(80 days)
The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart" System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The One Touch® UltraSmari™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.
The One Touch® UltraSmart™ System consists of the One Touch® UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch® Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter, when used with the One Touch® Ultra™ Blood Glucose Test Strips, quantitatively measures glucose in capillary whole blood. The One Touch® Ultra™ Control Solution verifies the performance of the One Touch® Ultra™ Blood Glucose Test Strips.
The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™ lancets are provided to facilitate obtaining a capillary blood sample.
The provided text is a 510(k) summary for the One Touch® UltraSmart™ Blood Glucose Monitoring System. It does not contain detailed acceptance criteria or a study protocol with the specific information requested in the prompt. Instead, it makes a general statement about performance.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Laboratory studies and clinical studies demonstrate that the One Touch® UltraSmart™ Blood Glucose System provides equivalent performance to the One Touch® Ultra™ Blood Glucose System."
It does not provide explicit numerical acceptance criteria (e.g., specific accuracy percentages, bias limits) or detailed reported device performance against such criteria for the One Touch® UltraSmart™ device itself. It only states equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the summary.
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 provided in the summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference method of glucose measurement (e.g., a laboratory analyzer), not "experts" in the clinical imaging sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and not provided in the summary. Adjudication is generally relevant to subjective interpretations, often in imaging studies.
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
Not applicable for this type of device. The device is a blood glucose monitor, not an AI-assisted diagnostic tool interpreted by human readers. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone glucose measurement system. The "performance data" mentioned in the summary refers to the device's ability to measure glucose. There's no AI algorithm here in the typical sense of a "standalone" performance study. The device provides a direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for performance comparison would be a reference glucose measurement method, likely from a laboratory analyzer, against which the device's readings are compared. However, this is not explicitly stated or detailed in the summary.
8. The sample size for the training set
Not applicable for this type of device. There isn't a "training set" in the context of an AI/machine learning model for this blood glucose monitor.
9. How the ground truth for the training set was established
Not applicable for this type of device, as there is no mention of a training set or AI model.
In summary:
The 510(k) summary only states that laboratory and clinical studies demonstrate equivalent performance to a predicate device (One Touch® Ultra™ Blood Glucose System). It does not provide the specific details of these studies that would answer the requested questions about acceptance criteria, sample sizes, ground truth establishment, or study methodologies. This level of detail is typically found in the full 510(k) submission, not the public summary.
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510(k) SUMMARY
(As required by 21 C.F.R. § 807.92)
| (As required by 21 C.F.R. § 807.92) | |
|---|---|
| K021819 | |
| Submitted By: | Lifescan, Inc.1000 Gibraltar DriveMilpitas, CA 95035 |
| Contact Person: | Mary Ellen HoldenSenior Regulatory Affairs SpecialistLifescan, Inc. |
| Date Summary | Phone: (408) 942-3589Fax: (408) 942-5906E-mail: mholden@lfsus.jnj.comJune 3, 2002 |
| Prepared:Device Name: | One Touch® UltraSmart™ Blood Glucose Monitoring System |
| ClassificationNames: | (1) The One Touch® UltraSmart™ Meter and ONE TOUCH®Ultra™ Test Strip are Class II devices (21 CFR § 862.1345,Glucose Monitor).(2) One Touch® Ultra™ Control Solution is a Class I device (21CFR § 862.1660, Single Analyte Control).(3) Sterile lancet, Lancing Device and accessories are Class I(exempt) devices (21 CFR § 878.4800, Lancet, Blood). |
| SubstantialEquivalence: | The One Touch® UltraSmart™ Blood Glucose Monitoring System issubstantially equivalent to the previously cleared One Touch®Ultra™ Blood Glucose Monitoring System (K002134), in that bothdevices are intended for the quantitative measurement of glucose incapillary whole blood (for in vitro diagnostic use) by people withdiabetes and healthcare professionals. Both devices use theidentical method of glucose detection and have the same safety andeffectiveness. In addition, it is substantially equivalent to the OneTouch® Profile® (K950727) Blood Glucose Monitoring System, apredicate device with similar advanced memory features |
| Description of theDevice: | The One Touch® UltraSmart™ System consists of the One Touch®UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch®Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter,when used with the One Touch® Ultra™ Blood Glucose Test Strips,quantitatively measures glucose in capillary whole blood. The OneTouch® Ultra™ Control Solution verifies the performance of theOne Touch® Ultra™ Blood Glucose Test Strips. |
| The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™lancets are provided to facilitate obtaining a capillary blood sample. | |
| Statement ofIntended Use: | The One Touch® UltraSmart™ Blood Glucose Monitoring System isintended to be used for the quantitative measurement of glucose infresh capillary whole blood. The One Touch® UltraSmart™ Systemis intended for use outside the body (for in vitro diagnostic use) bypeople with diabetes at home and by health care professionals in aclinical setting as an aid to monitor the effectiveness of diabetescontrol. |
| The One Touch® UltraSmart™ Blood Glucose Monitoring Systemprovides the user with electronic logbook functions that store datasuch as insulin and oral medication doses, food intake, amount ofexercise, and health information such as illnesses. The meterincludes a data port that enables the user to download electroniclogbook data to a personal computer | |
| Description ofSimilarities andDifferences: | The One Touch® UltraSmart™ System, provides the same glucosemonitoring capability as the predicate device, the One Touch®Ultra™ System (K002134). One Touch® UltraSmart™ and OneTouch® Ultra™ are essentially identical from the perspective ofmeasuring glucose. In fact, they use the same One Touch Ultra™test strip. The primary differences are in the advanced memoryfeatures. In this respect, the One Touch® UltraSmart™ System addselectronic logbook features similar to those offered commerciallyby the One Touch® Profile Meter (K950727). |
| The advanced memory features of One Touch® UltraSmart™ aresimilar to those of the One Touch® Profile Meter previously clearedfor market (K950727). The One Touch® UltraSmart™ meter offersmore memory, which allows advanced features not available withthe predicate devices. The increased data storage expandedmemory offers more opportunities to people with diabetes inmanaging their diabetes. | |
| Summary ofPerformance Data | Laboratory studies and clinical studies demonstrate that the OneTouch® UltraSmart™ Blood Glucose System provides equivalentperformance to the One Touch® Ultra™ Blood Glucose System. |
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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 stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2002
Ms. Mary Ellen Holden Sr. Regulatory Affairs Specialist LifeScan. Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
K021819 Re: Trade/Device Name: ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 3, 2002 Received: June 4, 2002
Dear Ms. Holden:
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.
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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 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
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3.0 ODE INDICATIONS FOR USE STATEMENT
Indications for Use Statement
| 510(k) Number: | K021819 |
|---|---|
| Device Name: | ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System |
Indications for Use:
The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart" System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The One Touch® UltraSmari™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ------------------------------------ |
Carol C Benson for Jean Cooper, DVM
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | KO21819 |
|---|---|
| --------------- | --------- |
ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System
§ 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.