(160 days)
The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.
The Precision·G Plus Point of Care Management System for Blood Glucose Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample providing a quantitative measure of glucose in whole blood and control solutions.
The provided text is a summary of a 510(k) premarket notification for a medical device (a blood glucose testing system). It doesn't contain detailed information about specific acceptance criteria or a dedicated study report with performance metrics. Rather, it states that performance studies were conducted and the device met substantial equivalence.
Therefore, many of the requested fields cannot be filled directly from the provided text. However, based on the general information available in a 510(k) summary for a blood glucose monitor, I can infer what common acceptance criteria and study designs are for such devices and how the provided text aligns with that.
Here's an attempt to answer your questions based on the available information and general knowledge of blood glucose meter submissions:
Acceptance Criteria and Study for K987303: Precision·G Plus Point of Care Management System for Blood Glucose Testing
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state the specific acceptance criteria (e.g., ISO 15197 accuracy limits such as "X% of results within ±Y mg/dL" or "X% within ±Z%"). It generally states that the device demonstrated "substantially equivalent" results and "acceptable" performance when compared to predicate devices and current methods.
| Acceptance Criteria Category (Inferred) | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Accuracy (Against Lab Reference) | (Likely ISO 15197 or similar) | "user can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurement" |
| Accuracy (Against Predicate Devices) | (Likely statistical equivalence limits) | "substantially equivalent to both the Precision·G® Blood Glucose Testing System and the Precision QID® Blood Glucose Testing System. In addition, ... substantially equivalent to an additional competitive predicate device, the Johnson and Johnson Surestep Pro Blood Glucose Monitoring System." |
| Precision/Reproducibility | (Likely within-run, between-run CV% or SD limits) | Implied as acceptable given the "substantially equivalent" conclusion. |
| User Performance (Lay User/Professional) | (Likely specific error rates or success rates for testing steps) | "Performance ... studied in the laboratory and in clinical settings by healthcare professionals and lay users." Implied as acceptable. |
| Interferences | (Likely no significant interference from common substances) | Not explicitly mentioned but assumed to be evaluated as part of "current methods" equivalence. |
| Linearity/Reportable Range | (Likely performance across the intended glucose range) | Not explicitly mentioned but assumed to be evaluated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. For blood glucose meters, clinical studies typically involve hundreds of samples from patients (capillary, venous, arterial, neonatal, as per intended use) to cover the analytical range and demonstrate accuracy.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings." The country of origin is not specified, but given the submitter's address in Massachusetts, USA, it's highly probable the studies were conducted in the US. The studies are prospective, as they involved "user[s]" obtaining results in these settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications: "Healthcare professionals" were involved in the clinical settings, implying medical professionals qualified to perform blood draws and potentially operate reference laboratory instruments. The "current methods for blood glucose measurement" (likely laboratory-based glucose analyzers, sometimes referred to as "gold standard" or "reference" methods) would have established the ground truth. These reference methods are themselves operated by trained laboratory personnel.
4. Adjudication Method for the Test Set:
Not explicitly mentioned. For blood glucose meters, adjudication (in the context of expert consensus) is less common for establishing the primary glucose value, as a reference laboratory method provides the quantitative "ground truth." Any discrepancies would typically be resolved by investigation into sample handling, instrument malfunction, or procedural errors, rather than expert consensus on the glucose value itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was one done? Not explicitly mentioned. MRMC studies are more common for imaging devices where human interpretation is a primary component. For a blood glucose meter, the focus is on the device's accuracy in providing a quantitative result, not on human interpretation of complex data. The "lay user" and "professional" studies evaluate the usability and performance of different user types, which has some overlap with reader variability, but it's not typically described as an MRMC comparative effectiveness study in the same way an imaging or diagnostic AI product would be.
- Effect size of human readers with vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic imaging or interpretation device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was one done? Yes, implicitly. The core performance of the device's "amperometric biosensor technology to generate a current" and subsequent calculation is a standalone function. The "laboratory" studies would likely represent a standalone assessment of the device's analytical performance against a reference method, without necessarily accounting for all human-in-the-loop variables that are tested in clinical settings with different user types. The clinical studies with "healthcare professionals and lay users" then assess the human-in-the-loop performance.
7. Type of Ground Truth Used:
The ground truth was established by "current methods for blood glucose measurement," which typically refers to reference laboratory-based glucose analyzers (e.g., hexokinase method) known for their high accuracy and precision. This is a form of "reference method comparison" or "established analytical standard."
8. Sample Size for the Training Set:
Not applicable/not specified. For an amperometric biosensor system like this, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed through engineering and chemistry principles, and then validated with the test set studies described.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the machine learning context for this type of device. The device's internal calibration parameters would be set during manufacturing based on known glucose standards, not through a "training set" with established ground truth in the AI sense.
{0}------------------------------------------------
;
Summary of Safety and Effectiveness
| Submitted by: | Michael HalpinManager, Regulatory Affairs and Quality SystemsMediSense, Incorporated4A Crosby DriveBedford, Massachusetts 01730 |
|---|---|
| Device Name: | Precision·G Plus Point of Care Management Systemfor Blood Glucose Testing |
| Common Name: | Blood Glucose Testing System |
| Classification: | Glucose Test SystemClass II per 21 CFR 862.1345 |
| Predicate Devices: | Precision·G® Blood Glucose Testing System--K963676Precision QID® Blood Glucose Testing System--K944195Precision QID® and Precision·G® Blood Glucose Test Strip--K945887, K962295, K971812Johnson and Johnson Surestep Pro System -- K970556 |
| Description: | The Precision·G Plus Point of Care Management System for BloodGlucose Testing utilizes amperometric biosensor technology togenerate a current. The size of the current is proportional to theamount of glucose present in the sample providing a quantitativemeasure of glucose in whole blood and control solutions. |
| Intended Use: | The Precision·G Plus Point of Care Management System is intendedfor the in vitro diagnostic use (i.e. for external use only) for thequantitative measurement of glucose in fresh capillary whole blood.The Precision·G Plus Point of Care Management System is forhome (lay user) or professional use. |
| The product may also be used by healthcare professionals for thequantitative measurement of glucose in venous, arterial or neonatalwhole blood, provided the sample is used within 30 minutes. | |
| Comparison toPredicate Device: | The proposed Precision·G Plus Point of Care Management Systemhas equivalent technological characteristics and the same intendeduse as both the Precision·G® Blood Glucose Testing System(K963676, K971812) and the Precision QID® Blood GlucoseTesting System (K944195, K971812). In addition, the Precision·GPlus Point of Care Management system is substantially equivalent |
| to an additional competitive predicate device, the Johnson andJohnson Surestep Pro Blood Glucose Monitoring System(K970556). | |
| PerformanceStudies: | The performance of the Precision G Point of Care ManagementSystem was studied in the laboratory and in clinical settings byhealthcare professionals and lay users. The studies demonstratedthat user can obtain blood glucose results that are substantiallyequivalent to the current methods for blood glucose measurementincluding the predicate devices named above. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that theperformance of the Precision G Point of Care Management systemwhen used according to the intended use stated above is acceptableand comparable to the performance of the predicate devicesmentioned above. |
{1}------------------------------------------------
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Halpin DEC 8 1998 Manager, Requlatory Affairs and Quality Systems MediSense, Incorporated 4A Crosby Drive Bedford, Massachusetts 01730
K982303 Re: Precision-G Plus Point of Care Management System for Trade Name: Blood Glucose Testing Requlatory Class: II Product Code: CGA Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Halpin:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
{3}------------------------------------------------
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 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 Putman
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
{4}------------------------------------------------
INDICATIONS FOR USE FORM
510(k) Number (if known):
Device Name: Precision G Plus Point of Care Management System for Blood Glucose
Indications For Use:
The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE) L Over-The-Counter Use Prescription Use Or (Per 21 CFR 801.108) (Division Sign-Off) Division of Clinical Labo
510(k) Number .
§ 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.