KetoSens BT Blood B-Ketone Monitoring System

K201551 · I-Sens, Inc. · JIN · Sep 9, 2020 · Clinical Chemistry

Device Facts

• Record ID: K201551
• Device Name: KetoSens BT Blood B-Ketone Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: JIN · Clinical Chemistry
• Decision Date: Sep 9, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1435
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The KetoSens BT Blood β-Ketone Monitoring System is intended for single-patient use.

Device Story

KetoSens BT Blood β-Ketone Monitoring System is a modified version of the previously cleared KetoSens Blood β-Ketone Monitoring System (K170463). The device measures blood β-ketone levels for single-patient use. Modifications include the addition of Bluetooth Low Energy (BLE) wireless communication, a reduction in battery life from 3,000 to 1,000 measurements, and updates to the display (Bluetooth icon) and error codes. The device is intended for use by patients for self-monitoring. Data is transmitted via BLE to external systems. The healthcare provider uses the output to assess ketone levels, aiding in clinical decision-making regarding metabolic status. The device maintains the same fundamental scientific technology as the predicate.

Clinical Evidence

No clinical data provided. The submission relies on design control activities, risk analysis, and verification/validation testing to demonstrate substantial equivalence. Disinfection efficacy and robustness studies (simulating 5 years of use) were previously established in K170463.

Technological Characteristics

Electrochemical biosensor system; measures ß-hydroxybutyrate in capillary whole blood; meter-based display; single-patient use.

Indications for Use

Indicated for single-patient use for the monitoring of blood β-ketone levels.

Regulatory Classification

Identification

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

Submission Summary (Full Text)

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September 9, 2020

i-SENS, Inc. Joon Ho Jung RA Team Deputy Senior Manager 43, Banpo-daero 28-gil, Seocho-gu Seoul, 06646, Republic of Korea

Re: K201551

Trade/Device Name: KetoSens BT Blood β-Ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (Nonquantitative) Test System Regulatory Class: Class I, meets the limitation of exemption 21 CFR 862.9(c)(5) Product Code: JIN Dated: August 10, 2020 Received: August 10, 2020

Dear Joon Ho Jung:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201551

## Device Name

KetoSens BT Blood B-Ketone Monitoring System

Indications for Use (Describe)

The KetoSens BT Blood ß-Ketone Monitoring System is intended for the quantitative measurement of 0-Ketone (betahydroxybutyrate) level in capillary whole blood drawn from the fingertip. The KetoSens BT Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of ketoacidosis control. The system is not intended for use in the diagnosis of or screening for ketoacidosis and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood 0-Ketone Test Strips work with the KetoSens BT Blood 0-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the finger.

| Type of Use (Select one or both, as applicable) |
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Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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