | 15 months | At least one month (4 weeks) | Both proposed and predicate |
| devices include labeling to | |||
| indicate endpoint stability. |
Table 4-1. Summary of CI Physical Description and Technological Properties
6
STERIS Traditional 510(k) PREMARKET NOTIFICATION K213262 CELERITY HP Chemical Indicator (CI)
The predicate and proposed devices are similar in terms of basic scientific technology and indications for use. Testing is included in the submission to demonstrate that the proposed CI meets the criteria of a multivariable indicator and to extend the endpoint color stability. The multivariable indicator claims change the product code from JOJ to QKM. Both product codes are under regulation number 21 CFR 880.2800.
.. Performance Testing
Performance testing was conducted to verify that the proposed Celerity CI meets the requirements for multivariable chemical indicator using the Type 4 vaporized hydrogen peroxide sterilization indicator requirements defined in ANSI/AAMI/ISO 11140-1:2014. In addition, ongoing endpoint color stability testing has demonstrated stability throughout 15 months, so the labeling has been updated to reflect this.
| Testing | Purpose | Acceptance Criteria | Study Result |
|---|---|---|---|
| Multivariable CI | |||
| Performance | |||
| Testing | Demonstrates that the indicator | ||
| reacts to all critical variables | Pass testing per Table 8 | ||
| of ISO 11140-1:2014 | Pass. All CI show a | ||
| complete color change | |||
| (time, temperature and sterilant | |||
| concentration) of the | |||
| sterilization process. | Fail testing per Table 8 | ||
| of ISO 11140-1:2014 | Pass. All CI show an | ||
| incomplete color change | |||
| Endpoint color | |||
| stability | Demonstrates that the | ||
| processed indicator color does | |||
| not significantly change over | |||
| the labeled time period. | Color remains stable | Pass. Color stable up to | |
| 15 months | |||
| Simulated Use | |||
| Testing | |||
| (Leveraged from | |||
| K192020) | Demonstrates that the indicator | ||
| performs as expected in a | |||
| commercial sterilizer with | |||
| worst-case load. | Complete color change in | ||
| a full cycle. | |||
| Incomplete color change | |||
| in an abbreviated cycle. | Pass. | ||
| Complete color change in | |||
| a full cycle. | |||
| Incomplete color change | |||
| in an abbreviated cycle. |
Table 5-1. Verification Results Summary
The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.
6. Conclusion
The conclusion drawn from the non-clinical test demonstrate that the subject device is as safe, as effective and perform as well as or better that the legally marketed predicate device (K203284, Class II as per 21 CFR 880.2800, product code QKM).