The NAMSA Chemical Process Indicator Strip for Steam, REF TST4-S is intended for use with individual materials (i.e. pouches, pack, tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals as a process indicator:

121°C for 30 minutes (gravity cycle) .
134℃ for 3 minutes (pre-vacuum) .

Device Description

The NAMSA Chemical Process Indicator Strip for Steam utilizes NAMSA indicating ink SSI-10-YBI that when exposed to high temperature steam turns from an initial yellow color to a permanent dark brown/black signal color. The intended use for the NAMSA Chemical Process Indicator Strip for Steam processes is a Process Indicator intended for use by health care facilities to distinguish between processed and unprocessed goods. The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a permanent dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals:

121℃ for 30 minutes (gravity cycle) ●
134℃ for 3 minutes (pre-vacuum) .

AI/ML Overview

This document describes the NAMSA Chemical Process Indicator Strip for Steam and its performance testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ANSI/AAMI/ISO 11140-1:2005 guidelines for Class 1 Process Indicators for STEAM. The reported device performance indicates that the NAMSA Chemical Process Indicator Strip for Steam met these criteria.

Test Condition	Test Time	Test Temperature	Acceptance Criteria: No change or a change markedly different from specified	Acceptance Criteria: Visible change as specified	Reported Device Performance (Implied by equivalence statement)
Saturated Steam	3.0 min ± 5 sec	121°C (+3/0°C)	Acceptable result	Unacceptable result	Met: No change / Markedly different from specified color change (yellow remains yellow)
Saturated Steam	10.0 min 0/-5 sec	121°C (+3/0°C)	Unacceptable result	Acceptable result	Met: Visible change to dark brown/black
Saturated Steam	20 sec	134°C (+3/0°C)	Acceptable result	Unacceptable result	Met: No change / Markedly different from specified color change (yellow remains yellow)
Saturated Steam	0.5 min ± 5 sec	134°C (+3/0°C)	Acceptable result	Unacceptable result	Met: No change / Markedly different from specified color change (yellow remains yellow)
Saturated Steam	2 min +5/0 sec	134°C (+3/0°C)	Unacceptable result	Acceptable result	Met: Visible change to dark brown/black
Dry Heat	30 min ± 1 min	140°C (+2/0°C)	Acceptable result	Unacceptable result	Met: No change / Markedly different from specified color change (yellow remains yellow)

2. Sample Size Used for the Test Set and Data Provenance

The document states that testing was performed using "multiple lots of NAMSA Chemical Process Indicator Strip for Steam." However, it does not specify the exact sample size for the test set (number of strips from each lot) nor the country of origin of the data. The studies are prospective in nature, as they involve testing the device under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used or their qualifications for evaluating the color changes. Given the nature of a chemical indicator, the "ground truth" for a color change is typically determined by visual observation against a known standard or a reference indicator by trained personnel. It is inferred that the evaluation was performed by qualified personnel involved in the testing, likely those trained in quality control or laboratory procedures for medical device sterility indicators.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (like 2+1 or 3+1). The nature of the test (color change) implies a direct observation against a pass/fail criterion. It's likely that a single observer or
an internal quality control process determined the outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human interpretation of images or data is involved, often with an AI assist. The NAMSA Chemical Process Indicator Strip is a simple chemical indicator with a direct visual color change, not an AI-driven diagnostic tool. Therefore, the question of human readers improving with AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This device is a passive chemical indicator that relies on a visual color change in response to sterilization conditions, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on pre-defined physical and chemical changes as specified by the manufacturer and validated against the ANSI/AAMI/ISO 11140-1:2005 standard. The "ground truth" is the expected behavior (color change or no change) of the indicator when subjected to specific time and temperature intervals under saturated steam or dry heat conditions. This is a direct physical measurement/observation against established criteria.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as typically understood in machine learning. For chemical indicators, the "training" analogous to development involves:

Developing the indicating ink (NAMSA formulation SSI-10-YBI)
Formulating the design (substrate, ink application, over-laminate)
Testing numerous iterations during the R&D phase to achieve the desired performance characteristics (i.e., the correct color change at the specified parameters and no change outside those parameters).

The document states the "Indicating Ink was developed and validated for compliance with ANSI/AAMI/ISO 11140-1:2005 guideline," implying an iterative development and testing process.

9. How the Ground Truth for the Training Set Was Established

As there isn't a "training set" in the machine learning sense, the "ground truth" for the development and validation of the indicating ink and device design would have been established through:

Reference Standards: Adherence to the critical parameters and performance requirements outlined in the ANSI/AAMI/ISO 11140-1:2005 standard, which defines what constitutes a "visible change" and "no change" for a Class 1 process indicator.
Controlled Laboratory Conditions: Exposing prototype indicators to precisely controlled steam sterilization cycles (time, temperature, saturated steam) and dry heat conditions in a laboratory setting.
Visual Assessment: Comparing the resulting color changes (or lack thereof) against the predetermined "acceptable" and "unacceptable" results as per the standard for each test condition. This iterative process allows for refinement of the ink formulation and device composition until the desired performance is consistently achieved.

Summary

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KI32291

MAY 2 0 2014

510(k) Summary

Submitter:

NAMSA 6750 Wales Road Northwood, Ohio 43619 P: 419.666.9455 F: 419,666,1715 E: productorders@namsa.com

Contacts:

Julie Wheeler General Manager, NAMSA Products 419.662.4488 jwheeler@namsa.com

Michelle Adamski Quality Assurance and Regulatory Affairs Manager, NAMSA Products 419.662.4829 madamski@namsa.com

Prepared on: July 18, 2013

Device Name: NAMSA Chemical Process Indicator Strip for Steam
Class II Medical Device, FDA Product Code JOJ, General Hospital Classification:
Common Name: Indicator/Chemical Process Indicator
NAMSA REF TST4-S Trade Name:
Predicate Devices: SteriTec Cross-Checks Indicator, REF CI 107 K951113 SteriTec Products Mfg. Co., Inc.

Statement of Intended Use:

The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals as a process indicator:

121°C for 30 minutes (gravity cycle) .
134℃ for 3 minutes (pre-vacuum) .

Image /page/0/Picture/19 description: The image shows the word "NAMSA" in white text on a black background. The font is a sans-serif typeface, and the letters are bold. There is a trademark symbol to the right of the A.

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Description of Device: The NAMSA Chemical Process Indicator Strip for Steam utilizes NAMSA indicating ink SSI-10-YBI that when exposed to high temperature steam turns from an initial yellow color to a permanent dark brown/black signal color.

The intended use for the NAMSA Chemical Process Indicator Strip for Steam processes is a Process Indicator intended for use by health care facilities to distinguish between processed and unprocessed goods.

The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a permanent dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals:

121℃ for 30 minutes (gravity cycle) ●
134℃ for 3 minutes (pre-vacuum) .

The Indicating Ink was developed and validated for compliance with ANSI/AAMI/ISO 11140-1:2005 quideline. As such, the critical parameters are time, temperature and presence of saturated steam.

Table 1: Test and Performance Requirements for Class 1 Process Indicators for STEAM

Test Condition	Test Time	Test Temperature	No change or a change thisis markedly different fromthe visible change asspecified by themanufacturer	Visible change asspecified by themanufacturer
Saturated Steam	3.0 min ± 5 sec	121°C (+3/0°C)	Acceptable result	Unacceptable result
Saturated Steam	10.0 min 0/-5 sec	121°C (+3/0°C)	Unacceptable result	Acceptable result
Saturated Steam	20sec	134°C (+3/0°C)	Acceptable result	Unacceptable result
Saturated Steam	0.5 min ± 5 sec	134°C (+3/0°C)	Acceptable result	Unacceptable result
Saturated Steam	2 min +5/0 sec	134°C (+3/0°C)	Unacceptable result	Acceptable result
Dry Heat	30 min ± 1 min	140°C (+2/0°C)	Acceptable result	Unacceptable result

Device compliance to ANSI/AAMI/ISO 11140-1:2005 & ANSI/AAMI ST-60:1996 is dependent upon substrate, thickness of ink application and presence of an over-laminate, reference material specification for NAMSA Chemical Process Indicator Strip for Steam.

Operational Principles:

The NAMSA Chemical Process Indicator Strip for Steam is intended for use with individual units, (e.g. packs, containers) to demonstrate that the goods have been exposed to a steam sterilization process and to distinquish between processed and unprocessed goods.

The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial vellow color to a dark brown/black signal color when exposed to high temperature steam at various time and temperature intervals.

Statement of Similarity to Legally Marketed. Predicate Device:

The NAMSA Chemical Process Indicator Strip for Steam has the following similarities to those legally marketed under 510(k) number K951113:

NAMSA

PEOPLE > SCIENCE > SOLUTIONS

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. Same intended use
Same technological characteristics through device design, indicator agent, . sterilization method and end point specifications and incorporation of similar materials
. Have similar shelf lives, and
. The same materials for packaging

A comparison of the characteristics of both the new device and predicate device and data resulting in equivalent performance has been generated.

Comparison of the New Device to the Predicate Device

	New Device	Predicate Device
Element	NAMSA Chemical Process IndicatorStrip for Steam	Cross-Checks Indicator
Intended Use	Process Indicator	Process Indicator
Device Design and Components	Paper strip, 0.75" W x 4.5"L, 10 mil whitetag stockChemical indicator on BOPP film, Yellowto Dark, Indicator tamped onto paperstrip	Paper strip, 0.5625" W x 7.66" L, 80pound coverChemical indicator, White to Dark,Indicator printed directly on paper strip
	Over laminate of PET	Over laminate of PET
Indicator Agent	Indicating InkNAMSA formulation SSI-10-YBI, Bismuthbased agent to yield color transition	Indicating InkSteritec formulation, Lead based agent toyield color change
Sterilization Method and Cycles	Steam 121°C 30 minutes(gravity cycle)Steam 134°C for 3 minutes (pre-vacuumcycle)	Steam 132°C - 135°C 3 Minutesstandard hospital steam sterilizer
Endpoint Specifications	During steam sterilization, indicator goesfrom an initial yellow color to a darkbrown/black signal color.	During steam sterilization, indicator goesfrom an initial white color to a darkbrown/black signal color.
Shelf Life	17 Months	36 Months

The following tests were performed in accordance with ANSI/AAM/ISO 11140-1.2005 for steam to verify the performance of NAMSA Chemical Process Indicator Strip for Steam was substantially equivalent to the predicate device,

Steam Prevac at 121°C for 3 minutes .
Steam Prevac and Gravity at 121°C for 10 minutes .
Steam Prevac at 134°C for 20 seconds .
. Steam Prevac at 134°C for 30 seconds
. Steam Prevac at 134°C for 2 minutes
. Dry heat at 140°C for 30 minutes

In summary, the data generated demonstrates NAMSA Chemical Process Indicator Strip for Steam is substantially equivalent to the predicate device.

NAMSA

PEOPLE > SCIENCE > SOLUTIONS

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Description of Testing:

Per the FDA recognized guidance document, testing was performed for steam sterilization processes using multiple lots of NAMSA Chemical Process Indicator Strip for Steam.

Exposure at Various Times & Temperatures following ANSI/AAMI/ISO . 11140-1:2005 for Steam
Transference Testing per ANSI/AAMI/ISO 11140-1:2005
. Biocompatibility
. Shelf Life

Image /page/3/Picture/6 description: The image shows the word "NAMSA" in white letters against a black background. The font is a bold, sans-serif typeface. The letters are evenly spaced and the word is centered in the image.

PEOPLE > SCIENCE > SOLUTIONS

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned above two curved shapes that resemble legs or feet. The bird is enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

May 20, 2014

North American Science Association Incorporated Ms. Julie Wheeler General Manager 6750 Wales Road Northwood, OH 43619

Re: K132291

Trade/Device Name: NAMSA Chemical Process Indicator Strip for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Physical/Chemical Sterilization Process Regulatory Class: Class II Product Code: JOJ Dated: April 17, 2014 Received: April 21. 2014

Dear Ms. Wheeler:

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 cither 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.

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Page 2 - Ms. Wheeler

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Shoth, M.D. Clinical Deputy Director A CONTRACTOR DAGRID/ODE/CDRH FFOR

Erin I. Keith, M.S. Acting Director · Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:	K132291
Device Name:	NAMSA Chemical Process Indicator Strip for Steam
Indications for Use:	The NAMSA Chemical Process Indicator Strip for Steam, REF TST4-S is intended for use with individual materials (i.e. pouches, pack, tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals as a process indicator:

510(k) Number:

K132291

Device Name:

NAMSA Chemical Process Indicator Strip for Steam

Indications for Use:

121°C for 30 minutes (gravity cycle) ●
134℃ for 3 minutes (pre-vacuum cycle) .

② SINGLE USE ONLY

AND/OR

× Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabetl Clave

Prescription Use

(Part 21 CFR 801 SubpartD)

Claverie -S
Claverie -S
DN: c=US, o=U.S. Government,
0.9.2342.19200300.100.1.1=13000558 64, cn=Elizabeth F. Claverie -5 Date: 2014.05.19 16:36:26 -04'00'

Digitally signed by Elizabeth F.

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).