POLYMAP PWR-08-03

K070559 · Polymap Wireless · NBW · Jun 29, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070559
• Device Name: POLYMAP PWR-08-03
• Applicant: Polymap Wireless
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Polymap PWR-08-03 is a remote communications link intended to be used to wirelessly transmit glucose meter readings from a Blood Glucose Monitor to a compatible access point or cellular phone, such as the Nokia 6620. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Device Story

The Polymap PWR-08-03 is a telemedicine accessory acting as a wireless communications link for blood glucose monitors. It connects to a glucose meter via a phono jack and utilizes Bluetooth v1.2 technology to transmit meter readings to compatible access points, such as cellular phones or personal computers. The device is battery-powered and operates in the 2.402 to 2.480 GHz frequency band. It does not generate real-time alarms; clinical judgment is required to interpret the transmitted data. The device facilitates remote data transfer, allowing healthcare providers or patients to review glucose information on secondary devices, potentially improving management of glucose monitoring workflows.

Clinical Evidence

No clinical trials performed. Usability study conducted with users to validate setup, Instructions for Use, and data transmission accuracy. Results confirmed users successfully followed instructions, and transmitted data (glucose readings, date, time) matched meter output without interference.

Technological Characteristics

Hardware: Cambridge Silicon Radio BC02-Ext chip with XAP2 processor. Connectivity: Class I Bluetooth radio. Power: Battery. Form factor: Plug-in accessory for glucose meter. Standards: IEC 60601-1-1:2000, IEC 60601-1-2:2001, ISO 14971:2000.

Indications for Use

Indicated for patients using a LifeScan OneTouch Ultra Blood Glucose Monitor who require remote transmission of glucose readings for monitoring and historical trending. Prescription use only.

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

• e-San Bluetooth Cradle

Submission Summary (Full Text)

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

A. 510(k) Number:
k070559

B. Purpose for Submission:
New submission for a glucose meter accessory to transmit data to compatible access points such as a personal computer or cellular phone with Bluetooth capability.

C. Manufacturer and Instrument Name:
Polymap Wireless
Polymap PWR-08-03

D. Type of Test or Tests performed:
Not Applicable

E. System Descriptions:
1. Device Description:
The Polymap PWR-08-03 is a battery-powered, plug-in accessory to the LifeScan OneTouch Ultra Blood Glucose Monitor. It acts as a remote unit to transmit data from the meter to a compatible access point, such as a Nokia Model 6620 cell phone or other compatible access point. The PWR-08-03 plugs into a port on the glucose meter. When a glucose reading is taken and the strip withdrawn from the meter, the PWR-08-03 turns on automatically, accepts the data, and transmits it wirelessly to the compatible Access Point. The Access Point may display the data and/or send the encrypted data via cell or land telephone lines to a computer server.

The access point can be a compatible cell phone, personal computer, or other device having Bluetooth capability. This allows glucose readings to be monitored from a remote location. The glucose readings transmitted by the Polymap glucose accessory are intended to be used for monitoring and historical trending. Clinical judgment and experience are required to check and interpret the information delivered. The unit does not transmit any alarms.

The device hardware platform is a Cambridge Silicon Radio BC02-Ext chip with XAP2 processor. The programming language used is C.

The PWR-08-03 will be sold only through approved groups who can offer service support. It will be advertised: to physicians; in a variety of publications, and; on the Polymap website which will direct interested users to contact one of the approved support groups that Polymap has identified. Users may contact Polymap directly, or go to the Polymap website. A support technician from one of the approved groups will visit the user, answer questions about the PWR-08-03, validate that it works properly with the user's particular access point, and validate accurate data transmission to the monitoring site.

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2. Principles of Operation:
Not Applicable

3. Modes of Operation:
Transmits data over a wireless Bluetooth link from a Lifescan OneTouch Ultra Blood Glucose Monitor to a compatible server.

4. Specimen Identification:
Glucose meter generated – unique unit ID

5. Specimen Sampling and Handling:
Not applicable

6. Calibration:
Not Applicable

7. Quality Control:
Not Applicable

8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☑ or No ☐

F. Regulatory Information:

1. Regulation Section:
21CFR Sec.- 862.1345-Glucose test system.

2. Classification:
Class II

3. Product Code:
NBW - SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

4. Panel:
Chemistry (75)

G. Intended Use:

1. Indication(s) for Use:
The Polymap PWR-08-03 is a remote communications link intended to be used to wirelessly transmit glucose meter readings from a Blood Glucose Monitor to a compatible access point or cellular phone, such as the Nokia 6620. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

2. Special Condition for use Statement(s):
Prescription use

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# H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:
e-San Bluetooth Cradle - k052343
2. Comparison with Predicate Device:

| | Predicate | Polymap PWR-08-03 |
| --- | --- | --- |
| Intended Use/ indications | Transmit data between monitoring devices and enabled cell phone | Transmit data between a monitoring device and enabled cell phone or other compatible device |
| Users | Patient & Healthcare provider | Patient & Healthcare provider |
| Site of use | In the home | In the home |
| Prescription | OTC | Sold through approved groups who set up the system |
| System description | Transmitting device that sends data from a glucose meter to an access point | Transmitting device that sends data from a glucose meter to an access point |
| Connection | Wired connection between glucometer and device. Wireless connection between glucometer and access point | Wired connection between glucometer and device. Wireless connection between glucometer and access point |
| Data Transmission | Cellular connections | Residential telephone lines or cellular connections |
| Patient interactions | Press button to start the data transmission | None |
| Monitoring devices | Blood Glucose Meter | Blood Glucose Meter |
| Wireless link | Class II Bluetooth radio | Class I Bluetooth radio |
| Power | Battery | Battery |
| Range | 10 Meters | 100 Meters |
| Alarms | None | None |

# I. Standard/Guidance Document Referenced (if applicable):

- IEC 60601-1-1:2000, Medical Electrical Equipment - Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems.
- IEC 6060 1-1-2:2001 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests
- ISO 14971:2000, Medical devices - Application of risk management to medical devices

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## J. Performance Characteristics:

### 1. Analytical Performance:

a. Accuracy:
Not Applicable

b. Precision/Reproducibility:
Not Applicable

c. Linearity:
Not Applicable

d. Carryover:
Not Applicable

e. Interfering Substances:
Not Applicable

### 2. Other Supportive Instrument Performance Data Not Covered Above:

A Usability study was conducted to answer the following questions:

1. Can users understand and follow the Instructions for Use and successfully set up and use the product in actual use? Do any outstanding usability issues affect device performance?
2. Does the configured glucose meter result match the transmitted data?
3. Are all data transmitted, e.g., test results, date, time, etc., accurate?

The study demonstrates users are able to successfully follow the Instructions for Use and use the device. No outstanding usability issues were discovered. In addition, the PWR-08-03 accurately transmits the glucose readings and other pertinent information such as date and time. Placing the Lifescan OneTouch Ultra glucose meter into the carrying pouch and attaching the PWR-08-03 lead to it does not impede or interfere with use of the meter.

## 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.