The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Device Description

OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data.

AI/ML Overview

The provided document (K232386) describes the premarket notification for the "ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6". This submission primarily focuses on the addition of cloud connectivity features (remote software updates and telemetry data transmission) to an existing device (predicate device K183320).

Crucially, the document explicitly states that "No clinical testing is provided in this pre-market notification" (page 4). Therefore, the information requested regarding acceptance criteria and study proving device performance (including sample sizes, expert involvement, ground truth, MRMC studies, and standalone performance) cannot be extracted from this document, as such studies were not performed or reported for this particular submission.

The document focuses on demonstrating substantial equivalence based on the updated software's functional similarity and verification and validation (V&V) testing.

Here's what can be inferred from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the non-clinical testing performed:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria (Inferred from V&V)	Reported Device Performance (as stated in the document)
Functionality of new cloud connectivity features (remote software updates, telemetry data transmission)	The device performs the stated functions. The core intent of the submission is that "Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data." The acceptance for these features would be their successful operation and secure data transfer.
Adherence to user needs and product specifications	"The results demonstrate that the AptiVue Software version E.6 meets the user needs and product specifications and is appropriate for its intended use and does not raise any new issues of safety and effectiveness." This implies that the software performed as designed and met its functional and non-functional requirements.
Compliance with internal design control procedures	"Software verification and validation tests were performed on OPTIS Systems with AptiVue E.6 Software in compliance with internal design control procedures." This indicates that the testing followed the company's established quality system for software development and validation.
Safety and effectiveness (no new issues)	"does not raise any new issues of safety and effectiveness." This is a key regulatory acceptance criterion for 510(k) applications demonstrating substantial equivalence. The V&V testing confirms that the added features do not negatively impact the safety or effectiveness of the device compared to the predicate. This would involve risk analysis and mitigation for the new features.

The remaining requested information (2-9) pertains to clinical studies and performance evaluation of an AI/ML algorithm against a ground truth, which is explicitly stated as not included in this submission.

Here's a breakdown of why the other points cannot be answered:

Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/ML performance was used. The V&V testing would have involved engineering and software test cases, not patient data in the context of an AI performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for AI/ML performance was established or reviewed for this submission.
Adjudication method for the test set: Not applicable.
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 submission is about adding cloud connectivity, not about AI-assisted interpretation or improvement of human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission concerns software and hardware systems for imaging, FFR, and RFR; the "AptiVue™ Imaging Software" is part of the system, but the document does not indicate a distinct AI/ML algorithm for standalone diagnostic performance beyond what the predicate device already provided. The predicate's capabilities (OCT, FFR, RFR) involve algorithms, but this submission does not describe a new or modified AI/ML algorithm requiring standalone clinical validation.
The type of ground truth used: Not applicable, as no clinical ground truth assessment (e.g., pathology, outcomes data) was reported for this submission. The "ground truth" for the V&V of the new features would be the expected functional behavior according to design specifications.
The sample size for the training set: Not applicable, as no machine learning model training was described or modified for this submission.
How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily address an update to existing software with new cloud-based functionalities. It clearly states that "No clinical testing is provided." Therefore, the detailed questions about acceptance criteria for AI/ML performance, clinical test sets, experts, and ground truth are not relevant to the information contained within this specific document.

Summary

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September 8, 2023

Abbott Medical Derek Pike Senior Regulatory Affairs Specialist 4 Robbins Road Westford, Massachusetts 01886

Re: K232386

Trade/Device Name: ILUMIEN™ OPTISTM System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system. Regulatory Class: Class II Product Code: NQQ Dated: August 8. 2023 Received: August 9, 2023

Dear Derek Pike:

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.

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

Sincerely.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices 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) K232386

Device Name

ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6

Indications for Use (Describe)

The AptiVue™ E series software is intended to be used only with compatible OPTIS™ imaging systems.

Type of Use (Select one or both, as applicable)
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 5.0

510(k) SummaryPer 21 CFR §807.92
510(k) Number	K232386
Date Prepared	September 7, 2023
Submitter Name& Address	Abbott Medical4 Robbins RoadWestford, MA, 01886
Contact Person	Derek Pike978-467-5880
AlternativeContact Person	Mingzi Deng781-640-4474
Proprietary /Trade Name	ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ MobileSystem, with AptiVue™ Imaging Software version E.6
Common / UsualName	Ultrasonic Pulsed Echo Imaging System
ProductClassification	Product Code: NQQ
ProductRegulationNumber	21 CFR 892.1560
Predicate Device	ILUMIEN™ OPTIS™, OPTIS™ Integrated, OPTIS™ Mobile with AptiVueSoftware version E.5 (K183320), cleared April 2, 2019
DeviceDescription	OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) performOptical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), andResting Full-cycle Ratio (RFR) procedures and provides images of the coronaryarteries in patients who are candidates for transluminal interventional procedures.Version E.6 adds cloud connectivity to enable remote installation of softwareupdates and transmission of system telemetry data.
Indications forUse / IntendedUse	The AptiVue™ E series software is intended to be used only with compatibleOPTIS™ imaging systems.The OPTIS imaging system with a compatible Dragonfly™ imaging catheter isintended for the imaging of coronary arteries and is indicated in patients who arecandidates for transluminal interventional procedures. The compatible Dragonflyimaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. Thecompatible Dragonfly imaging catheters are not intended for use in the left maincoronary artery or in a target vessel which has undergone a previous bypassprocedure.The OPTIS imaging system is intended for use in the catheterization and relatedcardiovascular specialty laboratories and will further compute and display
Feature	Predicate Device:AptiVue Software version E.5 (K183320)	Proposed Device:AptiVue Software version E.6
IntendedUse	The AptiVue™ E-seriessoftware is intended for useonly with compatibleOPTIST™ imaging systems.OPTIST™ imaging systems areintended for use in thecatheterization and relatedcardiovascular specialtylaboratories.	Same
Indicationsfor UseComparison ofSubject toPredicate Device	AptiVue™ E series softwareis intended to be used onlywith compatible OPTISTMimaging systems.The OPTIST™ imaging systemwith a compatibleDragonfly™ imaging catheteris intended for the imaging ofcoronary arteries and isindicated in patients who arecandidates for transluminalinterventional procedures. Thecompatible Dragonflyimaging catheters are intendedfor use in vessels 2.0 to 3.5mm in diameter. Thecompatible Dragonflyimaging catheters are notintended for use in the leftmain coronary artery or in atarget vessel which hasundergone a previous bypassprocedure.The OPTIS imaging system isintended for use in thecatheterization and related	Same
		laboratories and will furthercompute and display variousphysiological parametersbased on the output from oneor more electrodes,transducers, or measuringdevices. The physician mayuse the acquired physiologicalparameters, along withknowledge of patient history,medical expertise, and clinicaljudgment to determine if
		therapeutic intervention isindicated.
Summary onNon-ClinicalTesting	Software verification and validation tests were performed on OPTIS Systemswith AptiVue E.6 Software in compliance with internal design controlprocedures. The results demonstrate that the AptiVue Software version E.6 meetsthe user needs and product specifications and is appropriate for its intended useand does not raise any new issues of safety and effectiveness.
Summary ofClinical Testing	No clinical testing is provided in this pre-market notification.
Statement ofEquivalence	OPTIS Systems with AptiVue Imaging Software version E.6 is substantiallyequivalent to the predicate OPTIS Systems with AptiVue Imaging Softwareversion E.5 (K183320) in terms of intended use, indications for use, operationalcharacteristics, fundamental design, and technological characteristics.

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Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.