(301 days)
Not Found
No
The device is a chemical indicator strip that changes color based on exposure to steam, a purely chemical and physical process. There is no mention of any computational analysis, algorithms, or learning processes.
No
The NAMSA Chemical Process Indicator Strip for Steam is designed to indicate exposure to a steam sterilization process, distinguishing between processed and unprocessed goods, not to treat any medical condition or affect the body's structure or function.
No
The device is a chemical process indicator used to confirm exposure to a steam sterilization process, distinguishing between processed and unprocessed goods. It does not diagnose any condition or disease.
No
The device is a physical chemical indicator strip that changes color when exposed to steam sterilization, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to indicate whether materials have been exposed to a steam sterilization process. This is a quality control measure for sterilization, not a test performed on biological samples (like blood, urine, tissue, etc.) to diagnose a disease or condition.
- Device Description: The device is a chemical indicator strip that changes color based on exposure to steam and temperature. It does not analyze biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device being used with any biological samples or for any diagnostic purpose related to a patient's health.
- Testing and Performance: The performance studies focus on the indicator's response to steam sterilization parameters, not on its ability to detect or measure substances in biological samples.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It's a process indicator for sterilization equipment.
N/A
Intended Use / 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) .
Product codes (comma separated list FDA assigned to the subject device)
JOJ
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.
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
health care facilities
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)
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
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.
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
§ 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).
0
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, 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.
1
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
is markedly different from
the visible change as
specified by the
manufacturer | Visible change as
specified by the
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
2
- . 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 | |
| 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 | |
| tag stock |
Chemical indicator on BOPP film, Yellow
to Dark, Indicator tamped onto paper
strip | Paper strip, 0.5625" W x 7.66" L, 80
pound cover
Chemical indicator, White to Dark,
Indicator printed directly on paper strip |
| | Over laminate of PET | Over laminate of PET |
| Indicator Agent | Indicating Ink
NAMSA formulation SSI-10-YBI, Bismuth
based agent to yield color transition | Indicating Ink
Steritec formulation, Lead based agent to
yield color change |
| Sterilization Method and Cycles | Steam 121°C 30 minutes
(gravity cycle)
Steam 134°C for 3 minutes (pre-vacuum
cycle) | Steam 132°C - 135°C 3 Minutes
standard hospital steam sterilizer |
| Endpoint Specifications | During steam sterilization, indicator goes
from an initial yellow color to a dark
brown/black signal color. | During steam sterilization, indicator goes
from an initial white color to a dark
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
PEOPLE > SCIENCE > SOLUTIONS
3
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
4
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.
5
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
6
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.