(65 days)
Use the 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items processed in the following sterilizers:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1)
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 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 consists of a non-cellulosic 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. 3MTM Attest™ Hydrogen Peroxide Indicator Tape 1228 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.
The provided text describes the 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 and its substantial equivalence to a predicate device. It includes nonclinical testing to support its performance. Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Absence of hydrogen peroxide (ISO 11140-1:2014 Type 1) | Verify device requires the presence of vaporized hydrogen peroxide to reach endpoint. | 45 Min at 50°C: Device does not reach endpoint color. | Pass |
| Hydrogen peroxide (ISO 11140-1:2014 Type 1) | Confirm device meets the Type 1 process indicator for vaporized hydrogen peroxide requirements. | 7 Sec at 50°C and gas concentration of 2.3 mg/l: Device does not reach endpoint color. | |
| 6 Min at 50°C and gas concentration of 2.3 mg/l: Device reaches endpoint color. | Pass | ||
| Off-set/transference (ISO 11140-1:2014) | Confirm device meets the Type 1 process indicator requirements. | After exposure to 6 Min at 50°C and gas concentration of 2.3 mg/l: Ink does not transfer to another surface. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for each individual test. It mentions "nonclinical testing" was conducted.
The data provenance is from nonclinical laboratory testing conducted by 3M Company, likely in the US (given the FDA submission). It is retrospective in the sense that the results are reported after the tests were performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the "ground truth" for chemical indicators is defined by physical/chemical reactions to specific controlled environmental conditions (e.g., presence/absence of hydrogen peroxide, specific temperature, time, and concentration). Human experts are not used to establish this type of ground truth for these device tests.
4. Adjudication Method for the Test Set:
This information is not applicable for these types of physical/chemical tests. The outcome (color change or lack thereof, ink transfer or lack thereof) is objectively observed and does not typically require adjudication by multiple parties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or screening devices where human interpretation is a critical component. The 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 is a chemical indicator that shows a direct color change based on exposure to a sterilant, not a device requiring complex human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the testing described is effectively "standalone" in that it assesses the device's inherent physical and chemical properties and its reaction to controlled conditions. There is no "human-in-the-loop" component for the performance of the indicator itself, beyond observing its color change.
7. The Type of Ground Truth Used:
The ground truth used is based on controlled experimental conditions (e.g., specific concentrations of hydrogen peroxide, temperature, and time) as defined by the ISO 11140-1:2014 standard. The "truth" is whether the indicator performs as expected under these known conditions (e.g., changes color when exposed, does not change color when not exposed).
8. The Sample Size for the Training Set:
This information is not applicable. The 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 is a chemical indicator, not an AI/ML-enabled device. Therefore, it does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this 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).