(74 days)
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.
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.
The provided text describes a 510(k) summary for the Polytel® GMA (Glucose Meter Accessory). However, it does not contain the detailed information typically found in a study proving the device meets specific acceptance criteria with reported device performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Device identification and contact information.
- Predicate device identification.
- Device description: It's a telemedicine device using Bluetooth to transmit glucose meter data.
- Intended use and indications for use: Wirelessly transmits glucose meter readings to a compatible cellular phone or access point, which then sends the readings to a healthcare provider. It does not send real-time alarms.
- Claim of substantial equivalence to predicate devices based on fundamental scientific technology and intended use.
- Technological characteristics: Bluetooth technology, battery-powered, same frequency band (2.402 to 2.480 GHz).
- Testing: It broadly states that "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."
- Conclusions: Substantial Equivalence was demonstrated.
Based on the provided text, I can respond to your request as follows:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Wireless Transmission Functionality | "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." (Implies successful transmission and adherence to specifications.) |
| Adherence to Polymap Procedures & Specifications | "results were acceptable" |
| Performance under actual use conditions | "results were acceptable" |
| Adherence to performance standards | "results were acceptable" |
| Substantial Equivalence | Achieved based on fundamental scientific technology and intended use, and technological characteristics (Bluetooth, battery-powered, frequency band). |
Note: The document provides general statements of acceptance rather than specific quantitative performance metrics against predefined criteria. The acceptance criteria are inferred from the types of testing mentioned.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "bench testing," "field testing under actual use conditions," and "performance standards testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish a ground truth for a test set. The device is a data transmission accessory, not a diagnostic tool that would typically require expert-adjudicated ground truth for its core function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for a test set, as it does not describe a study involving human interpretation of data for which ground truth would be established through adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI (Artificial Intelligence) or CAD (Computer-Aided Detection/Diagnosis) systems where the device assists human readers in interpretation. The Polytel® GMA is a communication link device, not an AI or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation in the context of an algorithm's diagnostic accuracy was not performed because the Polytel® GMA is a data transmission device, not an algorithm that performs diagnostic analysis. Its "standalone" performance would refer to its ability to transmit data correctly, which is generally covered under the "bench testing" and "field testing" mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not describe the use of specific "ground truth" types like expert consensus, pathology, or outcomes data. For a device that merely transmits data, the "ground truth" would likely relate to the accuracy and integrity of the transmitted data compared to the input data, and the reliability of the wireless connection. These are assessed through technical performance standards rather than clinical ground truth establishment.
8. The sample size for the training set
The document does not mention a training set. This is because the Polytel® GMA is a hardware accessory for data transmission, not a learning algorithm or AI system that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set (see point 8), there is no ground truth established for it.
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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, PhDPresidentPolymap Wireless310 S. Williams Blvd. Ste. 350Tucson, AZ 85711(520) 747-1811Fax: (520) 747-1811Email: 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
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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
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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
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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)
§ 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.