(132 days)
The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose Meter to measure glucose (sugar) in whole blood. The EZ Smart Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The document does not contain explicit acceptance criteria in the format of a table with specific numerical targets for accuracy, precision, or other performance metrics. This is often the case for 510(k) submissions where substantial equivalence is demonstrated against a predicate device rather than meeting pre-defined, quantitative acceptance criteria established by a standard or regulatory body for a novel device.
Instead, the document states:
"An evaluation of the EZ Smart was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity, and presence of interferences. The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use."
This indicates that the "acceptance criteria" were implied by demonstrating performance "equivalent" to the predicate device (Bayer Elite with Elite Test Strips, K964630 for the meter and K991242 for the test strips). The specific numerical results of these evaluations (e.g., accuracy percentages, bias) are not provided in the submitted text.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Equivalent in performance to the predicate device (Bayer Elite). | "The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use." |
| Temperature Effects | Performance comparable to predicate. | Evaluated (results not detailed). |
| Hematocrit Levels | Performance comparable to predicate. | Evaluated (results not detailed). |
| Sensitivity & Linearity | Performance comparable to predicate. | Evaluated (results not detailed). |
| Interferences | Performance comparable to predicate. | Evaluated (results not detailed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
- Retrospective or Prospective: Not specified in the provided text.
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)
- Not applicable/Not specified. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not by expert consensus in the same way it would be for image interpretation. The document does not mention human experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data, which is not the primary method for evaluating blood glucose meters.
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 MRMC or AI comparative effectiveness study was mentioned. The device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, performance evaluations of the EZ Smart Blood Glucose Monitoring System were conducted as a standalone device. The description of "various conditions" (temperature, hematocrit, sensitivity, linearity, interferences) implies direct testing of the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- While not explicitly stated, for blood glucose monitoring systems, ground truth is typically established using laboratory reference methods (e.g., YSI analyzer) which are considered highly accurate for glucose measurement.
8. The sample size for the training set
- Not applicable/Not specified. This is a measurement device, not an AI/machine learning model that requires a distinct "training set." Any internal calibration or development data are not described.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As it's not an AI/ML device, the concept of a "training set" and its associated ground truth establishment is not relevant in the context of this 510(k) summary.
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AUG 11 2004
510(k) Summary
for
EZ Smart Blood Glucose Monitoring System
1. DATE PREPARED
March 29, 2004
2. SPONSOR INFORMATION
Address
VIP International Wholesalers, Corp. 1860 Clove Road Staten Island, NY 10304
Contact Person: George P. Drogaris, MS R.Ph.
(800) 566-3480 (telephone) (718) 390-0473 (facsimile)
Outside Regulatory Counsel
Gray Cary Ware & Freidenrich LLP 1625 Massachusetts Ave., NW Suite 300 Washington, DC 20036
Contact Person: David L. Rosen, B.S. Pharm., J.D.
(202) 238-7749 (telephone) (202) 238-7701 (facsimile)
3. DEVICE NAME
EZ Smart Blood Glucose Monitoring Proprietary Name: System
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| Common/Usual Name: | Blood Glucose MonitoringSystem |
|---|---|
| Classification Name: | Glucose Test System (per 21 C.F.R §862.1345 (2003)) |
4. DEVICE DESCRIPTION AND INTENDED USE
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose Meter to measure glucose (sugar) in whole blood. The EZ Smart Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
5. PREDICATE DEVICE
- Predicate device name 1. Bayer Elite with the Elite Test Strips
- Predicate K Number 2. K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips)
Substantial Equivalence Comparison 3.
| Item | Predicate DeviceBayer ELITE (K964630) | Proposed DeviceEZ Smart |
|---|---|---|
| Similarities | 1. Monitors glucose usingwhole blood. | 1. Monitors glucose usingwhole blood. |
| 2. Directly displays resultswithout requiringcalculation. | 2. Directly displays resultswithout requiringcalculation. | |
| 3. Test principle includesmeasuring a currentproduced by a chemicalreaction. | 3. Test principle includesmeasuring a currentproduced by a chemicalreaction. | |
| 4. Test principle: Usesglucose oxidase reaction. | 4. Test principle: Usesglucose oxidase reaction. | |
| 5. Measuring range:20 to 600mg/dL. | 5. Measuring range:20 to 600mg/dL. |
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| Differences | ELITE | EZ Smart |
|---|---|---|
| 1. Size: 97.8 x 56 x 14.5 mm2. Measuring time: 30 seconds | 1. Size: 94 x 49 x 17 mm.2. Measuring time: 10 seconds. |
6. PERFORMANCE CHARACTERISTIC SUMMARY
An evaluation of the EZ Smart was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity, and presence of interferences. The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
AUG 11 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
VIP International Wholesalers, Corp. c/o David Rosen 1625 Massachusetts Avenue NW Suite 300 Washington, DC 20036-2247
K040848 Re:
K040046
Trade/Device Name: EZ Smart Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: July 16, 2004 Received: July16, 2004
Dear Mr. Rosen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatisa provice Amendments, or to commerce prof to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been icclassified in accoraanse what a proval application (PMA). and Cosmetic Act (Act) that to not require subject to the general controls provisions of the Act. The You may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) into . Existing major regulations affecting your device il may be subject to such additional controllar contractions (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Code of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or a cosence complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must of any I cuclar statutes and regarations and limited to: registration and listing (21 Compry with an the Free 5 require 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) I mis lotter will and w yourse FDA finding of substantial equivalence of your device to a legally promatication of 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, If you desire upomotion 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 I va inal Manufacturers, International and Consumer 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,
Sean M. Cooper, US, DVM.
Jean M. Cooper, MS, 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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Indications for Use
K040848 510(k) Number:
Device Name: EZ Smart Blood Glucose Monitoring System
Indications For Use:
The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the Glasse (vegaliagnostic use ). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.
George P. Dungan R.Ph., M.S.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ves (21 CFR 807 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)
Carol Benson
Division Sign-Off
Page 1 of
e of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040848
§ 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.