(87 days)
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No
The device description and performance studies focus on biological indicators and their resistance to sterilization processes, with no mention of AI or ML.
No.
The device is a biological indicator used for monitoring sterilization processes, not for direct therapeutic treatment.
No
Explanation: The device is a biological indicator used for monitoring sterilization processes, not for diagnosing medical conditions in patients. It assesses whether sterilization conditions are met.
No
The device description clearly states it is a "calibrated population of bacterial spores... on or in a carrier," which is a physical, biological component, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the biological indicators are used for "monitoring of sterilization processes". This monitoring involves assessing whether sterilization conditions are met, which is a diagnostic function related to the effectiveness of a process.
- Device Description: The description further clarifies that the biological indicator "serves to demonstrate whether sterilization conditions are met." This is a direct assessment of a process outcome.
- Performance Studies: The performance studies involve culturing the biological indicators with a "proprietary Culturing Set Medium" and analyzing the results (e.g., spore population, resistance). This culturing and analysis process is a key characteristic of in vitro diagnostic testing.
While the device doesn't directly diagnose a disease in a patient, it performs a diagnostic function by assessing the effectiveness of a sterilization process, which is crucial for patient safety in healthcare settings. The use of a culturing medium and the analysis of biological activity (spore viability) firmly place it within the realm of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a callbrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
Product codes
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Device Description
A biological indicator is a callbrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
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
health care facilities.
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
Samples of both indicators were qualified for use in both steam and chemical vapor sterilization then placed under freezer (0°C), refrigerator (2°C - 8°C), and controlled room temperature (15° -30°C) conditions. Population analysis was conducted for all lots at each sampling interval. Each lot was sampled at intervals according to test protocol. Testing was conducted according to Standard Operating Procedures for spore population, steam resistance, and chemical vapor resistance. In addition to testing in steam and chemical vapor BIER (Biological Indicator Evaluator Resistometer) units, limited endpoint bracket testing was also conducted. The formaldehyde content of each lot of Vapo-Steril® employed in testing was confirmed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Between December 1992 and March 1995 MDT Biologic Company conducted a series of shelf life stability studies with different lots each of Unispore® dual-species paper strip biological indicators and Spor-Test® paper strip biological indicators. In addition, both Unispore® and Spor-Test® biological indicators were cultured with MDT's proprietary Culturing Set Medium.
Key Results:
- Revise the recommended storage conditions from freezer storage to refrigerator storage; 2) Revise the recommended storage conditions when employed with MDT's Culturing Service (mailer service) to storage in a cool, dry place or refrigeration; and 3) Revise the labeling of Unispore® to include a claim for use with chemical vapor sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K792649 & K801152 and K800482, & K801980
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.
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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).
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Image /page/0/Picture/0 description: The image shows a logo with the letters "MDT" in a bold, stylized font. The "D" is represented by a plus sign. Below the logo, the words "Technology for Life" are printed in a smaller, sans-serif font. The text is left-aligned and appears to be the company's slogan or tagline.
MAY
96077
MDT Bio
T Biologic Company
1777 East Henrietta Road (14623) P.O. Box 23077
Facsimile (716) 272-5271 Rochester, New York 14692-3077 U.S.A. Telephone (716) 475-1400
510(k) SAFETY AND EFFECTIVENESS SUMMARY
for
MDT Biologic Company
UNISPORE® and SPOR-TEST®
Biological Indicators
Submitted by
MDT Biologic Company 1777 East Henrietta Road Rochester, New York 14692-3077
Phone 716-475-1400 Fax 716-272-5033
Charles O. Hancock Senior Manager Regulatory Compliance Phone 716-272-5080 716-272-5271 Fax
Ref. 21 CFR 807.92(a)(1) & (c)
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This summary is for the:
| Trade name | MDT Biologic Company Unispore® and Spor-Test® |
|---|---|
| Common name | Biological Indicators |
| Classification name | Sterilization Process Biological Indicators (21 CFR 880.2800) |
| ref. 21 CFR 807.92(a)(2) |
We believe this product to be substantially equivalent to the Unispore® and Spor-Test® biological indicators currently having market clearance in accordance with K792649 & K801152 and K800482, & K801980 respectively.
ref. 21 CFR 807.92(a)(3)
The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a callbrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met. The predicate devices were required to be stored under refrigerated conditions. This submittal presents data substantiating storage either under refrigerated conditions or under controlled room temperature conditions. It is further shown that since Unispore® and Spor-Test® biological indicators are manufactured under identical conditions using the same strain of test organisms, the same outer packaging, and the same recovery medium, that Unispore® biological indicators be used to monitor chemical vapor sterilization.
ref. 21 CFR 807.92 (a)(4), (5) & (6)
Between December 1992 and March 1995 MDT Biologic Company conducted a series of shelf life stability studies with different lots each of Unispore® dual-species paper strip biological indicators and Spor-Test® paper strip biological indicators. In addition, both Unispore® and Spor-Test® biological indicators were cultured with MDT's proprietary Culturing Set Medium. Samples of both indicators were qualified for use in both steam and chemical vapor sterilization then placed under freezer (0°C), refrigerator (2°C - 8°C), and controlled room temperature (15° -30°C) conditions. Population analysis was conducted for all lots at each sampling interval. Each lot was sampled at intervals according to test protocol. Testing was conducted according to Standard Operating Procedures for spore population, steam resistance, and chemical vapor resistance. In addition to testing in steam and chemical vapor BIER (Biological Indicator Evaluator Resistometer) units, limited endpoint bracket testing was also conducted. The formaldehyde content of each lot of Vapo-Steril® employed in testing was confirmed. From the
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results of these tests we conclude that both Unispore® and Spor-Test® labeling be modified to: 1) Revise the recommended storage conditions from freezer storage to refrigerator storage; 2) Revise the recommended storage conditions when employed with MDT's Culturing Service (mailer service) to storage in a cool, dry place or refrigeration; and 3) Revise the labeling of Unispore® to include a claim for use with chemical vapor sterilization.
ref. 21 CFR 807.92(b)(1), (2) & (3)
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