(181 days)
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the 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 Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.
The EZ Smart Blood Glucose Test Strips are used 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 provided text includes a 510(k) summary for the "EZ Smart Blood Glucose Monitoring System," specifically for an additional labeling and indication for alternative site testing. However, it explicitly states that there has been no change to the performance characteristics or fundamental scientific technology of the device system.
Therefore, the document does not contain details about a study to prove new acceptance criteria related to its performance, an MRMC study, or a standalone algorithm performance study. The focus of this 510(k) is solely on labeling changes for alternative site testing.
Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what cannot be found:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on labeling changes, stating "There has been no change to the performance characteristics of the device system." Therefore, no new performance data or acceptance criteria related to a new study are included.
2. Sample size used for the test set and the data provenance:
This information is not provided as no new performance study was conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as no new performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as no new performance study was conducted.
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:
An MRMC study was not done. The device is a "Blood Glucose Monitoring System," which is an instrument for measuring glucose, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance study of an algorithm was not done. This device is a blood glucose monitoring system, not an algorithmic diagnostic tool. The submission explicitly states "There has been no changes to the fundamental scientific technology," implying no new algorithm or AI components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided as no new performance study was conducted for this 510(k) submission. For a blood glucose monitoring system, ground truth would typically be established against a laboratory reference method.
8. The sample size for the training set:
This information is not provided as no new performance study was conducted and there is no mention of a "training set" in the context of this device's technology.
9. How the ground truth for the training set was established:
This information is not provided as no new performance study was conducted and there is no mention of a "training set."
In summary, the provided 510(k) submission focuses solely on updating the labeling for the EZ Smart Blood Glucose Monitoring System to include alternative site testing. It explicitly states that there are no changes to the device's performance characteristics or fundamental scientific technology. Therefore, the document does not contain information about new acceptance criteria, a new study to prove device performance, or details regarding test sets, experts, or ground truth establishment.
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510(k) Summary
for
EZ Smart Blood Glucose Monitoring System New 510(k) For Additional Labeling And Indication For Alternative Site Testing
1. DATE PREPARED
December 3, 2004
2. SPONSOR INFORMATION
Address
VIP Diagnostics LLC 1796 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
Foley & Lardner LLP 3000 K St., NW Suite 500 Washington, DC 20007
Contact Person: David L. Rosen, B.S.Pharm., J.D.
(202) 672-5430 (telephone) (202) 672-5399 (facsimile)
3. DEVICE NAME
| Proprietary Name: | EZ Smart Blood Glucose Monitoring System |
|---|---|
| Common/Usual Name: | Blood Glucose Monitoring System |
| Classification Name: | Glucose Test System (per 21 C.F.R § 862.1345 (2003)) |
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4. DEVICE DESCRIPTION AND INTENDED USE
The EZ Smart Blood Glucose Test Strips are used 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 Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertip and forearm.
5. PREDICATE DEVICE
-
Predicate device name 1.
EZ Smart Blood Glucose Monitoring System Bayer Elite XL with the Elite Test Strips Baver Elite with the Elite Test Strips -
Predicate K Number 2.
K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips) -
Substantial Equivalence Comparison 3.
The modifications to the device encompass labeling changes only. There has been no changed to the intended use, fundamental scientific technology, physical design, operating principles, functionality or material composition of the device systems.
Modified labeling additions to EZ Smart:
Note: Alternative Site Testing Note: Incential.re brofessional prior to testing from a site other than vour fingertips.
Under certain conditions, blood glucose testing results from sites other than your fingertip may be significantly different. These differences may vary from
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individual to individual, and are physiological differences caused by factors such as food intake, health state and medication being used.
The conditions in which these differences are more likely to occur are when your I the conditions in maging rapidly such as following a meal, an insulin dose, or associated with physical exercise. When blood glucose is changing rapidly, associated with piry creat ense changes more quickly than other sample sites.
Use alternative test sites only for testing prior to, or more than two hours after meals, insulin dose, or physical exercise.
You should also use fingertip testing whenever you have a concern about 1 ou should also ass in relations) such as when driving a car, particularly if you nypog.fyouma (insuceness, as alternative site testing may fail to detect hypoglycemia.
If you perform testing other than from a fingertip (such as the forearm):
A. Select a soft, fleshy area of skin that is free from hair and visible veins.
B. Wash the puncture site with soap and warm water. Rinse and dry thoroughly. This ensures cleanliness and increases blood flow to the puncture site.
C. After you have determined the proper depth of your selected site, set the lancing device for that depth of puncture. Firmly press the lancing device against the skin at the selected lancing site, then press the button to lance the skin. When the skin at the belows on the surface of your skin, bring the meter and test strip up to touch the drop.
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PERFORMANCE CHARACTERISTIC SUMMARY 6.
There has been no change to the performance characteristics of the device system.
TECHNOLOGICAL CHARACTERISTICS 7.
There has been no changes to the fundamental scientific technology.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized symbol. The symbol is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
JUN 2 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
VIP International Wholesales, Corp. c/o David L. Rosen, B.S. Pharm., J.D. Foley & Lardner LLP 3000 K Street, NW, Suite 500 Washington, DC 20007-5143
Re: K043340
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: April 11, 2005 Received: April 11, 2005
Dear Mr. Rosen:
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 (240) 276-0484. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting 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
| 510(k) Number: | K 043340 |
|---|---|
| Device Name: | EZ Smart Blood Glucose Monitoring System |
| Indications For Use: | The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the 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 Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm. |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
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Ko43340 510(k)-
§ 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.