(172 days)
Not Found
No
The device description and performance studies focus on biological and chemical indicators, with no mention of AI or ML technologies.
No
The device is used to determine the efficiency of a steam sterilization cycle, not to treat or diagnose a medical condition in a patient.
No
The product description states it is a "biological indicator used for determining the efficiency of a 121°C steam sterilization cycle", not for diagnosing a medical condition or disease in a patient.
No
The device description clearly outlines physical components including a plastic tube housing, plastic cap, glass ampule, growth media, and a paper spore disc. This indicates a hardware-based device, not software-only.
Based on the provided information, ProSporeII® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for determining the efficiency of a 121°C steam sterilization cycle." This is a quality control measure for a sterilization process, not a test performed on a biological sample from a human or animal to diagnose, monitor, or treat a disease or condition.
- Device Description: The components (spores, growth media, pH indicator) are used to assess the effectiveness of sterilization, not to analyze a patient sample.
- Lack of Patient Interaction: The device does not interact with a patient or patient sample. It is used to test the sterilization equipment.
- Predicate Device: The predicate device (K915275; ProofPlus™ (AMSCO)) is also a biological indicator for sterilization, further supporting that this type of device is not classified as an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or compatibility purposes. ProSporeII® does not fit this description.
N/A
Intended Use / Indications for Use
ProSpore II® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle.
Product codes
Not Found
Device Description
ProSporeII® is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1 ml glass ampule of growth media consisting of Tryptic Soy Broth and a pH indicator of phenol red. Also inside of the tube housing is a paper spore disc impregnated with a population of 10^5 Bacillus stearothermophilus spores (ATCC #7953).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
ProSpore II has been tested for Population Stability over an 18 month self-life. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore II ampules. The recovery media has been tested to show stability in the recovery of "low numbers' of 'injured spores' over the 18 month shelf-life and the stability of the color change when growth occurred. For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles that has been demonstrated.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 1 6 1996
Image /page/0/Picture/1 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter 'K', followed by the numbers '960790'. The numbers and letter are written in a bold, handwritten style, and they appear to be part of a code or identification number.
Summary of "ProSpore II Self-contained Biologic for steam sterilization at 121℃
| Submitter: | Raven Biological Laboratories, Inc. |
|---|---|
| 5017 Leavenworth Street | |
| Omaha, Nebraska 68106 | |
| (402) 556-6690 | |
| (402) 556-4722 FAX | |
| Contact: | Russ Nyberg |
| Production Microbiologist | |
| Prepared on: | 29 May 1996 |
| Device name: | ProSpore II® self-contained biological indicator |
| Classification: | Class II medical device, General hospital |
| Predicate Devices (legally marketed): | ProofPlus™ (AMSCO) |
| Predicate Device 510 (k) number | K915275 |
DESCRIPTION:
ProSporeII® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. ProSpore II is comprised of a plastic tube housing with a plastic cap. Inside of the tube is a 1 ml glass ampule of growth media consisting of Tryptic Soy Broth and a pH indicator of phenol red. Also inside of the tube housing is a paper spore disc impregnated with a population of 105 Bacillus stearothermophilus spores (ATCC #7953).
OPERATIONAL PRINCIPLES:
The plastic cap of the ProSpore II vial has short 'tines' along it's lower edge. When placed on the plastic tube body, the space between the tines allow for the passage of steam into the tube and thus reach the spore disc. A ProSpore II unit is placed inside of the sterilizer along with a load to be sterilized. If all parameters are met for the cycle (exposure time and temperature), the steam entering the ProSpore II capsule will be sufficient to deactivate or kill the spores on the paper disc. Once the cycle is finished, the ProSpore II vial is removed from the sterilizer and the cap is pressed down with ones thumb. This seals the vial. After allowing the unit to cool for 10 to 15
1
minutes, the sides of the plastic tubes are squeezed which will result in crushing the glass of the media ampule. With this done, the spore disc is now in contact with the recovery media and the ProSpore II unit can be placed in an incubator and incubated at 55 to 60°C for a 7 day period of time. If the spores were killed in the sterilization cvcle, the recovery media will not change. If the cycle was 'failed cycle' and failed to kill the spores, the recovery media will change color from red to vellow indicating growth.
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 which lower the pH of the media and increases the acidity which causes the color to change from red to vellow. Detection of failed steam sterilization cycles is facilitated by the use of ProSpore II. The outer label of the ProSpore II plastic tube body has a chemical indicator on the label which changes color when exposed to saturated steam ate 121ºC thus making it easy to distinguish processed from unprocessed vials.
STATEMENT OF SIMILARITY TO LEGALLY MARKETED PREDICATE DEVICE
ProSpore II is similar in composition and function to the 'Legally Marketed Predicate Device' ProofPlus.
- both devices are intended for use in monitoring 'steam sterilization cycles at 121°C
- both devices utilize a USP recommended strain of B. stearothermophilus bacterial spore as it's organism of choice for steam resistance characteristics.
- both devices use a paper disc as the spore carrier.
- both devices utilize a plastic vial and cap to house the spore disc and media capsule.
- both devices contain a sealed recovery media ampule made of glass.
- both devices use a pH indicator in the recovery media which turns from red to yellow in color when growth is present.
- both devices require that the recovery media ampule be activated after sterilization by breaking the glass ampule to release the media to come in contact with the spore disc.
- both devices incorporate a 'chemical indicator' on the label which will change color when exposed to steam at 121°C so that exposed ampules or vials can be distinguished from unprocessed vials.
DESCRIPTION OF TESTING:
ﺴﻤﻌﺘﻌﻠﻬﺎ
ProSpore II has been tested for Population Stability over an 18 month self-life. This testing included both D-value stability and Population stability with three separate lots of finished product ProSpore II ampules. The recovery media has been tested to show stability in the recovery of "low numbers' of 'injured spores' over the 18 month shelf-life and the stability of the color change when growth occurred. For all lots tested, the stability of Resistance Characteristics, Spore Population, Media Recovery and overall effectiveness in monitoring routine steam sterilization cycles that has been demonstrated.
2
CONCLUSION:
Raven's ProSpore II is substantially equivalent in composition and function to the legally marketed predicate device, AMSCO's ProofPlus, for monitoring steam sterilization cycles at 121°C, based on the testing results and analysis of 18 month self-life stability data.