VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

K213412 · Steris Corparation · JOJ · Jan 21, 2022 · General Hospital

Device Facts

• Record ID: K213412
• Device Name: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
• Applicant: Steris Corparation
• Product Code: JOJ · General Hospital
• Decision Date: Jan 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

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 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 Story

Single-use chemical integrating indicator; placed inside sterilization packs/trays; monitors steam sterilization cycle parameters (time, temperature, steam). Device contains temperature-sensitive chemical/dye and wicking strip within embossed cavity. During cycle, dye migrates; if dark bar reaches 'ACCEPT' window, cycle is PASS; otherwise, FAIL. Used by healthcare providers in clinical settings to verify sterilization efficacy before item use. Provides immediate visual confirmation of cycle success; prevents use of improperly processed materials.

Clinical Evidence

Bench testing only. Simulated use testing in claimed sterilization cycles demonstrated 100% pass/fail performance. Parallel performance testing against biological indicators confirmed the integrator does not reach the endpoint before biological indicator inactivation.

Technological Characteristics

Single-use strip; backing material with embossed cavity; temperature-sensitive chemical/dye; wicking strip; laminated paper cover with windows. Conforms to ANSI/AAMI/ISO 11140-1:2014. Shelf life: 5 years. No software or electronics.

Indications for Use

Indicated for use by healthcare providers as an independent monitor of critical steam sterilization parameters (time, temperature, steam) within packs, pouches, containers, or trays during specified gravity and dynamic air removal steam sterilization cycles, including IUSS.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• VERIFY STEAM Integrating Indicator (K152630)
• VERIFY STEAM Integrating Indicator - Short (K162631)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

January 21, 2022

STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

### Re: K213412

Trade/Device Name: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator રુદ્ભ Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: October 18, 2021 Received: October 19, 2021

Dear Jennifer Nalepka:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, PhD Acting 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

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#### Indications for Use

510(k) Number (if known) K213412

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 sterlilization 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
- · 270ºF/132ºC. 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.

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#### Indications for Use

510(k) Number (if known) K213412

Device Name VERIFY STEAM Integrating Indicator 5CM

#### 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, 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.

{5}------------------------------------------------

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 [e-mail]

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Image /page/6/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is written in a bold, serif font. Below the word is a graphic of several horizontal wavy lines stacked on top of each other. The lines are blue.

# 510(k) Summary for VERIFY STEAM INTEGRATING Indicator K213412

#### Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone]

#### Manufacturing Facility

STERIS Franklin Park 11457 Melrose Ave. Franklin Park, IL 60131 Phone: [phone]

Contact: Jennifer Nalepka, M.S. Lead Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

Submission Date: January 18, 2022

Premarket Notification Number: K213412

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 |
|----------------------------|----------------------------------------------------|
| Classification/usual Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | II |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | JOJ |

#### 2. Predicate Device

VERIFY STEAM Integrating Indicator, K152630

## 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 or load 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
- 275°F/135°C, 3 minutes Dynamic Air Removal ●
- 275°F/135°C, 10 minutes Gravity ●

Steam Sterilization Cycles (IUSS):

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- 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 technical characteristics are summarized in Table 1.

| | VERIFY STEAM | VERIFY STEAM | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Feature | Integrating Indicator<br>(K213412) | Integrating Indicator<br>(K152630) | Comparison |
| Intended Use | The integrating indicator is<br>designed to chemically react<br>over time with the critical<br>parameters of a steam<br>sterilization cycle within a<br>specified tolerance. The<br>integrating indicator strip is<br>intended to be placed in each<br>pack, pouch, container, tray or<br>other containment device to<br>function as an independent<br>monitor of critical parameters for<br>the following sterilization<br>cycles:<br>Steam Sterilization Cycles:<br>• 250°F/121°C, 30 minutes<br>Gravity<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 5 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 6 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 7 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 8 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 9 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 10 minutes<br>Dynamic Air Removal | The integrating indicator is<br>designed to chemically react<br>over time with the critical<br>parameters of steam sterilization<br>cycle within a specified<br>tolerance. The integrating<br>indicator strip is intended to be<br>placed in each pack, pouch,<br>container, tray or other<br>containment device to function<br>as an independent monitor of<br>critical parameters for the<br>following sterilization cycles:<br>Steam Sterilization Cycles:<br>• 250°F/121°C, 30 minutes<br>Gravity<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 15 minutes<br>Gravity<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 10 minutes<br>Gravity<br>Steam Sterilization Cycles<br>(IUSS):<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 3 minutes<br>Gravity | Similar, the<br>proposed<br>device has<br>additional<br>cycle claims. |
| Feature | VERIFY STEAM<br>Integrating Indicator<br>(K213412) | VERIFY STEAM<br>Integrating Indicator<br>(K152630) | Comparison |
| | 273°F/134°C, 4 minutes<br>Dynamic Air Removal 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 10 minutes<br>Gravity Steam Sterilization Cycles<br>(IUSS): 270°F/132°C, 4 minutes<br>Dynamic Air Removal 270°F/132°C, 3 minutes<br>Gravity 270°F/132°C, 10 minutes<br>Gravity 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 3 minutes<br>Gravity 275°F/135°C, 10 minutes<br>Gravity | 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 3 minutes<br>Gravity 275°F/135°C, 10 minutes<br>Gravity | |
| Device Design<br>– components | Backing material with embossed<br>cavity containing temperature<br>sensitive chemical and coloring<br>dye, wicking strip, covered with<br>laminated paper containing<br>labeling and windows. | Backing material with embossed<br>cavity containing temperature<br>sensitive chemical and coloring<br>dye, wicking strip, covered with<br>laminated paper containing<br>labeling and windows. | Identical |
| Indicator<br>agent | Proprietary formulation | Proprietary formulation | Identical |
| Sterilization<br>method and<br>cycles | Steam Sterilization Cycles: 250°F/121°C, 30 minutes<br>Gravity 270°F/132°C, 4 minutes<br>Dynamic Air Removal 270°F/132°C, 5 minutes<br>Dynamic Air Removal 270°F/132°C, 6 minutes<br>Dynamic Air Removal 270°F/132°C, 7 minutes<br>Dynamic Air Removal 270°F/132°C, 8 minutes<br>Dynamic Air Removal 270°F/132°C, 9 minutes<br>Dynamic Air Removal 270°F/132°C, 10 minutes<br>Dynamic Air Removal | Steam Sterilization Cycles: 250°F/121°C, 30 minutes<br>Gravity 270°F/132°C, 4 minutes<br>Dynamic Air Removal 270°F/132°C, 15 minutes<br>Gravity 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 10 minutes<br>Gravity Steam Sterilization Cycles<br>(IUSS): 270°F/132°C, 4 minutes<br>Dynamic Air Removal | Similar, the<br>proposed<br>device has<br>additional<br>cycle claims. |
| | VERIFY STEAM<br>Integrating Indicator<br>(K213412) | VERIFY STEAM<br>Integrating Indicator<br>(K152630) | Comparison |
| Feature | 270°F/132°C, 15 minutes<br>Gravity 273°F/134°C, 4 minutes<br>Dynamic Air Removal 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 10 minutes<br>Gravity Steam Sterilization Cycles<br>(IUSS): 270°F/132°C, 4 minutes<br>Dynamic Air Removal 270°F/132°C, 3 minutes<br>Gravity 270°F/132°C, 10 minutes<br>Gravity 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 3 minutes<br>Gravity 275°F/135°C, 10 minutes<br>Gravity | 270°F/132°C, 3 minutes<br>Gravity 270°F/132°C, 10 minutes<br>Gravity 275°F/135°C, 3 minutes<br>Dynamic Air Removal 275°F/135°C, 3 minutes<br>Gravity 275°F/135°C, 10 minutes<br>Gravity | |
| Mechanism of<br>action | Proprietary | Proprietary | Identical |
| Endpoint<br>specification | The end point is determined by<br>the migration of the steam<br>sensitive dye to an area marked<br>ACCEPT (OK) on the indicator.<br>Endpoint is reached at the stated<br>value (SV) for each claimed<br>temperature. Endpoint is not<br>reached at the stated value -15%<br>time and/or -1°C. | The end point is determined by<br>the migration of the steam<br>sensitive dye to an area marked<br>ACCEPT (OK) on the indicator.<br>Endpoint is reached at the stated<br>value (SV) for each claimed<br>temperature. Endpoint is not<br>reached at the stated value -15%<br>time and/or -1°C. | Identical |
| Comparison<br>of integrator<br>stated values<br>at biological<br>indicator<br>growth-<br>negative cycle<br>conditions | Integrator does not reach<br>endpoint before the biological<br>indicator is inactivated. | Integrator does not reach<br>endpoint before the biological<br>indicator is inactivated. | Identical |
| Shelf life | 5 years | 5 years | Identical |
| Standard/<br>Guidance | Conforms to:<br>• Guidance for Industry and<br>FDA Staff: Premarket | Conforms to:<br>• Guidance for Industry and<br>FDA Staff: Premarket | Identical |
| Feature | VERIFY STEAM<br>Integrating Indicator<br>(K213412) | VERIFY STEAM<br>Integrating Indicator<br>(K152630) | Comparison |
| | Notification [510(k)]<br>Submissions for Chemical<br>Indicators<br>• ANSI/AAMI/ISO 11140-<br>1:2014: Sterilization of<br>Health Care Products –<br>Chemical Indicators – Part 1:<br>General Requirements | Notification [510(k)]<br>Submissions for Chemical<br>Indicators<br>• ANSI/AAMI/ISO 11140-<br>1:2014: Sterilization of<br>Health Care Products –<br>Chemical Indicators – Part 1:<br>General Requirements | |

#### Table 1. Summary of SCBI Physical Description and Technological Properties

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#### STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY STEAM Integrating Indicator and VERIFY STEAM Integrating Indicator 5CM

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#### STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY |STEAM Integrating Indicator and VERIFY |STEAM Integrating Indicator 5CM

### 6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 2 below.

| Test | Acceptance Criteria | Conclusion |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------|------------|
| Simulated Use Testing in<br>Claimed Sterilization Cycles | 100% pass under pass<br>conditions<br>100% fail under fail<br>conditions | PASS |
| Parallel performance as<br>biological indicator | Integrator does not reach<br>endpoint before the<br>biological indicator is<br>inactivated | PASS |

Table 2. Summary of nonclinical testing

# 7. Conclusion

Based on the intended use, technological characteristics and nonclinical performance data, the subject device (K213412) is as safe, as effective, and performs as well or better than the legally marketed predicate device (K152630), Class II (21 CFR 880.2800), product code JOJ.

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Image /page/12/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

# 510(k) Summary for VERIFY STEAM INTEGRATING Indicator 5CM

#### Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone]

#### Manufacturing Facility

STERIS Franklin Park 11457 Melrose Ave. Franklin Park, IL 60131 Phone: [phone]

Contact: Jennifer Nalepka, M.S. Lead Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

Submission Date: January 18, 2022

Premarket Notification Number: K213412

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 5CM |
|----------------------------|----------------------------------------------------|
| Classification/usual Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | II |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Classification Number: | 21 CFR 880.2800 |
| Product Code: | JOJ |

#### 2. Predicate Device

VERIFY |STEAM| Integrating Indicator - Short, K162631

## 3. Description of Device

The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator 5CM is included in a pack or load 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 ●
- 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 .

## 5. Summary of Technological Characteristics

A comparison of technical characteristics are summarized in Table 1.

| | | | Table 1. Summary of the Integrating Indicator Physical Description and Technological |
|------------|--|--|--------------------------------------------------------------------------------------|
| Properties | | | |

| Feature | VERIFY STEAM<br>Integrating Indicator 5CM<br>(K213412) | VERIFY STEAM<br>Integrating Indicator -Short<br>(K162631) | 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:<br>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 | 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:<br>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 | Similar, the proposed device has additional cycle claims. |
| Feature | VERIFY STEAM<br>Integrating Indicator 5CM<br>(K213412) | VERIFY STEAM<br>Integrating Indicator -Short<br>(K162631) | Comparison |
| Device Design<br>– components | Backing material with embossed<br>cavity containing temperature<br>sensitive chemical and coloring<br>dye, wicking strip, covered with<br>laminated paper containing<br>labeling and windows. | Backing material with embossed<br>cavity containing temperature<br>sensitive chemical and coloring<br>dye, wicking strip, covered with<br>laminated paper containing<br>labeling and windows. | Identical |
| Indicator<br>agent | Proprietary formulation | Proprietary formulation | Identical |
| Sterilization<br>method and<br>cycles | Steam Sterilization Cycles:<br>• 250°F/121°C, 30 minutes<br>Gravity<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 5 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 6 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 7 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 8 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 9 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 15 minutes<br>Gravity<br>• 273°F/134°C, 4 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 10 minutes<br>Gravity<br>Steam Sterilization Cycles<br>(IUSS):<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 3 minutes<br>Gravity<br>• 270°F/132°C, 10 minutes<br>Gravity<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 3 minutes<br>Gravity<br>• 275°F/135°C, 10 minutes<br>Gravity | Steam Sterilization Cycles:<br>• 250°F/121°C, 30 minutes<br>Gravity<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 15 minutes<br>Gravity<br>• 270°F/132°C, 3 minutes<br>Gravity<br>• 270°F/132°C, 10 minutes<br>Gravity<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 10 minutes<br>Gravity<br>• 275°F/135°C, 3 minutes<br>Gravity<br>Steam Sterilization Cycles<br>(IUSS): | Similar, the<br>proposed<br>device has<br>additional<br>cycle claims. |
| Feature | VERIFY STEAM<br>Integrating Indicator 5CM<br>(K213412) | VERIFY STEAM<br>Integrating Indicator -Short<br>(K162631) | Comparison |
| | • 270°F/132°C, 10 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 15 minutes<br>Gravity<br>• 273°F/134°C, 4 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 10 minutes<br>Gravity<br>Steam Sterilization Cycles (IUSS):<br>• 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 3 minutes<br>Gravity<br>• 270°F/132°C, 10 minutes<br>Gravity<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 3 minutes<br>Gravity<br>• 275°F/135°C, 10 minutes<br>Gravity | • 270°F/132°C, 4 minutes<br>Dynamic Air Removal<br>• 270°F/132°C, 3 minutes<br>Gravity<br>• 270°F/132°C, 10 minutes<br>Gravity<br>• 275°F/135°C, 3 minutes<br>Dynamic Air Removal<br>• 275°F/135°C, 3 minutes<br>Gravity<br>• 275°F/135°C, 10 minutes<br>Gravity | |
| Mechanism of action | Proprietary | Proprietary | Identical |
| Endpoint<br>specification | The end point is determined by<br>the migration of the steam<br>sensitive dye to an area marked<br>ACCEPT (OK) on the indicator.<br>Endpoint is reached at the stated<br>value (SV) for each claimed<br>temperature. Endpoint is not<br>reached at the stated value -15%<br>time and/or -1°C. | The end point is determined by<br>the migration of the steam<br>sensitive dye to an area marked<br>ACCEPT (OK) on the indicator.<br>Endpoint is reached at the stated<br>value (SV) for each claimed<br>temperature. Endpoint is not<br>reached at the stated value -15%<br>time and/or -1°C. | Identical |
| Comparison<br>of integrator<br>stated values<br>at biological<br>indicator<br>growth-<br>negative cycle<br>conditions | Integrator does not reach<br>endpoint before the biological<br>indicator is inactivated. | Integrator does not reach<br>endpoint before the biological<br>indicator is inactivated. | Identical |
| Feature | VERIFY STEAM<br>Integrating Indicator 5CM<br>(K213412) | VERIFY STEAM<br>Integrating Indicator -Short<br>(K162631) | Comparison |
| Standard/<br>Guidance | Conforms to:<br>• Guidance for Industry and<br>FDA Staff: Premarket<br>Notification [510(k)]<br>Submissions for Chemical<br>Indicators<br>• ANSI/AAMI/ISO 11140-<br>1:2014: Sterilization of<br>Health Care Products –<br>Chemical Indicators – Part 1:<br>General Requirements | Conforms to:<br>• Guidance for Industry and<br>FDA Staff: Premarket<br>Notification [510(k)]<br>Submissions for Chemical<br>Indicators<br>• ANSI/AAMI/ISO 11140-<br>1:2014: Sterilization of<br>Health Care Products –<br>Chemical Indicators – Part 1:<br>General Requirements | Identical |

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#### STERIS Traditional 510(k) PREMARKET NOTIFICATION VERIFY |STEAM Integrating Indicator and VERIFY |STEAM Integrating Indicator 5CM

### 6. Summary of Nonclinical Tests

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 2 below.

| Test | Acceptance Criteria | Conclusion |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------|------------|
| Simulated Use Testing in<br>Claimed Sterilization Cycles | 100% pass under pass<br>conditions | PASS |
| Simulated Use Testing in<br>Claimed Sterilization Cycles | 100% fail under fail<br>conditions | PASS |
| Parallel performance as<br>biological indicator | Integrator does not reach<br>endpoint before the<br>biological indicator is<br>inactivated | PASS |

Table 2. Summary of nonclinical testing

# 7. Conclusion

Based on the intended use, technological characteristics and nonclinical performance data, the subject device (K213412) is as safe, as effective, and performs as well or better than the legally marketed predicate device (K162631), Class II (21 CFR 880.2800), product code JOJ.