The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230.

The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone.

Device Description

The device is the e-San Bluetooth Cradle and it is connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and uses short-range low power wireless transmission (Bluetooth V1.2) to send the data to a Bluetooth compatible cellular telephone such as the Nokia Model 6230.

The Cradle is battery powered and fits over and plugs into a 3.5 mm 3-wire stereo socket that is in the end of the OneTouch® Ultra® device.

AI/ML Overview

The provided 510(k) summary for the "e-San Bluetooth Cradle" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic device would.

This document describes an accessory to a blood glucose test system that serves as a communication link. The regulatory review focuses on its electrical and wireless communication characteristics, and its equivalence to a predicate device that also facilitates data transmission. It is not assessing the accuracy of a diagnostic measurement, but rather the reliable transfer of data.

Therefore, many of the requested elements for a diagnostic device performance study are not applicable or not present in this submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Wireless Communication Standard Compliance: Bluetooth V1.2 compatibility	Device is Bluetooth V1.2 compatible. (Implied acceptability through equivalence to predicate and standard testing)
Frequency Band: 2.402 to 2.480 GHz	Device uses the same frequency band (2.402 to 2.480 GHz) as the predicate. (Implied acceptability through equivalence to predicate and standard testing)
Power Source: Battery powered	Device is battery powered. (A technological characteristic, rather than a performance metric, implies operational function)
Connectivity with LifeScan OneTouch® Ultra® Blood Glucose Monitoring System: Physical connection via 3.5 mm 3-wire stereo socket	Device fits over and plugs into the 3.5 mm 3-wire stereo socket of the OneTouch® Ultra® device. (Implied successful physical and electrical connection)
Data Transmission to Bluetooth Enabled Cellular Phone: Successful wireless transmission	Device wirelessly sends signals to a Bluetooth enabled cellular phone (e.g., Nokia 6230). (Implied successful data transfer)
Safety and EMC (Electromagnetic Compatibility): Compliance with relevant standards	"Consensus standard testing" was performed, and "The results were acceptable." (General statement, specific standards or results not detailed)
Internal Performance (Functionality):	"Internal testing using e-San or contractor procedures and specifications" was performed, and "The results were acceptable." (General statement, specific criteria or results not detailed)

Study Proving Device Meets Acceptance Criteria:

The document states: "The testing that was performed consisted of two types: internal testing using e-San or contractor procedures and specifications; and consensus standard testing. The results were acceptable."

This indicates that functional testing and compliance with relevant industry standards (likely relating to Bluetooth communication, electrical safety, and electromagnetic compatibility) were performed. However, no specific study details, protocols, or quantitative results are provided within this summary. The "acceptance criteria" are inferred from the device's technological characteristics and its intended function as a communication accessory.

Missing Information (Not present in the provided text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set size or data provenance is mentioned for the internal or consensus standard testing. Given the nature of the device (a communication accessory), "test set" might refer to units tested rather than patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not a diagnostic tool requiring expert interpretation of medical images or data for ground truth establishment. Its performance relates to data transmission, not diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes an accessory, not a standalone diagnostic algorithm. Its performance is always in conjunction with the blood glucose meter and a cellular phone.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic accuracy. For a communication device, "ground truth" would relate to successful and accurate data transfer, signal integrity, and connection stability, which would be assessed through technical measurements and functional testing against specifications.
The sample size for the training set: Not applicable. This is not a machine learning/AI device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) pertains to a communication accessory, and as such, the type of performance data and studies typically associated with diagnostic algorithms or devices are not relevant or included in this submission. The "acceptance criteria" are primarily functional and technical compliance standards for wireless communication and electrical components, with the "study" being internal and consensus standard testing confirming these functionalities.

Summary

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DEC 7 2005

510(k) Summary

e-San Bluetooth Cradle

Common/Classification Name:

Accessory to Blood Glucose Test System 21 CFR 862.1345

Sponsor:

e-San Ltd. Attn: Neil Townsend, D.Phil. Magdalen Centre Oxford Science Park Oxford OX4 4GA United Kingdom
Contact:

Becker & Associates Consulting, Inc. Attn: Kristin M. Zielinski 2001 Pennsylvania Avenue NW, Suite 575 Washington, DC 20006

A. Legally Marketed Predicate Device

The e-San Bluetooth Cradle is substantially equivalent to the RTX Healthcare® Model RTX3320 Wireless Telehealth Gateway (K041816). The RTX3320 is a telemedicine device that uses Bluetooth technology to transmit data from several types of compatible patient monitors to a hub/gateway for transmission to a compatible data server.

B. Device Description

The Cradle is battery powered and fits over and plugs into a 3.5 mm 3-wire stereo socket that is in the end of the OneTouch® Ultra® device.

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The Cradle is to be sold over-the-counter (OTC), as it plugs onto OneTouch® Ultra® glucose meter which is also an OTC device.

C. Intended Use

D. Substantial Equivalence Summary

The e-San Bluetooth Cradle has indications for use that are very similar to those of the named predicate device, the RTX Healthcare® Model RTX3320 Wireless Telehealth Gateway. The RTX device is intended to be used with a number of different types of wireless patient monitors that measure parameters such as, but not limited to, weight, blood pressure and blood glucose. The e-San Bluetooth Cradle is currently intended to be used with only one type and model of hard-wired device, the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System.

This premarket notification has described the characteristics of the e-San Bluetooth Cradle in sufficient detail to assure a substantial equivalence determination.

E. Technological Characteristics

The e-San Bluetooth Cradle has technological characteristics that are very similar to those of the RTX as both are Bluetooth V1.2 compatible. The e-San Bluetooth Cradle is battery powered while the RTX is DC-powered via an AC-powered remote supply. Each device uses the same frequency band (2.402 to 2.480 GHz).

F. Testing

The testing that was performed consisted of two types: internal testing using e-San or contractor procedures and specifications; and consensus standard testing. The results were acceptable.

G. Conclusions

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and guidance documents issued by the Center for Devices and Radiological Health.

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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 eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The eagle is black, and the text is also in black, set against a white background.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 7 2005

E-San Limited c/o Ms. Kristin M. Zielinski Project Manager Becker & Associates Consulting Inc. 2001 Pennsylvania Ave. NW. Suite 575 Washington, DC 20006

Re: K052343

Trade/Device Name: e-San Bluetooth Cradle Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 3, 2005 Received: November 3, 2005

Dear Ms. Zielinski:

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 (QS) 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) This icitic will anow you to oegin manening of substantial equivalence of your device to a legally promation netireation. "The 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 of quostions on the promotion and Safety at (240) 276-0484. Also, please note the vino Diaghestic 2010-12-2016 by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other general res, 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/industry/support/index.html.

Sincerely yours,

Alberto Gutt

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):__K052343

Device Name:_e-San Bluetooth Cradle

Indications For Use:

The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically The e-Sail Diactooth Oradio in Intention to a Blood Gucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230.

The e-San Bluetooth Cradle serves as the remote communication link between the The C-San Diactoon Orado Corrol Glucose Monitoring System and a cellular telephone.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CettSD Heusman MD.

Division Sign-Off

Office of In Vitro Diagnos
Device Evaluation and safety

510(k) 52343

Page 1 of 1

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.