NAMSA CHEMICAL PROCESS

K132291 · North American Science Assoc., Inc. · JOJ · May 20, 2014 · General Hospital

Device Facts

• Record ID: K132291
• Device Name: NAMSA CHEMICAL PROCESS
• Applicant: North American Science Assoc., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: May 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

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

Device Story

Chemical process indicator strip; used in healthcare facilities to verify steam sterilization exposure. Input: high-temperature steam during sterilization cycles. Operation: bismuth-based indicating ink (SSI-10-YBI) on paper substrate undergoes irreversible chemical color transition from yellow to dark brown/black upon exposure to specific time/temperature parameters (121°C/30min or 134°C/3min). Output: visual color change on strip. Healthcare providers place strip inside/on packs/trays; inspect color post-cycle to confirm processing. Benefits: provides immediate visual confirmation of sterilization exposure, preventing use of unprocessed goods.

Clinical Evidence

Bench testing only. Performance verified per ANSI/AAMI/ISO 11140-1:2005. Testing included exposure to various steam cycles (121°C/3min, 121°C/10min, 134°C/20sec, 134°C/30sec, 134°C/2min) and dry heat (140°C/30min). Results confirmed expected color transition and compliance with critical parameters (time, temperature, saturated steam). Biocompatibility and shelf-life testing also performed.

Technological Characteristics

Paper strip (0.75" x 4.5", 10 mil white tag stock) with bismuth-based indicating ink (SSI-10-YBI) and PET over-laminate. Complies with ANSI/AAMI/ISO 11140-1:2005 and ANSI/AAMI ST-60:1996. Single-use, non-electronic, passive chemical indicator.

Indications for Use

Indicated for use in healthcare facilities to distinguish between processed and unprocessed goods (pouches, packs, trays) following steam sterilization cycles (121°C gravity or 134°C pre-vacuum). No specific patient population restrictions.

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

• SteriTec Cross-Checks Indicator, REF CI 107 (K951113)

Submission Summary (Full Text)

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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: [e-mail]

Contacts:

Julie Wheeler General Manager, NAMSA Products 419.662.4488 [e-mail]

Michelle Adamski Quality Assurance and Regulatory Affairs Manager, NAMSA Products 419.662.4829 [e-mail]

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, 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) .

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 this<br>is markedly different from<br>the visible change as<br>specified by the<br>manufacturer | Visible change as<br>specified by the<br>manufacturer |
|-----------------|-------------------|------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 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 Indicator<br>Strip 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 white<br>tag stock<br><br>Chemical indicator on BOPP film, Yellow<br>to Dark, Indicator tamped onto paper<br>strip | Paper strip, 0.5625" W x 7.66" L, 80<br>pound cover<br><br>Chemical indicator, White to Dark,<br>Indicator printed directly on paper strip |
| | Over laminate of PET | Over laminate of PET |
| Indicator Agent | Indicating Ink<br>NAMSA formulation SSI-10-YBI, Bismuth<br>based agent to yield color transition | Indicating Ink<br>Steritec formulation, Lead based agent to<br>yield color change |
| Sterilization Method and Cycles | Steam 121°C 30 minutes<br>(gravity cycle)<br><br>Steam 134°C for 3 minutes (pre-vacuum<br>cycle) | Steam 132°C - 135°C 3 Minutes<br>standard hospital steam sterilizer |
| Endpoint Specifications | During steam sterilization, indicator goes<br>from an initial yellow color to a dark<br>brown/black signal color. | During steam sterilization, indicator goes<br>from an initial white color to a dark<br>brown/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

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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 [phone] or [phone] 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 [phone] or [phone] 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: |

- 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.