(74 days)
Not Found
No
The description focuses on data transmission via Bluetooth and does not mention any analytical or interpretive functions that would typically involve AI/ML.
No
The device transmits glucose meter readings but does not directly treat or diagnose a condition. It is a communication link for existing therapeutic processes.
No
The device transmits glucose meter readings but does not interpret or analyze them to diagnose a condition. It merely acts as a communication link.
No
The device description explicitly states it is a "telemedicine device" that "uses Bluetooth technology" and is "connected to the glucose meter by a phono jack" and is "battery powered." These are all hardware components.
Based on the provided information, the Polytel GMA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to wirelessly transmit glucose meter readings. It does not perform any diagnostic testing or analysis of biological samples itself. It acts as a communication link for data already generated by a separate device (the glucose meter).
- Device Description: The description confirms it's a "telemedicine device" that uses Bluetooth technology to transmit data. It connects to the glucose meter but doesn't perform any in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Providing a diagnostic result or interpretation
- Using reagents or other materials for testing
The device's function is purely data transmission, not diagnostic testing. The diagnostic function is performed by the compatible Blood Glucose Monitor, which would be considered an IVD.
N/A
Intended Use / Indications for Use
The Polytel GMA (models PWR-08-06, PWR-08-07, and PWR-08-09) are remote communications link devices intended to be used to wirelessly transmit glucose meter readings from a compatible Blood Glucose Monitor to a compatible cellular phone, such as the Nokia N73 or access point, such as the Polytel® APT. The receiving device, in turn, sends the readings to the healthcare provider in another location. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Product codes
NBW
Device Description
The Polytel® GMA is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer, standalone device or cellular phone with Bluetooth capability. It is connected to the glucose meter by a phono jack and uses short-range low power wireless transmission (Bluetooth v2.0) to send the data to Bluetooth compatible access point. The unit is battery powered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider in another location
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 1 7 2009
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
(520) 747-1811
Fax: (520) 747-1811
Email: pierre@polymap.net |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as submitter |
| Date of Summary: | April 10, 2009 |
| Trade Name: | Polytel® GMA (Glucose Meter Accessory), models PWR-08-06, PWR-08-07, PWR-08-09 |
| Common Name: | Accessory to Blood Glucose Meter |
| Classification: no: | NBW |
A. Predicate Device:
The Polytel® GMA is substantially equivalent to the PWR-08-03 manufactured by Polymap Wireless and the Think Positive (t+) diabetes management system, manufactured by e-San, Ltd. UK.
B.Device Description:
The Polytel® GMA is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer, standalone device or cellular phone with Bluetooth capability. It is connected to the glucose meter by a phono jack and uses short-range low power wireless transmission (Bluetooth v2.0) to send the data to Bluetooth compatible access point. The unit is battery powered.
C.Intended use and indications for use:
The Polytel GMA (models PWR-08-06, PWR-08-07, and PWR-08-09) are remote communications link devices intended to be used to wirelessly transmit glucose meter readings from a compatible Blood Glucose Monitor to a compatible cellular phone, such as the Nokia N73 or access point, such as the Polytel® APT. The receiving device, in turn, sends the readings to the healthcare provider in another location. The device does
1091296
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not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
D. Substantial Equivalence Summary
The Polytel GMA has the same fundamental scientific technology and intended use as the predicate devices (K070559 and K061328). .
E. Technological Characteristics
The Polytel GMA has technological characteristics that are very similar to those of the predicate devices as all use Bluetooth technology. All these devices are battery powered. Each device uses the same frequency band (2.402 to 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 bye the Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Polyman Wireless, LLC c/o Pierre Landau, Ph.D. 310 S. Williams Blvd. Ste. 350 Tucson, AZ 85711
JUL 1 7 2009
Re: K091296
Trade Name: Polytel GMA models PWR-08-06, PWR-08-07, and PWR-08-09 Regulation Number: 21 CFR & 862,1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Codes: NBW Dated: April 29, 2009 Received: May 4, 2009
Dear Dr. 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
G.C.H
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K091296
Device Name: Polytel® GMA
Indications For Use:
The Polytel GMA (models PWR-08-06, PWR-08-07, and PWR-08-09) are remote communications link devices intended to be used to wirelessly transmit glucose meter readings from a compatible Blood Glucose Monitor to a compatible cellular phone, such as the Nokia N73 or access point, such as the Polytel® APT. The receiving device, in turn, sends the readings to the healthcare provider in another location. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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
Ko91296 510(k)