Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chemical indicator that changes color based on physical parameters of a steam sterilization cycle. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No
The device is described as an "integrating indicator" designed to monitor steam sterilization cycles, not to provide therapy. Its function is to verify that sterilization criteria have been met.

Diagnostic

No

The device monitors the parameters of a steam sterilization cycle, indicating whether the sterilization criteria have been met or not. It does not diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single use device" that is a "strip" with a "dark bar" that "chemically react[s]" and is "observed" visually. This indicates a physical, chemical indicator, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The described device is an integrating indicator used to monitor the effectiveness of steam sterilization cycles for medical instruments and materials. It chemically reacts to the physical parameters of the sterilization process (temperature and time).
Intended Use: The intended use is to verify that the sterilization process has met the required criteria, ensuring the processed items are sterile and safe for use on patients. It does not involve testing human specimens.
Device Description: The description clearly states it's a single-use device included in a pack or load within a steam sterilizer. Its function is to provide a visual indication of whether the sterilization cycle was successful.

Therefore, the device falls under the category of a sterilization process indicator, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

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 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.

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.

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)

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

Simulated Use Testing in Claimed Sterilization Cycles: 100% pass under pass conditions, 100% fail under fail conditions. Conclusion: PASS.
Parallel performance as biological indicator: Integrator does not reach endpoint before the biological indicator is inactivated. Conclusion: PASS.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152630, K162631

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

2

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.

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Indications for Use

510(k) Number (if known) 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 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."

6

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: (440) 354-2600

Manufacturing Facility

STERIS Franklin Park 11457 Melrose Ave. Franklin Park, IL 60131 Phone: (847) 455-2881

Contact: Jennifer Nalepka, M.S. Lead Regulatory Affairs Specialist Phone: (440) 392-7458 Email: jennifer_nalepka@steris.com

Submission Date: January 18, 2022

Premarket Notification Number: K213412

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

7

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):

8

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
(K213412)	Integrating Indicator
(K152630)	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
• 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 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
Steam Sterilization Cycles
(IUSS):
• 270°F/132°C, 4 minutes
Dynamic Air Removal
• 270°F/132°C, 3 minutes
Gravity	Similar, the
proposed
device has
additional
cycle claims.
Feature	VERIFY STEAM
Integrating Indicator
(K213412)	VERIFY STEAM
Integrating Indicator
(K152630)	Comparison
	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	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.	Identical
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 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	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	Similar, the
proposed
device has
additional
cycle claims.
	VERIFY STEAM
Integrating Indicator
(K213412)	VERIFY STEAM
Integrating Indicator
(K152630)	Comparison
Feature	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, 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
reached at the stated value -15%
time and/or -1°C.	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
reached at the stated value -15%
time and/or -1°C.	Identical
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	5 years	5 years	Identical
Standard/
Guidance	Conforms to:
• Guidance for Industry and
FDA Staff: Premarket	Conforms to:
• Guidance for Industry and
FDA Staff: Premarket	Identical
Feature	VERIFY STEAM
Integrating Indicator
(K213412)	VERIFY STEAM
Integrating Indicator
(K152630)	Comparison
	Notification [510(k)]
Submissions for Chemical
Indicators
• ANSI/AAMI/ISO 11140-
1:2014: Sterilization of
Health Care Products –
Chemical Indicators – Part 1:
General Requirements	Notification [510(k)]
Submissions for Chemical
Indicators
• ANSI/AAMI/ISO 11140-
1:2014: Sterilization of
Health Care Products –
Chemical Indicators – Part 1:
General Requirements

Table 1. Summary of SCBI Physical Description and Technological Properties

9

10

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

11

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
Claimed Sterilization Cycles	100% pass under pass
conditions
100% fail under fail
conditions	PASS
Parallel performance as
biological indicator	Integrator does not reach
endpoint before the
biological indicator is
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: (440) 354-2600

Manufacturing Facility

STERIS Franklin Park 11457 Melrose Ave. Franklin Park, IL 60131 Phone: (847) 455-2881

Contact: Jennifer Nalepka, M.S. Lead Regulatory Affairs Specialist Phone: (440) 392-7458 Email: jennifer_nalepka@steris.com

Submission Date: January 18, 2022

Premarket Notification Number: K213412

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

13

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
Integrating Indicator 5CM
(K213412) | VERIFY STEAM
Integrating Indicator -Short
(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:
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:
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
Integrating Indicator 5CM
(K213412) | VERIFY STEAM
Integrating Indicator -Short
(K162631) | Comparison |
| 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. | Identical |
| 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
• 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, 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 | 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
• 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, 10 minutes
Gravity
• 275°F/135°C, 3 minutes
Gravity
Steam Sterilization Cycles
(IUSS): | Similar, the
proposed
device has
additional
cycle claims. |
| Feature | VERIFY STEAM
Integrating Indicator 5CM
(K213412) | VERIFY STEAM
Integrating Indicator -Short
(K162631) | Comparison |
| | • 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, 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
reached at the stated value -15%
time and/or -1°C. | 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
reached at the stated value -15%
time and/or -1°C. | Identical |
| 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 |
| Feature | VERIFY STEAM
Integrating Indicator 5CM
(K213412) | VERIFY STEAM
Integrating Indicator -Short
(K162631) | Comparison |
| 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 |

15

16

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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
Claimed Sterilization Cycles	100% pass under pass
conditions	PASS
Simulated Use Testing in
Claimed Sterilization Cycles	100% fail under fail
conditions	PASS
Parallel performance as
biological indicator	Integrator does not reach
endpoint before the
biological indicator is
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.