(458 days)
ProSpore2 is a biological sterilization process indicator for EtO (Ethylene Oxide) sterilization. This device is intended for use by a health care provider to accompany products being sterilized through an EtO sterilization procedure and to monitor the adequacy of sterilization. The testing and validations referred to in this document were done using a 10/90 Ethylene Oxide mixture at 600 mg/L, 54°C, and with a relative humidity between 30% and 80%.
ProSpore2 is a self-contained biological indicator used for determining the efficacy of an Ethylene Oxide sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1.2 - 1.5 ml glass ampoule of growth media consisting of Tryptic Soy Broth (soybean casein digest) and a pH indicator - bromothymol blue. Also inside of the tube housing is a paper spore disc impregnated with a population of 106 Bacillus subtilis spores (ATCC #9372).
The provided document describes the "PROSPORE 2ª SELF CONTAINED BIOLOGICAL VII. INDICATOR" for Ethylene Oxide sterilization. It details the device, its operational principles, and a summary of testing conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the acceptance criteria and study information, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative manner as one might find in a clinical study. Instead, it focuses on demonstrating "stability" and "effectiveness" in comparison to a predicate device. The performance is summarized as meeting these qualitative criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Shelf life stability (18 months) | Demonstrated D-value stability and Population stability with three separate lots. |
| Recovery media efficacy | Demonstrated consistent recovery of "low numbers" of "injured spores." |
| Incubation period | Achieved recovery and color change within a 48-hour incubation period. |
| Stability of color change | Color change (green to yellow) was stable and effectively indicated growth. |
| Overall effectiveness in monitoring EtO cycles | Demonstrated effectiveness in routine Ethylene Oxide sterilization cycles. |
| Substantial equivalence to predicate device (Attest™) | ProSpore2® is "substantially equivalent in composition and function" based on the testing results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "three separate lots of finished product ProSpore2 vials" were used for shelf-life stability testing. It doesn't specify the exact number of units per lot or the total number of units tested across various experiments (e.g., recovery media efficacy, 48-hr incubation).
- Data Provenance: The data appears to be prospective as it involves the testing of the newly developed ProSpore2® device by the manufacturer (Raven Biological Laboratories, Inc.) for the purpose of regulatory submission. The country of origin for the data is implied to be the United States, where the manufacturer is located and where the FDA regulatory process took place.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not detailed in the provided summary. Biological indicator testing typically relies on standardized laboratory procedures and measurements (e.g., spore enumeration, D-value calculation, growth observation) rather than expert consensus on subjective interpretations. Therefore, the "ground truth" is established by the inherent biological response and observable color change, not by expert interpretation.
4. Adjudication Method for the Test Set
This information is not detailed in the provided summary. Given the nature of biological indicator testing, adjudication by multiple human experts is typically not a primary method for determining the success or failure of the indicator itself. The outcome (color change or no color change) is a direct, objective result of spore viability.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging diagnostics or other AI-assisted diagnostic tools where human readers interpret complex data with and without AI assistance. The ProSpore2® is a self-contained biological indicator, and its performance is assessed directly through its biological response and observable color change, not through human interpretation that would be improved by AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the ProSpore2® device. The device itself is the "standalone" indicator. There is no AI algorithm being used, nor is there a human-in-the-loop interacting with an algorithm. The performance of the device is assessed by observers noting the color change (or lack thereof) after incubation.
7. Type of Ground Truth Used
The ground truth used is primarily biological response and physical observation. For spore viability, this involves:
- Biological viability: The ability of Bacillus subtilis spores to germinate and grow when not sufficiently sterilized, leading to metabolic activity.
- pH change: The metabolic activity of viable spores produces acidic byproducts, causing a quantifiable pH drop in the growth media.
- Colorimetric change: The pH indicator (bromothymol blue) visibly changes color from green to yellow in response to the pH drop, indicating viable spore growth.
This is a direct, objective measurement of the indicator's function.
8. Sample Size for the Training Set
This information is not applicable/not provided. The ProSpore2® is a physical biological indicator, not an AI model or algorithm that requires a "training set" in the computational sense. The device's design and formulation were developed through traditional biological and chemical engineering, not machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for developing such a device would involve extensive laboratory research, microbiology, and chemical principles to ensure the correct spore type, population, growth media, and indicator system are effectively integrated. This is a scientific and engineering development process, not the establishment of ground truth for a machine learning training set.
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SUMMARY OF " PROSPORE 2ª SELF CONTAINED BIOLOGICAL VII. INDICATOR" FOR ETHYLENE OXIDE
Submitter:
Raven Biological Laboratories, Inc. 8607 Park Drive Omaha, NE 68127 (402) 593-0781 (402) 593-0921 fax
Contact:
Robert Dwyer President
Wendy Royalty Quality Assurance Manager
Prepared on:
Device name:
Classification:
November 10, 1999
Class II medical device. General hospital
ProSpore2® self-contained biological indicator
Predicate Devices (legally marketed):
Predicate Device 510 (k) number:
DESCRIPTION:
ProSpore2 is a self-contained biological indicator used for determining the efficacy of an Ethylene Oxide sterilization cycle. ProSpore2 is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1.2 - 1.5 ml glass ampoule of growth media consisting of Tryptic Soy Broth (soybean casein digest) and a pH indicator - bromothymol blue. Also inside of the tube housing is a paper spore disc impregnated with a population of 106 Bacillus subtilis spores (ATCC #9372).
Attest™
OPERATIONAL PRINCIPLES:
The plastic cap of the ProSpore2® vial has short 'tines' along its lower edge. When placed on the plastic tube body, the space between the tines allows for the passage of Ethylene Oxide into the tube and to the spore disc. A ProSpore2® unit is placed inside of the sterilizer along with a load to be sterilized. If all parameters are met for the cycle (sterilant concentration, relative humidity, exposure time and temperature), the EtO entering the ProSpore2® capsule will be sufficient to deactivate or kill the spores on the paper disc. Once the cycle is finished, the ProSpore2® vial is
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removed from the sterilizer and sealed by depressing the cap. The sides of the plastic tubes are squeezed which will result in crushing the glass of the media ampoule. With this done, the spore disc is now in contact with the recovery media and the ProSpore2® unit can be placed in an incubator and incubated at 30 to 35°C for 48 hours. If the spores were killed in the sterilization cycle, the color of the recovery media will not change. If the cycle failed to kill the spores, the recovery media will change color from green to yellow, indicating growth, and a failed cycle.
The change in color is the result of 'viable' spores germinating and consuming the nutrients provided in the growth media. This consumption process involves the release of nitrogen waste products. This lowers the pH of the media and increases the acidity, which causes the color to change from green to yellow. Detection of failed EtO sterilization cycles is facilitated by the use of ProSpore2®. The outer label of the ProSpore2® plastic tube body has a chemical indicator on the label which changes color when exposed to EtO thus making it easy to distinguish processed from unprocessed vials.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
ProSpore2® is similar in composition and function to the 'Legally Marketed Predicate Device' -Attest™
- Both devices are intended for use in monitoring Ethylene Oxide sterilization cycles.
- Both devices utilize a USP recommended strain of B. subtilis bacterial spore as its organism of choice for Ethylene Oxide resistance characteristics.
- Both devices use paper as the spore carrier.
- Both devices utilize a plastic vial and cap to house the spore carrier and media capsule.
- Both devices contain a sealed recovery media ampoule made of glass.
- Both devices use a pH indicator in the recovery media that turns from green to yellow in color when growth is present.
- Both devices require that the recovery media ampoule be activated after sterilization by breaking the glass ampoule to release the media to come in contact with the spore carrier.
- Both devices incorporate a 'chemical indicator' on the label, which will change color when exposed to Ethylene Oxide so that exposed vials can be distinguished from unprocessed vials.
DESCRIPTION OF TESTING:
ProSpore2® has been tested for shelf life stability over 18 months. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore2 vials. The recovery media has been tested to show recovery of "low numbers' of 'injured spores', 48-hr incubation period, and the stability of the color change when growth occurred. For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery, 48-hr incubation, stability of color change and overall effectiveness in monitoring routine Ethylene Oxide sterilization cycles has been demonstrated.
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CONCLUSION
Raven's ProSpore2® is substantially equivalent in composition and function to the Legally
Marketed predicate device, Attest™, for monitoring Ethylene Oxide sterilization cycl incubation period of 48 hours based on the testing results and analysis of 18-month shelf-life stability data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2001
Ms. Wendy Royalty Quality Assurance Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
K994381 Re :
ProSpore2® Self-contained Biological Trade Name: Indicator Regulatory Class : II Product Code: FRC December 27, 2001 Dated: Received: January 5, 2001
Dear Ms. Royalty:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Ms. Royalty
this response to your premarket notification submission does chis response to your pou might have under sections 531 not arrect any obingat for devices under the Electronic Chrough 542 or the nee rol control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as fills recei will areas) premarket notification. The FDA described in your six (i) puivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate as the your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie additionally 809.10 for in regaracton (2) (2) devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 551 ising of your device, please contact 594-4639. Also, please note the Office of Compliance at (301) "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on your responsof Small Manufacturers Assistance oblained from the Drvinies (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Viktor
Timoth Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER: K994381 PRODUCT: PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR 7
I. INDICATION OF USE
ProSpore2 is a biological sterilization process indicator for EtO (Ethylene Oxide) sterilization. This device is intended for use by a health care provider to accompany products being sterilized through an EtO sterilization procedure and to monitor the adequacy of sterilization. The testing and validations referred to in this document were done using a 10/90 Ethylene Oxide mixture at 600 mg/L, 54°C, and with a relative humidity between 30% and 80%.
R.A. Victors
(Division Sign-Off Division of Dental, Infection Control, and General Hospital Dev 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).