(74 days)
Raven ProTest - EO is a self-contained Biological Indicator inoculated with viable Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization cycles. Raven ProTest - EO has a validated reduced incubation time of 48 hours.
The biological indicator consists of a self-contained unit that includes bacterial spores of The bloodioal manouler concluded onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromothymol Blue acting as a pH indicator encased in a plastic vial that serves as the culture tube.
Here's an analysis of the provided text regarding the ProTest - EO Biological Indicator, structured according to your request:
Acceptance Criteria and Device Performance Study
The document describes the ProTest-EO Biological Indicator, a self-contained unit for monitoring ethylene oxide (EO) sterilization cycles. The study to prove the device meets acceptance criteria involved testing based on AAMI ST59:1999.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Resistance (to Ethylene Oxide sterilization) | Tested and demonstrated for three separate lots using three different primary spore crops. (Specific resistance values are not provided in this summary, but the claim is that it meets the standard.) |
| Spore Population (of Bacillus atrophaeus) | Tested and demonstrated for three separate lots using three different primary spore crops. (Specific population counts are not provided in this summary, but the claim is that it meets the standard.) |
| Recovery of low numbers of injured spores | Tested and demonstrated for three separate lots using three different primary spore crops. (The ability to recover injured spores is crucial for accurately detecting sterilization failures, and the device is stated to effectively do so.) |
| Reduced Incubation Period (duration for growth detection) | A validated reduced incubation period of 48 hours. |
| Overall effectiveness in monitoring routine ethylene oxide sterilization cycles (as compared to predicate device) | Demonstrated for all lots tested, indicating substantial equivalence to the legally marketed predicate device EZTest - Gas in composition, function, and ability to monitor EO sterilization cycles. Evidence of growth (color change/turbidity) within 48 hours indicates sterilization failure, assuming viable control. |
2. 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." This implies testing was conducted on a sufficient number of product units from each of these distinct lots/spore crops to establish reliability and consistency. The exact number of individual biological indicators tested within each lot is not specified in the provided summary.
- Data Provenance: Not explicitly stated, but given it's for FDA submission, it's presumed to be from the manufacturer (Raven Biological Laboratories) in the United States. The study is prospective in the sense that the testing was performed specifically to validate the claims for this device prior to its market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of device relies on a biological response (spore viability/growth) as its "ground truth" rather than expert interpretation of images or clinical data. The "ground truth" for whether sterilization failed or succeeded is determined by the presence or absence of spore growth, indicated by a color change. The AAMI ST59:1999 standard itself dictates the parameters for determining effectiveness.
4. Adjudication Method for the Test Set
- Not Applicable. As described above, the outcome is a direct biological response (color change/turbidity) as per the operational principles, not a subjective interpretation requiring adjudication among experts. The "ground truth" is a direct experimental finding of spore viability.
5. 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 is a biological indicator, not an AI-powered diagnostic device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is effectively a standalone performance study. The device itself provides the result (color change or turbidity for growth, or no change for no growth) based on the biological reaction. Human involvement is limited to activating the device, incubating it, and observing the color change, which is a direct, objective read. There's no "algorithm" in the sense of a software-based AI, but the biological indicator system operates autonomously to indicate growth.
7. The Type of Ground Truth Used
- Experimental/Biological Ground Truth: The ground truth is the viability of the Bacillus atrophaeus spores after exposure to an ethylene oxide sterilization cycle.
- Negative Result (Sterilization achieved): No viable spores remain, thus no growth and no color change within 48 hours.
- Positive Result (Sterilization failed): Viable spores remain, leading to germination, metabolic activity, and a color change from green to yellow due to pH reduction, within 48 hours.
- A control unit (unprocessed) is run concurrently to ensure the spores are viable and the culture medium supports growth, confirming the validity of the test.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device that requires a "training set." The performance is based on the inherent biological properties of the spores and media, validated through direct experimental testing.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set was used. The ground truth for the performance study (resistance, spore population, recovery, incubation time) was established through controlled laboratory experiments, often comparing against established reference methods or standards (like AAMI ST59:1999) using known sterilization parameters and calibrated equipment to assess spore viability and growth.
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SEP 1 3 2004
510(k) Summary
510(k) Notification ProTest - EO Biological Indicator
| Submitted by: | Raven Biological Laboratories8607 Park DriveOmaha, NE 68127 |
|---|---|
| Contact: | Wendy Royalty-HannQuality Assurance/Regulatory Affairs ManagerOrRobert V. Dwyer, Jr.PresidentPhone: (402) 593-0781Fax: (402) 593-0921 |
| Prepared on: | |
| Device: | Trade name: ProTest – EOBiological IndicatorCommon name: Self-contained BiologicalIndicator for Ethylene Oxide Sterilization |
| Classification: | Class II |
| Predicate Device: | SGM EZTest® - GAS (K930683) |
DESCRIPTION
The biological indicator consists of a self-contained unit that includes bacterial spores of The bloodioal manouler concluded onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromothymol Blue acting as a pH indicator encased in a plastic vial that serves as the culture tube.
OPERATIONAL PRINCIPALS
The ProTest – EO Biological Indicator is placed with a load in the sterilization chamber rne i 10700 - LC Blorogical willing oxide 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 30-35℃ for 48 hours.
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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 green to yellow.
Evidence of growth by color change and/or turbidity within 48 hours should be interpreted as a failure to meet the conditions necessary for sterilization, provided signs of growth are present in the control unit.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
ProTest – EO is similar in composition and function to the legally marketed predicate device EZTest - Gas.
- Both are intended for use in monitoring ethylene oxide sterilization cycles. o
- Utilize the same strain of bacterial spores. ם
- a 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 - EO.
Three separate lots of product manufactured from three different primary spore crops were tested for resistance, spore population, recovery of low numbers of injured spores, and a reduced incubation period of 48 hours. For all lots tested, the above parameters and overall effectiveness in monitoring routine ethylene oxide 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 - EO Biological Indicator has been demonstrated to be substantially equivalent to and therefore, as safe and effect as, the legally marketed device EZTest - Gas.
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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 representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
SEP 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K041784
Trade/Device Name: Raven ProTest-EO Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: June 28, 2004 Received: July 1, 2004
Dear Ms. Royalty-Hann:
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 mendments, 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 the Federal F 6004). You may, therefore, market the device, subject to the general approvial applications of the Act. The general controls provisions of the Act include controls provided 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 such additional controls. Existing major regulations affecting (1 NE), it nay obe address 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 mean that I DTP nas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal barace and equirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 CF RT rat 807), and 1007), 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) This letter will and n your began finding of substantial equivalence of your device to a premarket notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at 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 maj obtain 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 | K041784 |
|---|---|
| Device Name | Raven ProTest - EO |
| Indications for Use | Raven ProTest - EO is a self-contained Biological Indicatorinoculated with viable Bacillus atrophaeus bacterial spores and isintended for monitoring the efficacy of ethylene oxide sterilizationcycles. Raven ProTest - EO has a validated reduced incubationtime of 48 hours. |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X ____________________________________________________________________________________________________________________________________________________________________________ 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)
Kein Mulay
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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ﻬﺎ ﺍﻟ 510(k) Number:_
§ 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).