(68 days)
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-of-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring 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.
Here's an analysis of the provided text regarding the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, structured to address your specific points.
The provided document is a 510(k) summary (K022182) for a blood glucose monitoring system, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and extensive study results in the manner you might expect for a novel or high-risk device. Therefore, some of your requested information (e.g., specific statistical acceptance criteria thresholds, detailed study designs for human reader improvement with AI, specific sample sizes for test/training sets with ground truth establishment) is not explicitly present in this type of regulatory document.
However, I will extract and infer as much as possible based on the provided text.
Acceptance Criteria and Device Performance for MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantial equivalence to predicate devices (Precision QID Blood Glucose Testing System, K944195, K971812) in terms of accuracy and reliability for blood glucose measurements. | "Results of laboratory and clinical testing demonstrate that the performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose testing." |
| Usability/Lay User Performance | Lay users (self-testers) should obtain blood glucose results substantially equivalent to current methods and trained operators. | "In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results." |
| Technological Characteristics | Equivalent technological characteristics. | "The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System has equivalent technological characteristics as the Precision QID Blood Glucose Testing System (K944195, K971812)." |
| Intended Use Equivalence | Same intended use as the predicate device. | "The Precision Easy also has the same intended use as the Precision QID." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "laboratory and clinical settings" and "clinical performance testing" involving "healthcare professionals and lay users," but does not provide specific numbers for the test set size.
- Data Provenance: The document implies the studies were conducted within the context of Abbott Laboratories, MediSense Products, likely in the US given the submission to the FDA. The data is prospective as it's generated for the purpose of demonstrating the device's performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The studies involved "healthcare professionals" and "trained operators," implying individuals with clinical expertise in blood glucose measurement. Specific qualifications (e.g., years of experience, specific medical degrees) are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The document refers to "results of laboratory and clinical testing" and "current methods" for comparison, which suggests reference standard measurements were used, but the specific process for resolving discrepancies or establishing the 'true' glucose value is not detailed.
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
- MRMC Study: No, this is not an MRMC study and AI is not mentioned as a component of this blood glucose monitoring system. This device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: Yes, the core of the submission relies on the standalone performance of the blood glucose monitoring system. While human users operate the device, the "performance" described refers to the accuracy of the device's measurement relative to a reference standard, which is a standalone assessment of the device's accuracy. The text emphasizes that the device itself (using "amperometric biosensor technology") generates the current and provides the quantitative measure.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for blood glucose measurements would typically be established by a highly accurate laboratory reference method for blood glucose, often referred to as a "gold standard." The document mentions "current methods" and "predicate devices listed above" as benchmarks, implying that these established, accurate methods served as the ground truth or reference for comparison.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not explicitly stated for this type of device. Blood glucose meters do not typically have a "training set" in the machine learning sense. Their performance is inherent in their design and manufacturing, validated through testing with known glucose concentrations and patient samples.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As noted above, this device doesn't use a "training set" with ground truth in the context of an algorithm that learns from data. Instead, the device is designed based on known electrochemical principles (amperometric biosensor technology), and its accuracy is verified against reference methods.
{0}------------------------------------------------
821
9 2002 SEP
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted by: | Janet Connolly, RACSr. Regulatory Affairs SpecialistAbbott Laboratories, MediSense Products4A Crosby DriveBedford, MA 01730-6230 |
|---|---|
| Device Name: | MediSense® Precision® Easy / MediSense® OptiumTM Easy BloodGlucose Monitoring System |
| Common Name: | Self-Monitoring Blood Glucose System |
| Classification: | Glucose Test SystemClass II per 21 CFR 862.1345 |
| Predicate Device: | Precision QID® Blood Glucose Testing System, K944195, K971812, |
| Description: | The MediSense Precision Easy / MediSense Optium Easy BloodGlucose Monitoring System for blood glucose testing utilizesamperometric biosensor technology to generate a current. The size ofthe current is proportional to the amount of glucose present in thesample, providing a quantitative measure of glucose in whole bloodand control solutions. |
| Intended Use: | The MediSense Precision Easy / MediSense Optium Easy BloodGlucose Monitoring System is intended for outside-the-body (in-vitrodiagnostic) use. The system is indicated for the quantitativemeasurement of glucose in fresh whole blood for self-testing by layusers (e.g., from the finger), or by health care professionals. |
| Comparison toPredicate Device: | The MediSense Precision Easy / MediSense Optium Easy BloodGlucose Monitoring System has equivalent technologicalcharacteristics as the Precision QID Blood Glucose Testing System(K944195, K971812). The Precision Easy also has the same intendeduse as the Precision QID. |
| PerformanceStudies: | The performance of the MediSense Precision Easy / MediSenseOptium Easy Blood Glucose Monitoring System was studied in thelaboratory and in clinical settings by healthcare professionals and layusers. The studies demonstrated that lay users can obtain bloodglucose results that are substantially equivalent to the current methods |
Abbott Laboratories Inc., MediSense Products
{1}------------------------------------------------
for blood glucose measurements, which include the predicate devices listed above.
- Results of laboratory and clinical testing demonstrate that the Conclusion: performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles a human figure with three arms or branches extending upwards.
9 2002 SEP
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janet Connolly, RAC Sr. Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-1402
K022182 Re:
Trade/Device Name: MediSense® Precision® Easy/MediSense® Optium™ Easy Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 2, 2002 Received: July 3, 2002
Dear Ms. Connolly:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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): K022182
Device Name:
MediSense® Precision® Easy / MediSense® Optium™ Easy Blood Glucose Monitoring System
Indications For Use:
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for selftesting by lay users (e.g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.
Han
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022182
Cooph
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.108) or
Over-The-Counter Use
er Use V
Lian Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices i 510(k) Number_ ( ( 2 ) 2 ) 2 2 2
§ 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.