(76 days)
Not Found
No
The device descriptions and intended uses are focused on chemical indicators that change color based on exposure to sterilization processes. There is no mention of AI or ML in the document.
No.
Explanation: The devices described are chemical indicators and tapes used to monitor sterilization processes, not to treat or diagnose patients.
No
Explanation: These devices are chemical indicators used to monitor sterilization processes by changing color. They indicate whether a unit has been exposed to a sterilization cycle, but they do not diagnose a disease or medical condition in a patient.
No
The device description clearly indicates these are physical chemical indicators and tapes that undergo a visible color change, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of these devices is to monitor sterilization processes for medical devices. They indicate whether a sterilization cycle has been completed successfully by changing color when exposed to vaporized hydrogen peroxide. This is a quality control measure for the sterilization process itself, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The descriptions detail chemical indicators and tapes that react to the sterilization agent. There is no mention of analyzing biological samples or providing diagnostic information about a patient's health.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Mentioning any patient-specific data or results
These devices are classified as sterilization process indicators, which are a type of medical device used to verify the effectiveness of sterilization cycles. They fall under a different regulatory category than IVDs.
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 or lighter, when the device 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 Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
The Celerity™ HP Multivariable 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, Fast or Specialty 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 VERIFY® HPU 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 to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
- . Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
- STERRAD® 100S Sterilizer (Default Cycle)
- . Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
- Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX . Sterilizer without ALLClear.
Product codes (comma separated list FDA assigned to the subject device)
JOJ, QKM
Device Description
The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 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/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.
The Celerity™ HP Multivariable 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 Specialty cycle.
The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.
The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.
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 completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Simulated Use Testing:
Acceptance Criteria: Complete color change, No reversion
Study Result: Complete color change, No reversion
The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Simulated Use Testing:
Acceptance Criteria: Complete color change, No reversion
Study Result: Complete color change, No reversion
The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Simulated Use Testing:
Acceptance Criteria: Complete color change, No reversion
Study Result: Complete color change, No reversion
The results of the performed testing demonstrate that the VERIFY HPU Chemical Indicator performs as intended.
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Simulated Use Testing:
Acceptance Criteria: Complete color change, Remain adhered after cycle
Study Result: Complete color change, Remained adhered after cycle
The results of the performed testing demonstrate that the VERIFY [VH2O2 Indicator Tape performs as intended.
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.
K192020, K213262, K172746, K183293
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
August 7, 2023
STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor. Ohio 44060
Re: K231488
Trade/Device Name: Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, QKM Dated: Mav 22, 2023 Received: May 23, 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 (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
1
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 (OS) 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 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 -2
for Clarence W. Murray, III, Ph.D. 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
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STE
510(k) Summary For K231488 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 |
May 22, 2023 Submission Date:
4
STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI)
1. Predicate Device
Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:
Celerity™ HP Chemical Indicator Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K192020
2. Device Description
The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 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/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.
3. 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 or lighter, when the device 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 Scope 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 the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.
| Feature | Proposed Celerity™ HP Chemical | Predicate: K192020 Celerity HP | Comparison |
|---|---|---|---|
| Indicator | Chemical Indicator | ||
| 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, | |||
| Fast or Specialty sterilization cycle of a V- | |||
| PRO® Low Temperature Sterilization | 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 | The Indications | ||
| for Use have | |||
| been modified | |||
| in the proposed | |||
| device in order | |||
| to include the | |||
| Specialty | |||
| cycles. |
5
| Feature | Proposed Celerity™ HP Chemical
Indicator | Predicate: K192020 Celerity HP
Chemical Indicator | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | System, or Standard, Advanced, Express,
Flex Scope or Duo cycles of an ASP
STERRAD® System, including those
systems with ALLClear Technology. | Standard, Advanced, Express, Flex Scope
or Duo cycles of an ASP STERRAD®
System, including those systems with
ALLClear Technology. | |
| Device design –
Component | Indicator Ink printed onto polypropylene
(indicator) or self-adhesive polypropylene
(adhesive label/vial label). | Indicator Ink printed onto polypropylene
(indicator) or self-adhesive polypropylene
(adhesive label/vial label). | Identical |
| Indicator agent | Proprietary | Proprietary | Identical |
| Mechanism of
action | Proprietary | Proprietary | Identical |
| 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 | Identical |
| Color change | Magenta to orange/yellow or lighter
yellow | Magenta to orange/yellow or lighter
yellow | Identical |
| Endpoint stability | 15 months (all versions) | 15 months (all versions) | Identical |
STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Chemical Indicator (CI)
The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.
ನ. Performance Testing
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Table 5-1. Verification Results Summary
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | Complete color change | |
| No reversion | ● Complete color change | |
| · No reversion |
The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs 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 at least as safely and effectively as the legally marketed predicate device (K192020, Class II as per 21 CFR 880.2800, product code JOJ).
6
510(k) Summary For K231488 CELERITY HP Multivariable 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
May 22, 2023 Submission Date:
7
Predicate Device 1.
| Trade Name: | Celerity™ HP Chemical Indicator (renamed |
|---|---|
| Celerity™ HP Multivariable 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: | K213262 |
2. Device Description
The Celerity™ HP Multivariable 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 Specialty cycle.
3. Indications for Use:
The Celerity™ HP Multivariable 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, Fast or Specialty 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.
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 the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.
8
STERIS Traditional 510(k) PREMARKET NOTIFICATION CELERITY HP Multivariable Chemical Indicator (CI)
| Table 4-1. Summary of CI Physical Description and Technological Properties | |||
|---|---|---|---|
| Feature | Proposed: Celerity™ Multivariable HP Chemical Indicator | Predicate: Celerity™ HP Chemical Indicator K213262 | Comparison |
| 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, Fast or Specialty | |||
| 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™ 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. | The Intended | ||
| Use of has been | |||
| modified in the | |||
| proposed device | |||
| to include the | |||
| Specialty Cycle | |||
| of the V-PRO | |||
| maX 2. | |||
| Device | |||
| design | Proprietary Indicator Ink printed onto | ||
| polypropylene. | Proprietary Indicator Ink printed onto | ||
| polypropylene. | Identical | ||
| Indicator | |||
| agent | Proprietary | Proprietary | Identical |
| Mechanism | |||
| of action | Proprietary | Proprietary | Identical |
| Critical | |||
| parameters | 4.7 mg/L - VH2O2 | ||
| 29 second - exposure time | |||
| 50 °C - exposure Temperature | 4.7 mg/L - VH2O2 | ||
| 29 second - exposure time | |||
| 50 °C - exposure Temperature | Identical | ||
| Color change | Magenta to orange/yellow or lighter yellow | Magenta to orange/yellow or lighter yellow | Identical |
| Endpoint | |||
| stability | 15 months | 15 months | Identical |
| Table 4-1. Summary of CI Physical Description and Technological Properties | |||
|---|---|---|---|
The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.
న. Performance Testing
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Table 5-1. Verification Results Summary
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | • Complete color change | |
| • No reversion | • Complete color change | |
| • No reversion |
The results of the performed testing demonstrate that the Celerity™ HP Chemical Indicator performs as intended.
9
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 safely and effectively as the legally marketed predicate device (K213262, Class II as per 21 CFR 880.2800, product code QKM).
10
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510(k) Summary For K231488 VERIFY HPU 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
May 22, 2023 Submission Date:
11
1. Predicate Device
Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:
VERIFY HPU Chemical Indicator Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K172746
2. Device Description
The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.
3. Indications for Use:
The VERIFY® HPU 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 to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.
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 the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to yellow.
| Feature | Proposed: VERIFY HPU
Chemical Indicator | Predicate: VERIFY HPU Chemical
Indicator (K172746) | Comparison |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY® HPU 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 to indicate, through a
visible change from magenta to yellow,
when the device has been exposed to the
Lumen, Non Lumen, Flexible, Fast Non
Lumen, or Specialty sterilization cycle of a | The VERIFY® HPU 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 to indicate, through a
visible change from magenta to yellow,
when the device has been exposed to the
Lumen, Non Lumen, Flexible or Fast Non | The Intended Use
has been modified
in the proposed
device in order to
include the
Specialty Cycle |
Table 4-1. Comparison of the Proposed VERIFY HPU Chemical Indicator with the Predicate
12
STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY HPU Chemical Indicator (CI)
| Feature | Proposed: VERIFY HPU
Chemical Indicator | Predicate: VERIFY HPU Chemical
Indicator (K172746) | Comparison |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | V-PRO® Low Temperature Sterilization
System | Lumen sterilization cycle of a V-PRO®
Low Temperature Sterilization System | |
| Device design -
components | Proprietary Indicator Ink printed onto spun-
bonded polyolefin, (indicator) or self-
adhesive spun-bonded polyolefin (indicator
label). | Proprietary Indicator Ink printed onto spun-
bonded polyolefin, (indicator) or self-
adhesive spun-bonded polyolefin (indicator
label). | Identical |
| Sterilization
method | Vaporized Hydrogen Peroxide | Vaporized Hydrogen Peroxide | Identical |
| Endpoint
specifications | No Endpoint Specifications (Type 1
Process Indicator) | No Endpoint Specifications (Type 1
Process Indicator) | Identical |
| Shelf-life | 9 months (both versions) | 9 months (both versions) | Identical |
The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.
న. Performance Testing
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Table 5-1. Verification Results Summary
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | • Complete color change | |
| • No reversion | • Complete color change | |
| • No reversion |
The results of the performed testing demonstrate that the VERIFY HPU Chemical Indicator performs 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 at least as safely and effectively as the legally marketed predicate device (K172746, Class II as per 21 CFR 880.2800, product code JOJ).
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STERIS®
Image /page/13/Picture/1 description: The image shows a logo with a series of horizontal, wavy lines stacked on top of each other. The lines are all the same color, a light blue, and they create a sense of depth and movement. The logo is simple and abstract, and it could be used to represent a variety of things, such as water, waves, or sound.
510(k) Summary For K231488 VERIFY VH2O2 Indicator Tape
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Manufacturing Facility
Hi-Tech Products 8530 Roland Street Buena Park, CA 90621
Contact:
Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 Tony piotrkowski(@steris.com
Submission Date: May 22, 2023
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1. Predicate Device
Trade Name: Common/Usual Name: Classification: Classification Name: 510(k) Submitter/Holder: 510(k) Number:
VERIFY VH2O2 Indicator Tape Chemical Indicator Class II Physical/chemical Sterilization Process Indicator STERIS Corporation K183293
2. Device Description
The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.
3. Indications for Use:
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
- . Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.
- STERRAD® 100S Sterilizer (Default Cycle)
- . Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
- Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX . Sterilizer without ALLClear.
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 the same and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible color change from magenta to orange/yellow or lighter yellow.
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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY VH2O2 Indicator Tape
| Feature | Proposed: VERIFY VH2O2 Indicator Tape | Predicate: VERIFY VH2O2 Indicator
Tape (K183293) | Comparison |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
including
Sterilization
Method and
Cycles | The Indicator Tape is intended to secure items
wrapped in synthetic wrap materials until used
and to distinguish between processed and
unprocessed units through a color change
from the start color (pink) to peach, yellow or
lighter. The Indicator Tape is also intended to
be used as an external process indicator when
applied to synthetic wrap materials and/or
Tyvek pouches.
The tape may be used in the following
sterilization cycles:
Lumen, Non Lumen, Flexible, Fast Non
Lumen, Fast, and Specialty Cycles of the
V-PRO: 1, 1 Plus, maX, maX 2, 60, and
s2 Low Temperature Sterilization
Systems.STERRAD® 100S Sterilizer (Default
Cycle)Standard and Advanced Cycles of the
STERRAD® NX Sterilizer with or
without ALLClearStandard, Flex Scope, Express and DUO
Cycles of the STERRAD® 100NX | The Indicator Tape is intended to secure items
wrapped in synthetic wrap materials until used
and to distinguish between processed and
unprocessed units through a color change
from the start color (pink) to peach, yellow or
lighter. The Indicator Tape is also intended to
be used as an external process indicator when
applied to synthetic wrap materials and/or
Tyvek pouches.
The tape may be used in the following
sterilization cycles:
Lumen, Non Lumen, Fast Non Lumen,
Fast and Flexible Cycles of the V-PRO:
1, 1 Plus, maX, maX 2 and s2 Low
Temperature Sterilization Systems.STERRAD® 100S Sterilizer (Default
Cycle)Standard and Advanced Cycles of the
STERRAD® NX Sterilizer with or
without ALLClearStandard, Flex Scope, Express and DUO
Cycles of the STERRAD® 100NX | The Intended
Use of has been
modified to
include the
Specialty Cycle
of the V-PRO
maX 2.
Inclusion of the
V-PRO 60. The
Indicator Tape
was cleared for
use in the V-
PRO 60 in
K172753 but
was
inadvertently
left off the
indications in
K183293 |
| | Sterilizer without ALLClear | Sterilizer without ALLClear | |
| Chemical
Indicator
Agent and
Performance
Specification | The indicator agent is a vaporized hydrogen
peroxide reactive ink that meets the
requirement specified in ANSI/AAMI/ISO
11140-1:2014 for a Type 1 Process Indicator
for a vaporized hydrogen peroxide process | The indicator agent is a vaporized hydrogen
peroxide reactive ink that meets the
requirement specified in ANSI/AAMI/ISO
11140-1:2014 for a Type 1 Process Indicator
for a vaporized hydrogen peroxide process | Identical |
| End Point
Specification | Tape: Pink to Peach/Yellow | Tape: Pink to Peach/Yellow | Identical |
| Device
Design | Tape: 3/4" wide by 60 yards long crepe
(masking) tape which is wound around a 3"
core. A hydrogen peroxide reactive ink is laid
down on the non-adhesive surface. The ink is
protected from transfer to the adhesive via a
coating. | Tape: 3/4" wide by 60 yards long crepe
(masking) tape which is wound around a 3"
core. A hydrogen peroxide reactive ink is laid
down on the non-adhesive surface. The ink is
protected from transfer to the adhesive via a
coating. | Identical |
| Shelf Life | 24 months | 24 months | Identical |
| Performance
Limitations
(taken from
instructions
for use) | Do not overlap the tape onto itself as this may
prevent the underlying layer from being
appropriately exposed to hydrogen peroxide
resulting in a failed indicator response. | Do not overlap the tape onto itself as this may
prevent the underlying layer from being
exposed to hydrogen peroxide resulting in a
failed indicator response. | Identical |
Table 4.1 Comparison of the Proposed VERIFY | VH2O2 Indicator Tape with the Predicate
The predicate and proposed devices are identical with regards to all features except for the indications for use. Testing is included in the submission to demonstrate that the CI is an appropriate monitor for the V-PRO maX 2 Sterilizer Specialty cycle.
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STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY VH2O2 Indicator Tape
ട്. Performance Testing
Performance testing was completed to simulate typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle.
Table 5-8. Verification Results Summary
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | • Complete color change | |
| • Remain adhered after cycle | • Complete color change | |
| • Remained adhered after cycle |
The results of the performed testing demonstrate that the VERIFY [VH2O2 Indicator Tape performs 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 at least as safely and effectively as the legally marketed predicate device (K183293, Class II as per 21 CFR 880.2800, product code JOJ).