POLYTEL(R) APT MODEL: PWA-08-01

K100524 · Polymap Wireless, LLC · DRG · May 24, 2010 · Cardiovascular

Device Facts

• Record ID: K100524
• Device Name: POLYTEL(R) APT MODEL: PWA-08-01
• Applicant: Polymap Wireless, LLC
• Product Code: DRG · Cardiovascular
• Decision Date: May 24, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management. The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care. Any device certified by Polymap Wireless as compatible can use the Polytel® APT to forward its data. The device is not intended for emergency calls, and may not be used to send any realtime alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention. The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient: alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service. A list of compatible devices and services will be available on the Polymap Wireless website.

Device Story

Polytel APT acts as a wireless gateway/bridge; receives physiological data (glucose, BP, weight, SpO2) from compatible wireless monitors via Bluetooth; transmits data over public switched telephone network or dial-up Internet to a remote server. Used in home settings; operated by patients or healthcare professionals. Device contains telephone jacks, power input, and status indicator lights. Does not measure, interpret, or analyze data; serves solely as a transport mechanism for historical data review. Benefits include facilitating remote health management and data access for clinicians. Not for emergency or time-critical monitoring.

Clinical Evidence

Bench testing using Polymap procedures and specifications, field testing under actual use conditions, and performance standards testing. Results were acceptable. No clinical trial data provided.

Technological Characteristics

Small plastic unit; line-powered; Bluetooth connectivity (2.402-2.480 GHz); integrated telephone modem for dial-up Internet/PSTN; status indicator LEDs; two standard telephone jacks; 5V power input.

Indications for Use

Indicated for home use by patients and healthcare professionals to transmit and review historical physiological data (blood glucose, weight, blood pressure, SpO2) from compatible wireless devices. Not for emergency use, real-time alarms, or patients requiring direct medical supervision.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• RTX3320 Wireless Telehealth Gateway (K041816)

Reference Devices

• K080538

Submission Summary (Full Text)

{0}------------------------------------------------

K100524 Pi/

5.1

# MAY 2 4 2010

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

Submitter:

Pierre Landau, PhD President Polymap Wireless 310 S. Williams Blvd. Ste. 350 Tucson, AZ 85711 [phone] Fax: [phone] Email: [e-mail]

Same as submitter Contact Person:

May 1, 2009 Date of Summary:

Polytel® APT (Access Point Terminal) Trade Name:

Physiological Measurement Tramitter and Receiver Common Name:

Classification: no: DRG

A. Predicate Devices:

The Polytel® APT is substantially equivalent to the following predicate devices:

| 510(k) number: | K041816 |
|----------------|-------------------------------------|
| Device Name: | RTX3320 Wireless Telehealth Gateway |
| Applicant: | RTX Healthcare |

## B. Device Description:

The Polytel® APT device performs transmission of physiological patient information to and from wireless patient monitors and a remote data server healthcare facility over an encrypted dialup Internet connection. The APT, with its built-in telephone modem, transmits data over the public switched telephone network and the dial-up Internet.

The APT is contained in a small plastic unit, containing two standard telephone jacks for connection to standard phone outlets, a 5V power input jack for connection to an AC adapter, and four indicator lights. The indicator lights are used to show the reception of a measurement from a transmitting device, to show when the telephone line is in use, and to indicate if there has been an error (delay) in transmission.

Image /page/0/Picture/18 description: The image contains a black circle against a white background. The circle is solid black and appears to be centered in the frame. There are no other objects or details present in the image, making it a simple and minimalist composition.

{1}------------------------------------------------

Two server-side components are involved in the operation of the APT, the first providing a centralized configuration database, the second providing for data collection and translation to a standard protocol.

The APT device is not used directly on a patient, nor attached electrically to any device that is used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

## C. Intended use and indications for use:

The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care.

Any device certified by Polyman Wireless as compatible can use the Polytel® APT to forward its data.

The device is not intended for emergency calls, and may not be used to send any realtime alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention.

The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient: alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service.

A list of compatible devices and services will be available on the Polymap Wireless website.

## D. Substantial Equivalence Summary:

The Polytel APT has the same fundamental scientific technology and intended use as the predicate devices (K041816, K080538).

### E. Technological Characteristics:

The Polytel APT has technological characteristics that are very similar to those of the predicate devices, as all use Bluetooth technology and dial-up modems. All of these

្រ

{2}------------------------------------------------

devices are line-powered, and each device uses the same frequency band of 2.402-2.480 GHz.

## F. Testing:

The testing consisted of three types: bench testing using Polymap procedures and specifications; field testing under actual use conditions, and performance standards testing. The results were acceptable.

## G. Conclusions

This pre-market submission has demonstrated substantial equivalence, as defined and understood in sections 513(0)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and guidance documents issued by the Center for Devices and Radiological Health.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 2 4 2010

Polymap Wireless LLC c/o Mr. Pierre Landau, Ph.D. President 310 S. Williams Blvd. Ste. 350 Tucson, AZ 85711

Re: K100524

Device Name: Polytel® APT (Access Point Terminal) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (Two) Product Code: DRG Dated: February 10, 2010 Received: February 24, 2010

Dear Mr. Landau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 - Mr. Pierre Landau, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events).(21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number (if known): K100524

Device Name: Polytel® APT

Indications For Use:

The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care.

Any device certified by Polymap Wireless as compatible can use the Polytel® APT to forward its data.

The device is not intended for emergency calls, and may not be used to send any real-time alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention.

The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient; alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service.

A list of compatible devices and services will be available on the Polymap Wireless website.

AND/OR Over-The-Counter Use Prescription Use × X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device

510(k)

Devices (OIVD)

Division Sign-Off

510(k) Numbe

Division of Cardiovascular Devi