(64 days)
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No
The summary describes a device for collecting and transmitting blood glucose data, with no mention of AI, ML, or any related technologies or performance metrics typically associated with such algorithms.
No
Explanation: The device is a communication tool for transmitting glucose meter data and is not intended for treatment decisions or as a substitute for professional judgment.
No
The device collects and transmits historical blood glucose data, serving as a communication tool for healthcare professionals. It explicitly states it is "not intended to provide automated treatment decisions, nor to be used as a substitute for a healthcare professional's judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional." This indicates it supports management but does not itself provide a diagnosis.
No
The device description explicitly states it collects and transmits historical blood glucose meter data, implying interaction with a physical glucose meter, which is a hardware component. While the device itself might be software, its function is dependent on and interacts with hardware.
Based on the provided text, the Health Buddy with Device Connect [Glucose Meter] is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for collecting and transmitting historical blood glucose meter data to healthcare professionals. It is a communication tool to enable healthcare providers to receive patient information.
- Not for Diagnosis or Treatment Decisions: The text explicitly states that the device is not intended to provide automated treatment decisions, nor to be used as a substitute for a healthcare professional's judgment. It emphasizes that all medical diagnosis and treatment are to be performed under the supervision of a healthcare professional.
- No Mention of In Vitro Testing: The description focuses on data collection and transmission, not on performing any tests on biological samples outside of the body, which is the core function of an IVD.
While it works in conjunction with a glucose meter (which is an IVD), the Health Buddy with Device Connect itself is a data management and communication device, not a diagnostic test.
N/A
Intended Use / Indications for Use
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose data to healthcare professionals to help support effective management of diabetes patients.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose meter data to healthcare professionals to help support effective management of diabetes patients.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
non-clinical settings / healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
NOV 23 1999
K993i28
510(k) Summary
| Submitter | Health Hero Network, Inc.
2570 W. El Camino Real Suite 111
Mountain View, CA 94040 |
|-----------------------------|---------------------------------------------------------------------------------------------|
| Contact Person | Joe Schwoebel
Director, Regulatory Affairs
Tel: (650) 559-1025
Fax: (650) 559-1050 |
| Date | September 15, 1999 |
| Proprietary Name | Health Buddy® with Device Connect [Glucose
Meter] |
| Common Name | Accessory to a Blood Glucose Test System |
| Classification No. and Name | Class II
Glucose Test System |
| Regulation No. | 21 CFR§862.1345 |
Device Description
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose meter data to healthcare professionals to help support effective management of diabetes patients.
Intended Use
Health Buddy with Device Connect is intended to be a communication tool to enable healthcare providers to receive patient blood glucose information. The product is intended to be used in conjunction with Health Hero Network Online Service, a communication tool to enable healthcare providers to educate, motivate, and receive patient information. Health Buddy with Device Connect and the Health Hero Network Online Service are not intended to provide automated treatment decisions, nor to be used as a substitute for a healthcare professional's judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Substantial Equivalence
In Health Buddy with Device Connect [Glucose Meter] is substantially equivalent to the currently marketed LifeScan ONE TOUCH Profile Diabetes Tracking System and the LifeScan IN TOUCH Diabetes Management Software.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nov 23 1999
Mr. Joe Schwoebel, RAC Director, Regulatory Affairs Health Hero Network, Inc. 2570 W. El Camino Real, Ste. 11 Mountain View, California 94040
Re: K993128
Trade Name: Health Buddy® with Device Connect [Glucose Meter] Regulatory Class: II Product Code: CGA Dated: September 16, 1999 Received: September 20, 1999
Dear Mr. Schwoebel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1993128 510(k) Number (if known):
Device Name: Health Buddy® with Device Connect [Glucose Meter]
Indications for Use:
Health Buddy with Device Connect [Glucose Meter] is indicated for use in nonclinical settings to collect and transmit historical blood glucose data to healthcare professionals to help support effective management of diabetes patients.
Sean Cooper
(Division Sign-Off)
Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ry
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(Optional Format 3-10-98)