(528 days)
SteriTer CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132" (270°F to 276°F to 276°F). When used as directed, the SteriToc Cross.Checks indicator strips give visible indication that sterilizing conditions were met. During steritization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.
The basic formula and concept of black to white chemical steam sterilization indicators has not changed dramatically since they were invented in 1932.
Below is the information regarding the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "CROSS-CHECKS Steam Sterilization Indicator Strip" are primarily based on the visual color change of the strip from white to black, becoming as dark or darker than a reference arrow, indicating proper sterilization, and an incomplete color change for improper sterilization. This performance is validated against biological spore strips.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Test 1: Completed Sterilization Cycle (3 Minutes @ 132°C (270°F)) Indicator strips change color to black. Biological spore strips show complete kill. | Results: All indicator strips changed color to black. All test spore strips showed a complete kill. All indicator strips passed this test. |
| Test 2: Incomplete Sterilization Cycle (20 Seconds @ 132°C (270°F)) Indicator strips show incomplete color change (none turn black). Biological spore strips show all survivors. | Results: All indicator strips showed incomplete color change (none turned to black). All test spore strips and the control strip showed all survivors. All indicator strips passed this test. |
| Test 3: Performance Data for Storage of Cross-Check Strips | A. Normal Storage: Strips appeared unchanged (white). B. Normal Storage then Sterilized: All indicator strips changed color to black, indicating proper functioning and no change in performance due to normal storage. C. Extreme Temperature Storage (57°C (134°F) for 8 days): Color of the strip had NOT changed from its original normal white color. D. Extreme Temperature Storage then Sterilized: All indicator strips changed color to black, indicating proper functioning and no change due to extreme heat storage. E. Extreme Humidity Storage (75% humidity for 7 days): Color of the strip had NOT changed from its original normal white color. F. Extreme Humidity Storage then Sterilized: All indicator strips changed color to black, indicating proper functioning and no change due to extreme humidity storage. G. Extreme Temperature and Humidity Storage (57°C (134°F) and 75% humidity for 8 days): Color of the strip had changed from its original white color to a light tan. H. Extreme Temperature and Humidity Storage then Sterilized: All indicator strips changed color to black, indicating proper functioning and no change due to extreme heat and humidity conditions. |
| Test 4: Performance Data for Cross-Checks Strips at Various Temperatures and Times Indicators should correlate with biological kill/survivor rates. "Passed as specified, and in all cases completed a color change only after the biological spore strips tested at the same time under the same conditions, had expired." | Results: Detailed in Tables 1, 2, 3, and 4 (presented across pages 6-9 in the document, but referred to as Tables 1-4 for clarity). The tables show the number of positive (Pos) and negative (Neg) reads for the indicator strips, along with the biological spore strip results (Bio +/-). The overall conclusion was that the product performed as specified. |
2. Sample Size Used for the Test Set and Data Provenance
- Test 1 & 2 (Completed/Incomplete Sterilization Cycle): The text mentions "All indicator strips" and one "spore strip" per run. The exact number of SteriTec and ATI strips per run is not explicitly stated, but it implies a small, controlled sample for these specific tests.
- Provenance: Not explicitly stated, but implies laboratory testing performed by an "independent testing laboratory."
- Retrospective/Prospective: Prospective (laboratory testing).
- Test 3 (Storage Tests): "SteriTec CROSS-CHECKS sterilization indicator strips" were used. The exact number is not stated, but the results are qualitative observations ("All strips appeared unchanged," "All indicator strips changed color").
- Provenance: Not explicitly stated, but implies laboratory testing performed by an "independent testing laboratory."
- Retrospective/Prospective: Prospective (laboratory testing).
- Test 4 (Various Temperatures and Times):
- Sample Size:
- For each temperature range (124°C, 128°C, 130°C, 132°C, 134°C): Approximately 300 strips (SteriTec Cross-Checks CI 102 and CI 111 combined) along with 12 biological spore strips.
- For each time duration (1 min, 2 min, 2.5 min, 3 min, 3.5 min at 132°C): Approximately 300 strips (SteriTec Cross-Checks CI 102 and CI 111 combined) along with 12 biological spore strips.
- Provenance: Not explicitly stated, but implies laboratory testing performed by an "independent testing laboratory."
- Retrospective/Prospective: Prospective (laboratory testing).
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Test 1, 2, 3 (Initial Interpretation): Implied that the "independent testing laboratory" personnel made the initial observations and recorded the results. Specific number and qualifications are not mentioned.
- Test 4 (Performance Data):
- First Interpretation: A panel of three people selected by the independent laboratory were used to make the PASS/FAIL determinations. Their specific qualifications are not mentioned.
- Second Interpretation: Another set of three interpreters were hired by SteriTec. Their qualifications are explicitly stated as nurses, who "generally have more experience in chemical indicator interpretations."
4. Adjudication Method for the Test Set
- Test 4 (Performance Data): The text indicates decisions were made by a panel of three for both rounds of interpretation, but it does not specify an adjudication method like 2+1 or 3+1. It simply states they were "used to make the PASS/FAIL determinations." The fact that a second panel was brought in due to a few results from the first set being "considered outside the product specifications" suggests a lack of consensus or issues with the first panel's interpretation, leading to a re-evaluation by the second panel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not explicitly done in the way typically understood for comparing AI to human-assisted AI.
- The study involved panels of human readers interpreting the chemical indicators. There was a comparison between two sets of human interpreters (first panel vs. nurses) for Test 4, noting that the "interpretations of the second set of interpreters (Nurses) were more uniform." This focuses on inter-rater variability and expertise among human readers, not on AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- No. The device is a physical chemical indicator strip that requires visual interpretation by a human. There is no algorithm or AI involved for standalone performance. The "performance" of the device itself (color change) is assessed by human observation.
7. The Type of Ground Truth Used
- For the indicator strips' performance: The primary ground truth for the effectiveness of the sterilization process itself (which the indicator is supposed to reflect) was established using biological spore strips. The indicator's color change was correlated directly with the kill/survival status of these biological indicators.
- For the interpretation of the color change: Expert consensus (from the panels of interpreters) was used to determine if the color change of the chemical indicator strip qualified as a "pass" or "fail."
8. The Sample Size for the Training Set
- Not applicable. This document describes the validation of a physical chemical indicator, not an AI or algorithm. Therefore, there is no "training set" in the context of machine learning. The "learning" for the product's design would have happened during its development, but this document focuses on its performance validation against established standards.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set mentioned for an AI/algorithm, there is no ground truth establishment for a training set.
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Image /page/0/Picture/3 description: The image shows the number 19 in bold font. The number is next to a black rectangle. The number and rectangle are on a white background.
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Steam Sterilization Indicator Strip FDA S10(k) Application
510(k) SUMMARY
510(k) PREMARKET NOTIFICATION SUMMARY
SUBMITTER:
Image /page/0/Picture/8 description: The image shows the company information for STERITEC PRODUCTS MFG. CO., INC. Their address is 680 Atchison Way - Suite 600, Castle Rock, CO 80104, and their phone number is (303) 660-4201. The establishment registration number is 2028456, and the date is AUGUST 12, 1996.
TOM ROLL Printed name of person required to submit 510(k)
Signature of person required to submit 310(k)
PRESIDENT Title of person submitting 510(k)
The
CROSS-CHECKS Steam Steritzation Indicator Strip Proprietary Name: Common/Usuul Name: Steam Sterilization Indicator Classification Name: Physical/Chemical Sterilization Indicator Classification: Class II
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P03
K951113 p.29110
SteriTex Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Addlication Revised August 12, 1996 as requested by Reviewer PAGE - 2
510(k) SUMMARY
Identification of Predicate devices:
The SteriTec product is similar in design, composition and function to the:
- . ATI Division of PyMah Corporation Sterilometer Steam Strip® chemical indicator strip for steam
The predicate product was marketed prior to May 28. 1976
Description of 510(k) submission device.
Intended use:
SteriTer CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132" (270°F to 276°F to 276°F). When used as directed, the SteriToc Cross.Checks indicator strips give visible indication that sterilizing conditions were met. During steritization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.
Comparison to Predicate device
The basic formula and concept of black to white chemical steam sterilization indicators has not changed dramatically since they were invented in 1932.
Luboratory resting
Laboratory tests were performed to substantiate and verify that the performance of the submitted Starilled product performed ins described These tests were performed by an independent testing laboratory
The following tests were performed.
Test 1 - Completed Sterilization Cycle
- 3 Minutes (@) 132°C (270°F)
ATI and SteriTec sterilization indicator strips were placed in the center of a steam bier vessel along with a spore strip and sterilized at 132°C. (270°F) for three minutes.
Results: All indicator strips changed color to black, indicating proper functioning of the strips. The test spore strips from each run and the control spore strip were tested. All of the test spore strips showed a
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K951113 p.3d/10
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviews PAGE - 3
SIU(k) SUMMARY
complete kill while the control strip showed all survivors. All indicator strips passed this test.
Test 2 - Incomplete Sterilization Cycle
20 Seconds (a), 132 °C (270°F)
ATI and SteriTec sterilization indicator strips were placed in the conter of a steam bier vessel along with a spore strip and sterilized at 132 °C (270°F) for only 20 seconds, to simulate improper sterilization conditions. Results: All indicator strips showed incomplete color change (none turned to black), indicating improper sterilization conditions and proper functioning of the strips. The test spore strips for each run and the control spore strip were tested. All of the test spore strips and the control strip showed all survivors. All indicator strips passed this test.
Test 3 - Performance Data for Storage of Cross-Check Strips
-
A. Cross-Checks Strips stored under normal conditions SteriTec CROSS CHECKS sterilization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10 ~38°C (50-100°F) and humidity
Results: The strips were examined for correct indicator color (white). All strips appeared unchanged by the storage process. -
મ . Cross-Checks Strips stored under normal conditions than sterilized. Sterilier CROSS-CHECKS sterifization indicator strips were stored for three (3) years and five (5) months at normal room temperatures 10°-38°C (50-100°F) and himidity. The indicator strips were placed in the center of a gravity steam sterilizer and sterilized at 121 "( (250°F) for fifteen minutes.
Results: All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by normal storage. -
ে. Cross-Checks Strips subjected to extreme tomperature.
SteriTec CROSS-CHECKS sterifization indicator strips were stored in a constant temperature chamber at 578 C. (134" F.) for eight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored.
Results: Following storage the strips were removed and examined The color of the strip had NOT changed from its original normal white color.
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K951113 p.4.
SteriTec Products Mfg. Co,, Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 4
510(k) SUMMARY
-
D. Cross-Checks Strips subjected to extreme temperature then sterilized. Cross-Check strips were stored in a constant temperature chamber at 57° C. (134" F.) for eight (8) days. Strips were placed in the conter of a gravity steam sterilizer and sterilized at 121 °C (250 "F) for fifteen minutes.
Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance cansed by storage in extreme heat conditions. -
E. Cross-Checks Strips subjected to extreme humidity. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jai was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days.
Results: Following storage the strips were removed and examined. The color of the strip had NOT changed from its original normal white color. -
F. Cross-Checks Strips subjected to extreme humidity then sterilized. SteriTec CROSS-CHECKS sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The hell jar was then stored in a constant temperature chamber at normal room temperature of 20° C. (68° F.) for seven (7) days. The indicator strips were placed in the center of a gravity steam sterilized and sterilized at 121 "C (250"F) for fillecn minutes.
Results: Following the fifteen minute sterilization cycle, all test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme humidity conditions. -
Cross-Checks Strips subjected to extreme temperature and humidity. G. SteriTec Cross-Check sterilization indicator strips were stored in a vacuum desiccator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° F.) for cight (8) days. The temperature of 57° C. (134° F.) was selected since it would represent a higher temperature than any storage area in institutions where the strips would be stored.
Results: Following storage the strips were removed und examined. The
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2
POS
K95///3
p.5df
Sterilice Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 5
510ik) SUMMARY
- color of the strip had changed from its original white color to a light tan. 11. Cross-Checks Strips subjected to extreme temperature and humidity then sterilized.
SteriTec Cross-Check sterilization indicator stored in a vacuum desiceator (bell jar) along a saturated sodium chloride solution with the humidity controlled at 75%. The bell jar was then placed in a constant temperature chamber at 57° C. (134° I'.) for eight (8) days Results: Following the fifteen minute sterilization cycle, the test strips were removed and evaluated. All indicator strips changed color to black, indicating proper functioning of the strips and no change in their performance caused by storage in extreme heat and humidity conditions.
Test 4 - Performance Data for Cross-Checks Strips sterilized at various sterilization temperatures and sterilization times
- SteriTec Cross-Checks sterilization indicator strips catalog (1) numbers CI 102 and CI 111 were subjected to a steam sterilization eveles for 3 minutes at the following sterilization temperatures: 124 "C 130°C 132°C 134°C. 128°C Approximately 300 strips along with 12 hiological spore strips were run at each temperature range.
- SteriTec sterilization indicator strips catalog numbers C1 102 and (2) CI 111 were subjected to a steam sterifization cycles at 132°C for the following times:
3 min 3% min 2% min 1 min 2 min Approximately 300 strips along with 12 biological spore strips were run at each temperature range.
Interpretation of Results:
To make the interpretation as objective as possible a panel of three people sclected by the independent laboratory were used to make the PASS/FAIL determinations. These results are shown in Tables I and 2. Since a fow of the results from the first set of interpreters were considered outside the product specifications another set of three interpreters were hired by Steritor to again make the interpretations of the same indivators described in (1) and (2) above. These interpreters were all nurses who generally have more experience in chemical indicator interpretations. These results are shown in Tables 3 and 4.
Conclusion:
Regults of performance testing of the SteriTee Cross-Checks Indicator Strips indicate that the submitted product, SteriTec Cross-Checks, performed as
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Image /page/5/Picture/2 description: The image contains handwritten text. The text on the top left reads 'K951113'. On the top right, the text reads 'P02'. The text on the bottom reads 'p6y10'.
SteriTec Products Mfg. Co., Inc. CROSS-CHECKS Chemical Sterilization Indicator FDA 510(k) Application Revised August 12, 1996 as requested by Reviewer PAGE - 6
510(k) SUMMARY
specified and in all cases completed a color change unly after the blological spore strips tested at the same time under the same conditions, had expired. The interpretations of the second set of interpreters (Nurses) were more uniform in their determinations of whether or not the indicators passed or failed.
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| Steritec Products Mfg. Co., Inc. |
|---|
| CROSS-CHECKS Chemical Sterilization Indicator |
| FDA 510(k) Application |
| Revised August 12, 1996 as requested by Reviewer |
| PAGE - 7 |
8YWMΩS (1)015
| TABLE 1 | ||||||
|---|---|---|---|---|---|---|
| Additional Performance Testing-Cross-Checks CI 102 | ||||||
| 3 Minutes Sterilization Time at: | ||||||
| 124°C | 128°C | 130°C | 132°C | 134°C | ||
| PosNegBio+/- | PosNegBio+/- | PosNegBio+/- | PosNegBio+/- | PosNegBio+/- | ||
| 027512/12 | 03001/12 | 1081830/12 | 342920/12 | 29200/12 | ||
| 132°C for: | ||||||
| 1 minute | 2 minutes | 2½ minutes | 3 minutes | 3½ minutes | ||
| PosNegBio+/- | PosNegBio+/- | PosNegBio+/- | PosNegBio-:- | PosNegBio+/- | ||
| 02929/12 | 172750/12 | 1421500/12 | 342920/12 | 29200/12 | ||
| TABLE 1 |
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| Additional Performance Testing -Cross-Checks CI 111 | |||||
|---|---|---|---|---|---|
| 124°C | 128°C | 130°C | 132°C | 134°C | |
| 3 Minutes Sterilization Time at: | |||||
| Pos | 0 | 0 | 292 | 233 | 292 |
| Neg | 300 | 300 | 0 | 217 | 0 |
| Bio+/- | 12/12 | 9/12 | 1/12 | 0/12 | 0/12 |
| 1 minute | 2 minutes | 2½ minutes | 3 minutes | 3½ minutes | |
| 132°C for: | |||||
| Pos | 0 | 0 | 283 | 192 | 233 |
| Neg | 300 | 0 | 0/12 | 108 | 0/12 |
| Bio+/- | 9/12 | 0/12 | 0 | 0/12 | 0/12 |
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| Additional Performance Testing-Cross-Checks CI 102(Nurse Interpreters) | |||||
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| 3 Minutes Sterilization Time at: | |||||
| 124°C | 128°C | 130°C | 132°C | 134°C | |
| Pos | Neg | Bio+/- | Pos | Neg | Bio+/- |
| 0 | 275 | 12/12 | 300 | 1/12 | 92 |
| Pos | Neg | Bio+/- | Pos | Neg | Bio+/- |
| 200 | 0/12 | 400 | 50 | 0/12 | 300 |
| 1 minute | 2 minutes | 2 ½ minutes | |||
| 132°C for: | |||||
| 3 minutes | 3 ½ minutes | ||||
| Pos | Neg | Bio+/- | Pos | Neg | Bio+/- |
| 0 | 300 | 9/12 | 300 | 0/12 | 133 |
| Pos | Neg | Bio+/- | Pos | Neg | Bio+/- |
| 167 | 0/12 | 400 | 50 | 0/12 | 300 |
| Pos | Neg | Bio+/- | |||
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| Additional Performance Testing-Cross-Checks CI 111(Nurse Interpreters)3 Minutes Sterilization Time at: | |||||
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| Pos | Pos | Pos | Pos | Pos | |
| Neg | Neg | Neg | Neg | Neg | |
| Bio+/- | Bio+/- | Bio+/- | Bio+/- | Bio+/- | |
| 027512/12 | 02921/12 | 502500/12 | 45880/12 | 30000 | |
| 132°C for: | |||||
| 1 minute | 2 minutes | 2½ minutes | 3 minutes | 3½ minute | |
| Pos | Pos | Pos | Pos | Pos | |
| Neg | Neg | Neg | Neg | Neg | |
| Bio+/- | Bio+/- | Bio+/- | Bio+/- | Bio+/- | |
| 02759/12 | 02830/12 | 1421500/12 | 45880/12 | 29200 |
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- SYNOPSIS
- DESCRIPTION
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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).