(112 days)
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.
The provided document describes the SteriTec Disposable Biological Test Pack and its 510(k) submission. It focuses on demonstrating equivalence to a predicate device, the AAMI standard biological test pack, rather than establishing specific acceptance criteria for a new performance claim. Therefore, the device performance is reported in terms of equivalence to the predicate, not against specific numerical thresholds.
Here's an analysis based on the provided text, addressing the requested points:
K961721: SteriTec Disposable Biological Test Pack
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical "acceptance criteria" in the typical sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance objective was to demonstrate equivalence to the AAMI standard biological test pack. The acceptance was based on the SteriTec pack "paralleling the results" of the AAMI pack.
| Category | Acceptance Criteria | Reported Device Performance (SteriTec Disposable Biological Test Pack) |
|---|---|---|
| Gravity Sterilizer (121°C) | "Paralleled the results of the AAMI standard cloth biological test pack" for survival/kill at various exposure times. | - After 10 minutes exposure: All biologicals survived in both AAMI and SteriTec packs. - After 12 minutes exposure: Both packs experienced partial survivors. - After 15 minutes and 20 minutes exposures: All biologicals were killed in both AAMI and SteriTec packs. Conclusion: SteriTec pack paralleled AAMI pack results. |
| Prevacuum Sterilizer (132°C) | "Paralleled the results of the AAMI standard cloth biological test pack" for survival/kill at various exposure times. | - After 1 minute and 2 minute exposures: Both packs experienced partial survivors. - After 3 minute exposure: All biologicals were killed in both AAMI and SteriTec packs. Conclusion: SteriTec pack paralleled AAMI pack results. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or runs. The study involved multiple "sterilization runs" and "tests" at different exposure times in two types of sterilizers. For each condition (e.g., 10 min gravity, 1 min prevacuum), it implies at least one AAMI pack and one SteriTec pack were used, with the "biologicals" (presumably multiple biological indicators per pack) being assessed. The phrase "all the biologicals survived" or "all biologicals were killed" suggests individual biological indicators within the packs were sampled. However, the exact number of packs or biological indicators tested for each condition is not quantified.
- Data Provenance: The tests were conducted in a laboratory setting:
- Gravity Sterilizer: "typical hospital gravity sterilizer" (AMSCO, Model 57CR, Type QDS-1624).
- Prevacuum Sterilizer: "specially constructed laboratory prevacuum steam sterilizer built around an Amsco 20" x 20" x 40" chamber."
- This indicates prospective, controlled laboratory testing. The country of origin is implicitly the US, given the FDA 510(k) submission context.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth in this study is objective biological growth or no growth of B. stearothermophilus spores, not an expert interpretation of data like imaging.
4. Adjudication Method for the Test Set
Not applicable. The ground truth (biological survival/kill) is determined by objective laboratory culturing methods, not by human adjudication of ambiguous results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this type of study was not performed. MRMC studies are typically for diagnostic imaging or similar scenarios where human readers interpret cases, often with and without AI assistance. This submission describes a performance equivalence study for a sterilization indicator.
6. Standalone Performance Study
Yes, a standalone study was performed in the sense that the SteriTec Biological Test Pack's performance was evaluated independently in various sterilization conditions. Its performance was then compared to the AAMI standard pack. There is no human-in-the-loop interaction with the device's function itself; the device either indicates effective sterilization or it doesn't.
7. Type of Ground Truth Used
The ground truth used was biological outcome: survival (growth) or kill (no growth) of B. stearothermophilus spores. This is determined by standard microbiological culture techniques where the biological indicator is incubated after sterilization exposure to check for microbial viability.
8. Sample Size for the Training Set
Not applicable. This device is a passive indicator, not an AI/ML algorithm that requires a training set. The study describes physical performance testing.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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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. |
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Sterites Products Mfg. Co., Inc. Steritec Disposable Biological Test Pack FDA 510(k) Application
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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.
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Steritec Products Mfg. Co., Inc. Steritec Disposable Biological Test Pack FDA 510(k) Application
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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 .
§ 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).