Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a chemical indicator that changes color based on physical parameters, not AI/ML processing.

Therapeutic

No
This device is an integrating indicator used to monitor the effectiveness of steam sterilization cycles for medical instruments, not to treat patients directly.

Diagnostic

No

This device is an integrating indicator used to monitor steam sterilization cycles by indicating whether the sterilization criteria have been met based on a chemical reaction, not a diagnostic device for medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single use device" that is "included in a pack or load in a steam sterilizer" and has a "dark bar on the device" that is observed in a "viewing window." This describes a physical, chemical indicator, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The described device is a chemical indicator used to monitor the effectiveness of steam sterilization cycles for medical instruments and materials. It reacts to the physical parameters of the sterilization process (temperature, time, steam presence).
No Biological Samples: The device does not interact with or analyze any biological samples from a patient. Its function is entirely related to the sterilization process itself.

Therefore, while it's a medical device used in a healthcare setting, it falls under the category of sterilization process indicators, not in vitro diagnostics.

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 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

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

JOJ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was 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.

Study Type: BIER Vessel Testing. Sample Size: Not specified, "Test of 3 Lots"
Key Results:

Pass result at SV for each temperature claimed (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 each temperature claimed: PASS
Fail result at 1°C below SV for each temperature claimed: PASS

Study Type: Simulated Use Testing in Claimed Sterilization Cycles. Sample Size: Not specified.
Key Results:

100% Pass result under pass conditions: PASS
100% Fail result under fail conditions: PASS

Study Type: Dry Heat Testing. Sample Size: Not specified.
Key Results: Fail result when exposed to 140°C dry heat for 30 min: PASS

Study Type: Verification of integrator stated values at biological indicator growth-negative cycle conditions. Sample Size: Not specified.
Key Results: Integrator does not reach endpoint before the biological indicator is inactivated: PASS

Study Type: Offset/ Transference. Sample Size: Not specified.
Key Results: Integrator shall not transfer or offset: PASS

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.

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

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

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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.

1

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

2

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

5

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 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:	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:	The intended use
statement is
identical between
the proposed and
predicate devices.
	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:
•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	Steam Sterilization Cycles
(IUSS):
•270°F/132°C, 4 minutes
Dynamic Air Removal
•270°F/132°C, 3 minutes
Gravity
•270°F/132°C, 10 minutes
Gravity
•275°F/135°C, 3 minutes
dynamic air removal
•275°F/135°C, 3 minutes
Gravity
•275°F/135°C, 10 minutes
Gravity
Device
design -
components	Backing material with
embossed cavity containing
temperature sensitive chemical
and coloring dye, wicking strip,
covered with laminated paper
containing labeling and a
viewing window.	Backing material with
embossed cavity containing
temperature sensitive chemical
and coloring dye, wicking strip,
covered with laminated paper
containing labeling and viewing
windows.	Device design and
components are
similar and any new
questions of safety
and effectiveness will
be mitigated through
performance data.
Indicator
agent	Proprietary formulation	Proprietary formulation	The indicator agent
is identical to the
predicate.
Feature	Proposed	K152630	Comparison
	VERIFY® STEAM
Integrating Indicator - Short	VERIFY® STEAM
Integrating Indicator
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, 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	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 intended cycles
are identical
between the
proposed and
predicate devices.
Mechanism
of action	Proprietary	Proprietary	Mechanism of
action is identical to
predicate.
Endpoint
specifications	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.	The end point is the
same for proposed
and predicate
devices.
	Proposed	K152630	Comparison
Feature	VERIFY® STEAM
Integrating Indicator - Short	VERIFY® STEAM
Integrating Indicator
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	Same performance
observed.
Shelf-life	5 years	5 years	Formulation of ink
is identical to
predicate.
Standard /
Guidance	Conforms to the Guidance for
Industry and FDA Staff:
Premarket Notification
[510(k)] Submissions for
Chemical Indicators for
integrating indicators and
ANSI/AAMI/ISO 11140-
1:2014: Sterilization of Health
Care Products - Chemical
Indicators - Part 1: General
Requirements.	Conforms to the Guidance for
Industry and FDA Staff:
Premarket Notification
[510(k)] Submissions for
Chemical Indicators for
integrating indicators and
ANSI/AAMI/ISO 11140-
1:2014: Sterilization of Health
Care Products - Chemical
Indicators - Part 1: General
Requirements.	Both proposed and
predicate devices
meet the same
applicable standard.

Table 5-1. Device Comparison Table

7

8

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 claimed
Stated 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 each
temperature claimed	PASS
	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
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

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.