As a Sterilizer Monitoring Device, the 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M[™ Attest™ eBowie-Dick Card Holder 10135CH is used in conjunction with the 3MTM Attest™ eBowie-Dick Auto-reader 1190 to monitor the equipment performance of steam sterilizers each. day, as well as after a steam sterilizer repair. The 3MTM Attest™ eBowie-Dick Test Card 10135 will detect steam penetration as a means of measuring air removal efficiency. The 3M™ Attest™ eBowie-Dick Test Card 10135 and 3MTM Attest™ eBowie-Dick Card Holder 10135CH is designed for testing air removal efficiency of 132°C (270°F). 134°C (273°F), and 135°C (275°F) for 3.5 minute test cycles in dynamic-air-removal steam sterilizers with chamber volumes greater than 54L (approximately 2 cubic feet).

The 3MTM Attest eBowie-Dick Auto-reader is designed to automatically interpret, store, and display the result of the 3MTM Attest™ eBowie-Dick Test Card.

Device Description

The 3M™ Attest™ eBowie-Dick Test Card consists of a laminated construction with a lead-free steam-sensitive chemical indicator positioned at the end of a lumen challenge. The 3MTM Attest™ eBowie-Dick Test Card undergoes a change in electrical resistance upon exposure to saturated steam. The test card includes a lumen challenge which is designed to restrict air removal and steam perfusion. At the completion of a Bowie-Dick test cycle, the resistance of the 3MTM Attest™ eBowie-Dick Test Card is read out using the 3MTM Attest™ eBowie-Dick Autoreader. The 3M™ Attest™ eBowie-Dick Test Card will reach a PASS value when adequate air removal and steam profusion is achieved. An air removal failure and or a steam penetration failure is indicated by a FAIL result.

The 3MTM Attest™ eBowie-Dick Card Holder is a reusable sterilizable plastic container for the Test Card which serves to support the laminated construction of the Test Card during the vacuum and pressure cycles of the air removal test, as well as anchor the Test Card in place inside the sterilization chamber through the increased mass of the Card Holder plus Test Card combination.

The 3M™ Attest™ eBowie-Dick Auto-reader is a wall powered electrical resistance measurement device which receives a processed Test Card via the card slot and contains pairs of internal mechanical contacts to probe the metallic contact pads on the Test Card. The Autoreader detects and confirms proper insertion of the Test Card, measures the PANI sensor electrical resistance, and returns a visible PASS, FAIL, or ERROR state indication to the user. The Auto-reader utilizes embedded firmware to detect and read the resistance of a Test Card. The device also includes USB or BLE connectivity for integrating with the optional 3M™ AttestTM Connect Software platform.

AI/ML Overview

This document describes the 3M™ Attest™ eBowie-Dick Test, a system designed to monitor steam sterilizer performance for air removal efficiency.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the Special Controls outlined in the document, reflecting the requirements for non-clinical performance testing. The reported device performance is based on the summary of bench studies provided.

Acceptance Criteria (Derived from Special Controls)	Reported Device Performance
Non-clinical Performance Testing:	Supported by Bench Studies:
(i) Performance comparison with a scientifically justified comparator.	- Comparison of air pocket size and position in a reference test pack to the sensor in eBD Test card for inadequate cycles, demonstrating comparable pass/fail testing.
(ii) Demonstrate measured response is dependent on sterilization cycle parameter(s).	- Not explicitly detailed, but implied by the device's function of detecting steam penetration (a cycle parameter) and linking resistance change to saturated steam exposure.
(iii) Identify relevant validation parameters, samples, conditions, and data analysis.	- Studies included characterization of air removal from eBD Test card lumen, testing of the sensor in adequate and inadequate cycles, quantifying resistance-color relationship, and determining accuracy, precision, and dynamic range of the auto-reader. Specific validation parameters and acceptance criteria for each parameter are not explicitly listed in the summary, but the breadth of testing indicates these were established.
(iv) Evaluate sensitivity and specificity to determine passing/failing conditions.	- Sensitivity and specificity testing as a function of changes in vacuum level and pressure during the conditioning phase of dynamic air removal cycles to support low occurrences of false positive/negative results.
(v) Determine and validate accuracy, precision, and range of the measuring device.	- Determination of accuracy, precision, and dynamic range of the 3M™ Attest™ eBowie-Dick Auto-reader 1190 for measuring resistance.
(vi) Evaluate end point stability.	- Testing showing endpoint stability for Adequate and Inadequate Cycles as a function of Dwell Time in the sterilizer and cooling time before reading.
(vii) Demonstrate reader maintains a defined range of accuracy over a defined time interval.	- Independent verification of Auto-reader accuracy completed during manufacturing final functional testing using external reference cards with verified resistance values. (This implies ongoing accuracy maintenance, but doesn't explicitly state a "defined time interval" for field accuracy.)
Shelf Life Performance Data.	- A shelf-life study and a hot and cold excursion stability study provided to demonstrate product performance is maintained throughout the 6-month shelf life.
Software Verification, Validation, and Hazard Analysis.	- Adequate software development, test plans, and documentation demonstrated according to FDA guidance.
Electromagnetic Compatibility (EMC) and Electrical Safety Performance Data.	- EMC Immunity testing conducted using consensus standard 60601-1-2. Electrical Safety testing conducted per IEC 61010-1.
Human Factors and Usability Engineering.	- Evaluated via simulated-use testing with representative users in accordance with FDA guidance, with no observed use errors, close calls, or difficulties for critical tasks.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each performance test (test sets for sensitivity, specificity, accuracy, precision, endpoint stability, etc.). It describes the types of tests conducted but not the number of units or cycles tested within each.

The data provenance is retrospective (bench studies already conducted) and likely originated from 3M's internal laboratories based in the USA (St. Paul, MN). The data is entirely non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts to establish ground truth for the test set in the context of interpreting the eBowie-Dick test results. The device is designed for automatic interpretation. The ground truth for the performance testing appears to be based on physical measurements and established scientific principles of sterilization (e.g., inadequate vs. adequate cycles, presence of non-condensable gasses, comparison to ISO 11140:2007-5 Standard Test Pack).

4. Adjudication Method for the Test Set

Not applicable. The device's automated interpretation (Pass/Fail/Error via auto-reader) means there is no human adjudication process described or required for its primary function. Ground truth determination for performance studies would be based on instrument readings and physical conditions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This device is an automated physical/chemical indicator system. It does not involve human readers interpreting images or data where a comparative effectiveness study with and without AI assistance would be relevant. The benefit is explicitly stated as increased testing sensitivity with a digital measurement and reduced false results/repeat testing with an automatic reader, suggesting it is intended to replace or significantly simplify manual interpretation or older methods.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes. The entire performance testing described, particularly for sensitivity, specificity, accuracy, precision, and endpoint stability, assesses the performance of the eBowie-Dick Test Card and Auto-reader system in a standalone capacity. The Auto-reader automatically interprets the card's resistance to provide a Pass, Fail, or Error result. Human interpretation is not part of the core performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for performance testing (e.g., sensitivity, specificity) is based on:

Physical Conditions: Deliberately created "inadequate" (e.g., specific air pocket sizes, insufficient vacuum/pressure) and "adequate" sterilization cycles.
Comparison to Reference Standards: Performance compared to the "Standard Test Pack as defined in ISO 11140:2007-5."
Known States: Testing the sensor in known adequate and inadequate cycles to show expected pass/fail results.
Instrument Calibration/Verification: Verified resistance values for Auto-reader accuracy.

8. Sample Size for the Training Set

The document does not provide a specific sample size for a "training set." The device utilizes embedded firmware with "predefined thresholds" for interpreting resistance measurements. This suggests the thresholds were established through internal development and testing, but the explicit size of any dataset used to develop or "train" these thresholds is not disclosed.

9. How the Ground Truth for the Training Set Was Established

Given the nature of the device (measuring electrical resistance that changes with saturated steam exposure), the "ground truth" for establishing the predefined thresholds would likely involve:

Controlled Laboratory Experiments: Exposing test cards to precisely controlled steam sterilization cycles (adequate and various levels of inadequate) in laboratory settings.
Physical Measurements: Correlating the electrical resistance measurements from these controlled exposures with the known physical conditions (e.g., presence/absence of saturated steam, degree of air removal failure).
Engineering Principles: Establishing the resistance values that correspond to a successful steam penetration (Pass) and those that indicate a failure (Fail). This would be based on the scientific principles of the chemical indicator's electrical resistance change upon exposure to saturated steam.
Comparison to Existing Standards: Aligning the "Pass" and "Fail" thresholds to be equivalent to the performance of established Bowie-Dick tests, such as those compliant with ISO 11140:2007-5.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR 3MTM ATTESTTM EBOWIE-DICK TEST

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Digital physical/chemical sterilization process sensor. A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.

NEW REGULATION NUMBER: 21 CFR 880.2801

CLASSIFICATION: Class II

PRODUCT CODE: SBE

BACKGROUND

DEVICE NAME: 3MIM Attest™ eBowie-Dick Test Card, 3M™ Attest™ eBowie-Dick Card Holder, 3MTM Attest™ eBowie-Dick Auto-reader

SUBMISSION NUMBER: DEN230068

DATE DE NOVO RECEIVED: September 29, 2023

SPONSOR INFORMATION:

3M Company 2510 Conway Ave. St. Paul. MN 55144 USA

INDICATIONS FOR USE

3MTM Attest eBowie Dick Test Card and 3MTM Attest eBowie-Dick Card Holder

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3MTM Attest eBowie-Dick Auto-reader

The 3MTM Attest™ eBowie-Dick Auto-reader is designed to automatically interpret, store, and display the result of the 3MTM Attest™ eBowie-Dick Test Card.

LIMITATIONS

The 3MTM Attest™ eBowie-Dick Test is intended to be marketed for Over-The-Counter (OTC) use.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS

DEVICE DESCRIPTION

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Image /page/2/Picture/0 description: The image shows the 3M Attest system for Bowie-Dick testing. The system includes the 3M Attest Connect PC application, an eBowie-Dick test card, an eBowie-Dick card holder, and an eBowie-Dick auto-reader. The image also shows a close-up of the eBowie-Dick test card, highlighting the process indicator, steam inlet opening, top paper graphic layer, measurement contact pads, challenge channel, PANI coating, and electrode pads.

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SUMMARY OF BENCH STUDIES

REPROCESSING, STERILITY AND SHELF-LIFE

The 3MTM Attest™ eBowie-Dick Test Card is single use and does not require reprocessing or sterilization. A shelf-life study and a hot and cold excursion stability study are provided to demonstrate that the product performance (e.g., Fail Cycle, Pass Cycle, and Process Indicator Dot Color) is maintained throughout the 6-month shelf life of the device.

3M™ Attest™ eBowie-Dick Auto-reader do not require reprocessing or sterilization. Cleaning instructions for the 3MTM Attest™ eBowie-Dick Auto-reader are included in the labeling.

The 3MTM Attest™ eBowie-Dick Card Holder is a device that does not have a designated shelf life due to its ability to be replaced. A re-use study is provided to support the re-use of the Card Holder for up to 500 uses in steam sterilization. The Instructions for Use has information pertaining to the maintenance of the Card Holder.

BIOCOMPATIBILITY

The 3MTM AttestTM eBowie-Dick Test does not have any direct tissue contacting components.

SOFTWARE

The 3MTM Attest™ eBowie-Dick Auto-reader utilizes embedded firmware to detect and read the resistance of a 3MTM Attest™ eBowie-Dick Test Card. The embedded firmware stores measurements, which determine individual card results by comparing the measured resistance against a predefined threshold. Adequate software development, test plans, and documentation were demonstrated according to FDA guidance document, "Content of Premarket Submissions for Device Software Functions", Content of Premarket Submissions for Device Software Functions (fda.gov).

The hardware interfaces of the device provide users with access to the most recent 1000 records. They also allow remote firmware update. Additionally, they offer the ability to enable or disable an audible alarm and configure the date and time settings. These interfaces include:

1. CDC over USB connection.
(b)(4) Bluetooth (b)(4) Module. 2)

The 3MTM Attest™ eBowie-Dick Auto-reader can be connected via USB and BLE connection to a Windows PC. This allows communications between the auto-reader and PC. where such communications are directed to a PC application that collects results and configuration. The name of the PC application is 3MTM Attest™ Connect. Attest Connect

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can also facilitate firmware updates over the USB or BLE connection and enable or disable the audible alarm.

A backend server with a database, web services, and a registration portal developed and hosted in 3M's Azure Cloud infrastructure will be utilized as part of the Attest™ Connect app. This cloud server will be used to collect some customer information and data on cards read. It will also keep all the Auto-reader configurations from manufacturing and will be checked real time when card results are uploaded. With this check, 3M can monitor if any Attest™ Auto-reader configurations have changed. Additionally, the backend cloud server will facilitate application and firmware updates.

Adequate cybersecurity and software functionality were demonstrated according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

3M controls deployment of software updates as per change control and procedures within the Software Development Plan. All potential firmware and software updates are reviewed against the most recent versions of the SRS.

ELECTROMAGNETIC COMPATIBILITY & ELECTRICAL SAFETY

EMC Immunity testing was conducted on the Auto-reader using consensus standard 60601-1-2 and includes testing to IEC 61000-4-8 with levels directed by IEC 60601-1- 2. Electrical Safety testing was conducted per IEC 61010-1.

HUMAN FACTORS

The 3MTM Attest™ eBowie-Dick Test System was evaluated via simulated-use testing with users representative of the use specification in accordance with the guidance "Applying Human Factors and Usability Engineering to Medical Devices." This study included identification of known risks for commercially available similar devices, analysis of similarities and differences between potential use errors, risks, and harms, and evaluation of the risk mitigations and residual risks. No use errors, close calls or difficulties were observed during the use of the 3MTM Attest™ Electronic Bowie-Dick (eBD) System for Critical Task related Use Scenarios. In conclusion, the results demonstrate that the 3MTM Attest™ eBowie-Dick Test System, with the associated risk control measures, are safe and effective, and no design or labeling modifications are necessary.

PERFORMANCE TESTING - BENCH

The sponsor conducted the following performance tests to support that the device can achieve its intended use:

. Comparison of air pocket size and position in a reference test pack to the sensor size

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and location in eBD Test card for an inadequate cycle to demonstrate comparable pass/fail testing performance to the test pack.

. Comparison of air pocket size and position in a reference test pack to the sensor size and location in eBD Test card to determine the impact of the presence of noncondensable gasses.
. Characterization of air removal from eBD Test card lumen construction and demonstration of equivalence to reference test pack.
Testing of the sensor in the standard test pack in adequate and inadequate cycles to . show expected pass/fail results.
. Quantifying the relationship between the resistance and the color of the sensor to show that they are related to the oxidation state of the polymer.
. Sensitivity and specificity testing as a function of changes in the vacuum level and pressure reached during the conditioning phase of a dynamic air removal cycle to support low occurrences of false positive and/or false negative results.
. Determination of equivalent performance to the Standard Test Pack as defined in ISO 11140:2007-5.
Determination of accuracy, precision, and dynamic range of the 3MTM AttestTM . eBowie-Dick Auto-reader 1190 for measuring resistance.
Testing showing endpoint stability for Adequate and Inadequate Cycles as a function . of Dwell Time in the sterilizer at the completion of a test cycle as well as a function of cooling time (referred to as Measurement Time in the report) once the device is removed from the sterilizer and before reading the test result.
. Independent verification of Auto-reader accuracy is completed during manufacturing final functional testing using external reference cards with verified resistance values.

LABELING

The labeling consists of a user manual, instructions for use, and packaging labels.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of a digital. physical/chemical sterilization process indicator and the measures necessary to mitigate these risks.

Risks to Health	Mitigation Measures
Infection resulting from exposure tounsterile instruments due to falsepassing results or failure to properlymonitor sterilizer performance	Non-clinical performance testingSoftware verification, validation, and hazard analysis
Delayed or cancelled procedure dueto false positive results	Non-clinical performance testingSoftware verification, validation, and hazard analysis
Electrical shock	Electrical safety testingNon-clinical performance testing

Identified Risks to Health and Mitigation Measures

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Risks to Health	Mitigation Measures
Interference with other devices	Electromagnetic compatibility testingElectrical safety testing

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the digital physical/chemical sterilization process sensor is subject to the following special controls:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must fulfill the following:
- Testing must compare performance with a scientifically justified comparator; (i)
- (ii) Testing must demonstrate that the measured response is dependent on the sterilization cycle parameter(s);
- Testing must identify relevant validation parameters (analytical performance (iii) characteristics) and include scientifically justified samples, conditions, and data analysis to evaluate said parameters with established acceptance criteria for each. parameter:
- (iv) Testing must evaluate sensitivity and specificity to determine conditions for passing and failing results:
- Testing must determine and validate accuracy, precision, and range of the (v) measuring device:
- Testing must evaluate end point stability; and (vi)
- (vii) Testing must demonstrate that the reader maintains a defined range of accuracy over a defined time interval.
(2) Performance data must support the shelf life of the device by demonstrating continued device functionality over the labeled shelf life under the proposed storage conditions. Transport stability testing must demonstrate device resilience to transport conditions.
Software verification, validation, and hazard analysis must be performed for any (3) software components.
(4) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

BENEFIT-RISK DETERMINATION

Risks:

The risks of the device are based on nonclinical laboratory testing described above.

The main probable risk of the proposed device is false results which may lead to ineffective sterilization of medical devices with a false negative result or may lead to re-running the Bowie-Dick cycle with a false positive result that causes a delayed procedure or procedures. There is an additional risk of electrical shock and interference with other devices. Both are mitigated with the performance testing, warnings, precautions, and special controls.

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Benefits:

The probable benefits of the device are based on non-clinical laboratory testing described above.

The probable benefits of the subject device, include:

1 ) increases testing sensitivity with a digital measurement

reduces false results and repeat testing with an automatic reader
general patient benefit with improved sterilization process monitoring that reduces the risk of infection from improperly sterilized devices.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

Benefit/Risk Conclusion

Based on the performance testing provided (in particular; sensitivity, end point stability, shelf life, software validation, labeling, and human factors study), the sponsor has adequately supported that the subject device is a digital physical/chemical sterilization process sensor.

In conclusion, given the testing provided above, for the following indication statement:

As a Sterilizer Monitoring Device, the 3MTM Attest™ eBowie-Dick Test Card and 3M™ Attest eBowie-Dick Card Holder are used in conjunction with the 3MTM Attest™ eBowie-Dick Auto-reader to monitor the equipment performance of steam sterilizers each day, as well as after a steam sterilizer repair. The 3M™ Attest™ eBowie-Dick Test Card will detect steam penetration as a means of measuring air removal efficiency. The 3MTM Attest™ eBowie-Dick Test Card and 3M™ Attest™ eBowie-Dick Card Holder is designed for testing air removal efficiency of 132-135°C (270-275°F) dynamic-airremoval steam sterilizers with chamber volumes greater than 54L (approximately 2 cubic feet).

The 3M™ Attest™ eBowie-Dick Auto-reader is designed to automatically interpret, store, and display the result of the 3MTM Attest™ eBowie-Dick Test Card.

The probable benefits outweigh the probable risks for the 3M™ Attest™ eBowie-Dick Test. The device provides benefits, and the risks can be mitigated using general controls and the identified special controls.

CONCLUSION

The De Novo request for the 3M™ Attest™ eBowie-Dick Test is granted and the device is classified as follows:

Product Code: SBE

De Novo Summary (DEN230068)

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Device Type: Digital physical/chemical sterilization process sensor Regulation Number: 21 CFR 880.2801 Class: II

Regulation Number and Section

§ 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).