(122 days)
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Not Found
No
The description focuses on data transmission via Bluetooth and does not mention any AI/ML capabilities for data analysis or interpretation.
No.
The device functions as a communication link for transmitting glucose meter readings and does not directly provide therapy or affect the body's function.
No
The device is a remote communications link that transmits glucose meter readings. It does not perform any analysis or interpretation of health data to diagnose a condition.
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 hardware components, not solely software.
Based on the provided information, the Polymap PWR-008-03 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit glucose meter readings. It does not perform any diagnostic testing or analysis of the sample itself. The diagnostic part is done by the Blood Glucose Monitor.
- Device Description: The device is described as a "telemedicine device" that uses Bluetooth technology to transmit data. It acts as a communication link, not a diagnostic tool.
- Lack of Diagnostic Function: The device does not analyze blood, urine, or any other biological sample to provide diagnostic information. It simply facilitates the transfer of data generated by a separate diagnostic device (the glucose meter).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Polymap PWR-008-03 does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The PWR-08-03 is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer 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 VI .2) to send the data to a Bluetooth compatible access point. The unit is battery powered.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
5.1
K070559
SECTION 5 - 510(K) SUMMARY
Submitter: Polymap Wireless LLC 310 S. Williams Blvd. Suite 346 Tucson, AZ, 85771. Pierre Landau, Ph.D. Contact: Telephone: (520)747-1811 Email: Pierre@polymap.net Date of Summary: September 15, 2006 Common Name: Accessory to Blood Glucose Meter
PWR-08-03
862.1345
Classification Name: Glucose test system.
JUN 2 9 2007
A. Predicate Device
Classification No .:
Trade Name:
The Polymap PWR-08-03 is substantially equivalent to the e-San Bluetooth Cradle, manufactured by e-San, Ltd., UK.
B. Device Description
The PWR-08-03 is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer 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 VI .2) to send the data to a Bluetooth compatible access point. The unit is battery powered.
C. Intended 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.
D. Substantial Equivalence Summary
The Polymap PWR-08-03 has indications for use that are identical to those of the named predicate device, the e-San Cradle. The e-San Cradle connects to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and sends data from the meter to a Bluetooth compatible access point for transmission to a computer server. This premarket notification has described and compared the characteristics of the Polymap PWR-08-03 to the e-San Cradle in sufficient detail to assure the devices are substantially equivalent.
1
E. Technological Characteristics
The Polymap PWR-08-03 has technological characteristics that are very similar to those of the e-San Bluetooth Cradle as both are Bluetooth VI.2 compatible. Both 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 by the Center for Devices and Radiological Health.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Polymap Wireless c/o Dr. Pierre Landau President 310 S. Williams Blvd, Ste. 346 Tucson, AZ 85711
JUN 2 9 2007
Re: K070559
Trade/Device Name: Polymap PWR-08-03 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 08, 2007 Received: May 09, 2007
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, listing 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and this, perceits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (2) Ort I and Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
SECTION 4 - INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): 《Ο 705 S 9
Device Name: Polymap PWR-08-03
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.
X . AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division/Sign-Off
Office of In Vito Diagnostic Device Evaluation and Safety