(178 days)
Not Found
No
The device description and intended use focus on a biological indicator spore strip for sterilization efficacy testing, relying on bacterial growth and visual observation. There is no mention of AI or ML in the provided text.
No
This device is intended for testing the efficacy of sterilization processes, not for treating or preventing a disease or condition in humans or animals.
No
This device is intended for testing the efficacy of sterilization processes, not for diagnosing an individual's health condition or disease.
No
The device description clearly states it consists of a filter paper strip inoculated with bacterial spores, which is a physical component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "testing the efficacy of steam sterilization... and steam and ethylene oxide sterilization". This is a quality control or process monitoring function, not a diagnostic test performed on a biological sample from a human or animal to determine a disease or condition.
- Device Description: The device is a spore strip used to challenge a sterilization process. It does not interact with or analyze biological samples for diagnostic purposes.
- Operational Principles: The operational principle is based on the survival or death of the spores after exposure to a sterilization process, indicating the effectiveness of that process. This is not a diagnostic principle.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVDs, such as diagnosing, detecting, measuring analytes, or analyzing biological specimens.
Therefore, this device falls under the category of a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.
Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
Product codes
FRC
Device Description
The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105) or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine pouch.
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
General Hospital
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)
Per FDA recognized consensus standards and guidance documents, testing was performed for steam for single specie spore strips and steam and Ethylene Oxide (EO) sterilization processes for dual species. Multiple lots of NAMSA Biological Indicator Spore Strips were utilized.
- Total Viable Spore Count
- Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows
- Carrier and Primary Packaging Materials Evaluation
- Holding Time Assessment
- Recovery Protocols Reduced Incubation Time Studies
- Medium Suitability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| 510(k) Summary of NAMSA Biological Indicator Spore Strips | APR 27 2012 | |||
|---|---|---|---|---|
| Submitter: | NAMSA | |||
| 6750 Wales Road | ||||
| Northwood, Ohio 43619 | ||||
| P: 419.666.9455 | ||||
| F: 419.666.1715 | ||||
| E: info@namsa.com | ||||
| Contacts: | Julie Wheeler | |||
| General Manager, NAMSA Products | ||||
| 419.662.4488 | ||||
| jwheeler@namsa.com | ||||
| Michelle Adamski | ||||
| Quality Assurance Specialist, NAMSA Products | ||||
| 419.662.4829 | ||||
| madamski@namsa.com | ||||
| Prepared on: | October 28, 2011 | |||
| Device Name: | NAMSA Biological Indicator Spore Strips | |||
| Classification: | Class II Medical Device, FDA Product Code FRC, General Hospital | |||
| Predicate Devices: | ||||
| (Legally Marketed) | NAMSA Biological Indicator Spore Strips | |||
| Predicate Device | ||||
| 510(k) Number: | K912796, K020026 and K050591 | |||
| Description: | The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip | |||
| inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105) | ||||
| or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus | ||||
| atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine | ||||
| pouch. | ||||
| Operational Principles: The NAMSA Biological Indicator Spore Strip (single species Geobacillus | ||||
| stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® | ||||
| 7953 and Bacillus atrophaeus ATCC® 9372) is intended for use in testing the efficacy of | ||||
| steam sterilization for single species and steam and ethylene oxide sterilization for dual | ||||
| species. | ||||
| Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 | ||||
| and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 | ||||
| mg/L, 60% RH and 55°C for 2 hours, 10 minutes. | ||||
| The media containing the spore strip should be incubated at the organism's growth | ||||
| temperature. Media should be monitored daily for visible signs of growth and results | ||||
| recorded. |
NAMSA
1
When standard media is utilized, incubate strips for a minimum of 7 days. Growth will be indicated by the presence of turbidity. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
Statement of Similarity to Legally Marketed Predicate Device:
The NAMSA Biological Indicator Spore Strip has the following similarities to the legally marketed Pre-amendment Biological Indicator Spore Strip:
- Same indication for use
- Incorporate the same materials .
- Have the same shelf life, and .
- The same materials for packaging .
In summary, the data provided demonstrates NAMSA Biological Indicator Spore Strip are substantially equivalent to the predicate device.
| Description of Testing: | Per FDA recognized consensus standards and guidance documents, testing was performed for steam for single specie spore strips and steam and Ethylene Oxide (EO) sterilization processes for dual species. Multiple lots of NAMSA Biological Indicator Spore Strips were utilized. |
|---|---|
| Total Viable Spore CountResistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows |
- Carrier and Primary Packaging Materials Evaluation .
- Holding Time Assessment .
- Recovery Protocols Reduced Incubation Time Studies .
- Medium Suitability .
Image /page/1/Picture/13 description: The image shows the word "NAMSA" in white font against a black background. The font is a sans-serif typeface, and the letters are bold. The letters are evenly spaced and aligned horizontally. The overall impression is clean and professional.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three overlapping shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ms. Julie Wheeler General Manager North American Science Assoc, Incorporated 6750 Wales Road Northwood, Ohio 43619
APR 2 7 2012
Re: K113221
Trade/Device Name: NAMSA Biological Indicator Spore Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: FRC Dated: April 16, 2012 Received: April 17, 2012
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 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.
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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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number:
K113221
Device Name:
NAMSA Biological Indicator Spore Strip
Indications for Use:
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus
stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.
Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
Prescription Use (Part 21 CFR 801 SubpartD) AND/OR
Over-The-Counter Use ਮ (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)
Susan Kummerle
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113221