(410 days)
Not Found
Not Found
No
The description focuses on monitoring physical parameters (gas concentration, temperature, humidity, time) and compares performance to a predicate device based on these parameters. There is no mention of AI, ML, or any data processing that would suggest such technology.
No
The device is an ethylene oxide sterilization integrator, used to monitor sterilization conditions, not to treat patients.
No
The device is an ethylene oxide sterilization integrator, which monitors sterilization conditions, not diagnoses a medical condition or disease.
No
The device description and intended use clearly describe a physical sterilization integrator, which is a hardware component used to monitor sterilization parameters. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "ethylene oxide sterilization integrator" used to monitor the conditions of an EO sterilization process. It does not mention analyzing samples from the human body or diagnosing any medical condition.
- Device Description: The description identifies it as an "Ethylene Oxide Sterilization Integrator."
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Being used in a laboratory or clinical setting for patient testing
Instead, the device is used to monitor a sterilization process, which is a quality control measure for medical devices or other items being sterilized. This falls under the category of a process indicator, not an IVD.
N/A
Intended Use / 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.
Product codes
JOJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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)