(28 days)
The Precision Xceed Diabetes Monitoring System is intended for in vitro diagnostic use (i.e. external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xceed is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision Xceed system is indicated for home (lay user) or professional use.
The Precision® Xceed™ Diabetes Monitoring System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose or β-hydroxybutytate (β-ketone) present in the sample, providing a quantitative measure of glucose or β-ketone in whole blood and control solutions.
The provided text describes the Precision Xceed Diabetes Monitoring System and its substantial equivalence to a predicate device, but it lacks detailed acceptance criteria and the specific study report details that would allow for a comprehensive answer to all questions.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states that the studies "demonstrated that lay users can obtain blood glucose and ß-Ketone results that are substantially equivalent to the current methods for blood glucose and ß-ketone measurements." and that the "performance... is acceptable and comparable to the performance of the previously mentioned predicate device".
However, specific numerical acceptance criteria (e.g., accuracy, precision targets) and the corresponding reported performance values are NOT provided in this summary. To create such a table, more detailed study results are needed.
2. Sample sized 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 this document. The text only mentions "clinical settings by healthcare" and "lay users".
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings". The country of origin and whether the studies were retrospective or prospective are not specified.
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)
This information is not specified. For a glucose/ketone monitoring system, "ground truth" would typically be established by laboratory reference methods, not by human experts in the way clinical images might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable in the context of a glucose/ketone monitoring system where the "ground truth" is typically a quantitative measurement from a reference lab method. There would be no need for expert adjudication.
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: Not applicable. This device is a standalone blood glucose and ketone monitoring system, not an AI-assisted diagnostic tool that aids human readers in image interpretation.
- Effect Size of Human Reader Improvement: Not applicable for the same reason above.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes. The performance studies for the Precision Xceed Diabetes Monitoring System itself, measuring glucose and β-ketone levels, represent its standalone performance. The document states "Results of laboratory and clinical testing demonstrate that the Conclusion: Rooms of the Precision Xceed Diabetes Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose and ß-ketone testing." This indicates that the device's output (glucose/ketone readings) was evaluated directly against reference methods or the predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a glucose and ketone monitoring system, the ground truth would inherently be established by comparison to accepted laboratory reference methods for glucose and β-ketone measurements. The document implies this by stating the results are "substantially equivalent to the current methods for blood glucose and ß-ketone measurements."
8. The sample size for the training set
Not specified. Given that this is a 2004 submission for a biosensor technology, it's highly unlikely that a "training set" in the context of modern machine learning algorithms as we understand it today was used. The device's calibration would be based on chemical and electrical engineering principles and likely internally validated, but not via an external "training set" of patient data that would then be distinct from a "test set" for performance evaluation.
9. How the ground truth for the training set was established
Not applicable or not specified. As explained above, for a device of this nature and era, a distinct "training set" with established ground truth as used in contemporary AI/ML development is improbable. The calibration and internal validation of the biosensor would be part of its engineering design and manufacturing process.
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JAN - 8 2004
Image /page/0/Picture/2 description: The image shows the word "MediSense" in a bold, sans-serif font. A curved line appears above the word, starting from the left and extending over the "M" and part of the "e". A registered trademark symbol is located to the upper right of the word.
Precision Xceed Diabetes Monitoring System Special 510(k) Submission
510(k) Summary
(as required by 21 CFR 807.92)
| Submitted by: | Tracey H. Wielinski RACStrategic Quality Assurance and Regulatory Affairs ManagerAbbott Laboratories, MediSense Products4A Crosby DriveBedford, MA 01730 |
|---|---|
| Device Name: | Precision® Xceed™ Diabetes Monitoring System |
| Common Name: | Whole Blood Glucose and Ketone Test System |
| Classification: | Glucose Test SystemClass II per 21 CFR 862.1345 |
| Ketone Test SystemClass I per 21 CFR 862.1435 | |
| Product Code: | NBW, LFR, JIN |
| Predicate Device: | Precision Xtra® Advanced Diabetes Management System, K983504 |
| Description: | The Precision® Xceed™ Diabetes Monitoring System utilizesamperometric biosensor technology to generate a current. The size of thecurrent is proportional to the amount of glucose or β-hydroxybutytate (β-ketone) present in the sample, providing a quantitative measure ofglucose or β-ketone in whole blood and control solutions. |
| Intended Use: | The Precision® Xceed™ Diabetes Monitoring System is intended for invitro diagnostic use (i.e., external use only) for the quantitativemeasurement of glucose in fresh capillary whole blood. The PrecisionXceed is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The PrecisionXceed system is indicated for home (lay user) or professional use. |
| Comparison toPredicate Device: | The Precision® Xceed™ Diabetes Monitoring System uses the samefundamental scientific technology and has the same intended use as thepredicate Precision Xtra Advanced Diabetes Management System(K983504). |
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Performance The performance of the Precision Xceed Diabetes Monitoring System Studies: was studied in the laboratory and in clinical settings by healthcare was otadiou in the studies demonstrated that lay users can obtain blood glucose and ß-Ketone results that are substantially equivalent to the current methods for blood glucose and ß-ketone measurements. Results of laboratory and clinical testing demonstrate that the Conclusion: Rooms of the Precision Xceed Diabetes Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate
device for blood glucose and ß-ketone testing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized symbol that resembles a human figure embracing another, or possibly a bird in flight, represented by a series of curved lines.
Public Health Service
JAN - 8 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tracey H. Wielinski, RAC Strategic Quality Assurance and Regulatory Affairs Manager Abbott Laboratories MediSense Products 4A Crosby Drive Bedford, MA 01730-1402
Re: K033845
R055645
Trade/Device Name: Precision® Xceed™ Diabetes Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JKF, LFR Dated: December 10, 2003 Received: December 11, 2003
Dear Ms. Wielinski:
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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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director 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 (if known): | K033845 |
|---|---|
| Device Name: | Precision® Xceed™ Diabetes Monitoring System |
| Indications For Use: | The Precision Xceed Diabetes Monitoring System isintended for in vitro diagnostic use (i.e. external use only)for the quantitative measurement of glucose in freshcapillary whole blood. The Precision Xceed is alsointended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood.The Precision Xceed system is indicated for home (layuser) or professional use. |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033845
§ 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.