(128 days)
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 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, 15 minutes Gravity
- · 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
The VERIFY® STEAM Integrating Indicator – Short is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator - Short is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer 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) area of the viewing 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) area of the viewing window, 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.
This document describes the performance testing and acceptance criteria for the VERIFY® STEAM Integrating Indicator – Short, a chemical indicator used to monitor steam sterilization cycles.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Study Result |
|---|---|---|
| BIER Vessel Testing | ||
| At Stated Values (SV) | Pass result at SV for each temperature claimed: | PASS |
| 26.5 min at 121°C | ||
| 2.7 min at 132 °C | ||
| 1.4 min at 135 °C | ||
| At 15% below SV | Fail result at 15% below SV for each temperature claimed | PASS |
| At 1°C below SV | Fail result at 1°C below SV for each temperature claimed | PASS |
| Simulated Use Testing in Claimed Sterilization Cycles | 100% Pass result under pass conditions | PASS |
| 100% Fail result under fail conditions | PASS | |
| Dry Heat Testing | Fail result when exposed to 140°C dry heat for 30 min | PASS |
| Verification of integrator stated values at biological indicator growth-negative cycle conditions | Integrator does not reach endpoint before the biological indicator is inactivated | PASS |
| Offset/Transference | Integrator shall not transfer or offset | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "Test of 3 Lots" for the BIER Vessel Testing. For Simulated Use Testing, it implies a sufficient number of tests to achieve "100% Pass result under pass conditions" and "100% Fail result under fail conditions." Specific numerical sample sizes for each test condition are not explicitly provided beyond the "3 lots" for BIER testing.
- Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA. This indicates the data is prospective, generated specifically for regulatory approval. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying either U.S. or internationally generated data adhering to U.S. regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This device is a chemical indicator that directly reacts to physical parameters (temperature and time) of a sterilization cycle. The "ground truth" for its performance is established by the controlled physical conditions of the sterilization cycles themselves (e.g., using an ISO 18472-conforming steam resistometer for BIER vessel testing).
- Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of complex medical images (like radiology) does not apply here. The device's pass/fail outcome is based on a direct chemical reaction against predefined physical parameters, not subjective human assessment.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, the assessment of the device's performance is objective, based on its chemical reaction against controlled physical parameters, rather than requiring human interpretation and adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This device is a chemical indicator, not an AI or imaging diagnostic tool that would be used by human readers for interpretation. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this product.
6. Standalone (Algorithm Only) Performance:
- This section describes the standalone performance of the chemical indicator itself. The device is designed to function independently by chemically reacting to sterilization conditions. Its "performance" refers to its ability to accurately reflect whether the critical parameters of a steam sterilization cycle have been met. The entire "Performance Testing" section (Table 5-2) details this standalone performance. For example, "Pass result at SV for each temperature claimed" demonstrates its performance when exposed to the specified sterilization parameters without human intervention for the primary assessment (though humans read the final indicator).
7. Type of Ground Truth Used:
- The ground truth used is based on controlled physical parameters of steam sterilization cycles, as defined by industry standards (e.g., ANSI/AAMI/ISO 11140-1:2014) and governmental guidance (FDA Guidance for Industry and FDA Staff: Premarket [510(k)] Submissions for Chemical Indicators).
- Specifically, this includes:
- Stated Values (SV): Precise temperature and time combinations at which the sterilization is expected to be successful.
- Sub-optimal Conditions: Conditions below the SV (e.g., 15% below SV or 1°C below SV, or "fail conditions" in simulated use testing) where sterilization is expected to fail.
- Biological Indicator Inactivation: Comparison to the known performance of biological indicators which serve as the gold standard for sterilization efficacy.
8. Sample Size for the Training Set:
- This device is a physical/chemical indicator, not a machine learning or AI algorithm that requires a "training set." Its function is based on inherent chemical properties and design, not on learned patterns from data. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, with flowing lines connecting them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Steris Corporation Tricia Cregger, Ph.D. Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K162631
Trade/Device Name: Verify Steam Integrating Indicator - Short Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: December 19, 2016 Received: December 19, 2016
Dear Tricia Cregger:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162631
Device Name VERIFY STEAM Integrating Indicator- Short
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 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, 15 minutes Gravity
- · 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a serif font, with the registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal wavy lines, resembling water.
510(k) Summary For K162631 VERIFY® STEAM Integrating Indicator – Short
STERIS Corporation 11457 Melrose Street Franklin Park, IL 60131
Contact:
Tricia Cregger, Ph.D. Manager, Regulatory Affairs Telephone: (440) 392-7189 Fax No: (440) 357-9198 e-mail: Tricia_Cregger@steris.com
Submission Date: January 23, 2017
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | VERIFY® STEAM Integrating Indicator – Short |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Indicator, physical/chemical sterilization process |
| Classification Name: | Indicator, physical/chemical sterilization process(21 CFR 880.2800, JOJ) |
2. Predicate Device
VERIFY® |STEAM Integrating Indicator (K152630)
3. Description of Device
The VERIFY® STEAM Integrating Indicator – Short is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator - Short is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer 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) area of the viewing 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) area of the viewing window, 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
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, 15 minutes Gravity
- · 275°F/135°C, 3 minutes dynamic air removal
- · 275°F/135°C, 10 minutes Gravity
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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
ട്. Description of Substantial Equivalence
The proposed and predicate devices are both single use integrating indicators for use in monitoring steam sterilization cycles. The differences between the proposed VERIFY® |STEAM Integrating Indicator - Short and the predicate device are limited to differences in the materials used and the overall length of the device. However, these differences do not affect the intended use or performance characteristics, nor do the differences raise any new concerns of equivalence when compared to the predicate device. Performance testing has been conducted for monitoring all claimed steam sterilization cycles in accordance with the Guidance for Industry and FDA Staff: Premarket [510(k)] Submissions for Chemical Indicators.
Technological Characteristics 6.
The proposed and predicate devices are single use integrating indicators for use in monitoring particular steam sterilization cycles. The device components, mechanism of action, and endpoint are the same as the predicate's and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible migration of the included chemistry to indicate that stated values have been achieved.
Table 5-1 contains a comparison of technological characteristics and specifications of the proposed VERIFY® STEAM Integrating Indicator - Short to the predicate VERIFY® STEAM Integrating Indicator.
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| Proposed | K152630 | Comparison | |
|---|---|---|---|
| Feature | VERIFY® STEAM | VERIFY® STEAM | |
| Integrating Indicator - Short | Integrating Indicator | ||
| Intended use | The integrating indicator isdesigned to chemically reactover time with the criticalparameters of a steamsterilization cycle within aspecified tolerance. Theintegrating indicator strip isintended to be placed in eachpack, pouch, container, tray orother containment device tofunction as an independentmonitor of critical parametersfor the following sterilizationcycles: | The integrating indicator isdesigned to chemically reactover time with the criticalparameters of steamsterilization cycle within aspecified tolerance. Theintegrating indicator strip isintended to be placed in eachpack, pouch, container, tray orother containment device tofunction as an independentmonitor of critical parametersfor the following sterilizationcycles: | The intended usestatement isidentical betweenthe proposed andpredicate devices. |
| Steam Sterilization Cycles:•250°F/121°C, 30 minutesGravity•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 15 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 10 minutesGravity | Steam Sterilization Cycles:•250°F/121°C, 30 minutesGravity•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 15 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 10 minutesGravity | ||
| Steam Sterilization Cycles(IUSS):•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 3 minutesGravity•270°F/132°C, 10 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 3 minutesGravity•275°F/135°C, 10 minutesGravity | Steam Sterilization Cycles(IUSS):•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 3 minutesGravity•270°F/132°C, 10 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 3 minutesGravity•275°F/135°C, 10 minutesGravity | ||
| Devicedesign -components | Backing material withembossed cavity containingtemperature sensitive chemicaland coloring dye, wicking strip,covered with laminated papercontaining labeling and aviewing window. | Backing material withembossed cavity containingtemperature sensitive chemicaland coloring dye, wicking strip,covered with laminated papercontaining labeling and viewingwindows. | Device design andcomponents aresimilar and any newquestions of safetyand effectiveness willbe mitigated throughperformance data. |
| Indicatoragent | Proprietary formulation | Proprietary formulation | The indicator agentis identical to thepredicate. |
| Feature | Proposed | K152630 | Comparison |
| VERIFY® STEAMIntegrating Indicator - Short | VERIFY® STEAMIntegrating Indicator | ||
| Sterilizationmethod andcycles | Steam Sterilization Cycles:•250°F/121°C, 30 minutesGravity•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 15 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 10 minutesGravitySteam Sterilization Cycles(IUSS):•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 3 minutesGravity•270°F/132°C, 10 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 3 minutesGravity•275°F/135°C, 10 minutesGravity | Steam Sterilization Cycles:•250°F/121°C, 30 minutesGravity•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 15 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 10 minutesGravitySteam Sterilization Cycles(IUSS):•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 3 minutesGravity•270°F/132°C, 10 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 3 minutesGravity•275°F/135°C, 10 minutesGravity | The intended cyclesare identicalbetween theproposed andpredicate devices. |
| Mechanismof action | Proprietary | Proprietary | Mechanism ofaction is identical topredicate. |
| Endpointspecifications | The end point is determinedby the migration of the steamsensitive dye to an areamarked ACCEPT (OK) on theindicator. Endpoint is reachedat the stated value (SV) foreach claimed temperature.Endpoint is not reached at thestated value - 15% time and/or1°C. | The end point is determinedby the migration of the steamsensitive dye to an areamarked ACCEPT (OK) on theindicator. Endpoint is reachedat the stated value (SV) foreach claimed temperature.Endpoint is not reached at thestated value - 15% time and/or1°C. | The end point is thesame for proposedand predicatedevices. |
| Proposed | K152630 | Comparison | |
| Feature | VERIFY® STEAMIntegrating Indicator - Short | VERIFY® STEAMIntegrating Indicator | |
| Comparisonof integratorstated valuesat biologicalindicatorgrowth-negativecycleconditions | Integrator does not reachendpoint before the biologicalindicator is inactivated. | Integrator does not reachendpoint before the biologicalindicator is inactivated | Same performanceobserved. |
| Shelf-life | 5 years | 5 years | Formulation of inkis identical topredicate. |
| Standard /Guidance | Conforms to the Guidance forIndustry and FDA Staff:Premarket Notification[510(k)] Submissions forChemical Indicators forintegrating indicators andANSI/AAMI/ISO 11140-1:2014: Sterilization of HealthCare Products - ChemicalIndicators - Part 1: GeneralRequirements. | Conforms to the Guidance forIndustry and FDA Staff:Premarket Notification[510(k)] Submissions forChemical Indicators forintegrating indicators andANSI/AAMI/ISO 11140-1:2014: Sterilization of HealthCare Products - ChemicalIndicators - Part 1: GeneralRequirements. | Both proposed andpredicate devicesmeet the sameapplicable standard. |
Table 5-1. Device Comparison Table
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7. Performance Testing
Performance testing was conducted to verify that the proposed VERIFY® STEAM Integrating Indicator - Short meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.
Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the proposed VERIFY® |STEAM | Integrating Indicator - Short is as safe and is as effective as the predicate device. 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 claimed steam sterilization cycles.
Stated Values
The subject device (integrator indicator) testing was performed in an ISO 18472conforming steam resistometer using the following stated values shown below at the following temperatures (see Table 5-2). The integrator indicator showed a passing result when the chemicals in the subject device reacted to all critical parameters in the bier vessel.
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| Test of 3 Lots | Acceptance Criteria | Study Result |
|---|---|---|
| BIER Vessel Testing | Pass result at SV for each temperature claimedStated values are:• 26.5 min at 121°C• 2.7 min at 132 °C• 1.4 min at 135 °C | PASS |
| Fail result at 15% below SV for eachtemperature claimed | PASS | |
| Fail result at 1°C below SV for eachtemperature claimed | PASS | |
| Simulated Use Testing inClaimed SterilizationCycles | 100% Pass result under pass conditions100% Fail result under fail conditions | PASS |
| Dry Heat Testing | Fail result when exposed to 140°C dry heatfor 30 min | PASS |
| Verification of integratorstated values at biologicalindicator growth-negativecycle conditions | Integrator does not reach endpoint before thebiological indicator is inactivated | PASS |
| Offset/ Transference | Integrator shall not transfer or offset | PASS |
| Table 5-2. Verification Results Summary | |
|---|---|
The results of the VERIFY® |STEAM Integrating Indicator – Short performance testing demonstrate that it performs as intended in the claimed steam sterilization cycles and the proposed device is substantially equivalent to the predicate device.
8. Conclusion
Based on the conclusions from the non-clinical tests, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K152630), Class II (21 CFR 880.2800), product code JOJ.
§ 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).