(103 days)
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.
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.
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.
§ 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.