MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100

K062377 · Medapps, Inc. · NBW · Jul 3, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062377
• Device Name: MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
• Applicant: Medapps, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The MedApps Wellness System is intended for use in non-clinical settings to collect and transmit historical data to healthcare professionals to help support effective management of patients. The System is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are performed under the supervision and oversight of an appropriate healthcare professional.

Device Story

System acts as accessory to FDA-cleared medical devices (e.g., blood glucose monitors); collects historical patient data via Bluetooth V1.2; transmits data from medical device to cellular phone 'Hub' software; Hub forwards data to central server 'MedApps Engine'. Engine stores data and applies provider-defined business rules to determine if Interactive Voice Response (IVR) call is required to collect additional behavioral information. Data repository accessible by healthcare providers for review. Used in non-clinical/home settings by patients; operated by patients. Output consists of historical data and IVR-collected behavioral information. Benefits include supporting effective patient management through remote data collection; does not provide automated treatment decisions or substitute for professional judgment.

Clinical Evidence

No clinical data. Bench testing only. Alpha validation testing included execution of all software design specification scripts, verification of executable code, and confirmation that all identified hazards were addressed by software functionality, user interface, or documentation. Operational performance data confirmed system met design requirements.

Technological Characteristics

System consists of Hub software (cell phone) and MedApps Engine (server). Connectivity via Bluetooth V1.2 (2.402-2.480 GHz) and cellular network. Power source: wall plug for hub and device batteries. Software-based data transmission and business-rule processing. Complies with IEC 60601-1, ISO 9001, ISO 13485, and ISO 14971.

Indications for Use

Indicated for patients using FDA-cleared medical devices (e.g., LifeScan OneTouch Ultra, Polytel PWR-08-03) to collect and transmit historical physiological data to healthcare practitioners for review. Not for emergency use, real-time alarms, time-critical data, or patients requiring direct medical supervision.

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

• Think Positive (t+) Diabetes Management System (k061328)
• The Hermes System (k050929)

Reference Devices

• LifeScan OneTouch Ultra Blood Glucose Monitoring System (k024194/k043197)
• Polytel PWR-08-03 Remote Module (k070559)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k062377

B. Purpose for Submission:
Software allowing data transfer from a cell phone to a central server for viewing.

C. Manufacturer and Instrument Name:
MedApps, Inc., MedApps Remote Patient Monitoring System

D. Type of Test or Tests Performed:
This device does not directly test glucose. This is an accessory to previously a cleared glucose monitor (k024194/k043197).

E. System Descriptions:

1. Device Description:
The MedApps Remote Patient Monitoring System ("System") is designed to be used by patients to send their data from the LifeScan OneTouch Ultra glucose meter to a central server for subsequent storage and display.

The System is comprised of a "Hub" (cell phone software) and the MedApps Engine, which runs on a central server.

The Hub is a software program that runs on a cell phone and takes in data from the OneTouch Ultra (sent via the Polytel device (k070559)) and then transmits it to the central server for storage and processing.

2. Principles of Operation:
The MedApps Engine is a software program that runs on a common Web / Internet secure server platform. The MedApps Engine picks up the stored data sent to it by the Hub and through a set of business rules set by the healthcare providers, determines if a follow-up Interactive Voice Response (IVR) call is required to be made to the patient to collect additional Behavioral information from the patient.

Once all the data is collected, then it is stored in a repository for access by the healthcare provider.

The Hub will utilize the OneTouch Ultra integrated Short-range low power wireless transmission (Bluetooth V1.2) or a FDA approved accessory to the medical devices that to transmits the medical device data via Bluetooth to a compatible cellular telephone, such as the Nokia 6620, or other /compatible cellular phones.

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3. **Modes of Operation:**
Wireless data transfer of stored glucose measurements from a cell phone to a central server where the data is accessible via the internet.

4. **Specimen Identification:**
For an example, see k024194/k043197.

5. **Specimen Sampling and Handling:**
For an example, see k024194/k043197.

6. **Calibration:**
For an example, see k024194/k043197.

7. **Quality Control:**
For an example, see k024194/k043197.

8. **Software:**
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X ☐ or No ☐

F. **Regulatory Information:**

1. **Regulation section:**
21 CFR § 862.1345, Glucose Test System

2. **Classification:**
Class II

3. **Product code:**
NBW

4. **Panel:**
75 (Clinical Chemistry)

G. **Intended Use:**

1. **Indication(s) for Use:**
The MedApps Remote Patient Monitoring System model d-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner.

The following medical devices and measuring systems are fully validated for this intended use at this time:

- LifeScan OneTouch® Ultra® Blood Glucose Monitoring System (k024194/k043197)
- Polytel PWR-08-03 Remote Module (k070559)

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The MedApps Remote Patient Monitoring System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The MedApps Remote Patient Monitoring System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.

Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.

This device is not for use in systems which substitute for medical care.

This device is not intended for patients requiring direct medical supervision or emergency intervention.

2. Special Conditions for Use Statement(s):

For over-the counter use

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

k061328, Think Positive (t+) Diabetes Management System

k050929, The Hermes System

2. Comparison with Predicate Device:

| Feature | Think Positive k061328 | The Hermes k050929 | MedApps (Submission Device) |
| --- | --- | --- | --- |
| Indications of Use | Enables healthcare providers to monitor and manage chronic conditions of patients remotely | Same | Same |
| Intended Use | Telemedicine System | Same | Same |
| Intended Users | Home users and Healthcare providers | Same | Same |

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| Site of Use | Home, Clinic | Same | Same |
| --- | --- | --- | --- |
| Data Collection Software | Think Positive Proprietary Software | The Hermes Proprietary Software | MedApps Proprietary Software |
| Data Collection Software Functionality | Transmit data from Sensor devices to Central Database | Same | Same |
| Communication method of hub with Central Server | Via Cellular Phone | Same | Same |
| Types of sensors which can be interfaced (wired or wirelessly) to receiver hub | Glucose Levels | Same | Same |
| Implementation method of collecting data from sensors | Short range radio system using Bluetooth and Cellular technology | Same | Same |
| Sensor Software | Sensor Software unchanged | Same | Same |
| Connectivity | Short range radio system using Bluetooth and Cellular technology | Same | Same |
| Communication method of hub with devices | Short range radio system using Bluetooth and Cellular technology | Same | Same |
| Communication s Protocol | Bluetooth V1.2 | Same | Same |

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| Communication Frequency | 2.402 to 2.480 GHz | Same | Same |
| --- | --- | --- | --- |
| Power Source | Wall power plug for hub (120 VAC/50-60) and batteries in devices | Same | Same |
| Display | On devices and hub, and monitors connected to central server | Same | Same |
| Communication with Patients | On screen display | Same | On screen display of Readings and Interactive Voice Response (IVR) |

I. Special Control/Guidance Document Referenced (if applicable):

1) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
2) Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Reviewers, April 19, 2001
3) Guidance for Industry – Part 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003
4) Design Control Guidance for Medical Device Manufacturers, March 11, 1997
5) ISO 9001:2000 – Quality Management Systems – Requirements
6) ISO 13485:2003 – Quality Management Systems – Requirements for Medical Devices
7) 93/42/EEC – Medical Device Directive
8) ISO 14971:2000 Medical Devices – Application of Risk Management to Medical Devices
9) ANSI/AAMI HE74: 2001 – Human factors design process for medical devices
10) IEC 60601-1 – Medical electrical equipment – Parts 1-8: General requirements for safety

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

The sponsor validated overall software usage and data transfer functionality.

Software usage validation entailed testing each of the software’s design

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requirements to ensure that they were met. Data transfer was tested by transferring sets of data from the transmitter (phone) to the database and checking that the data was downloaded in its entirety, and that the data points (results) that were transferred from the phone to the database matched the original data taken from the phone. Data transmitted from the glucose meter to the phone was validated in k070559.

For an example of performance of the glucose meter and strips see k024194/k043197.

b. Precision/Reproducibility:
For an example of performance of the glucose meter and strips see k024194/k043197.

c. Linearity:
For an example of performance of the glucose meter and strips see k024194/k043197.

d. Carryover:
For an example of performance of the glucose meter and strips see k024194/k043197.

e. Interfering Substances:
For an example of performance of the glucose meter and strips see k024194/k043197.

2. Other Supportive Instrument Performance Data Not Covered Above:

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.