(176 days)
The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact System is for home (lay user) use.
The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the base of the thumb.
The Abbott Laboratories MediSense Sof-Tact™ Diabetes 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 Sof-Tact Diabetes Management System integrates the process of blood collection from body sites including the forearm, upper arm and base of the thumb and glucose assay into a single operation by the user. A separate test port is available for blood collection glucose assay from the fingertip.
Here's a breakdown of the acceptance criteria and study information for the Sof-Tact Diabetes Management System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the Sof-Tact Diabetes Management System does not explicitly state quantitative acceptance criteria in terms of specific glucose difference values or accuracy percentages. Instead, the acceptance criteria are framed in terms of substantial equivalence to predicate devices and acceptable clinical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Precision Xtra, TheraSense FreeStyle, Amira AtLast) regarding technological characteristics and intended use. | "The Sof-Tact Diabetes Management System has equivalent technological characteristics and a similar intended used as the Precision Xtra System (K983504), TheraSense FreeStyle Meter (K992684) and the Amira AtLast Meter (K982076)." |
| Lay users can obtain blood glucose results substantially equivalent to current methods (including predicate devices). | "The studies demonstrated that lay users can obtain blood glucose that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate devices listed above." |
| Clinically insignificant glucose difference between arm and finger measurements. | "Clinical evaluations indicate that under variable glycemic conditions, glucose difference between arm and finger was clinically insignificant as determined by Clarke Error Grid." |
| Trained operators and lay users obtain equivalent whole blood glucose results. | "Results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results." |
| No clinically significant difference between arm glucose results at various post-prandial times (up to 3 hours) and finger glucose results. | "The Sof-Tact arm glucose results at various post-prandial times up to 3 hours show no clinically significant difference from finger glucose results." |
| Acceptable performance when used according to intended use. | "Results of laboratory and clinical testing demonstrate that the performance of the Sof-Tact Diabetes Management System, when used according to the intended use stated above, is acceptable..." |
| Comparable performance to predicate devices. | "...and comparable to the performance of the previously mentioned predicate devices for blood glucose testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set used in the clinical studies. It mentions "studies" in the plural, suggesting multiple individuals and tests were involved.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings." No specific country of origin is mentioned, but the submission is to the U.S. FDA, so it's reasonable to assume the studies were conducted in the U.S. The studies assessed current methods and user performance, implying a prospective data collection approach for the performance of the Sof-Tact system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience). However, it refers to:
- "healthcare professionals" who participated in "clinical settings" performance studies.
- The "Clarke Error Grid" as the method for determining clinical significance, which is a standard analytical tool typically interpreted by medical professionals.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method like 2+1 or 3+1. The use of the "Clarke Error Grid" implies a comparison to a reference method, but not necessarily a consensus-based adjudication process for individual results beyond confirming clinical significance.
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
This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the core of the evaluation is the standalone performance of the Sof-Tact Diabetes Management System itself, both in laboratory settings and when used by lay users without assistance, and also with trained operators. The device's measurement of glucose is an automated process (amperometric biosensor technology).
7. The Type of Ground Truth Used
The ground truth used for comparison appears to be:
- Current methods for blood glucose measurements: This specifically includes the predicate devices (Precision Xtra, TheraSense FreeStyle, Amira AtLast). This implies that a reference measurement from these established devices was used as the ground truth against which the Sof-Tact system's readings were compared.
- Clinically accepted standards: The use of the "Clarke Error Grid" signifies that the clinical significance of the glucose differences was evaluated against established medical criteria for blood glucose accuracy.
8. The Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its sample size. This type of device (a medical measurement instrument) typically undergoes extensive validation rather than machine learning training in the context commonly understood for AI/ML systems. Any "training" would refer to the development and calibration of the intrinsic measurement technology, not a distinct dataset for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional "training set" in the machine learning sense, the establishment of ground truth for a training set is not applicable to this document. The development of the device's measurement principles and calibration would be based on established chemical and electrical engineering principles for biosensors, with accuracy validated against known glucose concentrations.
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Sof-Tact Diabetes Management System 510(k) Notification
Summary of Safety and Effectiveness
| Submitted by: | Janet S. Connolly, RAC |
|---|---|
| Senior Regulatory Affairs Specialist | |
| Abbott Laboratories, MediSense Products | |
| 4A Crosby Drive | |
| Bedford, MA 01730 |
- Sof-Tact™ Diabetes Management System Device Name: SoftSense™ Diabetes Management System
Self-Monitoring Blood Glucose System Common Name:
Glucose Test System Classification: Class II per 21 CFR 862.1345
Precision Xtra™ Advanced Diabetes Management System-K983504 Predicate Devices: Amira AtLast Blood Glucose Monitoring System--K982076 TheraSense FreeStyle™ Blood Glucose Monitoring System-K992684
- The Abbott Laboratories MediSense Sof-Tact™ Diabetes Description: 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 Sof-Tact Diabetes Management System integrates the process of blood collection from body sites including the forearm, upper arm and base of the thumb and glucose assay into a single operation by the user. A separate test port is available for blood collection glucose assay from the fingertip.
Intended Use: The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact is for home (lay user) use. The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and base of the thumb.
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| Comparison toPredicate Device: | The Sof-Tact Diabetes Management System has equivalenttechnological characteristics and a similar intended used as thePrecision Xtra System (K983504), TheraSense FreeStyle Meter(K992684) and the Amira AtLast Meter (K982076). |
|---|---|
| PerformanceStudies: | The performance of the Sof-Tact Diabetes Management System wasstudied in the laboratory and in clinical settings by healthcareprofessionals and lay users. The studies demonstrated that lay userscan obtain blood glucose that are substantially equivalent to thecurrent methods for blood glucose measurements, which include thepredicate devices listed above. Clinical evaluations indicate thatunder variable glycemic conditions, glucose difference between armand finger was clinically insignificant as determined by Clarke ErrorGrid. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that theperformance of the Sof-Tact Diabetes Management System, whenused according to the intended use stated above, is acceptable andcomparable to the performance of the previously mentioned predicatedevices for blood glucose testing. In addition, results of clinicalperformance testing demonstrate that trained operators and lay usersobtain equivalent whole blood glucose results. The Sof-Tact armglucose results at various post-prandial times up to 3 hours show noclinically significant difference from finger glucose results. |
:
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2002
Ms. Janet S. Connolly, RAC Senior Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, Massachusetts 01730
Re: K012975
Trade/Device Name: Sof-Tact™ Diabetes Management System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, LFR Dated: January 4, 2002 Received: January 7, 2002
Dear Ms. Connolly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becall be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars comment date of the Medical Device American by and commence prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been results in assee approval of a premarket approval application (PMA). and Cosmetic Act (710) that to her request to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the revilabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller Lineang components of the 21, In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In ad be found in the Outs ocements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a backers. In other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any Federal Statutes and regulations and admitted to: registration and listing (21 comply with an the Act 3 requirements, morealing, which and and in the disclined as set CFK Part 807), ademig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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
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Indications For Use Form
510(k) Number (if known):
Sof-Tact™ Diabetes Management System Device Name:
Indications For Use:
The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact System is for home (lay user) use.
The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the base of the thumb.
Cean (open
(Division Sign-Off)
Division of Clinical Laboratory Devices
K012975
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
510/k) Num
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use (Per 21 CFR 801.108) Over-The-Counter Use
§ 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.