(73 days)
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No
The description details a biological indicator that changes color based on bacterial growth after sterilization, which is a chemical/biological reaction, not AI/ML. There is no mention of computational analysis or algorithms.
No
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to provide therapy for a patient.
No
Explanation: The device is used to monitor the efficacy of sterilization processes, not to diagnose a medical condition in a patient. It assesses the performance of equipment, not the health status of an individual.
No
The device description clearly outlines a physical biological indicator (SCBI) that is incubated and visually inspected for color change and turbidity, indicating a hardware component and a manual interpretation process.
Based on the provided text, the NAMSA SCBI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor the efficacy of saturated steam sterilization processes. This is a quality control measure for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains a biological indicator (spores) and growth medium. Its function is to determine if the sterilization process killed the spores, indicated by a color change in the medium. This is a test of the sterilization process itself, not a test of a patient sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) from a patient.
- Providing information for the diagnosis, treatment, or prevention of a disease or condition in a patient.
- Being used in a clinical laboratory setting for patient testing.
The NAMSA SCBI is a biological indicator used for sterilization process monitoring. It falls under the category of devices used to ensure the effectiveness of sterilization procedures, which is a critical aspect of healthcare but is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The NAMSA SCBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 121°C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
Exposure times at 121°C are 30 minutes and 3 minutes for exposures at 132°C, 134°C and 135°C. Reference the sterilizer user manual for specific exposure timeframes.
The NAMSA Steam SCBIs are placed into a sterilization load in a location that has been determined to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. The SCBI is removed after the cycle is complete and has cooled to a point where the SCBI can comfortably be handled. The SCBI is activated by pushing the sides with enough force to break the ampoule containing the growth medium. The activated SCBI is incubated at 58-62°C for 24 hours. A reduced incubation time of 24 hours has been validated.
Product codes
FRC
Device Description
The activated SCBI should be incubated at 58-62°C for a minimum of 24 hours. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow and/or the presence of turbidity. The absence of growth indicates the exposure was effective.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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510(k) Summary for NAMSA Steam Self-Contained Biological Indicators (SCBIs)
1
The activated SCBI should be incubated at 58-62°C for a minimum of 24 hours. The SCBI should be monitored for visible signs of growth. Growth will be indicated by a color shift from purple to yellow and/or the presence of turbidity. The absence of growth indicates the exposure was effective.
Statement of Similarity to Legally Marketed Predicate Device:
The NAMSA Steam Self-Contained Biological Indicators have the following similarities to the legally marketed predicate device:
- Same indication for use .
- Incorporation of the same or similar materials .
- Have the same or similar shelf life, and .
- . The same or similar materials for packaging
In summary, the data provided demonstrates substantial equivalence to the predicate device.
Description of Testing: Per FDA recognized consensus standards and guidance documents testing was performed for steam sterilization processes using multiple lots of NAMSA Steam Self-Contained Biological Indicators over the range of the shelf life.
- · Total Viable Spore Count
- Resistance Characteristic Studies including D value, z value, Survival/Kill . Windows
- Carrier and Primary Packaging Materials Evaluation .
- . Holding Time Assessment
- Recovery Protocols Reduced Incubation Time Studies �
- Medium Suitability .
Image /page/1/Picture/15 description: The image shows the word "NAMSA" in white letters against a black background. The letters are slightly distressed, with some areas appearing faded or broken. The letters are in a sans-serif font and are evenly spaced. There is a trademark symbol after the A.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is oriented towards the upper right corner of the image. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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 Association, Incorporation 6750 Wales Road Northwood, Ohio 43619
JAN 2 0 2012
Re: K113302
Trade/Device Name: NAMSA Steam Self-Contained Biological Indicator (SCBI) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 3, 2012 Received: January 4, 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 ( veperior 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 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 Compilance: "Theo; pread 107.97). 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 Tou may 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,
hh for
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: | K113302 |
|---|---|
| ---------------- | --------- |
NAMSA Steam Self-Contained Biological Indicator (SCBI) Device Name:
Indications for Use:
The NAMSA SCBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 121°C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
Exposure times at 121°C are 30 minutes and 3 minutes for exposures at 132°C, 134°C and 135°C. Reference the sterilizer user manual for specific exposure timeframes.
The NAMSA Steam SCBIs are placed into a sterilization load in a location that has been determined to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. The SCBI is removed after the cycle is complete and has cooled to a point where the SCBI can comfortably be handled. The SCBI is activated by pushing the sides with enough force to break the ampoule containing the growth medium. The activated SCBI is incubated at 58-62°C for 24 hours. A reduced incubation time of 24 hours has been validated.
Prescription Use (Part 21 CFR 801 SubpartD) AND/OR
Over-The-Counter Use X (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)
Elizabeth F. Claverie-Wills
(Division Sian-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K113302