AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution are sold separately.

It is intended for over-the counter home use by diabetics to monitor their blood glucose levels or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.

AI/ML Overview

The provided document describes a 510(k) summary for the AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System. The modification pertains to the wireless upload of glucose readings; therefore, the core performance of the glucose measurement itself likely relies on previously established data or adherence to recognized standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the manufacturer certifies the device complies with ISO 15197:2003 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus." This standard outlines performance requirements for blood glucose meters.

While the document states compliance with ISO 15197:2003, it does not provide a specific table of acceptance criteria from ISO 15197 or the detailed reported device performance against those criteria. It merely makes a general declaration of compliance. To fully answer this, the specific ISO 15197:2003 criteria (e.g., accuracy within certain percentage or mg/dL for different glucose ranges) and the AgaMatrix Jazz Wireless™ device's performance data against those criteria would be needed, but they are not included in this document.

What is present in the document:

Acceptance Criteria Category	Reported Device Performance
ISO 15197:2003 Compliance	Device certified to comply with ISO 15197:2003. (Specific numerical criteria and performance data are not provided in this document.)
Intended Use Performance	"The system performs as intended and raises no new safety of effectiveness issues."
Technological Characteristics	"Has the same intended uses, with similar technological characteristics as the predicate device."
Risk Management	Complies with ISO 14971:2000.
Electrical Safety	Complies with IEC 61010-1 and IEC 61010-2-101.
Electromagnetic Compatibility (EMC)	Complies with IEC 61000-4-3.

2. Sample size used for the test set and the data provenance

The document states "Based upon the testing and comparison to the predicate device". However, it does not specify the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way image analysis or clinical diagnosis might use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for a test set.

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

This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

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

The document indicates that the device itself performs the measurement. The "testing" mentioned implies standalone performance studies were conducted to demonstrate compliance with ISO 15197:2003. However, specific details of such standalone testing (e.g., protocol, metrics, results) are not provided, beyond the general statement of compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods (e.g., YSI analyzer). The document does not explicitly state the type of ground truth used, but this is the standard practice for demonstrating accuracy of blood glucose meters against a known, highly accurate method.

8. The sample size for the training set

The document does not provide any information about a "training set." This term is typically associated with machine learning or AI algorithms. While the device likely has internal algorithms for glucose measurement, the document does not discuss a separate training phase or associated sample sizes.

9. How the ground truth for the training set was established

As no training set is discussed, no information is provided on how its ground truth might have been established.

Summary

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K083263

FEB - 3 2009

AgaMatrix

l 0 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

unknown

1. Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.
  Submitter's Name: AgaMatrix, Inc. 10 Manor Parkway Salem, NH 03079

Contact Person:	Connie HertelDirector Quality & Regulatory Affairs
Telephone:	(603) 328-6051
Fax:	(603) 893-4191

Date the summary prepared: September 30, 2008

2. Device Name -

Trade/Proprietary Name:	WaveSense Jazz Wireless™ Blood Glucose Monitoring System
Common/Usual Name:	Blood Glucose Monitoring System
Classification Name:	Glucose Test System (per 21 CFR 862.1345)
Class:	II
Panel:	Chemistry

3. Modification Device

The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.

4. Description of the Device:

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10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

The Jazz Wireless™ Blood Glucose Monitoring System is intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips, palm, or forearm. The Jazz 10 test strips are for in vitro diagnostic (outside of the body) use only. The Jazz Wireless™ System is not intended for use with neonates.

Testing:

The manufacturer of the Jazz Wireless™ Blood Glucose Monitoring System certifies that the device complies with the following:

ISO 15197:2003 In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus

ISO 14971:2000 Medical devices - Application of risk management to Medical devices

IEC 61010-1 Medical electrical equipment - General requirements for safety

IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control and laboratory use - particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61000-4-3 Electromagnetic compatibility (EMC)

8. Conclusions

Based upon the testing and comparison to the predicate device, the Jazz Wireless™ Blood Glucose Monitoring System has the same intended uses, with similar technological characteristics as the predicate device. The system performs as intended and raises no new safety of effectiveness issues.

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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 or bird-like figure with stylized wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Agamatrix Inc c/o Connie Hertel 10 Manor Parkway Salem, NH 03079

FEB - 3 2009

Re: K083265

Trade/Device Name: Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 5, 2009 Received: January 6, 2009

Dear Ms. Hertel:

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 thus, permits 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 (301) 594-3084. 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 the Act from the Division of Small Manufacturers, International and Consumer Assistance at its the normalized (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

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

For the will be the mass

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Image /page/4/Picture/0 description: The image contains the word "AgaMatrix" in a simple, sans-serif font. The text is horizontally aligned and appears to be a logo or brand name. There are some small dots in the upper right corner of the image.

10 Manor Parkway Salem. NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

Indications For Use

K083265 510(k) Number (if known): unknown AgaMatrix JAZZ Wireless"M Blood Glucose Monitoring System Device Name:

Indications for Use:

AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System:

AgaMatrix AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ Wireless™ Blood Glucose Meter:

AgaMatrix JAZZ Blood Glucose Test Strips:

AgaMatrix WaveSense™ Control Solution:

AgaMatrix WaveSense"10 Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription X (21 CFR 801 Subpart D) AND/OR

Over the Counter X (21 CFR 801 Subpart C)

Mo (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off Concurrence of CDRH Office of In Vitro Diagnostic Devices (OVD)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device Evaluation and Safety

3 Olka

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.