(157 days)
The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a prevacuum sterilizer operating at 134°C the indicator will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no air is detected. It is designed to be used for daily Bowie Dick testing of steam sterilizers as described in ANSVAAMI ST79.
The SPSmedical AirView™ Bowie Dick Test Pack is a disposable device which is intended for use as a replacement for the ANSI/AAMI ST79 Bowie Dick Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AAMI ST79 Bowie Dick test pack. The layers of paper within the SPSmedical AirView™ Bowie Dick Test Pack provide resistance to steam penetration and also trap air between them which is difficult for marginal performing prevacuum sterilizers to remove. Both products are comprised of paper sheets, foam, a containment box or wrap, external chemical indicator label and printed indicator sheet.
The provided text describes a submission for a 510(k) premarket notification for the "AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets". This device is a chemical indicator used to detect residual air in pre-vacuum steam sterilizers.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified manner typical of a medical device study (e.g., "Sensitivity must be >90%"). Instead, it presents performance claims and criteria for substantial equivalence to a predicate device. The core performance criterion is the ability to detect residual air by displaying a non-uniform color change.
| Criterion Type | Acceptance Criterion (Implied/Claimed) | Reported Device Performance |
|---|---|---|
| Intended Use | Detect the presence of residual air in pre-vacuum steam sterilizers operating at 134°C. | Same as intended use. Provides visual indication if residual air was left. |
| Visual Indication | Uniform dark brown/black signal color under proper sterilization and air removal conditions. Non-uniform color change for failure. | Achieved; uniform dark brown/black with proper conditions, non-uniform with failure. |
| Air Detection | Sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C or greater temperature difference in the test pack. | Demonstrated with testing, resulting in a non-uniform color change. |
| Shelf Life | Three (3) years from date of manufacture. | Verified three (3) years. |
| Biocompatibility | Non-toxic (as the device is intended to be run in an empty chamber, but addressed for safety). | Concluded to be non-toxic. |
| Storage | Store in a cool, dry place (15-30°C). | Confirmed. |
| Interfering Substances | Not sensitive to acidic or basic environments (both unprocessed and processed forms). | Verified not sensitive to acidic or basic environments. |
| Equivalence to Predicate | "AirView™ Bowie Dick Test Pack & AirView™ Bowie Dick Indicator Sheets (K041017)" for intended use, functional characteristics, design, endpoint color, indicator agent, sterilization method, device materials, and performance. | Demonstrated and claimed substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states: "We have demonstrated with testing that the SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick Indicator Sheets perform consistently with results which indicate that the indicator is sensitive enough to detect when enough air is left within the sterilizer chamber to create a 2°C or greater temperature difference in the test pack as compared to the sterilizer chamber when running pre-vacuum sterilization at 134°C."
- Sample Size for Test Set: Not specified. The document mentions "test data obtained during validation studies" and "testing verified," but does not provide specific numbers of test packs/sheets used or the number of tests performed.
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter (SPSmedical Supply Corp. in Rush, NY, U.S.A.) and the submission to the FDA, it's highly probable the testing was conducted in the USA. The data is retrospective in the sense that it's presented as already completed validation studies for the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a chemical indicator with an objective visual color change. The ground truth for its performance is established by physical measurements (e.g., temperature difference in the sterilizer chamber) and the objective observation of color change, not by expert interpretation of complex images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "failure" or "success" of the test pack is determined by a visual color change and the physical conditions it's designed to detect (presence of residual air creating a temperature differential). There is no mention of a human adjudication process for interpreting results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This device is a chemical indicator, not a diagnostic imaging or AI-driven decision support system. MRMC studies are used to assess the impact of a device (often AI) on human reader performance. This device has an objective output (color change).
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in essence. The "study" described is the standalone performance of the Bowie Dick test pack itself. Its function is to autonomously detect residual air and produce a visual signal. The described testing verifies the indicator's sensitivity to physical conditions (2°C temperature difference). There is no "human-in-the-loop" component to the detection mechanism of this device; humans merely observe and interpret the final color change.
7. The Type of Ground Truth Used:
The ground truth used is based on physical conditions and outcomes in a sterilizer environment:
- The actual presence of residual air within the sterilizer chamber.
- The resulting temperature difference (specifically, a 2°C or greater difference) in the test pack compared to the sterilizer chamber due to this residual air.
- The absence of proper sterilization and air removal conditions, leading to a non-uniform color change.
- The presence of proper sterilization and air removal conditions, leading to a uniform dark brown/black color change.
8. The Sample Size for the Training Set:
Not applicable. This device is a passive chemical indicator, not an AI or machine learning algorithm that requires a training set. Its functionality is based on chemical reactions and physical design, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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).