MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR

K960777 · Mdt Corp., Inc. · FRC · May 23, 1996 · General Hospital

Device Facts

• Record ID: K960777
• Device Name: MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
• Applicant: Mdt Corp., Inc.
• Product Code: FRC · General Hospital
• Decision Date: May 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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 calibrated 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.

Device Story

Biological indicators consist of bacterial spores on a carrier within protective packaging. Used in healthcare facilities to monitor sterilization efficacy (steam and chemical vapor). Users place indicators in sterilization cycles; post-cycle, indicators are cultured in proprietary medium to assess spore survival. Survival indicates sterilization failure; death indicates successful process. Device provides objective verification of sterilization conditions. This submission updates storage requirements to include controlled room temperature (15-30°C) in addition to refrigeration, and expands Unispore® labeling to include chemical vapor sterilization monitoring.

Clinical Evidence

Bench testing only. Shelf-life stability studies conducted (Dec 1992–Mar 1995) across multiple lots. Indicators tested in steam and chemical vapor BIER units. Endpoints included spore population counts, steam resistance, and chemical vapor resistance across freezer, refrigerator, and controlled room temperature storage conditions. Results confirmed stability and efficacy for updated storage and usage claims.

Technological Characteristics

Biological indicator consisting of bacterial spores on a carrier in protective packaging. Utilizes proprietary Culturing Set Medium for recovery. Tested in steam and chemical vapor BIER (Biological Indicator Evaluator Resistometer) units.

Indications for Use

Indicated for monitoring sterilization processes in health care facilities. Used to verify sterilization conditions via calibrated bacterial spore populations.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• Unispore® (K792649)
• Unispore® (K801152)
• Spor-Test® (K800482)
• Spor-Test® (K801980)

Submission Summary (Full Text)

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MDT
Technology for Life
MAY 23 1996
k%o777
MDT Biologic Company
1777 East Henrietta Road (14623) P.O. Box 23077 Rochester, New York 14692-3077 U.S.A. Telephone [phone] Facsimile [phone]

# 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 [phone]
Fax [phone]

Charles O. Hancock
Senior Manager
Regulatory Compliance
Phone [phone]
Fax [phone]

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 calibrated 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 carrier, 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)