(76 days)
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.
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.
This document describes the Raven ProTest - Steam Biological Indicator, a self-contained biological indicator designed to monitor the efficacy of steam sterilization cycles.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance is described in the context of validating its labeled claims and characteristics during testing. The primary performance goal is to demonstrate effective monitoring of steam sterilization cycles.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with steam sterilization cycles (121℃ to 135℃) | "Testing was performed in accordance with AAMI ST59:1999 to validate the labeled claims and performance characteristics of ProTest - Steam... monitoring routine steam sterilization cycles has been demonstrated." The device is intended for "monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles)." |
| Reliable detection of spore growth/no growth | "Evidence of growth by color change and/or turbidity within 24 hours should be interpreted as a sterilization failure... provided signs of growth are present in the control unit." This indicates the device successfully shows growth when sterilization fails and conversely, no growth when it succeeds. |
| Reduced Incubation Time | "Raven ProTest - Steam has a validated reduced incubation time of 24 hours." |
| Resistance Characteristics | "Three separate lots of product manufactured from three different primary spore crops were tested for resistance..." (Details of the resistance value are not provided, but it implies meeting a standard). |
| Spore Population | "...spore population, recovery of low numbers of injured spores, were tested..." (Details of the population count are not provided, but it implies meeting a standard). |
Study Information:
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Sample size used for the test set and data provenance:
- Sample Size: "Three separate lots of product manufactured from three different primary spore crops" were tested. While the exact number of individual biological indicators within these lots isn't specified, it indicates an evaluation across different production batches.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was "performed in accordance with AAMI ST59:1999," which is a US standard. The study seems to be internal validation by the manufacturer, Raven Biological Laboratories. The study is retrospective in the sense that it evaluates the manufactured product against established standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of biological indicator study does not typically involve human experts establishing ground truth in the way a diagnostic imaging study would. The ground truth for biological indicators is established by the known conditions of the steam sterilization cycle (e.g., fully successful sterilization vs. partial/failed sterilization conditions). The "ground truth" of whether spores survived or not is determined by their biological response (growth/no growth) and color change.
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Adjudication method for the test set:
- Not applicable as the "ground truth" is determined by the biological reaction of the spores themselves and their nutrient media, rather than expert interpretation of complex data. The "adjudication" is essentially the observation of a color change or turbidity.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a biological indicator, not an AI-powered diagnostic tool. There are no "human readers" interpreting images or complex data in the sense of an MRMC study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its biological and chemical components.
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The type of ground truth used:
- Biological Response: The ground truth is established by the biological viability of the Geobacillus stearothermophilus spores under different sterilization conditions. A successful sterilization cycle should render the spores non-viable, leading to no growth and no color change in the media. An unsuccessful cycle should leave viable spores, leading to growth (turbidity) and a color change (purple to yellow). This is a direct biological and chemical outcome.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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510(k) Summary
510(k) Notification ProTest - Steam Biological Indicator
| Submitted by: | Raven Biological Laboratories8607 Park DriveOmaha, NE 68127 |
|---|---|
| Contact: | Wendy Royalty-HannQuality Assurance/Regulatory Affairs Manager |
| Or | |
| Robert V. Dwyer, Jr.President | |
| Phone: (402) 593-0781Fax: (402) 593-0921 | |
| Prepared on: | May 19, 2004 |
| Device: | Trade name: ProTest - SteamBiological IndicatorCommon name: Self-contained BiologicalIndicator for Steam |
| Classification: | Class II |
| Predicate Device: | SGM EZTest® - Steam (K963841) |
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.
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 and activated by crushing the glass media ampoule inside. The processed unit and an unprocessed (control) unit are incubated at 55-60℃ for 24 hours.
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- During incubation, the available food supply (Tryptic Soy Broth) and temperature During incubation, the available lood Supply (Trypts es germinate and consume the media promote grown of any viable spores. TAS viable speres sing the acidity of the media
provided nutrients waste products are released, increasing the acidity of the media provided nuthents waste products are reterange from purple to yellow.
Evidence of growth by color change and/or turbidity within 24 hours should be Evidence of growth by color onango undrer takensy for sterilizations, provided signs of growth are present in the control unit.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
ProTest – Steam is similar in composition and function to the legally marketed predicate device EZTest - Steam.
- o Both are intended for use in monitoring steam sterilization cycles from 121℃ to 135°C.
- Utilize the same strain of bacterial spores.
- ם Utilize the same carrier material.
- o Virtually the same size and shape.
- a Activated in the same manner.
DESCRIPTION OF TESTING
Testing was performed in accordance with AAMI ST59:1999 to validate the labeled claims and performance characteristics of ProTest - Steam.
Three separate lots of product manufactured from three different primary spore crops I hree separate foto of production, recovery of low numbers of injured spores, were tested for resistante, opors population, For all lots tested, the above parameters and a readood moubation penonitoring 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 Dasod on the entillar of indicator has been demonstrated to be substantially r rollest - Gtoum Blerogical masafe and effect as, the legally marketed device EZTest -Steam.
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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 features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2004
Ms. Wendy Royalty-Hann Quality Assurance, Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K041386
R041500
Trade/Device Name: Raven ProTest Self-Contained Biological Indicator for Steam Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: FRC Dated: May 20, 2004 Received: May 25, 2004
Dear Ms. Royalty-Hann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in the device is substantially equivalent (for the referenced above and have decemblied and to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisece prior to frid, 20, 10, 10, 10, 10, 10, 20, 10, 2011, 10, 2011, 10, 2019, 10, 10, 2019, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Amendinents, or to devroos and navic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmen's , therefore, market the device, subject to the general approval application (1 MIT). 1 Car een controls provisions of the Act include Controls provisions of the Fea. "The girling 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 If your device is classified (see as 10) inn a controls. Existing major regulations affecting (PMA), It may be subject to such adaltions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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 | K041386 |
|---|---|
| Device Name | Raven ProTest - Steam |
| Indications forUse | Raven ProTest - Steam is a self-contained Biological Indicatorinoculated with viable Geobacillus stearothermophilus bacterialspores and is intended for monitoring the efficacy of steamsterilization cycles (121°C gravity displacement and 121°C - 135°Cprevacuum cycles). Raven ProTest - Steam has a validatedreduced incubation time of 24 hours. |
Prescription Use (Part 21 CFR 801 Subpart D)
...
AND/OR
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)
Kei Mulvey
(Division Sign-Off) (UNIsion of Anesthesiology, General Hospital, Infection Control, Dental Devi
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510(k) Number: K041386
§ 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).