The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microlNR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick. The microlNR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For Self-testing use: The System is intended for properly trained users under specific prescription of a physician. Caution: The microINR System is not in patients who are transitioning from heparin treatment to VKA therapy. The microINR System is not intended to be used for screening purposes.

Device Description

The modified device microINR System containing the microINR Link Meter is derived from the existing device microINR Meter. The change is for the addition of Bluetooth connectivity to the meter. Bluetooth functionality stays inactive during the testing/measuring process. All the actions related to Bluetooth functionality are set before or after performing the analytical test. The fundamental scientific technology of the modified device and its performance has not changed. No performance changes to the microINR System have been implemented since its clearance on K201185.

AI/ML Overview

This document (K231711) describes a Special 510(k) submission for the microINR System. This type of submission is used when changes are made to a previously cleared device, and it aims to demonstrate that the modified device remains substantially equivalent to the original cleared device. In this specific case, the change introduced is the addition of Bluetooth connectivity to the meter.

Because this is a Special 510(k), the focus of the testing is to demonstrate that the new functionality (Bluetooth) does not adversely affect the device's original performance and does not raise new questions of safety or effectiveness. Therefore, the acceptance criteria and study described are not for the primary device performance (e.g., accuracy of INR measurement), but rather for the impact of the newly added feature.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table detailing acceptance criteria and reported device performance for the primary function of the microINR System (PT/INR measurement accuracy). This is because the original performance was established in the predicate K201185, and this submission focuses on the new Bluetooth functionality.

However, it does state general acceptance regarding the performed testing:

Acceptance Criteria Category	Reported Device Performance (Satisfied)
Radiofrequency	All testing results met pre-determined acceptance criteria.
Electromagnetic Compatibility	All testing results met pre-determined acceptance criteria.
Electrical Safety	All testing results met pre-determined acceptance criteria.
Cybersecurity Analysis	All testing results met pre-determined acceptance criteria.
Usability Testing	All testing results met pre-determined acceptance criteria.
Software Verification and Validation	All testing results met pre-determined acceptance criteria.
Risk Analysis	Concluded no significant detectable risks compared to the predicate; all residual risks deemed acceptable. Bluetooth connectivity features were correctly implemented.

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

The document does not explicitly state the sample size used for the test set in the context of clinical performance or the data provenance (country of origin, retrospective/prospective). This is because the core analytical performance related to measuring INR was established with the predicate device (K201185). The testing for this Special 510(k) focused on the new Bluetooth functionality, which typically involves engineering or software testing, not patient-based clinical trials for accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The testing described for the Bluetooth feature (Radiofrequency, EMC, Electrical Safety, Cybersecurity, Usability, Software V&V) does not typically involve expert clinical ground truth establishment in the same way that a diagnostic accuracy study would.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing is for the impact of the new Bluetooth feature, not for diagnostic accuracy, and therefore does not rely on clinical adjudication of results.

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. The microINR System is a prothrombin time test device, not an AI-assisted diagnostic imaging device, and therefore MRMC studies or AI assistance effect sizes are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is a system (meter and test strips) for measuring PT/INR. While the new Bluetooth functionality itself operates without direct human intervention once initiated, the overall device includes human interaction. The "standalone" performance here refers to the device functions for Radiofrequency, EMC, Electrical Safety, Cybersecurity, Usability, and Software verification and validation, all of which were tested without requiring a human operator to compensate for potential deficiencies in the Bluetooth module itself. The document states "Bluetooth functionality stays inactive during the testing/measuring process. All the actions related to Bluetooth functionality are set before or after performing the analytical test." This indicates the Bluetooth module's performance was assessed without interfering with the core measurement, and implicitly, its standalone function (transferring data) was verified.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the testing related to the Bluetooth functionality:

Radiofrequency, Electromagnetic Compatibility, Electrical Safety: Ground truth would be defined by relevant international and national standards and regulations (e.g., ISO, IEC standards for medical devices and radio equipment).
Cybersecurity Analysis: Ground truth is established by recognized cybersecurity standards, best practices, and vulnerability assessment methodologies.
Usability Testing: Ground truth is established by user feedback and observation against established usability heuristics and design principles for medical devices, potentially defined by standards like IEC 62366.
Software Verification and Validation: Ground truth is established by the software requirements specification, design documents, and coding standards, ensuring the software performs as intended according to its formal definition.

For the primary device function (PT/INR measurement accuracy) which was established with the predicate, the ground truth would typically be a laboratory reference method for PT/INR.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. The testing performed here (Radiofrequency, EMC, Electrical Safety, Cybersecurity, Usability, Software V&V) involves engineering and software validation, not the development of a predictive model.

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

Not applicable, as there is no "training set" for this type of device and submission.

Summary

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July 11, 2023

iLine Microsystems S.L. Miren Hormaeche Regulatory Affairs and Quality Director Paseo Mikeletegi. 69 San Sebastian-Donostia, Gipuzkoa 20009 Spain

Re: K231711

Trade/Device Name: microINR System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: June 12, 2023 Received: June 12, 2023

Dear Miren Hormaeche:

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

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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 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 (OS) 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Takeesha Taylor-bell -S

Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics 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) K231711

Device Name microINR System

Indications for Use (Describe)

The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microlNR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

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

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

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510(k) SUMMARY

This Special 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. SUBMITTER INFORMATION

Owner	iLine Microsystems, S.L.Paseo Mikeletegi, 6920009 Donostia, GuipúzcoaSpain
Contact	Miren Itsaso Hormaecheihormaeche@ilinemicrosystems.comTel. +34 943 005 651Fax: +34 943 008 737
Date Summary Prepared	July 10, 2023

2. DEVICE INFORMATION

Proprietary Name	microINR System (microINR Chips,microINR Kit, microINR Link Kit)
Common Name	Prothrombin time test
Panel	Hematology

Regulatory Information:

Classification
Device	RegulationSection	DeviceClass	ProductCode	Test
microINR System	21 CFR 864.7750	II	GJS	Prothrombin time test

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3. SUBSTANTIAL EQUIVALENCE INFORMATION:

Element	Predicate Device
Predicate Device Name	microINR System
Common Name	Prothrombin time test
510 (k) Number	K201185
Manufacturer	iLine Microsystems S.L.

4. DEVICE DESCRIPTION:

5. INDICATIONS FOR USE/INTENDED USE:

The microINR System measures prothrombin time (PT) expressed in International Normalized Ratio (INR), for monitoring oral anticoagulant therapy with warfarin.

The microINR System consists of a meter and chips (test strips) and uses fresh capillary whole blood from a fingerstick.

The microINR System is intended for patient self-testing use as well as for healthcare professionals at Point of Care settings.

The microINR System is intended for use in patients 18 years old or older. Patients must be stable on warfarin medication for at least 6 weeks before starting to use the microINR System.

For Self-testing use: The System is intended for properly trained users under specific prescription of a physician.

Caution: The microINR System is not intended for use in patients who are transitioning from heparin treatment to VKA therapy. The microINR® System is not intended to be used for screening purposes.

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6. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS (PREDICATE):

The microINR System containing the microINR Link Meter uses the same test strips (the microINR Chips) and measuring algorithm as the predicate, the microINR System for self-testing use and professional use in CLIA waived settings (K201185). The only change is the addition of Bluetooth connectivity to the Meter. The performance characteristics of the microINR System remain the same.

7. TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Testing on the modified device was conducted as follows: testing for Radiofrequency, Electromagnetic Compatibility, and Electrical Safety; Cybersecurity analysis; Usability testing; and Software verification and validation.

All testing results met the pre-determined acceptance criteria. Based on the testing, the microINR System including the microINR Link Meter performs as intended, with no new questions of safety or effectiveness identified during testing.

The risk analysis of the implemented changes concluded that the microINR System including the microINR Link Meter has no significant detectable risks compared to the predicate device and all residual risks have been deemed acceptable.

8. CONCLUSION

The microINR System with the microINR Meter was previously cleared for self-testing use and professional use in CLIA waived settings under premarket notification K201185.

This Special 510(k) is being submitted to obtain clearance for the microINR System including the microINR Link Meter for patient self-testing, and CLIA waiver for professional use in Point of Care settings. The verification and/or validation activities required based on the Risk Analysis were evaluated and revealed that the Bluetooth connectivity features were correctly implemented.

Based on the comparative analysis, the intended use, principles of operation, performance characteristics and technological characteristics, the microINR System including the microINR Link Meter does not introduce any new significant risks or any new questions of safety and effectiveness. The difference in terms of Bluetooth functionality between the subject and the predicate microINR System device raises no new issues of safety or effectiveness. Therefore, the microINR System containing the microINR Link Meter is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).