(153 days)
Not Found
No
The device is a biological indicator for steam sterilization, relying on bacterial spore growth and a color indicator, with no mention of AI or ML in the description or performance studies.
No
The device is a biological indicator used for monitoring the efficacy of sterilization processes, not for treating patients.
No
The device is a biological indicator used to monitor the efficacy of sterilization processes, not to diagnose medical conditions in patients.
No
The device description clearly outlines physical components: bacterial spores, a paper carrier, a glass ampule with culture medium, and a plastic vial. This indicates a hardware-based biological indicator, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor the efficacy of saturated steam sterilization processors." This means it's used to check if a sterilization process is working correctly, not to diagnose a condition in a patient or analyze a biological sample from a patient.
- Device Description: The device contains bacterial spores and culture medium. It's designed to be exposed to a sterilization process and then incubated to see if the spores are killed. This is a quality control measure for the sterilization equipment, not a diagnostic test on a patient sample.
- Lack of IVD Characteristics: The description does not mention analyzing human or animal specimens, diagnosing diseases, or providing information about a patient's health status.
Therefore, the EZTest® - Steam self contained biological indicator is a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 121 C steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132 C , 134 C and 135 C.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.
Spores: Bacterial endospores of Bacillus stearothermophilus, ATCC 7953 or equivalent, are inoculated onto a 591 Schleicher & Schuell. Inc. filter paper carrier* cut into strips of a convenient size to be placed inside the plastic body of the device. The population of spores on each individual piece of paper will be between 0.5 x 10 00 and 5 x 10 00. The spore concentration will be labeled as a 105 concentration.
Culture Tube: The culture tube is made of a polypropylene. The plastic culture tube is a) 1.75" in length and 0.34" in OD. The 0.02" wall allows the culture tube to be flexible so that the culture media glass ampule can be broken to activate the test.
Culture Medium: The culture medium, consisting of a formulated soybean casein digest base, is filled into ampules of Type III pharmaceutical grade glass, flame sealed and sterilized. The sealed ampules are of convenient size to be placed into the plastic body with the spore paper. Following filling, the ampules are exposed to a steam processing cycle to render them sterile. The ampule is a thin wall glass which allows it to be easily crushed when the plastic body is compressed. This provides the spores with nutrient medium for growth. The culture medium has a pH indicator (bromcresol purple) added to it which appears as a purple color prior to crushing for incubation. When the spores grow, they produce acid and alter the pH. This causes the medium to change to a yellow color. If the medium changes to yellow, viable spores are present and the sterilization process is not acceptable, If the medium remains purple, the spores did not grow, which means they are not viable.
Filter Paper Vent: The plastic body is closed with a ½" disc filter vent material that allows the exchange of gases from the sterilizer or from the environment.
Cap: A polypropylene plastic cap is used to hold the vent material in place. This cap has three small holes in it to allow steam and air to freely move in and out of the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of EZTest® - Steam was evaluated for the following characteristics:
- Bacterial spore species
- Bacterial spore concentration
- Sample purity
- Resistance characteristics including:
- D values at 121°C, 132°C, 134°C and 135°C.
- Survival/Kill times at 121°C, 132°C, 134°C and 135°C.
- Z values
- Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots.
- Resistance characteristics were evaluated to determine the effect of holding time after the exposure to the sterilant until incubation, upon the recovery of injured spores.
- Validation of 48 hours incubation read out time following the CDRH guideline.
- Evaluation of the effect of the pH indicator upon the recovery of injured spores.
- Validation of the effect of the sterilization process on the ability of the media to support the growth of injured spores.
- Stability of the product over the eighteen (18) month shelf life claim.
Conclusion: EZTest® - Steam is appropriate for monitoring steam sterilization processes of 121°C, 132°C, 134°C and 135°C and EZTest® - Steam meets the USP XXIII requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
EZTest® - SGM Biotech, Inc. (K930682), ATITEST® - PyMaH Corp. (K902344), ATTEST® - 3M Co. (pre 1976 device), PROOF® - AMSCO (K801109)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
"510(k) Summary"
[as required by Section 807.92(c)]
FEB 25 1997
510(k) Notification
EZTest® - Steam biological indicator monitor for steam sterilizers
Submitted by:
SGM Biotech, Inc. 10 Evergreen Drive, Suite E Bozeman, MT 59715
Contact:
John R. Gillis, Ph.D. President Phone: (406) 585-9535 FAX: (406) 585-9219
This summary was prepared on September 18, 1996 Amended on January 8, 1997 [as required by Section 807.92(a)(1)]
DEVICE:
Trade name: EZTest® - Steam biological indicator Common name: Self-contained biological indicator for steam [as required by Section 807.92(a)(2)]
11-2
1
SUBSTANTIALLY EQUIVALENT TO THE FOLLOWING LEGALLY MARKETED DEVICES:
EZTest® - SGM Biotech, Inc. (K930682)
ATITEST® - PyMaH Corp. (K902344)
ATTEST® - 3M Co. (pre 1976 device)
PROOF® - AMSCO (K801109)
[as required by Section 807.92(a)(3)]
DESCRIPTION OF DEVICE: EZTest® - Steam
[as required by Section 807.92(a)(4)]
The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.
Spores
Bacterial endospores of Bacillus stearothermophilus, ATCC 7953 or equivalent, are inoculated onto a 591 Schleicher & Schuell. Inc. filter paper carrier* cut into strips of a convenient size to be placed inside the plastic body of the device. The population of spores on each individual piece of paper will be between 0.5 x 10 00 and 5 x 10 00
The spore concentration will be labeled as a 105 concentration. The guideline in the general section on sterilization, USP XXI, p. 121. indicates that the population of spores for a 10° biological indicator should be between 0.5 x 10° and 5.0 x 10°. This is also the SGM Biotech. Inc. specification.
The population data is based on the heat shock population assay. The heat shock procedure is 95°C to 100°C for 15 minutes as outlined in USP XXIII official monographs. P. 205.
-
- reference USP XXIII p. 204
2
Culture Tube
- The culture tube is made of a polypropylene. The plastic culture tube is a) 1.75" in length and 0.34" in OD. The 0.02" wall allows the culture tube to be flexible so that the culture media glass ampule can be broken to activate the test.
Culture Medium
The culture medium, consisting of a formulated soybean casein digest base, is filled into ampules of Type III pharmaceutical grade glass, flame sealed and sterilized. The sealed ampules are of convenient size to be placed into the plastic body with the spore paper. Following filling, the ampules are exposed to a steam processing cycle to render them sterile. The ampule is a thin wall glass which allows it to be easily crushed when the plastic body is compressed. This provides the spores with nutrient medium for growth.
The culture medium has a pH indicator (bromcresol purple) added to it which appears as a purple color prior to crushing for incubation. When the spores grow, they produce acid and alter the pH. This causes the medium to change to a yellow color. If the medium changes to yellow, viable spores are present and the sterilization process is not acceptable, If the medium remains purple, the spores did not grow, which means they are not viable.
Filter Paper Vent
The plastic body is closed with a ½" disc filter vent material that allows the exchange of gases from the sterilizer or from the environment.
Cap
A polypropylene plastic cap is used to hold the vent material in place. This cap has three small holes in it to allow steam and air to freely move in and out of the body.
These materials are all compatible with steam sterilization. These materials have no effect on the resistance of the biological indicator. They are similar to those used in the 3M Attest®.
11-4 29
3
INTENDED USE OF DEVICE:
fas required by Section807.92(a)(5)]
EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 121 C steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132 C , 134 C and 135 C.
The operational principles of the device are as follows. The EZTest® -Steam indicator is placed into a sterilizer load and an appropriate sterilization cycle is run. As sterilization conditions are met, the bacterial spores are destroyed by logarithmic thermal death principles. Following the sterilization cycle, the Bl is removed from the load, the operator activates the self-contained ampule by mechanically flexing the side wall of the plastic vial or by using the plastic crusher provided to break the glass ampule containing the culture medium. The activated EZTest® -Steam Bl is then placed in an incubator which will provide temperatures 55°C to 60°C which is conducive for growth of any bacterial spores which might have survived the sterilization cycle. Microbial growth of the indicator organisms will produce acid in the microbiological culture medium containing bromcresol purple, thus lowering the pH of the solution and invoking a yellow and/or cloudy color change of the media components. If all spores have been killed the media will remain clear and purple.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF EZTest® -Steam COMPARED TO THE CHARACTERISTICES OF THE PREDICTATE DEVICE:
[as required by Section 807.92(a)(6)]
EZTest® - Steam, being similar in type to other products presently in the marketplace whose useful intent is the monitoring of sterilizer efficacy. has been determined to be safe and effective.
4
Active components of the indicator have been in routine use more than 20 years. They predate the medical device amendment of the Food and Drug Cosmetic Act and are recognized by the United States Pharmacopoeia XXIII.
Spores of Bacillus stearothermophilys are the microorganisms of choice for the evaluation of steam sterilization processes because of their high degree of resistance to this type of processes. The USP XXIII specifically indicates that this species of microorganism be used to monitor steam sterilization process. Numerous biological indicators on the marketplace, such as Proof®, Attest®, and ATITest®, use these microorganisms and have proved to be both safe and efficacious.
EZTest® - Steam biological indicators are produced under a manufacturing in-process quality control system to specifications defining exacting parameters for production to assure a consistent product and good manufacturing procedures. Upon completion of production, each lot is inspected and tested to a quality assurance specification to affirm functional conformance to product specifications. A significant portion of the quality assurance specification is testing to the performance characteristics of biological indicators as outlined in USP XXIII. Such compliance is required on each lot prior to release.
DETERMINATION OF SUBSTANTIALLY EQUIVALENT BASED ON PHYSICAL CHARACTERISTICS:
[as required by Section 807.92(b)(1)]
A comparison is provided of the EZTest® - Steam to the legally marketed predicate device describing similarities and differences such as technology and other important characteristics.
A. EZTest® - Steam (K930682):
Is manufactured in precisely the same manner as this device. The difference is the extension of the label claims for use in high temperature saturated steam processes of 132°C. 134°C and 135°C.
- B. ATITest® PyMaH/ATI (K902344):
This device is exactly the same as the PyMaH ATITest® disclosed in 510(k) notification K902344. The ATITest® was developed by
5
SGM Biotech for private label to PyMaH/ATI.
- C. Attest® 3M - Pre '76 Product:
This device is virtually identical is size and shape to the 3M Attest®. It has virtually the same carrier material for the spores with the same concentration of Bacillus stearothermophilus spores (10°). The volume of culture medium in the crushable glass ampule is similar. The pH indicator is bromcresol purple in the Attest®, as well as the EZTest®. Therefore, when viable spores grow, the color changes from purple to vellow.
The glass of the crushable glass ampule in Attest® is virtually the same as that used in the EZTest®.
The culture medium in the 3M Attest® is a sovbean casein digest derived culture medium. EZTest® uses a soybean casein digest derived culture medium. The specific formulation of the SGM Biotech medium is considered proprietary and confidential.
Activation of the 3M Attest® biological indicator devices are performed by compressing the flexible sides of the plastic culture tubes to break the crushable glass ampule containing the culture medium. This is exactly the way EZTest® -Steam is activated.
-
D. PROOF® - AMSCO (K801109):
The EZTest® - Steam is similar to the AMSCO PROOF® in that: -
- similar concentration B. stearothermophilus spores are used, i.e. 10°.
-
- spores are carried on chromatography grade pure cotton derived filter paper.
-
- culture medium is contained in crushable glass ampule.
-
- culture medium is a soybean casein digest derived medium.
-
- spore growth is detected by lowering the pH of the culture medium. This shift in pH is detected by the addition of a pH indicator to the medium.
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DETERMINATION OF SUBSTANTIALLY EQUIVALENCE BASED ON IN USE PERFORMANCE:
[as required by Section 807.92(b)(2)]
The performance of EZTest® - Steam was evaluated for the following characteristics (Certificate of Performance - attached):
- a. Bacterial spore species
- b. Bacterial spore concentration
- c. Sample purity
- d. Resistance characteristics including:
-
- D values at 121°C, 132°C, 134°C and 135°C.
-
- Survival/Kill times at 121°C, 132°C, 134°C and 135°C.
-
- Z values
-
- e. Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots.
- Resistance characteristics were evaluated to determine the ﻧﮯ effect of holding time after the exposure to the sterilant until incubation, upon the recovery of injured spores.
- g. Validation of 48 hours incubation read out time following the CDRH guideline.
- h. Evaluation of the effect of the pH indicator upon the recovery of iniured spores.
- Validation of the effect of the sterilization process on the ability i. of the media to support the growth of injured spores.
- Stability of the product over the eighteen (18) month shelf life j. claim.
CONCLUSION:
[as required by Section 807.92(b)(3)]
EZTest® - Steam is appropriate for monitoring steam sterilization processes of 121°C, 132°C, 134°C and 135°C and EZTest® - Steam meets the USP XXIII requirements.