(29 days)
No
The device is a chemical process indicator that changes color based on exposure to a sterilization process. There is no mention of AI or ML in the description or performance studies.
No
The device is a process indicator used for sterilization, not for treating a disease or condition in a patient.
No
Explanation: The device is a process indicator for sterilization, designed to show if a pack has been exposed to a sterilization cycle, not to diagnose a medical condition in a patient.
No
The device is a physical adhesive label with a chemical indicator that changes color. It is 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 to indicate whether a sterilization process has occurred by changing color when exposed to vaporized hydrogen peroxide. This is a process indicator for sterilization, not a diagnostic test performed on biological samples to diagnose a disease or condition.
- Device Description: The description reinforces its function as a visual indicator for sterilization exposure.
- Lack of Biological Sample Interaction: The device is affixed to packs to be sterilized, not used to test biological samples from a patient.
- No Mention of Diagnostic Purpose: There is no mention of diagnosing, treating, or preventing any disease or condition.
- Predicate Device: The predicate device (K192020) is also described as a process indicator, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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
JOJ
Device Description
The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PI) is to be affixed to the outside of a pack by means of the adhesive back. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen Fast or Specialty 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.
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)
Testing was submitted as part of K231490 to demonstrate that the VERIFY V24 Self-Contained Biological Indicator (SCBI) label remained adhered to the vial and had appropriate color change in the Specialty Cycle and this testing is also applicable to the Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label for the following reasons:
- The subject device has the same indicator ink as the reference vial indicator ● label of the VERIFY V24 SCBI
- The subject device has the same substrate as the reference vial indicator label of the VERIFY V24 SCBI
- The subject device has the same adhesive as the reference vial indicator label of the VERIFY V24 SCBI
- The subject device is used to monitor the same cycle (Specialty) as the reference ● vial indicator label of the VERIFY V24 SCBI
- The subject device is cleared for use in the V-PRO maX 2 Fast Non Lumen ● Cycle which has identical preconditioning and exposure phases to the Specialty Cycle.
- . The subject device is adhered to plastic of a pouch and the reference vial indicator label of the VERIFY V24 SCBI adheres to the plastic SCBI vial.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2023
Steris Anthony Piotrkowski Director, Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060
Re: K233187
Trade/Device Name: Celerity Vaporized VH202 Process Indicator Adhesive Label (PCC078) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 28, 2023 Received: September 28, 2023
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 (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.
Christopher K. Dugard -S
Christopher K. Dugard, M.S. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
Indications for Use (Describe)
The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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510(k) Summary For K233187 Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Tony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: Tony_Piotrkowski@steris.com
Summary Date: October 17, 2023
Premarket Notification Number: K233187
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
K233187 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label
1. Device Name
| Trade Name: | Celerity™ Vaporized VH2O2 Process Indicator
Adhesive Label |
|------------------------|---------------------------------------------------------------|
| Device Class: | Class II |
| Common/usual Name: | Chemical Indicator |
| Classification Name: | Physical/chemical process indicator |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | JOJ |
2. Predicate Device
Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label K192020
| Feature | Celerity™ Vaporized $VH2O2$ Process
Indicator Adhesive Label (Predicate
Device/K192020) | Celerity™ Vaporized $VH2O2$ Process
Indicator Adhesive Label (Modified
Device) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Celerity™ Vaporized $VH2O2$ Process
Indicator Adhesive Label is a Type 1
vaporized hydrogen peroxide sterilization
process indicator. It is designed to
distinguish between processed and
unprocessed units, when affixed to packs to
be sterilized, through a visible change from
magenta to orange/yellow or lighter, when
the pack has been exposed to the:
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. | The Celerity™ Vaporized $VH2O2$ Process
Indicator Adhesive Label is a Type 1
vaporized hydrogen peroxide sterilization
process indicator. It is designed to
distinguish between processed and
unprocessed units, when affixed to packs to
be sterilized, through a visible change from
magenta to orange/yellow or lighter, when
the pack has been exposed to the:
Lumen, Non Lumen, Flexible, Fast Non
Lumen, Fast or Specialty 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. | Added
indication for
use in the
Specialty
Cycle which is
the subject of
this
submission |
| Device design -
components | Indicator Ink printed onto spun-bonded
polyolefin with an adhesive and a glassine
backing | Indicator Ink printed onto spun-bonded
polyolefin with an adhesive and a glassine
backing | Same |
| Indicator agent | Non-transferable indicator ink of
proprietary formulation which changes
color when exposed to $VH2O2$ | Non-transferable indicator ink of
proprietary formulation which changes
color when exposed to $VH2O2$ | Same |
| Sterilization method
and cycles | Vaporized Hydrogen Peroxide in the V-PRO
1, V-PRO 1 Plus, V-PRO maX, V-PRO 60,
V-PRO maX 2, V-PRO s 2 Low
Temperature Sterilizers and ASP STERRAD
100S, NX and 100NX System, including
those systems with ALLClear Technology. | Vaporized Hydrogen Peroxide in the V-PRO
1, V-PRO 1 Plus, V-PRO maX, V-PRO 60,
V-PRO maX 2, V-PRO s 2 Low
Temperature Sterilizers and ASP STERRAD
100S, NX and 100NX System, including
those systems with ALLClear Technology. | Same |
| Endpoint
specifications | No Endpoint Specifications (Type 1 Process
Indicator) | No Endpoint Specifications (Type 1 Process
Indicator) | Same |
| Endpoint stability | 15 months | 15 months | Same |
Table 1. Device Comparison Table for Modified Label and Predicate
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K233187 STERIS SPECIAL 510(k) PREMARKET NOTIFICATION Modification to Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label
| Feature | Celerity™ Vaporized VH2O2 Process
Indicator Adhesive Label (Predicate
Device/K192020) | Celerity™ Vaporized VH2O2 Process
Indicator Adhesive Label (Modified
Device) | Comparison |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Recommended
storage conditions | 5-25°C/41-77°F, away from direct light. Do
not store indicator labels near heat,
moisture, oxidizing agents, acids/alkalis or
cleaning/disinfecting agents. | 5-25°C/41-77°F, away from direct light. Do
not store indicator labels near heat,
moisture, oxidizing agents, acids/alkalis or
cleaning/disinfecting agents. | Same |
| Specification | Conforms to ANSI/AAMI/ISO 11140-
1:2014 requirements for a VH2O2 Type 1
Process Indicator | Conforms to ANSI/AAMI/ISO 11140-
1:2014 requirements for a VH2O2 Type 1
Process Indicator | Same |
3. Reference Device
K231490 VERIFY V24 Self-Contained Biological Indicator (SCBI)
4. Description of Device
The Celerity™ Vaporized | H2O2 Process Indicator Adhesive Label (PI) is to be affixed to the outside of a pack by means of the adhesive back. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen Fast or Specialty 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.
న. Intended Use/Indications for Use
The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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.
6. Summary of Nonclinical Tests
Testing was submitted as part of K231490 to demonstrate that the VERIFY V24 Self-Contained Biological Indicator (SCBI) label remained adhered to the vial and had appropriate color change in the Specialty Cycle and this testing is also applicable to the Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label for the following reasons:
- The subject device has the same indicator ink as the reference vial indicator ● label of the VERIFY V24 SCBI
7
- The subject device has the same substrate as the reference vial indicator label of the VERIFY V24 SCBI
- The subject device has the same adhesive as the reference vial indicator label of the VERIFY V24 SCBI
- The subject device is used to monitor the same cycle (Specialty) as the reference ● vial indicator label of the VERIFY V24 SCBI
- The subject device is cleared for use in the V-PRO maX 2 Fast Non Lumen ● Cycle which has identical preconditioning and exposure phases to the Specialty Cycle.
- . The subject device is adhered to plastic of a pouch and the reference vial indicator label of the VERIFY V24 SCBI adheres to the plastic SCBI vial.
6. 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 well as the legally marketed predicate device K192020, Class II (21 CFR 880.2800), product code JOJ.