(103 days)
Not Found
No
The description focuses on the device's function as a communication link for transmitting data via Bluetooth, with no mention of data analysis, interpretation, or any learning capabilities.
No
The device serves as a communication link for a blood glucose monitoring system, it does not directly treat or prevent any medical condition.
No
The device acts as a communication link for existing diagnostic data; it does not perform any diagnostic function itself.
No
The device description explicitly states it is a "Bluetooth Cradle" which is a physical hardware component that connects to another device and transmits data wirelessly. It is battery-powered and plugs into a socket, indicating it is not solely software.
Based on the provided information, the e-San Bluetooth Cradle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "remote communication link" that sends signals from a blood glucose monitoring system to a cellular phone. It does not perform any diagnostic testing itself.
- Device Description: The description reinforces that it's a cradle that connects to a blood glucose monitor and transmits data wirelessly. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of Diagnostic Function: The device's purpose is data transmission, not the in vitro examination of specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The diagnostic function is performed by the connected LifeScan OneTouch® Ultra® Blood Glucose Monitoring System.
The e-San Bluetooth Cradle is a communication accessory for an IVD (the blood glucose monitor), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
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.
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
patients at home
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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.
0
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 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.
1
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
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.
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
4
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
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