(128 days)
Not Found
No.
The device is a chemical indicator that reacts over time to critical parameters of a steam sterilization cycle. It functions mechanically based on chemical reactions, and there is no indication of any computational or cognitive functions associated with AI, machine learning, or neural networks.
No.
The device is an integrating indicator used to monitor the effectiveness of steam sterilization cycles, not to directly treat or diagnose a medical condition.
No
Explanation: This device is an integrating indicator used to monitor steam sterilization cycles. It assesses whether the sterilization criteria (temperature, time, and steam presence) have been met, rather than diagnosing a medical condition in a patient.
No
The device description clearly states it is a "single use device" which uses a "dark bar on the device" that "enters the ACCEPT (OK) window" to indicate a pass. It chemically reacts over time. This describes a physical, chemical indicator, not a software product. The validation involves physical tests like "Stated Value Testing" and "Simulated Use Testing" with physical appearance criteria like "no visible deterioration of the film." There is no mention of software components, algorithms, or digital processing.
No.
This device is an integrating indicator used to monitor the effectiveness of steam sterilization cycles for medical instruments and materials, not for in vitro diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
- 250°F/121°C, 30 minutes Gravity
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 5 minutes Dynamic Air Removal
- 270°F/132°C, 6 minutes Dynamic Air Removal
- 270°F/132°C, 7 minutes Dynamic Air Removal
- 270°F/132°C, 8 minutes Dynamic Air Removal
- 270°F/132°C, 9 minutes Dynamic Air Removal
- 270°F/132°C, 10 minutes Dynamic Air Removal
- 270°F/132°C, 15 minutes Gravity
- 273°F/134°C, 4 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 3 minutes Gravity
- 270°F/132°C, 10 minutes Gravity
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Gravity
- 275°F/135°C, 10 minutes Gravity
Product codes
JOJ
Device Description
The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
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
healthcare providers
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)
Stated Value Testing per ANSI/AAMI/ISO 11140-1:2014 section 11
- Acceptance Criteria:
- All integrators processed will demonstrate no visible deterioration of the film
- All integrators processed in a dry heat cycle will demonstrate a failing result
- The Stated Values for time at 121 °C and 135 °C shall be specified and shall not be less than 16.5 min at 121 °C and 1.2 min at 135 °C
- The temperature coefficient shall not be less than 10°C and not more than 27°C.
- The correlation coefficient shall not be less than 0.9
- Result: PASS
Simulated Use Testing
- Acceptance Criteria:
- All integrators processed in a full cycle will demonstrate a passing result with no physical deterioration of the film
- All integrators processed in a partial cycle will demonstrate a passing result with no physical deterioration of the film
- No integrators will exhibit a leak in the viewing window
- Result: PASS
Stability Study
- Acceptance Criteria:
- All CIs processed in pass/full cycles in the BIER vessel will demonstrate pass results and shall not be under minimum specification limits as per the standard ISO 11140-1
- All CIs processed in fail/partial cycles in BIER vessel will demonstrate fail results
- All CIs processed for dry heat testing will demonstrate fail results.
- Result: PASS
Comparison Testing with Biological Indicator
- Acceptance Criteria: The Chemical Indicator does not reach its endpoint before the biological indicator is inactivated.
- Result: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - VERIFY STEAM Integrating Indicator
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 25, 2025
STERIS Corporation
Logan Persons
Regulatory Affairs Specialist
5960 Heisley Rd
Mentor, Ohio 44060
Re: K243876
Trade/Device Name: VERIFY STEAM Integrating Indicator
Regulation Number: 21 CFR 880.2800
Regulation Name: Sterilization process indicator
Regulatory Class: Class II
Product Code: JOJ
Dated: December 17, 2024
Received: December 18, 2024
Dear Logan Persons:
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"
Page 2
K243876 - Logan Persons Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K243876 - Logan Persons Page 3
Sincerely,
Stephen A. Anisko -S Digitally signed by Stephen A. Anisko -S Date: 2025.04.25 14:59:45 -04'00'
for: Christopher K. Dugard
Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K243876
Device Name
VERIFY STEAM Integrating Indicator
Indications for Use (Describe)
The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
- 250°F/121°C, 30 minutes Gravity
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 5 minutes Dynamic Air Removal
- 270°F/132°C, 6 minutes Dynamic Air Removal
- 270°F/132°C, 7 minutes Dynamic Air Removal
- 270°F/132°C, 8 minutes Dynamic Air Removal
- 270°F/132°C, 9 minutes Dynamic Air Removal
- 270°F/132°C, 10 minutes Dynamic Air Removal
- 270°F/132°C, 15 minutes Gravity
- 273°F/134°C, 4 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 3 minutes Gravity
- 270°F/132°C, 10 minutes Gravity
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Gravity
- 275°F/135°C, 10 minutes Gravity
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.
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 1 of 7
510(k) Summary (K243876)
For
VERIFY STEAM Integrating Indicator
Sponsor Facility
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060
Phone: (440) 354-2600
Fax: (440) 357-9198
Manufacturing Facility
STERIS Corporation Franklin Park
11457 Melrose Ave.
Franklin Park, IL 60131
Phone: (847) 455-2881
Contact
Logan Persons
Regulatory Affairs Specialist
Phone: (440) 392-7325
Fax: (440) 357-9198
Email: Logan_Persons@steris.com
Updated Date:
April 24, 2025
Page 6
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 2 of 7
1. Device Name
Trade Name: VERIFY STEAM Integrating Indicator
Common/usual Name: Chemical Indicator
Device Classification: Class II
Classification Name: Indicator, physical/chemical sterilization process [21 CFR 880.2800(b)]
Product Code: JOJ
2. Predicate Device
Proprietary Name: VERIFY STEAM Integrating Indicator
Common/usual Name: Chemical Indicator
Classification Name: Indicator, physical/chemical sterilization process [21 CFR 880.2800(b)]
Product Code: JOJ
510(k) Submitter/Holder: STERIS Corporation
510(k) Number: K213412
3. Description of Device
The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.
4. Intended Use/Indications for Use
The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
- 250°F/121°C, 30 minutes Gravity
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 5 minutes Dynamic Air Removal
- 270°F/132°C, 6 minutes Dynamic Air Removal
- 270°F/132°C, 7 minutes Dynamic Air Removal
- 270°F/132°C, 8 minutes Dynamic Air Removal
- 270°F/132°C, 9 minutes Dynamic Air Removal
- 270°F/132°C, 10 minutes Dynamic Air Removal
- 270°F/132°C, 15 minutes Gravity
- 273°F/134°C, 4 minutes Dynamic Air Removal
Page 7
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 3 of 7
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
- 270°F/132°C, 4 minutes Dynamic Air Removal
- 270°F/132°C, 3 minutes Gravity
- 270°F/132°C, 10 minutes Gravity
- 275°F/135°C, 3 minutes Dynamic Air Removal
- 275°F/135°C, 3 minutes Gravity
- 275°F/135°C, 10 minutes Gravity
5. Summary of Technological Characteristics
A comparison of technological characteristics are summarized in Table 1.
Table 1. Summary of SCBI Physical Description and Technological Properties
| Feature | VERIFY STEAM Integrating Indicator (K243876) | VERIFY STEAM Integrating Indicator (K213412) | Comparison |
|---|---|---|---|
| Intended Use | The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: |
Steam Sterilization Cycles:
• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal | The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Steam Sterilization Cycles:
• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal | Identical |
Page 8
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 4 of 7
| Feature | VERIFY STEAM Integrating Indicator (K243876) | VERIFY STEAM Integrating Indicator (K213412) | Comparison |
|---|---|---|---|
| • 270°F/132°C, 9 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 10 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 15 minutes Gravity | |||
| • 273°F/134°C, 4 minutes Dynamic Air Removal | |||
| • 275°F/135°C, 3 minutes Dynamic Air Removal | |||
| • 275°F/135°C, 10 minutes Gravity |
Steam Sterilization Cycles (IUSS):
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity | • 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity | |
| Device Design – components | Backing material with embossed cavity containing temperature sensitive chemical and coloring dye, wicking strip, covered with laminated paper containing labeling and windows. | Backing material with embossed cavity containing temperature sensitive chemical and coloring dye, wicking strip, covered with laminated paper containing labeling and windows. | Similar. Plastic layer was changed |
| Indicator agent | Proprietary formulation | Proprietary formulation | Identical |
| Sterilization method and cycles | Steam Sterilization Cycles:
• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal | Steam Sterilization Cycles:
• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal | Identical |
Page 9
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 5 of 7
| Feature | VERIFY STEAM Integrating Indicator (K243876) | VERIFY STEAM Integrating Indicator (K213412) | Comparison |
|---|---|---|---|
| • 270°F/132°C, 6 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 7 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 8 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 9 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 10 minutes Dynamic Air Removal | |||
| • 270°F/132°C, 15 minutes Gravity | |||
| • 273°F/134°C, 4 minutes Dynamic Air Removal | |||
| • 275°F/135°C, 3 minutes Dynamic Air Removal | |||
| • 275°F/135°C, 10 minutes Gravity |
Steam Sterilization Cycles (IUSS):
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity | • 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity
Steam Sterilization Cycles (IUSS):
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity | |
| Mechanism of action | Proprietary | Proprietary | Identical |
| Endpoint specification | The end point is determined by the migration of the steam sensitive dye to an area marked ACCEPT (OK) on the indicator. Endpoint is reached at the stated value (SV) for each claimed temperature. Endpoint is not | The end point is determined by the migration of the steam sensitive dye to an area marked ACCEPT (OK) on the indicator. Endpoint is reached at the stated value (SV) for each claimed temperature. Endpoint is not | Identical |
Page 10
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 6 of 7
| Feature | VERIFY STEAM Integrating Indicator (K243876) | VERIFY STEAM Integrating Indicator (K213412) | Comparison |
|---|---|---|---|
| reached at the stated value -15% time and/or -1°C. | reached at the stated value -15% time and/or -1°C. | ||
| Comparison of integrator stated values at biological indicator growth-negative cycle conditions | Integrator does not reach endpoint before the biological indicator is inactivated. | Integrator does not reach endpoint before the biological indicator is inactivated. | Identical |
| Shelf life | 22 Months | 5 years | Similar |
| Standard/ Guidance | Conforms to: | ||
| • Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators | |||
| • ANSI/AAMI/ISO 11140-1:2014: Sterilization of Health Care Products – Chemical Indicators – Part 1: General Requirements | Conforms to: | ||
| • Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators | |||
| • ANSI/AAMI/ISO 11140-1:2014: Sterilization of Health Care Products – Chemical Indicators – Part 1: General Requirements | Identical |
6. Summary of Non-clinical Tests
Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.
Table 2. Performance Testing
| Test | Acceptance Criteria | Result |
|---|---|---|
| Stated Value Testing per ANSI/AAMI/ISO 11140-1:2014 section 11 | • All integrators processed will demonstrate no visible deterioration of the film | |
| • All integrators processed in a dry heat cycle will demonstrate a failing result | ||
| • The Stated Values for time at 121 °C and 135 °C shall be specified and shall not be less than 16.5 min at 121 °C and 1.2 min at 135 °C | ||
| • The temperature coefficient shall not be less than 10°C and not more than 27°C. | ||
| • The correlation coefficient shall not be less than 0.9 | PASS |
Page 11
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
April 24, 2025 K243876 Page 7 of 7
| Test | Acceptance Criteria | Result |
|---|---|---|
| Simulated Use Testing | • All integrators processed in a full cycle will demonstrate a passing result with no physical deterioration of the film | |
| • All integrators processed in a partial cycle will demonstrate a passing result with no physical deterioration of the film | ||
| • No integrators will exhibit a leak in the viewing window | PASS | |
| Stability Study | • All CIs processed in pass/full cycles in the BIER vessel will demonstrate pass results and shall not be under minimum specification limits as per the standard ISO 11140-1 | |
| • All CIs processed in fail/partial cycles in BIER vessel will demonstrate fail results | ||
| • All CIs processed for dry heat testing will demonstrate fail results. | PASS | |
| Comparison Testing with Biological Indicator | • The Chemical Indicator does not reach its endpoint before the biological indicator is inactivated. | PASS |
7. Conclusion
The VERIFY STEAM Integrating Indicator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device (K243876) is as safe, as effective, and performs as well as the legally marketed predicate device (K213412), Class II (21 CFR 880.2800), product code JOJ.