(32 days)
Not Found
No
The summary describes a device that transmits data via Bluetooth and stores it on a phone and remote database. There is no mention of AI or ML in the intended use, device description, or any other section.
No inquiries were made about this category.
No.
Explanation: The device acts as a communication link for existing blood glucose monitoring systems, transmitting data from the monitor to a phone and then to a database. It does not perform any diagnostic function itself beyond what the connected LifeScan OneTouch® Ultra® Blood Glucose Monitoring System already does. Its purpose is data transfer and display, not the diagnosis of a condition.
No
The device description explicitly states it is a "Bluetooth Cradle" which is a physical hardware component that connects to a blood glucose monitor and transmits data wirelessly.
Based on the provided information, the e-San Bluetooth Cradle itself is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: An IVD is a medical device used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- e-San Bluetooth Cradle's Function: The e-San Bluetooth Cradle's primary function is to transmit data from an existing IVD (the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System) to another device (a cellular phone). It does not perform any diagnostic testing or analysis on the blood sample itself.
- Role in the System: It acts as a communication link within a larger system (the t+ Diabetes System) that facilitates data management and transmission.
While the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System that it connects to is an IVD, the e-San Bluetooth Cradle is a peripheral device that supports the data flow from the IVD, but is not an IVD itself.
N/A
Intended Use / Indications for Use
The intended use of the t+ Diabetes System is for transmission and storage of blood glucose data obtained from a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System.
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 t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.
Product codes
NBW
Device Description
The e-San Bluetooth Cradle 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 t+ Diabetes System allows the blood glucose data to be stored and displayed on a cell phone, and transmitted to a centralized database for storage and display.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) SUMMARY
JUN 1 3 2006
Think Positive (t+) Diabetes Management System
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 modified t+ Diabetes System is substantially equivalent to the previous version of the device (K052343).
B. Device Description
The e-San Bluetooth Cradle 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 t+ Diabetes System allows the blood glucose data to be stored and displayed on a cell phone, and transmitted to a centralized database for storage and display.
C. Intended Use
The intended use of the t+ Diabetes System is for transmission and storage of blood glucose data obtained from a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System.
CONFIDENTIAL
0023
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D. Substantial Equivalence Summary
The t+ Diabetes System has the same fundamental scientific technology and intended use as the predicate device.
E. Conclusions
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(l) of the Federal Food, Drug, and Cosmetic Act and guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2006
e-San Limited c/o Ms. Kristin M. Zielinski Project Manager Becker & Associate Consulting, Inc. 2001 Pennsylvania Avenue NW, Suite 575 Washington, DC 20006
- Re: K061328
Trade/Device Name: Think Positive (t+) diabetes Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 12, 2006 Received: May 12, 2006
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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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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Alberto G.
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): K061328
Device Name: Think Positive (t+) Diabetes Management System
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.
The t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.
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)
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Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kob1328
CONFIDENTIAL