The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Device Description

The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.

AI/ML Overview

The submitter for the K061118 device is LifeScan, Inc. The device is the OneTouch® UltraMini™ Blood Glucose Monitoring System which is a modification of the predicate device, the OneTouch Ultra Blood Glucose Monitoring System. The claim for the device is substantial equivalence to the predicate. The performance characteristics of the new device are the same as the predicate since there has been no change to the fundamental scientific technology.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "The modified meter was tested in accordance with ISO 15197:2003(E) including System Accuracy, Clinical Accuracy, and Consumer Evaluation to assess ease of use (human factors and user acceptance)."

However, specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) and the detailed study results for these criteria are not explicitly provided in the given summary. It only states that the testing was performed and confirmed equivalence.

Therefore, a table with specific numbers cannot be generated from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The summary mentions a "meter equivalence study" and "Design Verification (including software verification and validation) testing." It also states "The modified meter was tested in accordance with ISO 15197:2003(E)."

Sample Size for Test Set: The document does not specify the sample size used for the test set in any of the studies (meter equivalence, design verification, or ISO 15197 testing).
Data Provenance (Country of Origin, Retrospective/Prospective): The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any of the testing mentioned.

4. Adjudication Method for the Test Set

The document does not provide any information regarding the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to the predicate device, not on human reader performance improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device is a blood glucose monitoring system, which inherently involves human interaction for obtaining a blood sample and reading the meter. Therefore, a purely standalone "algorithm only" performance study in the context of AI is not applicable to this type of medical device as described. The performance studies would naturally involve the device being used as intended.

7. Type of Ground Truth Used

While the document doesn't explicitly state "ground truth," for blood glucose monitoring systems, the generally accepted "ground truth" for assessing accuracy is the comparison of device readings to a laboratory reference method (e.g., YSI analyzer) performed on the same blood sample. Given the reference to ISO 15197:2003(E), which directly addresses accuracy against reference methods, it can be inferred that a laboratory reference method would have been used.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is consistent with a device that does not employ machine learning or AI in a way that requires a separate "training set" in the conventional sense for algorithm development. The device is a modification of an existing system, and the studies focus on verifying its equivalence.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or implied for an AI/machine learning algorithm, this question is not applicable based on the provided text.

Summary

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K061118

Image /page/0/Picture/1 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in bold, sans-serif font, with the tagline "a Johnson & Johnson company" in a smaller, more delicate font underneath. To the left of the wordmark is a stylized graphic element that resembles a sphere with an orbital path around it.

19 3000

OneTouch® UltraMini™ Blood Glucose Monitoring System

510(k) Summarv

Submitter

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

510(k) Contact Name: Mary Ellen Holden, Regulatory Project Leader. LifeScan. Inc. (408) 942-3589 or E-Mail: Mholden@lfsus.jni.com

510(k) Prepared by: Alison Wilson, Regulatory Specialist, LifeScan Scotland Limited

OneTouch® UltraMini™ Blood Glucose Monitoring System Common name: Glucose test system

Classification:

(1) OneTouch® UltraMini™ Blood Glucose Meters and OneTouch® Ultra® Test Strips are Class II devices (21 CFR § 862.1345)
(2) OneTouch® Ultra® Control Solution is a Class I device (21 CFR § 862.1660)
(3) OneTouch® Lancing Device with ASTTM Clear Cap, OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap and OneTouch® UltraSoft® Sterile Lancets are Class I (exempt) devices (21 CFR § 878.4800)

System Description

Predicate Device

OneTouch Ultra Blood Glucose Monitoring System

Device Name

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Image /page/1/Picture/0 description: The image shows the LifeScan logo, which includes the company name in bold, sans-serif font. Above the name is a curved line that starts with a globe-like shape on the left. Below the name, in a smaller font, is the text "a Johnson & Johnson company." The logo is simple and professional, conveying a sense of trust and reliability.

510(K) Summary, Page 2

Intended Use

Comparison to Predicate Device

The modifications to the device encompass meter ergonomic/physical design, electronic/hardware, software/firmware and labeling changes. There has been no change to the intended use, fundamental scientific technology, operating principle, or essential functionality of the device.

Technological Characteristics

There has been no change to the fundamental scientific technology.

Summary of Performance Characteristics

There has been no change to the performance characteristics of the system.

A meter equivalence study demonstrated that the OneTouch UltraMini Blood Glucose Monitoring System and the currently marketed OneTouch Ultra Blood Glucose Monitoring System are substantially equivalent.

Design Verification (including software verification and validation) testing confirmed that the performance, safety and effectiveness of the OneTouch UltraMini Blood Glucose Monitoring System were equivalent with that of the predicate device.

The modified meter was tested in accordance with ISO 15197:2003(E) including System Accuracy, Clinical Accuracy, and Consumer Evaluation to assess ease of use (human factors and user acceptance). In addition, reading level assessment of the product labeling was conducted and validated for comprehension,

Conclusion

The modified OneTouch UltraMini Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra Blood Glucose Monitoring System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows a logo for the Department of Health & Human Services, USA. The logo features a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 19 2006

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312 Attn: Mary Ellen Holden, Regulatory Project Leader

Re: K061118

Trade/Device Name: One-Touch® UltraMini™ Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: April 20, 2006 Received: April 21, 2006

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. Iisting 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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KOG // /8

Device Name: OneTouch® UltraMini™ Blood Glucose Monitoring System

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Indications For Use:

The OneTouch UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1

Carol C. Benson

Office of In Vitro Diagnostic Device Evaluation and Safety

11000 K061118

Regulation Number and Section

§ 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.