(88 days)
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
The 3MTM Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.
The provided text describes the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 and its clearance by the FDA. However, it does not contain the detailed acceptance criteria or a comprehensive study that proves the device meets those criteria in the format requested.
The document states that the device is "the same design as the previously cleared device... (K170563). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K170563 was referenced in this submission to support performance of the device in the claimed sterilizers." This implies that the current submission (K183209) is primarily for expanding the indications for use to additional sterilizers and cycles, leveraging prior testing.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly quantifiable metrics with specific thresholds in the provided text. Instead, the performance is described as "Pass" for the conducted non-clinical tests. The core acceptance criterion for a chemical indicator (CI) is its ability to accurately change color after exposure to the sterilizing agent (hydrogen peroxide) and to differentiate between processed and unprocessed items.
| Acceptance Criteria (Inferred from regulatory guidance and description) | Reported Device Performance (from Table 6.1) |
|---|---|
| Color Change in Health Care Facility Cycle: The chemical indicator stripes must reliably change color from blue to pink (or "toward pink") after exposure to vaporized hydrogen peroxide in the specified sterilizers and cycles. | Pass |
| Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: The indicator must change color at or beyond the minimum exposure parameters required for sterilization in the specified sterilizers and cycles, demonstrating it is sensitive enough to the sterilant. | Pass |
| End Point Color Stability: The final color of the indicator after exposure must be stable and clearly distinguishable. | Pass |
| Biocompatibility: The device should not pose an unacceptable health risk due to its material composition. | "The exposure to health care professional is minimal and well below any identified toxic thresholds for the compounds." (Identical to predicate) |
| Stability of the endpoint reaction: The color change should remain stable over a specified period. | Twelve (12) months (Identical to predicate) |
| Shelf life: The device should maintain its performance over its specified shelf life. | Eighteen (18) months (Identical to predicate) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of indicators or sterilization runs) used for the non-clinical testing detailed in Table 6.1. It also does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the testing was "in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of human experts to establish ground truth for the test set. For chemical indicators, the ground truth is typically based on objective chemical and physical measurements of whether the indicator has been exposed to the sterilant and changed color as expected, often compared against a biological indicator or other established sterilization validation methods.
4. Adjudication Method for the Test Set
Not applicable, as human expert adjudication is not mentioned for establishing the ground truth of chemical indicator performance in this context.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned for this device. This type of study is more common for diagnostic imaging devices where human interpretation is a critical component.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a passive chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical properties.
7. Type of Ground Truth Used
The ground truth for the performance of this chemical indicator is implicitly based on:
- Exposure to validated sterilization cycles: The indicators are exposed to specific, defined cycles in validated sterilizers (such as STERRAD® and AMSCO® V-PRO® systems).
- Expected color change: The ground truth is that a correctly functioning indicator will change color from blue to pink upon adequate exposure to vaporized hydrogen peroxide.
- Comparison to expected outcome: The "Pass" results indicate that the observed color change matched the expected color change for properly exposed indicators.
8. Sample Size for the Training Set
No training set is mentioned or applicable. This is a physical/chemical device, not a machine learning model.
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).