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.

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.

Device Description

AI/ML Overview

The provided text describes a 510(k) submission for the Health Buddy® with Device Connect [Glucose Meter], a device intended to collect and transmit historical blood glucose meter data to healthcare professionals. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, or details regarding device performance metrics.

The document is a US FDA 510(k) summary and the accompanying FDA clearance letter, which focuses on:

Device Description and Intended Use: Explains what the device does (collects and transmits blood glucose data) and its purpose (to help healthcare professionals manage diabetes patients).
Substantial Equivalence: States that the device is substantially equivalent to legally marketed predicate devices (LifeScan ONE TOUCH Profile Diabetes Tracking System and LifeScan IN TOUCH Diabetes Management Software). This is the primary basis for 510(k) clearance, rather than a de novo performance study against pre-defined acceptance criteria.
Regulatory Classification: Identifies it as a Class II device under 21 CFR §862.1345 (Glucose Test System).
Administrative Details: Contact information, dates, and FDA correspondence.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The 510(k) clearance is based on substantial equivalence, not a direct comparison against explicit performance acceptance criteria in the provided document.
Sample size used for the test set and the data provenance: Not available. No "test set" in the context of a performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
Standalone performance study: Not mentioned.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission for substantial equivalence clearance, not a clinical or performance study report that would contain the requested details on acceptance criteria and performance data.

Summary

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NOV 23 1999

K993i28

510(k) Summary

Submitter	Health Hero Network, Inc.2570 W. El Camino Real Suite 111Mountain View, CA 94040
Contact Person	Joe SchwoebelDirector, Regulatory AffairsTel: (650) 559-1025Fax: (650) 559-1050
Date	September 15, 1999
Proprietary Name	Health Buddy® with Device Connect [GlucoseMeter]
Common Name	Accessory to a Blood Glucose Test System
Classification No. and Name	Class IIGlucose Test System
Regulation No.	21 CFR§862.1345

Device Description

Intended Use

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.

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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)

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.