AMD HOME HEALTH MONITORING SYSTEM

K960337 · Advanced Medical Devices, Inc. · CGA · Sep 24, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960337
• Device Name: AMD HOME HEALTH MONITORING SYSTEM
• Applicant: Advanced Medical Devices, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood

Device Story

System comprises home-use blood glucose meter and companion PC monitoring station. Meter uses electrochemical biosensor technology (glucose oxidase) to measure current generated by oxidation of glucose in capillary blood samples; current magnitude is proportional to glucose concentration. Meter features internal modem for data transmission to remote PC station. PC station used in clinical settings (physician offices, nurse stations) to receive, process, and review patient test data. System facilitates remote clinical oversight of home-based glucose monitoring; enables healthcare providers to review patient results and adjust clinical decision-making based on transmitted data.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance specifications of the glucose measurement component (MediSense Pen 2 technology).

Technological Characteristics

Electrochemical biosensor using glucose oxidase (Aspergillus niger) on disposable dry reagent strips. Meter includes alphanumeric 2-line LCD, 4 control buttons, and internal modem for data transmission. Power provided by internal rechargeable batteries with external DC supply. Assay range 20-600 mg/dL. Operates at 64-86° F and 20-80% RH.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood for patients requiring blood glucose monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MediSense Pen 2 Blood Glucose Monitoring System
• Lifescan, Inc. ONE TOUCH® II Blood Glucose Monitoring System
• BioStore Technologies BioStore™ L Diabetes Data Management System (K960337)

Submission Summary (Full Text)

{0}

K960337

AMD

ADVANCED

MEDICAL DEVICES

INCORPORATED

SEP 24 1995

152 WEST WISCONSIN AVE.

MILWAUKEE, WI 53203

PHONE: [phone]

FAX: [phone]

# Premarket Notification

Advanced Medical Devices, Inc.

AMD Home Health Monitoring System

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

Contact Person: President

Date Prepared: December 18, 1995

Proprietary Name: AMD Home Health Monitoring System

Common/Usual Name: Self-Monitoring Blood Glucose Device

Classification Name: Test system, glucose (procode 75CGA)

Device Description/Intended Use: The AMD Home Health Monitoring System consists of the home-use, blood glucose meter, the AMD Home Health Glucose Monitor, with accessories, and the companion physician's monitoring device, the AMD PC Monitoring Station. The AMD Home Health Glucose Monitor contains the glucose measurement technology of the MediSense Pen 2 device. MediSense Companion 2 Test Strips and Control Solutions are to be used with the AMD Home Health Glucose Monitor.

The AMD Home Health Glucose Monitor testing system has been developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique. This biosensor system employs a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). When a blood drop is applied to the target area of the test strip, the glucose oxidase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons are transferred by way of an electrochemical mediator to the electrode surface. This in turn generates a current that is measured by the Home Health Glucose Monitor. The size of the current generated is proportional to the amount of glucose present in the blood drop, thus giving an accurate reading of the blood glucose concentration.

Technology for Better Health

992

{1}

The computer-controlled Home Health Glucose Monitor facilitates efficient blood glucose testing and has an internal modem for the transmission of glucose test results to the remote AMD PC Monitoring Station. The AMD PC Monitoring Station is a personal computer-based system used in the clinical setting (e.g., physician's office, nurse's station, etc.) to receive and process blood glucose test data transmitted by the Home Health Glucose Monitor. This device allows remote clinical review of test results obtained in the patient's home.

**Predicate Devices:** The AMD Home Health Monitoring System is substantially equivalent to the MediSense Pen 2 Blood Glucose Monitoring System, the Lifescan, Inc. ONE TOUCH® II Blood Glucose Monitoring System, and the BioStore Technologies BioStore™ L Diabetes Data Management System (intended for use with ONE TOUCH® II System).

**Predicate Comparison:** A chart comparing the AMD Home Health Monitoring System to the cited predicate devices, demonstrating substantial equivalence, is attached.

Submitted by:
Brian W. Petersen
President
Advanced Medical Devices, Inc.
152 West Wisconsin Avenue
Milwaukee, WI 53203

267

{2}

DEVICE COMPARISON CHART

| Device Characteristic | AMD Home Health Monitoring System | MediSense Pen 2 Blood Glucose Testing System | Lifescan ONE TOUCH II Blood Glucose Monitoring System | *BioStore Technologies
*BioStore L Data
*Management System |
| --- | --- | --- | --- | --- |
| Brief Device Description | 1. Portable home-use blood glucose test meter with test strips and control solutions
2. Dedicated clinical-use computer system for receipt and management of patient blood glucose test results by clinician | Portable home-use blood glucose test meter with test strips and control solutions | 1. Portable home-use blood glucose test meter with test strips and control solutions | *2. Dedicated home-use computer software for use by Lifescan ONE TOUCH II device patients for management of personal blood glucose test results and transmission of test data to remote clinical computer |
| Indication For Use | In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood | In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood | In vitro diagnostic use in monitoring whole blood glucose in patients diagnosed with diabetes mellitus by conventional means | * |
| Is Meter Hand-Held/Portable? | Yes | Yes | Yes | *N/A |
| Dimensions
Length (in.):
Width (in.):
Height (in.): | 6.00
3.50
1.25 | 3.65
2.15
.038 | 4.75
2.38
1.06 | *N/A |

{3}

DEVICE COMPARISON CHART (cont.)

| Device Characteristic | AMD Home Health Monitoring System | MediSense Pen 2 Blood Glucose Testing System | Lifescan ONE TOUCH II Blood Glucose Monitoring System | *BioStore Technologies
*BioStore L Data
*Management System |
| --- | --- | --- | --- | --- |
| Number of Control Buttons | 4 | 1 | 1 | *N/A
* |
| Display Type | Alphanumeric, 2-line, 24-character liquid crystal display (LCD) | Alphanumeric, 3-character LCD | Alphanumeric, 6-character LCD | *N/A
* |
| Power Source | Internal, rechargeable batteries with external DC power supply | Internal, non-replaceable battery | Internal, replaceable battery | *N/A
* |
| Estimated Battery Life | 20 hours with fully-charged batteries | 4000 glucose tests | 1 year (@ 2 tests/day) | *N/A
* |
| Assay Range | 20-600 mg/dL (1.1-33.3 mmol/L) | 20-600 mg/Dl (1.1-33.3 mmol/L) | 0-600 mg/Dl (0-33.3 mmol/L) | *N/A
* |
| Sample Volume | 10-50 microliters | 10-50 microliters | Not specified | *N/A
* |
| Operating Temp. Range | 64-86° F (18-30° C) | 64-86° F (18-30° C) | 59-95° F (15-35° C) | *N/A
* |
| Operating Humidity Range | 20-80% RH | 20-80% RH | 0-90% RH | *N/A
* |

{4}

DEVICE COMPARISON CHART (cont.)

| Device Characteristic | AMD Home Health Monitoring System | MediSense Pen 2 Blood Glucose Testing System | Lifescan ONE TOUCH II Blood Glucose Monitoring System | *BioStore Technologies
*BioStore L Data
*Management System |
| --- | --- | --- | --- | --- |
| Test Strips Specified | MediSense Companion 2 Blood Glucose test Strips (private-labeled for AMD) | MediSense Companion 2 Blood Glucose test Strips | Lifescan ONE TOUCH Test Strips | *N/A |
| Control Solutions Specified | MediSense Companion 2 HIGH and LOW Control Solutions (private-labeled for AMD) | MediSense Companion 2 HIGH and LOW Control Solutions (private-labeled for AMD) | Lifescan ONE TOUCH Normal Glucose Control Solution-
Blue Formula | *N/A |