(397 days)
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No
The document describes a biological indicator for steam sterilization, which is a physical/chemical device and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is a self-contained biological indicator designed to monitor the efficacy of steam sterilization cycles, not to treat or therapeutically affect a patient.
No
This device is a biological indicator used to monitor the efficacy of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly outlines a physical biological indicator with bacterial spores, a glass ampoule, and a plastic vial. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the efficacy of steam sterilization cycles. This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a human or animal to determine a medical condition.
- Device Description: The device contains bacterial spores and a culture medium to assess if the sterilization process killed the spores. This is a biological indicator for sterilization, not a diagnostic reagent or instrument used to analyze a biological sample.
- No mention of analyzing biological samples: The description focuses on the device's use in a sterilization process and subsequent incubation to check for spore growth. There is no indication that it is used to test blood, urine, tissue, or any other biological sample from a patient.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.
Product codes
FRC
Device Description
The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. ProTest - Steam is intended for use in 10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles.
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
Testing was performed in accordance with AAMVISO 11138-1:2006 to validate the labeled claims and performance characteristics of ProTest - Steam.
Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, effectiveness in high temperature gravity cycles, recovery of low numbers of injured spores, and a reduced incubation period of 24 hours. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.
Key Metrics
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Predicate Device(s)
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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OCT 21 2009
510(k) Summary
510(k) Notification ProTest - Steam Biological Indicator
Submitted by:
Contact:
Raven Biological Laboratories 8607 Park Drive Omaha, NE 68127
Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager
Or -
Robert V. Dwyer, Jr. President
Biological Indicator
Indicator for Steam
Phone: (402) 593-0781 Fax: (402) 593-0921
Prepared on:
Device:
Classification:
Predicate Device:
Class II
ProTest Steam (K041386)
Trade name: ProTest - Steam
Common name: Self-contained Biological
DESCRIPTION
The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. ProTest - Steam is intended for use in 10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles.
OPERATIONAL PRINCIPALS
The ProTest - Steam Biological Indicator is placed with a load in the sterilization chamber and subjected to a normal steam sterilization cycle. The unit is then removed
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and activated by crushing the glass media ampoule inside. The processed unit and an unprocessed (control) unit are incubated at 55-60°C for 24 hours.
During incubation, the available food supply (Tryptic Soy Broth) and temperature promote growth of any viable spores. As viable spores germinate and consume the provided nutrients waste products are released, increasing the acidity of the media which lowers the pH and causes a color change from purple to yellow.
Evidence of growth by color change and/or turbidity within 24 hours should be interpreted as a failure to meet the conditions necessary for sterilizations, provided signs of growth are present in the control unit.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
The subject device ProTest - Steam is identical in composition and function to the legally marketed predicate device ProTest - Steam. This submission is to expand the label claims for the device to include 132ºC gravity/flash gravity cycles.
- Both are intended for use in moniforing steam sterilization cycles O
- ם Utilize the same strain of bacterial spores.
- Utilize the same carrier material. ם
- The same size and shape.
- Activated in the same manner.
DESCRIPTION OF TESTING
Testing was performed in accordance with AAMVISO 11138-1:2006 to validate the labeled claims and performance characteristics of ProTest - Steam.
Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, effectiveness in high temperature gravity cycles, recovery of low numbers of injured spores, and a reduced incubation period of 24 hours. For all lots tested, the above parameters and overall effectiveness in monitoring routine steam sterilization cycles has been demonstrated.
STATEMENT OF SAFETY AND EFFECTIVENESS
Based on the similar claims, design and results from the above mentioned testing, the ProTest - Steam Biological Indicator has been demonstrated to be substantially equivalent to and therefore, as safe and effect as, the legally marketed device ProTest -Steam.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Wendy Royalty-Hann Director of Quality and Regulatory Affairs Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
OCT 21 2009
Re: K082756
Trade/Device Name: Raven ProTest - Steam Regulation Number: 21CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: June 25, 2009 Received: October 2, 2009
Dear Ms. Royalty-Hann:
. 1998
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.
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. Royalty-Hann
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Arthen D. Anster fer
Susan Runner, D.D.S., M.A. Acting 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
Device Name
Raven ProTest - Steam
Indications for Use
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Myleskey. 10
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082256