K Number
DEN230068
Device Name
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
Manufacturer
Date Cleared
2024-05-21

(235 days)

Product Code
Regulation Number
880.2800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

Not Found

No
The description focuses on electrical resistance measurement and embedded firmware for interpreting a chemical indicator's state, with no mention of AI or ML algorithms for analysis or decision-making.

No.
The device is a sterilizer monitoring device used to check the performance of steam sterilizers, not to provide therapy directly to a patient.

No

This device is a sterilizer monitoring device used to assess the performance of steam sterilizers by detecting steam penetration and air removal efficiency. It does not diagnose medical conditions in patients.

No

The device description clearly outlines multiple hardware components: the Test Card (with laminated construction, chemical indicator, and electrical resistance change), the Card Holder (a reusable plastic container), and the Auto-reader (a wall-powered electrical resistance measurement device with internal contacts and connectivity). While there is mention of optional software ("3M™ AttestTM Connect Software platform"), the core medical device functionality relies on the interaction and operation of these physical components.

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use is clearly stated as a "Sterilizer Monitoring Device" to "monitor the equipment performance of steam sterilizers." It is used to detect steam penetration and measure air removal efficiency within the sterilizer.
  • Device Description: The device components (test card, card holder, auto-reader) are described in terms of their function in monitoring the sterilization process, not in analyzing biological samples or providing diagnostic information about a patient's health.
  • Lack of Biological Sample Analysis: The device works by measuring the electrical resistance of a chemical indicator on the test card after exposure to steam. There is no mention of analyzing blood, urine, tissue, or any other biological sample.
  • Focus on Equipment Performance: The entire description revolves around evaluating the performance of the steam sterilizer itself, not diagnosing a condition in a patient.

IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.

N/A

Intended Use / Indications for Use

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

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).

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.

Product codes (comma separated list FDA assigned to the subject device)

SBE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • 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 accuracy, precision, and dynamic range of the 3MTM AttestTM eBowie-Dick Auto-reader 1190 for measuring resistance.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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

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).

1

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

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.

2

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.

3

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

4

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

5

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 HealthMitigation Measures
Infection resulting from exposure to
unsterile instruments due to false
passing results or failure to properly
monitor sterilizer performanceNon-clinical performance testing
Software verification, validation, and hazard analysis
Delayed or cancelled procedure due
to false positive resultsNon-clinical performance testing
Software verification, validation, and hazard analysis
Electrical shockElectrical safety testing
Non-clinical performance testing

Identified Risks to Health and Mitigation Measures

6

Risks to HealthMitigation Measures
Interference with other devicesElectromagnetic compatibility testing
Electrical 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.

7

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

  1. reduces false results and repeat testing with an automatic reader

  2. 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)

8

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