(410 days)
Propper EO LINE™ is indicated to be an ethylene oxide sterilization integrator for use in EO sterilizers with 10% ethylene oxide : 90% HCFC gas mixtures. Its function is to monitor the exposure conditions for EO sterilization and to ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met.
Propper EO LINE™ Ethylene Oxide Sterilization Integrator
This document is a 510(k) clearance letter from the FDA for a medical device called "Propper EO LINE™ Ethylene Oxide Sterilization Integrator". It doesn't contain a detailed study report with specific acceptance criteria and performance data. Instead, it indicates that a study was done and found the device to be "comparable" to a predicate device.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study particulars.
However, I can extract the following limited information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not available in this document. The document states:
- "The performance of Propper EO LINE™ Integrator was comparable to SteriGage® EO Integrator when tested in a Joslyn BIER vessel."
This implies that the acceptance criterion was likely "comparable performance" to the predicate device (SteriGage® EO Integrator), but the specific metrics for comparability are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/available. This device is an integrator for sterilization, not a diagnostic device requiring expert interpretation. The ground truth would be based on physical/chemical sterilization parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/available.
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 not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. It is a physical sterilization integrator.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The type of ground truth for a sterilization integrator would typically be the successful or unsuccessful sterilization based on established physical (temperature, humidity, time) and chemical (EO gas concentration) parameters, often confirmed by biological indicators. The document mentions: "ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met."
8. The sample size for the training set
Not applicable/available. Sterilization integrators are typically tested and validated, not "trained" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable/available.
In summary, the provided document is an FDA clearance letter, not the detailed study report itself. It indicates that a "comparable" study was performed against a predicate device (SteriGage® EO Integrator) using a Joslyn BIER vessel, but it does not contain the specifics of that study.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 6 1998
Frank E. Platko, Ph.D. Vice President, Research & Development Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101
Re : K973585 Propper EO LINE™ Ethylene Oxide Trade Name: Sterilization Integrator Requlatory Class: II Product Code: JOJ September 3, 1998 Dated: September 4, 1998 Received:
Dear Dr. Platko:
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. A 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Platko
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Timot Ulatowsk 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 (if known):
K973585
Propper EO LINE™ Ethylene Oxide Sterilization Integrator Device Name:
Indications For Use:
Propper EO LINE™ is indicated to be an ethylene oxide sterilization integrator for use in EO sterilizers with 10% ethylene oxide : 90% HCFC gas mixtures.
Its function is to monitor the exposure conditions for EO sterilization and to ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met.
The performance of Propper EO LINE™ Integrator was comparable to SteriGage® EO Integrator when tested in a Joslyn BIER vessel.
:
All testing was conducted with 10% EO : 90% HCFC gas mixtures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General |
510(k) Number ________________________________________________________________________________________________________________________________________________________________
rescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
…
(Optional Format 1-2-96)
§ 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).