The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

Device Description

The ATLAST Blood Glucose Monitoring System measures the amount of glucose in capillary whole blood. When whole blood is applied to the ATLAST Test Strip, reagents on the Test Strip react with the blood and a color is formed, the intensity of which is measured by the ATLAST System. The ATLAST Blood Glucose Monitoring System consists of the following components: (1) a reflectance photometer which incorporates a lancing device ("ATLAST System"), (2) glucose reagent test strips ("ATLAST Test Strips") and calibration chip, and (3) sterile lancets ("ATLAST Lancets").

AI/ML Overview

The Amira Medical ATLAST Blood Glucose Monitoring System is a medical device intended for the quantitative measurement of glucose in whole blood for individuals with diabetes mellitus.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria (e.g., specific percentages within a certain glucose range based on an error grid). However, it outlines the general approach to evaluating performance and states that the device met these requirements.

Acceptance Criteria (Inferred from text)	Reported Device Performance
Meets or exceeds performance requirements for intended clinical use.	"The System meets or exceeds the performance requirements for the intended clinical use of the device."
Satisfies all performance specifications for safety and effectiveness.	"The results demonstrated that the ATLAST Blood Glucose Monitoring System satisfies all of its performance specifications, which are designed to ensure that the System is safe and effective for its intended use."
Correlates well with laboratory blood glucose reference test method.	"The clinical data demonstrate that the performance of the ATLAST Blood Glucose Monitoring System correlates well with the laboratory blood glucose reference test method."
Provides results within the range of clinically acceptable accuracy (based on Error Grid Analysis).	"When the blood glucose test results were analyzed by the Error Grid Analysis of Clarke et al., the System provided results within the range of clinically acceptable accuracy."
Substantially equivalent to a predicate device.	"The data also demonstrate that the ATLAST Blood Glucose Monitoring System's performance is substantially equivalent to that of a predicate device."
Performs equivalently in the hands of diabetic lay users and trained technicians.	"The clinical data demonstrate that the ATLAST Blood Glucose Monitoring System performs equivalently in the hands of the diabetic lay user and when used by a trained technician."

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

Sample Size: The document does not specify the exact sample size for the "multi-center, subject controlled clinical study."
Data Provenance: The data was collected through a "multi-center, subject controlled clinical study." This indicates a prospective study where participants were actively recruited and data was collected specifically for the study. The country of origin is not explicitly stated, but the submission is to the US FDA, implying US-based or internationally recognized standards.

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

The document implies that a "laboratory reference method for measuring blood glucose levels" was used to establish ground truth.
It does not specify the number of experts or their qualifications for performing this reference method. It can be inferred that these would be licensed clinical laboratory professionals following standard laboratory procedures.

4. Adjudication Method for the Test Set:

No explicit adjudication method is mentioned for reconciling discrepancies in the ground truth. The ground truth was established by a "laboratory reference method," which typically implies a single, highly accurate measurement serving as the definitive value.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 imaging or diagnostic device that requires human "readers" or AI assistance in interpretation in the typical sense of an MRMC study.
The study compared the device's performance when used by lay users (diabetic patients) versus trained technicians. This is a comparison of user groups rather than a human-AI comparison.
Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI vs. without AI assistance was not applicable and not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a standalone system. The "ATLAST System" measures glucose, and the results are directly displayed to the user.
Bench/Laboratory testing was performed to evaluate the system in isolation, and the clinical study evaluated the system's performance both by lay users and trained technicians.
While human interaction is required to obtain the blood sample and initiate the test, the measurement and calculation of glucose levels are performed solely by the device's internal algorithms. Therefore, a standalone performance evaluation of the "algorithm only" (as part of the finished device) was inherently performed.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The ground truth for the test set was established using a laboratory reference method for measuring blood glucose levels. This is considered a highly accurate and objective measure in clinical chemistry.

8. The Sample Size for the Training Set:

The document does not provide information about a separate "training set" or its sample size. The description focuses on the performance testing carried out on the finished device. For a device like a blood glucose meter, the "training" (calibration) is typically done during the device's manufacturing and validation process, often using standardized solutions and internal quality control, not a separate clinical training set in the way AI algorithms are trained.

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

Since a separate "training set" as understood in AI/machine learning is not explicitly mentioned, the method for establishing its ground truth is also not described. Device calibration and internal validation would rely on established laboratory standards and methods for glucose concentration.

Summary

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PAGE 04

DEC 1 0 1998

L982076

Amira Medical ATLAST Blood Glucose Monitoring System 510(k) Premarket Notification

510(k) SUMMARY

Submitter's Name, Address, Telephone Number, and Contact Person

Amira Medical 4742 Scotts Valley Road Scotts Valley, CA 95065 (408) 408-439-0700 X305 Phone: (408) 439-0907 Facsimile:

Nina Peled, Ph.D. Contact Person: Vice President, Scientific Affairs

Date Prepared: June 10, 1998

Name of Device and Name/Address of Sponsor

Trade name: ATLAST Blood Glucose Monitoring System

Amira Medical 4742 Scotts Valley Road Scotts Valley, CA 95065

Classification Names:

Colorimeter, photometer, spectrophotometer for clinical use (21 C.F.R. § 862.2300); Glucose oxidase, glucose test system (21 C.F.R. § 862.1345) Single analyte control (21 C.F.R. § 862.1660) Blood lancet (21 C.F.R. § 878.4800)

Predicate Devices

1. LifeScan One Touch Basic Blood Glucose Monitoring System (K922888)
1. Boehringer Mannheim Accu-Chek Easy Blood Glucose Monitoring System (K923048)

Amira Medical Confidential

Revised: 11/24/98

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Intended Use/Indications

The ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

Device Description

Principle of Operation

The user obtains a blood sample using the ATLAST System. A sterile lancet is inserted into the lancing component of the ATLAST System by inserting a sterile lancet into the sampler head and re-attaching it to the ATLAST System. The unit is cocked by pulling the cocking knob until it latches, then the user releases the knob. With the sampler head positioned firmly on the forearm, the user fully depresses the body of the unit which releases the lancet to pierce the skin. Immediately following the lancing action, the lancet is automatically retracted. A sliding motion is required to obtain an adequate blood sample. While maintaining the lancet and sampler head in position on the sample site, the body of the unit is depressed and released several times to draw blood from the incision point. After obtaining a sample, the user is ready to touch the test strip to the blood sample to begin the testing process.

The user inserts the test strip into the test strip holder of the ATLAST System and turns the ATLAST System on. The test strip is then brought to the lancing site and the user touches the capillary tip of the ATLAST Test Strip to the blood sample. Blood is drawn into the test strip by capillary action. The meter "beeps" when an adequate blood sample has been received and the testing sequence begins.

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The glucose in the blood sample reacts with glucose oxidase to yield gluconic acid. This reaction is catalyzed by the peroxidase present in the test strip. The hydrogen peroxide formed then oxidizes the dye couple in the test strip. This reaction, which is catalyzed by the enzyme peroxidase, oxidizes the dye couple to form a dye that intensifies in color with increasing glucose concentrations. The color change on the reagent test strip pad is proportional to the concentration of the glucose present in the whole blood sample.

The user obtains blood glucose results in approximately 10-30 seconds, depending on glucose levels. The ATLAST System will "beep" when the test is complete and the blood glucose results will appear on the meter display.

Data Demonstrating Substantial Equivalence

Performance testing on the ATLAST Blood Glucose Monitoring System demonstrated that the System meets or exceeds the performance requirements for the intended clinical use of the device. Laboratory/Bench Testing was conducted in accordance with FDA's draft guidance, Review Criteria for Assessment of Portable Blood Glucose Monitoring In-Vitro Diagnostic Devices Using Glucose Oxidase Methodology. The results demonstrated that the ATLAST Blood Glucose Monitoring System satisfies all of its performance specifications, which are designed to ensure that the System is safe and effective for its intended use.

A multi-center, subject controlled clinical study was conducted to evaluate the accuracy of the ATLAST Blood Glucose Monitoring System when used by lay users with diabetes mellitus and by experienced technicians trained in blood glucose testing techniques. In addition, the ATLAST Blood Glucose Monitoring System was compared to a predicate blood glucose monitoring system. Blood glucose results obtained with the ATLAST Blood Glucose Monitoring System and predicate device were compared to results obtained using a laboratory reference method for measuring blood glucose levels.

The clinical data demonstrate that the performance of the ATLAST Blood Glucose Monitoring System correlates well with the laboratory blood glucose reference test method. When the blood glucose test results were analyzed by the Error Grid Analysis of Clarke et al., the System provided results within the range of clinically acceptable accuracy. The data also demonstrate that the ATLAST Blood Glucose Monitoring System's performance is substantially equivalent to that of a predicate device. The clinical data demonstrate that the ATLAST Blood Glucose Monitoring System performs equivalently in the hands of the diabetic lay user and when used by a trained technician.

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Conclusion

Laboratory/Bench Testing and Clinical Correlation Studies demonstrate that the Labordvery/Bener February and Glucose Monitoring System is safe and effective for its intended use.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three heads, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEC 10 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nina Peled, Ph.D. Vice President, Scientific Affairs Amira Medical 4742 Scotts Valley Road Scotts Valley, California 95065

Re : K982076 Trade Name: ATLAST Blood Glucose Monitoring System Requlatory Class: II Product Code: CGA Dated: June 10, 1998 Received: June 12, 1998

Dear Dr. Peled:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982076 510(k) Number (if known):

Device Name: Amira Medical ATLAST Blood Glucose Monitoring System

Indications For Use:

The Amira Medical ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates (newborn children).

The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices 12982076 510(k) Number.

Prescription Use

OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.