(38 days)
No
The device is a chemical indicator that changes color based on exposure to sterilization processes. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a chemical indicator designed to distinguish between processed and unprocessed units in sterilization cycles, not to provide therapy or treatment.
No
Explanation: The device is a process indicator for sterilization, not a diagnostic device for medical conditions. It distinguishes between processed and unprocessed units based on a color change after exposure to sterilizing agents.
No
The device is a physical chemical indicator that changes color based on exposure to sterilization processes. It is described as being manufactured by printing ink onto a substrate and comes in different physical formats (inside packs, adhesive labels). There is no mention of software components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vaporized hydrogen peroxide sterilization process indicator." Its purpose is to indicate whether a sterilization process has occurred by changing color. It is used within or on packs being sterilized, not for testing biological samples from a patient.
- Device Description: The description reinforces that it's a chemical indicator printed on a substrate, designed to react to the sterilization process.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing a disease or condition
- Monitoring a patient's health status
- Providing information for clinical decision-making
The device is a process indicator used to monitor the effectiveness of a sterilization cycle, which is a quality control measure for medical devices, not a diagnostic test performed on a patient.
N/A
Intended Use / Indications for Use
The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device 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 Scope 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 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 Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI 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 Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The Celerity HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/yellow or lighter, when the device 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 "10 HP Chemical indicator is provided in three formats:
- Version 1: Celerity™ Chemical Indicator (CI) .
- . Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
- Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)
The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.
The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:
- Construction C Polypropylene ●
- Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper
- Construction D - polypropylene with an adhesive and a glassine backing paper.
The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.
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™ HP Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. Additional testing was completed to simulate typical in-use applications.
The verification activities performed include:
Type 1 Performance Testing (Methodology: ANSI/AAMI/ISO 11140-1:2014):
- When exposed to VHP Resistometer cycles at the Fail parameters (Test Points 2 and 3), 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result. (Result: Pass)
- When exposed to VHP Resistometer cycles at the Pass condition (Test Point 1), Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. (Result: Pass)
Simulated Use Testing (Methodology: Internal Method Used): - When exposed to V-PRO maX Non Lumen 1/84 cycles with ≥50 lb load (Fail condition), 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result. (Result: Pass)
- When exposed to V-PRO and STERRAD cycles with the worst case loads, Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. (Result: Pass)
Fluorescent Light Stability Testing (Methodology: Internal Method & ANSI/AAMI/ISO 11140-1:2014): - Indicator start color to remain unchanged after exposure to fluorescent lighting for ≥ 30 days before processing. (Result: Pass)
- When exposed to VHP Resistometer cycles at the Fail parameters following exposure to fluorescent lighting for ≥ 30 days, 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow). (Result: Pass)
- When exposed to VHP Resistometer cycles at the PASS parameters following exposure to fluorescent lighting for ≥ 30 days, Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). (Result: Pass)
Temperature Extremes Exposure (Freeze/Thaw) Testing (Methodology: Internal Method & ANSI/AAMI/ISO 11140-1:2014): - Indicator start color to remain unchanged after exposure to extreme temperatures before processing. (Result: Pass)
- When exposed to VHP Resistometer cycles at the Fail parameters following exposure to extreme temperatures, 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow). (Result: Pass)
- When exposed to VHP Resistometer cycles at the PASS parameters following exposure to extreme temperatures, Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). (Result: Pass)
Transference Testing (Methodology: ANSI/AAMI/ISO 11140-1:2014): - Indicators placed between a piece of the same substrate and held together with tape, then processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for off-set, bleed and migration. (Result: Pass)
- Samples with reference and text ink processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for smearing, discoloration and fading. (Result: Pass)
Adhesion Stability (Vials) Testing (Methodology: Internal Method Used): - When exposed to two consecutive V-PRO maX 2 Lumen cycles:
- 0% samples show bleeding of the adhesive
- 100% must be firmly affixed
- 0% must show signs of peeling
- Minimum 90% must show a PASS result (Result: Pass)
Shelf Life Testing (Methodology: ANSI/AAMI/ISO 11140-1:2014):
- After the process indicator has been aged: Minimum of 90% of indicators must PASS Type 1 PASS conditions. (Result: Pass)
- After the process indicator has been aged: 100% of indicators must FAIL. (Result: Pass)
Post-Processing Stability Testing (Methodology: Internal Method Used): - Indicator processed ink color remains unchanged for a minimum of 6 months following exposure to a PASS or FAIL cycle. (Result: Pass)
Key Results: The results demonstrate that all three models of the device, Celerity™ HP Chemical Indicator (Construction C), V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (Constructions B and D), perform as intended and meet the requirements of ANSI/AAMI/ISO 11140-1:2014 and simulated in-use applications.
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.
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 Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
September 5, 2019
STERIS Corporation Gregory Land Sr Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44077
Re: K192020
Trade/Device Name: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label Regulation Number: 21 CFR 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 28, 2019 Received: August 29, 2019
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 (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.
1
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 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 531-542 of the Act); 21 CFR 1000-1050.
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 medical devices and radiation-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,
Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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)
Device Name Celerity HP Chemical Indicator
Indications for Use (Describe)
The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device 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 Scope 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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."
3
Indications for Use
510(k) Number (if known)
K192020
Device Name Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label
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 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 Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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
Indications for Use
510(k) Number (if known)
Device Name VERIFY V24 Self-Contained Biological Indicator Vial Label
Indications for Use (Describe)
The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI 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 Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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."
5
Image /page/5/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in large, bold, black font at the top of the image. Below the word STERIS is a graphic of several horizontal wavy lines in shades of blue. The STERIS logo is simple and modern.
510(k) Summary For Celerity™ HP Chemical Indicator
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 Chancery House Rayns Way Watermead Business Park System Leicester LE7 1PF United Kingdom
Contact: Gregory Land Senior Regulatory Affairs Specialist Telephone: (440) 392-7424 Fax No: (440) 357-9198
Submission Date: September 5, 2019
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
6
1. Predicate Device and Reference Device
1.1 Predicate Device
| Trade Name: | Celerity™ HP Chemical Indicator & VERIFY V24
Self-Contained Biological Indicator Vial Label |
|--------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Chemical Indicator |
| Classification: | Class II |
| Classification Name: | Physical/chemical sterilization process indicator |
| 510(k) Submitter/Holder: | STERIS Corporation |
| 510(k) Number: | K183295 |
1.2 Reference Device
| Trade Name: | VERIFY® V-PRO Chemical Indicator |
|---|---|
| Common/Usual Name: | Chemical Indicator |
| Classification: | Class II |
| Classification Name: | Physical/chemical sterilization process indicator |
| 510(k) Submitter/Holder: | STERIS Corporation |
| 510(k) Number: | K172746 |
2. Device Description
The Celerity HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/yellow or lighter, when the device 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 "10 HP Chemical indicator is provided in three formats:
- Version 1: Celerity™ Chemical Indicator (CI) .
- . Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
- Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)
The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.
7
Table 1 below contains information related to the different constructions and use locations of the 3 versions of the proposed device.
Version 1, the Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from magenta to orange/vellow or lighter, when the device 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.
Version 2, 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 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.
Version 3, the VERIFY® V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the SCBI 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.
2.1 Physical Description - Design, Construction, Components
The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:
- Construction C Polypropylene ●
- Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper
8
● Construction D - polypropylene with an adhesive and a glassine backing paper.
The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.
Note that for Constructions B and D, the glassine backing paper serves as a carrier for the label and is removed from the VERIFY® V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label prior to affixing to a surface and processing.
Table 1 Correlates the three versions of the device to the constructions of substrates.
| | Version 1:
Celerity™
Chemical Indicator | Version 2:
Vaporized VH2O2
Process Indicator
Adhesive Label | Version 3: VERIFY®
V24 Self-Contained
Biological Indicator
Vial Label |
|--------------|-----------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Construction | C | B or D | B or D |
| Use Location | Within pack | Affixed to outside of
pack | Affixed to outside of
Self-Contained
Biological Indicator |
Table 1: Construction Materials and Use Locations
3. Indications for Use: Indications for Use – Celerity™ HP Chemical Indicator 3.1
The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the device 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.
9
Indications for Use – Celerity™ Vaporized VH2O2 Process Indicator 3.2 Adhesive Label
The Celerity™ Vaporized | H2O2 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.
Indications for Use – VERIFY® V24 Self-Contained Biological Indicator 3.3 Vial Label
The VERIFY® V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the SCBI 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.
4. Technological Characteristics
The proposed and predicate devices are Type 1 single use process indicators in accordance with ISO 11140-1:2014 for use in monitoring Vaporized Hydrogen Peroxide sterilization cycles. The mechanism of action and endpoint are the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta or red to orange/vellow, respectively.
Table 2 contains a comparison of technological characteristics and specifications of the proposed Celerity™ HP Chemical Indicator to Predicate 1, Celerity™ HP Chemical Indicator & VERIFY V24 Self-Contained Biological Indicator Vial Label.
10
| Feature | Proposed
Celerity™ HP Chemical
Indicator
Constructions
B, C and D | K183295
Celerity™ HP Chemical
Indicator
Constructions B and C | Comparison |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use –
Celerity™ HP
Chemical
Indicator | The Celerity™ HP Chemical
Indicator is a Type 1 vaporized
hydrogen peroxide sterilization
process indicator. It is designed
to distinguish between processed
and unprocessed units, when
placed within packs to be
sterilized, through a visible
change from magenta to
orange/yellow or lighter, when
the device 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™ HP Chemical
Indicator is a Type 1 vaporized
hydrogen peroxide sterilization
process indicator. It is designed
to distinguish between processed
and unprocessed units, when
placed within packs to be
sterilized, through a visible
change from red to
orange/yellow, when the device
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. | Similar |
| Feature | Proposed
Celerity™ HP Chemical
Indicator
Constructions
B, C and D | K183295
Celerity™ HP Chemical
Indicator
Constructions B and C | Comparison |
| Indications
for Use –
VERIFY®
V24 Self-
Contained
Biological
Indicator
Vial Label | The V24 Self-Contained
Biological Indicator Vial Label is
a Type 1 vaporized hydrogen
peroxide sterilization process
indicator. It is designed to
distinguish between processed
and unprocessed SCBIs, whilst
affixed to SCBI vials to be
sterilized, through a visible
change from magenta to
orange/yellow or lighter, when
the SCBI 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 V24 Self-Contained
Biological Indicator Vial Label is
a Type 1 vaporized hydrogen
peroxide sterilization process
indicator. It is designed to
distinguish between processed
and unprocessed SCBIs, whilst
affixed to SCBI vials to be
sterilized, through a visible
change from red to
orange/yellow, when the SCBI
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. | Similar |
| Indications
for Use –
Celerity™
Vaporized
VH2O2
Process
Indicator
Adhesive
Label | 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 packs, whilst
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 V24 Self-Contained
Biological Indicator Vial Label is
a Type 1 vaporized hydrogen
peroxide sterilization process
indicator. It is designed to
distinguish between processed
and unprocessed SCBIs, whilst
affixed to SCBI vials to be
sterilized, through a visible
change from red to
orange/yellow, when the SCBI
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. | Similar |
| Feature | Proposed
Celerity™ HP Chemical
Indicator
Constructions
B, C and D | K183295
Celerity™ HP Chemical
Indicator
Constructions B and C | Comparison |
| Device design
-components | Indicator Ink printed spun-bonded
polyolefin with an adhesive and a
glassine backing (Construction B)
polypropylene (Construction C)
and polypropylene substrate with
an adhesive supplied and a
backing paper (Construction D) | Indicator Ink printed onto spun-
bonded polyolefin with an
adhesive and a glassine backing
(Construction B) and
polypropylene (Construction C) | Similar |
| 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 |
| Side by side
testing with
biological
indicators? | No | No | 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 |
Table 2. Device Comparison to Predicate 1, Celerity™ HP Chemical Indicator & VERIFY V24 Self-Contained Biological Indicator Vial Label
11
12
Summary
The predicate and proposed devices are identical with regards to all features except for the materials. The differences between the proposed Celerity™ HP Chemical Indicator (Version 1) and the predicate Celerity™ HP Chemical Indicator (K183295, Construction C) are limited to a change in the indicator ink. The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.
The differences between the proposed VERIFY V24 Self-Contained Biological Indicator Vial Label to the predicate VERIFY V24 Self-Contained Biological Indicator
13
Vial Label (K183295, Construction B) are limited to a change to the indicator ink and the addition of a substrate, polypropylene with an adhesive back and a glassine backing paper (Construction D). The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.
Version 3 of the proposed device, the Celerity™ Vaporized | VH2O2 Process Indicator Adhesive Label is similar to the predicates VERIFY V24 Self-Contained Biological Indicator Vial Label, K183295. The differences between the proposed and the predicate device are limited to a change to the indicator ink and the addition of a substrate (Construction D); the later two changes are the subject of this submission. The mechanism of action is the same. The starting color was amended from Red to Magenta and the endpoint when exposed to the defined processing conditions, was amended to "orange/yellow or lighter.
ട്. Performance Testing
Performance testing was conducted to verify that the proposed Celerity™ HP Chemical Indicator meets the requirements for Type 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2014. Additional testing was completed to simulate typical in-use applications.
Table 4 summarizes the verification activities that were performed. with their respective Report Name and result to demonstrate that the proposed Celerity™ HP Chemical Indicator is safe and effective. These studies confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria and intended uses, and qualify the proposed device for use in the V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, V-PRO maX 2 and V-PRO s 2 Low Temperature Sterilization Systems and Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
Table 4. Verification Results Summary
14
| Testing | Methodology | Acceptance Criteria | Study
Result |
|--------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Type 1 Performance
Testing | ANSI/AAMI/ISO
11140-1:2014 | When exposed to VHP
Resistometer cycles at
the Fail parameters
(Test Points 2 and 3):
100% Celerity™ HP
Chemical Indicator
stripes must show a
FAIL result. | Pass |
| | | When exposed to VHP
Resistometer cycles at
the Pass condition
(Test Point 1):
Minimum 90%
Celerity™ HP
Chemical Indicator
stripes must show a
PASS result. | Pass |
| Simulated Use
Testing | Internal Method
Used | When exposed to V-
PRO maX Non Lumen
1/84 cycles with ≥50
lb load (Fail
condition): 100%
Celerity™ HP
Chemical Indicator
stripes must show a
FAIL result. | Pass |
| | | When exposed to V-
PRO and STERRAD
cycles with the worst
case loads: Minimum
90% Celerity™ HP
Chemical Indicator
stripes must show a
PASS result | Pass |
| Testing | Methodology | Acceptance Criteria | Study
Result |
| Fluorescent Light
Stability Testing | Internal Method
&
ANSI/AAMI/ISO
11140-1:2014 | Indicator start color to
remain unchanged
after exposure to
fluorescent lighting for
≥ 30 days before
processing. | Pass |
| | | When exposed to VHP
Resistometer cycles at
the Fail parameters
following exposure to
fluorescent lighting for
≥ 30 days: 100% of
Indicators tested must
show a FAIL results
(non-visible color
change or color
change to another
color except
orange/yellow | Pass |
| | | When exposed to VHP
Resistometer cycles at
the PASS parameters
following exposure to
fluorescent lighting for
≥ 30 days: Minimum
90% Indicators tested
must show a PASS
result (orange/yellow
or lighter) | Pass |
| Temperature
Extremes Exposure
(Freeze/Thaw)
Testing | Internal Method
&
ANSI/AAMI/ISO
11140-1:2014 | Indicator start color to
remain unchanged
after exposure to
extreme temperatures
before processing | Pass |
| Testing | Methodology | Acceptance Criteria | Study
Result |
| | | When exposed to VHP
Resistometer cycles at
the Fail parameters
following exposure to
extreme temperatures:
100% of Indicators
tested must show a
FAIL results (non-
visible color change or
color change to
another color except
orange/yellow | Pass |
| | | When exposed to VHP
Resistometer cycles at
the PASS parameters
following exposure to
extreme temperatures:
Minimum 90%
Indicators tested must
show a PASS result
(orange/yellow or
lighter) | Pass |
| Transference Testing | ANSI/AAMI/ISO
11140-1:2014 | Indicators placed
between a piece of the
same substrate and
held together with
tape, then processed in
a double V-PRO maX
2 Lumen cycle (no
load) and evaluated
for off-set, bleed and
migration. | Pass |
| Testing | Methodology | Acceptance Criteria | Study
Result |
| | | Samples with
reference and text ink
processed in a double
V-PRO maX 2 Lumen
cycle (no load) and
evaluated for
smearing,
discoloration and
fading | Pass |
| Adhesion Stability
(Vials)
Testing | Internal Method
Used | When exposed to two
consecutive V-PRO
maX 2 Lumen cycles:
• 0% samples
show bleeding of the
adhesive
• 100% must be
firmly affixed
• 0% must show
signs of peeling
• Minimum 90%
must show a PASS
result | Pass |
| Shelf Life Testing | ANSI/AAMI/ISO
11140-1:2014 | After the process
indicator has been
aged: Minimum of
90% of indicators
must PASS Type 1
PASS conditions. | Pass |
| | | After the process
indicator has been
aged: 100% of
indicators must FAIL
| Pass |
| Testing | Methodology | Acceptance Criteria | Study
Result |
| Post-Processing
Stability Testing | Internal Method
Used | Indicator processed
ink color remains
unchanged for a
minimum of 6 months
following exposure to
a PASS or FAIL cycle | Pass |
15
16
17
18
The results of the Celerity™ HP Chemical Indicator performance testing demonstrate that all three models of the device, Celerity™ HP Chemical Indicator (Construction C), V24 Self-Contained Biological Indicator Vial Label and Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (Constructions B and D), perform as intended.
6. 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 (K183295, Class II, 21 CFR 880.2800, product code JOJ).