(170 days)
Not Found
Not Found
No
The document describes a biological indicator for monitoring sterilization, with no mention of AI or ML technology.
No.
The device is used for monitoring sterilizers, not for treating patients.
No
The device is described as a "Biological Test-Pak" for monitoring ethylene oxide sterilizers, not for diagnosing medical conditions in patients. It's used to verify the effectiveness of sterilization equipment.
No
The device description clearly states it consists of physical components like a biological indicator, plastic syringe, record card, absorbent towel, and a paper/plastic peel pouch. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "biological monitoring of ethylene oxide sterilizers in health care facilities." This is a quality control or process monitoring function for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains a biological indicator (likely spores) and is placed inside a syringe and pouch for use in a sterilizer. This is consistent with a sterilization monitoring device, not an IVD.
- Lack of Diagnostic Language: The text does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health.
- Focus on Sterilizer Performance: The performance studies described focus on the device's ability to indicate whether the ethylene oxide sterilization process was effective, not on diagnosing a patient.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Prior BI O.K." EO Gas Biological Test-Pak is intended for use as a disposable device for the biological monitoring of ethylene oxide sterilizers in health care facilities. Its construction closely duplicates that described for such testing by AAMI/ANSI ST41-1992.
The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas mixture.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The BI-O.K. EO Gas Biological Test-Pak consists of a BI-O.K. EO Gas Biological Indicator placed inside a plastic syringe. The syringe along with a Record Card and absorbent towel are enclosed in a paper/plastic peel pouch suitable for use in ethylene oxide sterilizers.
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
health care facilities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Propper BI-O.K. EO Gas Biological Test-Pak was tested in-house in a Joslyn BIER vessel to determine the performance characteristics of the system under controlled, reproducible conditions consisting of 60% RH, 600 mg/L ethylene oxide and 54.4°C. The results obtained are similar to those reported for similar devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness
JAN - 9 1998
510(k) Submission K97 _2747
Propper BI-O.K. EO Gas Biological Test-Pak
General Information:
Submitters Name/Address:
Propper Manufacturing Co., Inc. 36-04 Skillman Avenue Long Island City, New York 11101 Attn: John D. Dyckman Ph.D.
Common Name of the Device:
Biological/Chemical Indicator
Trade Name of the Device:
BI-O.K.Th Ethylene Oxide Gas Biological Test-Pak
Classification Information:
Class II
Sterilization Process Indicator
Indications for Use:
The Prior BI O.K." EO Gas Biological Test-Pak is intended for use as a disposable device for the biological monitoring of ethylene oxide sterilizers in health care facilities. Its construction closely duplicates that described for such testing by AAMI/ANSI ST41-1992.
1
Device Description:
。
The BI-O.K. EO Gas Biological Test-Pak consists of a BI-O.K. EO Gas Biological Indicator placed inside a plastic syringe. The syringe along with a Record Card and absorbent towel are enclosed in a paper/plastic peel pouch suitable for use in ethylene oxide sterilizers.
Substantial Equivalence:
The Propper BI-O.K. EO Gas Biological Test-Pak is substantially equivalent to the standard pack described by AAMI as well as commercially available test packs marketed by 3M and ATI which employ biological indicators for monitoring ethylene oxide sterilization in health care facilities.
Performance studies:
The Propper BI-O.K. EO Gas Biological Test-Pak was tested in-house in a Joslyn BIER vessel to determine the performance characteristics of the system under controlled, reproducible conditions consisting of 60% RH, 600 mg/L ethylene oxide and 54.4°C. The results obtained are similar to those reported for similar devices.
Conclusion:
Based upon the indications for use, construction, and performance, the Propper BI-O.K. EO Gas Biological Test-Pak has been shown to be suitable for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with arms outstretched, embracing a stylized cross.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
John D. Dyckman, Ph.D. Director, Product Research Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue 11101 Long Island City, New York
K972747 Re : BI-0.K.™ EO Gas Biological Test-Pak Trade Name: (269305,269310,269320) Requlatory Class: II Product Code: FRC November 17, 1997 Dated: Received: November 20, 1997
Dear Dr. Dyekman:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
3
Paqe 2 - Dr. Dyekman
not affect any obligation you might have under sections 531 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general 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/dsmamain.html".
Sincerely yours,
Clifford
v A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:_
Indications For Use:
INDICATIONS FOR USE
Page
of
The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas mixture.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chim S. Lim
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number: K972747
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)