(86 days)
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No
The device description and performance studies focus on biological and chemical indicators, with no mention of AI or ML.
No
The device is used to determine the efficiency of a sterilization cycle, not to treat a medical condition.
No
Explanation: The device is a biological indicator used to test the efficiency of a sterilization cycle, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "self-contained biological indicator" and describes physical components like Bacillus stearothermophilus and a recovery medium. This indicates a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 diagnostic test performed on a biological sample from a human or animal to diagnose a disease or condition.
- Device Description: The device contains Bacillus stearothermophilus spores and a growth medium. It's designed to assess the effectiveness of sterilization by seeing if the spores are killed, not to analyze a patient sample.
- Lack of Patient Information: There is no mention of an anatomical site, patient age range, or intended user/care setting related to patient diagnosis or treatment.
- Performance Studies: The performance studies focus on the device's ability to indicate sterilization effectiveness (incubation period, spore recovery, stability), not on diagnostic accuracy metrics like sensitivity, specificity, etc.
- Predicate Devices: The predicate devices listed are also biological indicators for sterilization, not IVDs.
In summary, the device's purpose is to evaluate the effectiveness of a sterilization process, which falls under quality control for medical devices or procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle.
Product codes
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Device Description
ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. The device is a Bacillus stearothermophilus in a recovery medium of Tryptic Soy Broth with Bromocresol purple, a pH indicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
Testing was performed to validate the labeled claims and performance characteristics for ProSpore®. These included studies on the labeled incubation period, recovery of damaged spores, the effect of the pH indicator on the recovery of injured spores, and the stability of population and D-value after a real time of one year. Test results confirmed that the tested samples conformed to the labeled claims.
Key Metrics
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
Summary of "ProSpore Self-contained Biological Indicator" for steam sterilization at 121ºC Submitter: Raven Biological Laboratories, Inc.
5017 Leavenworth Street Omaha, NE 68106
Production Microbiologist
(402) 556-6690 (402) 556-4722 FAX
Russ Nyberg
20 June 1996
Kilt™ (BBL)
Contact:
Prepared on:
Device name:
Classification:
.
Predicate Devices (legally marketed)
Predicate Devices 510(k) number:
Kilit™(BBL) - Grandfather In* Spor View™ (SPSmedical) K905425
Spor View™ (SPSmedical)
ProSpore® self-contained biological indicator
Class II medical device, General Hospital
Description
ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle. The device is a Bacillus stearothermophilus in a recovery medium of Tryptic Soy Broth with Bromocresol purple, a pH indicator.
Specifications
- BI
Bacillus stearothermophilus (ATCC # 7953) Microorganism:
Population: 1.0 x 105 - 4.0 x 105 cfu/unit
Resistance Characteristics: (for saturated steam at 121ºC)
1
D-value: (determined using Spearman - Karber method on pages 43-50).
| Survival time: | (USP XXII, p. 204 - Attachment #9)
=[min] labeled D-value x (log10 labeled spore count per carrier -2) |
|----------------|------------------------------------------------------------------------------------------------------------|
| Kill time: | (USP XXII, p. 204 - Attachment #9))
=[max] labeled D-value x (log10 labeled spore count per carrier +4) |
Incubation period: 77 days
2) Components
Ampule: USP type 1. 4-ml flame-seal flint glass ampule
Culture/recovery medium: 10 ml of Bromocresol Purple (BCP) stock solution to each liter of Trypticase® Soy Broth (TSB), adjusted to a pH of 7.0 with Sodium Hydroxide (NaOH) and/or Hydrochloric Acid (HCL
- Trypticase® Soy Broth powder (Becton Dickinson), as per manufacturer's nutrient: instructions
neutralizers: Sodium Hydroxide (NaOH) and Hydrochloric Acid (HCL) pH indicator: Bromocresol Purple (4 grams BCP powder to each liter of deionized distilled water)
Operational Principles
The ProSpore® ampule is placed with a load in the sterilization chamber, and subjected to a normal steam sterilization cycle. The ampule is then removed and cooled to room temperature. Next, the processed ampule and an unprocessed (control) ampule are placed in incubation for a period of 7 days at a temperature favorable for growth (55° - 60° C. for B. stearothermophilus).
During incubation, the available food supply (TSB) and temperature promote growth of viable spore. The growth process may be accompanied by turbidity and/or a release of acidic waste by products which reduce the pH level of the surrounding medium. Bromocresol purple reacts to this reduction by changing in color to or toward yellow
Within 7 days, growth will become evident by a change in color from purple to/toward yellow and/or turbidity in the test ampule. This may be interpreted as a failure to meet the conditions necessary for sterilization, provided these signs are present in the control ampule.
Statement of similarity to legally marketed (predicate) devices:
ProSpore® is similar in composition and function to Kilt™ and SporView™, as these devices, like ProSpore® combines Bacillus stearothermophilus spores and a recovery medium (combined
2
with a pH indicator) in a flame-sealed glass ampule for use in determining the efficacy of steam sterilization cycles.
Clinical Tests: No clinical tests have been performed.
Discussion of results from nonclinical tests:
Testing was performed to validate the labeled claims and performance characteristics for ProSpore®. These included studies on the labeled incubation period, recovery of damaged spores, the effect of the pH indicator on the recovery of injured spores, and the stability of population and D-value after a real time of one year. Test results confirmed that the tested samples conformed to the labeled claims.
Statement of safety and effectiveness
Based on similar claims and design, and results from the nonclinical studies mentioned above, the ProSpore® biological indicator has been determined to be substantially equivalent and, therefore, as safe and effective to the legally marketed devices Kilt™ and Spor View™
*Kilit™(BBL) does not have a 510 (k) number. It was marketed under the grandfather clause, which exempts devices in commercial distribution prior to May 28, 1976. We have obtained the results of the Trademarkscan search of the U.S. Patent Office trademark filing showing that the product was introduced into commerce on June 8, 1955 (Attachment 10). The FDA # is M452998