(233 days)
The Nova Max Plus Blood Glucose and B-Ketone Monitoring System Monitor is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (βketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings 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 Nova Max Blood Glucose and B-Ketone Monitor is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm and palm or B-hydroxybutvrate (8-ketone) in fresh capillary whole blood obtained from the fingertip only.
Nova Max Glucose Test Strips are intended for use only with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and B-Ketone Monitor. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).
The Nova Max Plus Ketone Test Strips are intended for use only on the Nova Max Plus Blood Glucose and B-Ketone Monitor.
Nova Max Glucose Control Solutions are intended for use with the Nova Max Blood Glucose Monitor, the Nova Max Plus Blood Glucose and B-Ketone Monitor and Nova Max Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Normal, Low and High).
Nova Max Plus Ketone Control Solutions are intended for use with Nova Max Plus Blood Glucose and B-Ketone Monitor and Nova Max B-Ketone Test Strips as a quality control check to verify the accuracy of blood ketone test results. There are three levels of controls, (Levels 1,2 and 3).
The Nova Max Plus Blood Glucose and B- Ketone Monitoring System consists of:
- Nova Max Plus Blood Glucose and B-Ketone Monitor
- Nova Max Glucose Test Strips
- Nova Max Glucose Control Solutions (Normal, Low and High)
- Nova Max Plus B-Ketone Test Strips
- Nova Max Plus B-Ketone Control Solutions (Levels 1,2 and 3)
The provided text is a 510(k) summary for the Nova Max Plus Blood Glucose and B-Ketone Monitoring System. Medical device 510(k) summaries, especially for in vitro diagnostic (IVD) devices like this one, typically don't include the detailed statistical acceptance criteria or the full study reports. Instead, they focus on demonstrating substantial equivalence to a predicate device.
However, I can extract the information that is present and highlight what is not explicitly stated in this type of document, but would typically be part of the full submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific statistical acceptance criteria (e.g., % within +/- X mg/dL or % within +/- Y%). It states the general conclusion that the device "performs as intended" and "can produce results that are substantially equivalent to results obtained on the predicate devices."
For blood glucose meters, typical acceptance criteria often align with ISO 15197 for accuracy, which specifies standards like:
- ≥95% of results for glucose concentrations < 75 mg/dL differ by no more than ± 15 mg/dL from the reference measurement.
- ≥95% of results for glucose concentrations ≥ 75 mg/dL differ by no more than ± 20% from the reference measurement.
For β-ketone meters, similar accuracy criteria would be applied.
Since the specific criteria and detailed performance statistics (e.g., bias, precision, linearity over a range) are not provided in this summary, a table cannot be fully populated. The document only offers a high-level summary of the performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The performance of the Nova Max Plus Blood Glucose and B-Ketone Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users."
- Sample Size: Not explicitly stated. This would be detailed in the full performance study report within the 510(k) submission.
- Data Provenance: The studies were conducted in "the laboratory and in clinical settings" by "healthcare professionals and lay users." The country of origin is not specified, but Nova Biomedical Corporation is a U.S. company, suggesting the studies likely occurred in the U.S. The studies are implicit retrospective in the sense that they are evaluating a device that has already been developed and tested, but data collection would be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts/Reference Methods: Not explicitly stated. For IVD devices, "ground truth" (or reference method) for glucose and β-ketone is typically established using a high-precision laboratory analyzer (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer for glucose, and a specific enzymatic method for β-ketone), rather than human experts reviewing images or clinical cases. These reference methods are themselves subject to strict quality control and calibration.
- Qualifications of Experts (if applicable): Not applicable in the traditional sense of human readers. The "experts" are the validated laboratory reference instruments and the trained personnel operating them according to standard protocols.
4. Adjudication Method for the Test Set
- Not applicable for this type of IVD device where ground truth is established by a reference laboratory method. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human readers interpret data, and discrepancies need to be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists reading X-rays). For a blood glucose and ketone monitoring system, the "reader" is essentially the device itself, and its performance is compared directly to a reference method, not to how it aids human interpretation of complex data.
6. Standalone Performance Study
- Yes, a standalone study was done. The entire "Performance Studies" section describes the evaluation of the device as a standalone system. The statement, "The studies demonstrated that lay users can obtain blood glucose and blood ß-Ketone results that are substantially equivalent to the current methods for blood glucose and blood ß-ketone measurements," directly refers to the device's independent performance.
7. Type of Ground Truth Used
- Reference Laboratory Methods: The ground truth for both glucose and β-ketonetest results would be established by highly accurate and precise laboratory reference instruments. The text mentions "current methods for blood glucose and blood ß-ketone measurements" and that the "Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods," strongly implying the use of such reference methods.
8. Sample Size for the Training Set
- Not Applicable/Not Explicitly Stated. For a traditional electrochemical blood glucose/ketone meter, there isn't a "training set" in the sense of machine learning algorithms that require vast amounts of data to learn patterns. The device's calibration curve and algorithms are developed through R&D and then validated. If any specific data were used for initial calibration curve development, that information is not provided here.
9. How Ground Truth for the Training Set Was Established
- Not Applicable/Not Explicitly Stated. As mentioned above, a "training set" with established ground truth is not typically relevant for this type of IVD device in the same way it is for AI/ML-driven devices. Device calibration and algorithm development would rely on controlled solutions and known concentrations, not a "ground truth" derived from patient samples with expert consensus.
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510(k) Summary
(as required by 21 CFR 807.92)
Submitter:
Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 U.S.A.
NAN 1 5 2010
Correspondent: Paul W. MacDonald Chief Quality Assurance and Regulatory Affairs Officer
Time: 7:30-10:30 a.m. - 7:30-10:30 a.m.
Phone: 781-894-0800; Fax: 781-891-4806 Email: pmacdonald@novabio.com
Device Name:
Nova Max Plus Blood Glucose and B-Ketone Monitoring System
Common Name:
Whole Blood Glucose and Ketone Test System
Classification:
Division of Clinical Laboratory Devices Clinical Chemistry and Toxicology Panel Glucose Test System Class II per 21 CFR 862.1345 Ketone Test System Class I per 21 CFR 862.1435
Product Codes:
NBW, CGA, JIN, JJX
Predicate Devices:
Nova Max Blood Glucose Monitor, K070255. Precision Xtra Advanced Diabetes Management System, K040814
Description of the Device:
The Nova Max Plus Blood Glucose and B- Ketone Monitoring System consists of:
-
- Nova Max Plus Blood Glucose and B-Ketone Monitor
-
- Nova Max Glucose Test Strips
-
- Nova Max Glucose Control Solutions (Normal, Low and High)
-
- Nova Max Plus B-Ketone Test Strips
-
- Nova Max Plus B-Ketone Control Solutions (Levels 1,2 and 3)
Intended Use/Indications for Use:
The Nova Max Plus Blood Glucose and B-Ketone Monitoring System Monitor is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (βketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to
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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 Nova Max Blood Glucose and B-Ketone Monitor is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm and palm or B-hydroxybutvrate (8-ketone) in fresh capillary whole blood obtained from the fingertip only.
Nova Max Glucose Test Strips are intended for use only with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and B-Ketone Monitor. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).
The Nova Max Plus Ketone Test Strips are intended for use only on the Nova Max Plus Blood Glucose and B-Ketone Monitor.
Nova Max Glucose Control Solutions are intended for use with the Nova Max Blood Glucose Monitor, the Nova Max Plus Blood Glucose and B-Ketone Monitor and Nova Max Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Normal, Low, High).
Nova Max Plus Ketone Control Solutions are intended for use with Nova Max Plus Blood Glucose and B-Ketone Monitor and Nova Max B-Ketone Test Strips as a quality control check to verify the accuracy of blood ketone test results. There are three levels of controls, (Levels 1,2 and 3).
Summary of Technological Characteristics:
The Nova Max Plus Blood Glucose and Ketone Monitoring System has the same fundamental scientific technology and the same intended use as the current on-market Nova Max Blood Glucose Monitor (K070255) for glucose. The Nova Max Plus Blood Glucose and Ketone Monitoring System is substantially equivalent to the predicate device, Precision Xtra Advanced Diabetes Management System, K040814, for ketone measurements.
The Nova Max Plus Blood Glucose and B- Ketone Monitoring System measures glucose electrochemically utilizing the glucose oxidase test system described in K070255 (Nova Max Glucose Monitor System. In the same manner, the magnitude of the current is proportional to the amount of glucose or, B-hydroxybutyrate (B- ketone) present in the sample, providing a quantitative measure of glucose or ß-ketone in whole blood and control solutions.
Comparison to Predicate Devices:
The modified Nova Max Plus Blood Glucose and ß-Ketone Monitoring System uses the same fundamental scientific technology and has the same intended use as the predicate Nova Max Blood Glucose Monitor (K070255) and the Precision Xtra Advanced Diabetes Management System (K040814).
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Performance Studies:
The performance of the Nova Max Plus Blood Glucose and B-Ketone Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose and blood ß-Ketone results that are substantially equivalent to the current methods for blood glucose and blood ß-ketone measurements.
Conclusion:
Results of laboratory and clinical testing demonstrate that the performance of the Nova Max Plus Blood Glucose and ß-Ketone Monitoring System, has the same intended uses, with similar technological characteristics and can produce results that are substantially equivalent to results obtained on the predicate devices. The system performs as intended and raises no new safety or effectiveness issues. .
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes across its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 15 2010
Nova BioMedical Corporation c/o Mr. Paul W. MacDonald Chief Quality Assurance & Regulatory Affairs Officer 200 Prospect Street Waltham, MA 02454-9141
Re: K091547
Trade Name: Nova Max Plus Blood Glucose and B-Ketone Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA, JIN, JJX Dated: November 17, 2009 Received: November 18, 2009
Dear Mr. MacDonald:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
CA
Courtney C. Harper, Ph.D. 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:
Device Name:
Nova Max Plus Blood Glucose and B-Ketone Monitor System
Indications for Use:
The Nova Max Plus Blood Glucose and B-Ketone Monitor is intended to be used for the quantitative measurement of glucose or p-hydroxybutyrate (B-ketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings 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 Nova Max Blood Glucose and 3-Ketone Monitor is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood samples obtained for the fingertip, forearm and paint or fi-hydroxybutyrate (B-ketone) in fresh capillary whole blood obtained from the fingertip only.
Nova Max Glucose Test Strips are intended for use only with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and f-Ketone Monitor. The Glucose Monitor is calibrated to provide plasma equivalent glucose results to laboratory methods. Nova Max Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).
The Nova Max Plus Ketone Test Strips are intended for use only on the Nova Max Plus Blood Glucose and 3-Ketone Monitor.
Nova Max Glucose Control Solutions are intended for use with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and B-Ketone Montor and Nova Max Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of glucose controls, (Normal, Low, High).
Nova Max Plus Ketone Control Solutions are intended for use with the Nova Max Plus Blood Glucose and p-Ketone Monitor and the Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood ketone test results. There are three levels of ketone controls, (Levels 1,2 and 3).
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
RH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Concurrence of
Carol S. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091547
Page L of L
§ 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.