(112 days)
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No
The device description and performance studies focus on a biological indicator and its physical response to sterilization, with no mention of AI/ML technologies or data processing beyond simple survival/kill results.
No.
The device is a steam sterilization monitor designed specifically for biological testing of steam sterilizers, not for treating any medical condition or disease.
No
The device is designed to monitor the effectiveness of steam sterilizers by containing biological indicators that show whether the sterilization process has successfully killed spores. It is for quality control of medical equipment, not for diagnosing a condition in a patient.
No
The device description clearly states it consists of a self-contained biological indicator containing spores inside a package of porous and nonporous materials, indicating a physical, hardware-based device.
Based on the provided information, the SteriTec Disposable Biological Test Pack is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed for "biological testing of 121 "C (250" F) gravity or 132" ( (270°F) pre-vacuum steam sterilizers." This indicates it's used to assess the effectiveness of a sterilization process, which is a critical step in ensuring the safety of medical devices and preventing the spread of infection.
- Device Description: It contains a "self-contained biological indicator containing B. stearothermophilus spores." Biological indicators are a common type of IVD used to monitor sterilization processes by determining if viable microorganisms remain after the process.
- Performance Studies: The studies described involve testing the device's ability to indicate sterilization effectiveness by observing the survival or death of the biological spores after exposure to different sterilization cycles. This is a direct assessment of the biological indicator's performance in a diagnostic context (determining if the sterilization was successful).
While the device itself isn't directly used to diagnose a patient's condition, it is used in vitro (outside the body) to assess the performance of a process (sterilization) that directly impacts patient safety. This aligns with the definition of an IVD, which includes devices used to examine specimens derived from the human body or to provide information about a physiological state, pathological state, or congenital abnormality, or to determine the safety and efficacy of a medical device or process. In this case, it's providing information about the efficacy of a medical device sterilization process.
N/A
Intended Use / Indications for Use
The SteriTec Disposable Biological Test Pack is a steam sterilization monitor designed specifically for biological testing of 121 "C (250" F) gravity or 132" ( (270°F) pre-vacuum steam sterilizers.
Product codes
80FRC
Device Description
The pack consists of a self-contained biological indicator containing B. stearothermophilus spores inside a small package of porous and nonporous materials.
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
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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
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Summary of Performance Studies
Laboratory tests were performed to substantiate and verify that the performance of the submitted SteriTec product performed as described and is equivalent in function to the predicate device. Two series of tests were performed to show that the SteriTec Disposable Biological Test Pack performed equivalently to the standard AAMI Biological Challenge Test packs.
Series 1: Gravity Sterilizer 121 "C. Sterilization runs were conducted in a typical hospital gravity sterilizer (AMSCO, Model 57CR, Type QDS-1624 gravity steam sterilizer) at 10 minutes, 12 minutes, 15 minutes and 20 minutes exposures. After 10 minutes exposure, all the biologicals survived both in the AAM1 standard pack and the Steritec Disposable Biological test packs. After 12 minutes exposure, both packs experienced partial survivors. After 15 minutes and 20 minutes exposures, all the biologicals were killed in both the AAM1 and Steritec test packs.
Series 2: Prevacuum sterilizer at 132 C. Sterilization runs were conducted in a specially constructed laboratory prevacuum steam sterilizer built around an Amsco 20" x 20" x 40" chamber, using a typical Amsco Hagle Series cycle consisting of a one minute purge and four prevacuum pulses. Tests were run at one (1) minute, two (2) minutes and three (3) minutes at 132 C. After 1 minute and 2 minute exposures, both packs experienced partial survivors. After 3 minute exposure, all the biologicals were killed in both the AAMI and Steritec test packs.
Conclusion: The results of this testing show that the SteriTcc Disposable Biological Test Packs paralleled the results of the AAMI standard cloth biological test pack.
Key Metrics
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Predicate Device(s)
The SteriTec disposable biological test pack is equivalent in function and operation to the standard AAMI biological test pack which consists of 16 surgical towels measuring 16" x 26" which when folded according to AAMI directions form a 9" x 9" x 6" test pack. A biological indicator is placed in the middle of the AAMI pack which is considered the "Standard" for conducting a biological test in steam sterilizers. The AAMI standard test pack is the predicate device used in this submission.
Reference Device(s)
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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).
0
3 pages
AUG 23 1000
Steritec Products Mfg. Co., Inc. Steritec Disposable Biological Test Pack FDA 510(k) Application
Page 30
510(k) SUMMARY
SUBMITTER:
- STERITEC PRODUCTS MFC. CO., INC. œ 680 Atchison Way - Suite 600 Castle Rock, CO 80104 (303) 660-4201 (303) 660-4213 Fax
Establishment Registration Number: 2028456
Date Summary was Prepared __ August 20, 1996 (Revised)
TOM ROLL Printed name of person required to submit 510(k)
Signature of person required to submit 510(k)
PRESIDENT Title of person submitting 510(k)
| Proprietary Name: | SteriTec Disposable Biological Test Pack |
|---|---|
| Common/Usual Name: | Biological Test Pack |
| Classification Name: | Biological |
| Classification: | The SteriTec Disposable Biological Test Pack is a disposable biological test pack for testing steam sterilizers. It falls under the FDA classification of Indicator, Biological Sterilization Process in Class II under Classification Number 80FRC, Regulation Number 880.2800. |
1
Sterites Products Mfg. Co., Inc. Steritec Disposable Biological Test Pack FDA 510(k) Application
Page 31
510(k) Summary - continued
Identification of Predicate device:
The SteriTec disposable biological test pack is equivalent in function and operation to the standard AAMI biological test pack which consists of 16 surgical towels measuring 16" x 26" which when folded according to AAMI directions form a 9" x 9" x 6" test pack. A biological indicator is placed in the middle of the AAMI pack which is considered the "Standard" for conducting a biological test in steam sterilizers. The A AMI standard test pack is the prodicate device used in this submission.
Description of 510(k) submission device:
Intended use:
The SteriTec Disposable Biological Test Pack is a steam sterilization monitor designed specifically for biological testing of 121 "C (250" F) gravity or 132" ( (270°F) pre-vacuum steam sterilizers. The pack consists of a self-contained biological indicator containing B. stearothermophilus spores inside a small package of porous and nonporous materials.
Comparison to Predicate devices:
Laboratory lesting
Laboratory tests were performed to substantiate and verify that the performance of the submitted SteriTec product performed as described and is equivalent in function to the predicate device.
Two series of tests were performed to show that the SteriTee Dispossible Biological Test Pack performed equivalently to the standard AAMI Biological Challenge Test packs.
Series 1
Gravity Sterilizer 121 "C
Sterilization runs were also conducted in a typical hospital gravity sterilizer. The sterilizor used was a AMSCO, Mudel 57CR, Type QDS-1624 gravily steam sterilizer. Tests were conducted at 10 minutes, 12 minutes, 15 minutes and 20 minutes exposures.
2
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Steritec Products Mfg. Co., Inc. Steritec Disposable Biological Test Pack FDA 510(k) Application
Page 32
Series 2
Prevacuum sterilizer at 132 C
Sterilization runs wre also conducted in a pre-vacuum sterilizer run at 132 C (270 F). The sterilizer used for this scries was a specially constructed laboratory prevacuum steam steam sterilizer built around an Amsco 20" x 20" x 40" chamber. All runs were done using a typical Amsco Hagle Series cycle consisting of a one minute purge and four prevacum pulses. Tests were " run at one (1) minute, two (2) minutes and three (3) minutes at 132 C.
Results
Gravity Sterilizer 121 "C
After 10 minutes exposure, all the biologicals survived both in the AAM1 standard pack and the Steritec Disposable Biological test packs. After 12 minutes exposure, both packs experienced partial survivors. After 15 minutes and 20 minutes exposures, all the biologicals were killed in both the AAM1 and Steritec test packs.
Prevacuum Sterilizer 132 C
After 1 minute and 2 minute exposures, both packs experienced partial survivors. After 3 minute exposure, all the biologicals were killed in both the AAMI and Steritec test packs.
Conclusion:
The results of this testing show that the SteriTcc Disposable Biological Test Packs paralleled the results of the AAMI standard cloth biological test pack .