(624 days)
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No
The device description details a biological indicator that relies on the growth of spores and a pH indicator for its function, with no mention of AI or ML technologies.
No
Explanation: This device is a biological indicator used to test the effectiveness of steam sterilizers, not to treat a medical condition or disease in a patient.
No
The device is a biological indicator used to test the effectiveness of steam sterilizers, not to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components (plastic vial, cap, paper strip, glass ampule, medium) and a biological process (spore growth, pH change), indicating it is a hardware-based biological indicator, not a software-only device.
Based on the provided information, the Propper BI-O.K. steam biological indicator is an IVD (In Vitro Diagnostic).
Here's why:
- In Vitro: The device is used to test the effectiveness of a sterilization process outside of the human body. It involves a biological indicator (spores) and a growth medium in a contained system.
- Diagnostic: While not diagnosing a disease in a patient, it is used to diagnose whether a sterilization process was successful. The color change indicates whether viable spores remain, which is a diagnostic test for the efficacy of the sterilization cycle.
The description clearly outlines a test performed in vitro (in a lab-like setting, within the vial) to determine the effectiveness of a process (sterilization), which fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
Product codes
FRC
Device Description
The Propper BI-O.K. self contained steam biological indicator consists of a plastic vial and cap which contain a paper strip impregnated with a known number of B. stearothermophilus spores and a sterile sealed glass ampule containing a modified Soybean Casein Digest Medium with pH indicator. Following exposure in a steam sterilizer, the glass ampule is crushed by squeezing the sides of the plastic vial, thus bringing the medium into contact with the spores. The vial is incubated at 56± 2℃ for at least 24 hours. If any of the spores survived the sterilization process, they will grow and produce acid. This will cause a drop in pH of the medium and change the indicator from red to yellow.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 2 4 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
510 (k) Submission K99_14 18
Propper BI - O.K.™ Self-Contained Biological Indicator (for use in steam autoclaves)
General Information:
Submitter's Name/Address
Propper Manufacturing Company Inc. 36-04 Skillman Avenue Long Island City, NY 11101 Attn: John D. Dyckman Ph.D.
Common Name of the Device:
Biological/Chemical Indicator
Trade Name of the Device:
BI-O.K.
Classification Information:
Class II, Sterilization Process Indicator
Indications for Use:
The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
Device Description;
The Propper BI-O.K. self contained steam biological indicator consists of a plastic vial and cap which contain a paper strip impregnated with a known number of B. stearothermophilus spores and a sterile sealed glass ampule containing a modified
1
Soybean Casein Digest Medium with pH indicator. Following exposure in a steam sterilizer, the glass ampule is crushed by squeezing the sides of the plastic vial , thus bringing the medium into contact with the spores. The vial is incubated at 56± 2℃ for at least 24 hours. If any of the spores survived the sterilization process, they will grow and produce acid. This will cause a drop in pH of the medium and change the indicator from red to yellow.
Substantial Equivalence:
The Propper BI-O.K. Self Contained Steam Biological Indicator has been patterned from the same materials, size, and construction as a biological indicator which has been on the market for over 20 years as well as one that has been marketed for over five years. It has a spore population and D value which are in the range of other products of this type on the market. The instructions for use and handling are typical for indicators of this type.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2001
Mr. John D. Dyckman Vice President of Product Research Propper Manufacturing company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101
K991618 Re: BI-O.K. Self-Contained Biological Indicator Trade Name: Requlatory Class: II Product Code: FRC October 26, 2000 Dated: Received: October 26, 2000
Dear Mr. Dyckman:
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). provisions of the reasian room, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಡಿ 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: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic
3
Page 2 - Mr. Dyckman
Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia equivalence of your device to a legally I marketed predicate device results in a classification for your marketed predicate device bur 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 regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreason 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 general information on your responsibilities under the Act may be Information on your responsof Small Manufacturers Assistance obcarned from the bring (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
Timot 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): BI-O.K. Th Device Name:
...
Indications For Use:
The Propper BI-O.K. steam biological indicator is indicated for use in testing both The Propper BI-O.K. steam biological indicator is increator is the count of the county of the 134°C.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
· Concurrence of CDRH, Office of Device Evaluation (ODE)
Qhi si lim
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of Beneral Hospital Devices 510(k) Number
Prescription Usc (Pcr 21 CFR 801.109) .
· OR
Over-The-Counter Use X
Section 807.87 (a)
(Optional Format 1-2-90)