The Polymap PWR-008-03 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 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.

AI/ML Overview

This 510(k) summary describes a remote communication link (Polymap PWR-08-03) that transmits glucose meter readings wirelessly. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies or specific acceptance criteria for the device's functional performance in terms of data transmission accuracy or reliability.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would typically see for diagnostic accuracy or clinical effectiveness. Instead, the "performance" discussed relates to the device's functional operation and compliance with technical standards.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Functional Equivalence	Identical Indications for Use to predicate device.	"The Polymap PWR-08-03 has indications for use that are identical to those of the named predicate device, the e-San Cradle."
Technological Equivalence	Bluetooth V1.2 compatible. Battery powered. Same frequency band (2.402 to 2.480 GHz).	"The Polymap PWR-08-03 has technological characteristics that are very similar to those of the e-San Bluetooth Cradle as both are Bluetooth V1.2 compatible. Both devices are battery powered. Each device uses the same frequency band (2.402 to 2.480 GHz)."
Testing Outcomes	Bench testing using Polymap procedures and specifications. Field testing under actual use conditions. Performance standards testing.	"The results were acceptable."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "bench testing" and "field testing under actual use conditions" but does not specify any sample sizes for these tests. There's no information provided regarding the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This type of information is not applicable to this submission. The device is a data transmission accessory, not a diagnostic tool requiring expert interpretation of results. The "ground truth" here would relate to the accurate transmission of data, which is typically verified through technical validation rather than expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As the device is for data transmission, there's no adjudication process relevant to clinical or diagnostic outcomes.

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:

Not applicable. This device is a communication link and does not involve AI or human interpretation of medical images or data in a way that an MRMC study would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone communication module, meaning it functions without direct human interaction during data transmission. Its performance (e.g., successful data transfer, range, battery life) would have been assessed as part of the "bench testing" and "field testing" mentioned, but no specific details on these standalone tests or their metrics are provided beyond "results were acceptable."

7. The Type of Ground Truth Used:

The "ground truth" for this device would be the accurate and complete wireless transmission of glucose meter readings. This would be validated by comparing the data received at the access point/cellular phone with the original data recorded by the glucose meter. The document states "bench testing using Polymap procedures and specifications" and "field testing under actual use conditions," implying that such validation was performed, but it doesn't elaborate on the specific methodology or metrics.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware accessory for data transmission and does not utilize machine learning or AI models, therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. (See point 8.)

Summary

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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

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.

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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.

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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

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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:

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

K070559

Regulation Number and Section

§ 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.