The BDTM Diabetes Software is intended for use as a data management tool for acceptance, transfer, display, storage, processing (e.g. averaging), reporting, and printing of patient blood glucose monitoring data.

The device is intended for use with the BD Blood Glucose Monitoring Systems only.

Device Description

BD™ Diabetes Software is data management software intended for use with BD Blood Glucose Monitoring Systems only. The software is designed to operate on a Windows/Intel compatible platform, and is available in home use and professional use options. Data may be downloaded from a BD Blood Glucose Monitor or manually entered.

BD™ Diabetes Software provides data management tools for acceptance, transfer, display, storage, processing (e.g. averaging), reporting, and printing of patient blood glucose monitoring data. In addition, the BDTM Diabetes Software has an online help feature.

AI/ML Overview

The provided text is a 510(k) summary for the BD™ Diabetes Software. It describes a data management tool for blood glucose monitoring data. However, it does not contain the detailed performance study information typically found for medical devices that require demonstrating diagnostic accuracy or clinical effectiveness.

Here's an analysis based on the provided text, indicating where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
The software will perform as intended (data acceptance, transfer, display, storage, processing, reporting, printing of patient blood glucose monitoring data).	"System verification and validation activities demonstrate that BD™ Diabetes Software will perform as intended when used in accordance with device labeling." (General statement, no specific metrics)
Electrical components conform to appropriate voluntary and mandatory standards.	"Electrical components have been tested and certified to conform to appropriate voluntary and mandatory standards." (General statement, no specific test results)
Operates on specified Windows/Intel platforms.	"BD™ Diabetes Software is designed to operate an Intel compatible PC with Microsoft Windows 95 or later, and Microsoft NT version 4.0 or later operating system." (Stated as a design characteristic)
Compatibility with BD Blood Glucose Monitoring Systems.	"Intended for use with a BD Blood Glucose Monitoring System only." (Stated as intended use and design)
Missing: Specific quantitative performance metrics (e.g., data transfer speed, accuracy of averaging calculations, error rates in data storage/retrieval).	Missing: Actual test results or detailed metrics for system performance, hardware, software, packaging, or end-user evaluation.

Study Details:

The document states: "BD™ Diabetes Software testing consisted of system, hardware, software, packaging, electrical safety, and end-user evaluation. System verification and validation activities demonstrate that BD™ Diabetes Software will perform as intended when used in accordance with device labeling."

This indicates a validation process was performed, but the document does not provide details on specific studies, methodologies, or results for performance criteria that would typically be described with the questions below.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. The text mentions "system verification and validation activities" and "end-user evaluation" but gives no details about the size or nature of any test sets or the origin of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. For a software managing blood glucose data, "ground truth" as typically defined for diagnostic image analysis or clinical prediction is not directly relevant in the same way. The software's performance would primarily be validated against functional requirements (e.g., correct data transfer, accurate calculation of averages, proper display). Validation would likely involve software engineers, quality assurance testers, and perhaps medical professionals or end-users to verify functionality, but not "experts establishing ground truth" in a diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided. This concept is generally used in studies where human readers are interpreting data or images and their agreement is critical for ground truth. For software functionality testing, standard software quality assurance practices (e.g., bug reporting, verification steps, user acceptance testing) would be used, not a multi-reader adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, not performed/applicable. This device is a data management tool, not an AI diagnostic or assistance system. The text does not describe any AI functionality or MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The "System verification and validation activities" for the software itself would be a standalone assessment of the algorithm's functionality (e.g., data processing, display logic). However, no specific metrics or study details are provided in the summary. The "end-user evaluation" would involve human interaction, but the core software functions are assessed standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Functional correctness / Source data integrity. For this type of software, "ground truth" would relate to the accurate handling of data. For example:
- Data transfer: Verifying that data transferred from the glucose meter exactly matches the source data in the meter.
- Calculations: Verifying that the software's calculated averages (e.g., 7-day average glucose) are mathematically correct based on the stored data.
- Display/Reporting: Verifying that the displayed and printed reports accurately reflect the stored and calculated data according to design specifications.
The document implies that these verifications were part of the "system verification and validation activities," but no specific details on how "ground truth" for these functional aspects was established are provided.

8. The sample size for the training set:

Not applicable/Not provided. The BD™ Diabetes Software is described as a traditional data management application, not an machine learning/AI model that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable/Not provided. As there is no mention of a training set for an AI model, this question is not relevant to the information provided.

Summary

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K0233219

510K Summary of Safety and Effectiveness

1. Submitted By:

John Schalago Manager, Regulatory Affairs

Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883

Phone: 201-847-5663 201-848-0457 Fax:

2. Device Name:

BDTM Diabetes Software Trade Name: Common Names: Blood Glucose Meter and Data Management System Classification Name: Glucose test system Classification: 862.1345

3. Predicate Device:

WinGlucofacts

Manufactured by: Bayer Diagnostics

Device Description: 4.

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510K Summary of Safety and Effectiveness (Continued)

ડ. Intended Use:

The device is intended for use with a BD Blood Glucose Monitoring System only.

Technological Characteristics: 6.

The BDTM Diabetes Software is a Microsoft Windows based software application for diabetes data management. The software allows for data transfer from a BD Blood Glucose Monitor via a BD Interface serial or USB cable. BD™ Diabetes Software is designed to operate an Intel compatible PC with Microsoft Windows 95 or later, and Microsoft NT version 4.0 or later operating system.

7. Performance Summary:

BD™ Diabetes Software testing consisted of system, hardware, software, packaging, electrical safety, and end-user evaluation. System verification and validation activities demonstrate that BD™ Diabetes Software will perform as intended when used in accordance with device labeling. Electrical components have been tested and certified to conform to appropriate voluntary and mandatory standards.

The term "substantial equivalence" as used in this 510(k) Notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the logo. The logo is black and white.

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. John A. Schalago MS. RAC Regulatory Affairs Manager Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417

K023219 Re:

Trade/Device Name: Becton Dickinson Diabetes Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; JQP Dated: September 18, 2002 Received: September 26, 2002

Dear Mr. Schalago:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment XI .A.1

Page l of

510(k) Number (if known):

Device Name: Becton Dickinson Diabetes Software

Indications For Use:

The device is intended for use with the BD Blood Glucose Monitoring Systems only.

(Division Sign-Off)

vision of Clinical Laboratory Devices

510(k) Number. X02309

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

RTC_

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.