The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Device Description

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter is introduced percutaneously or via surgical cutdown into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. The document details the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices.

However, the information provided does not include acceptance criteria or a study directly proving the device meets specific performance metrics in terms of diagnostic accuracy or clinical effectiveness in the way a typical AI/ML medical device would. This is because the device described is an intravascular ultrasound (IVUS) catheter, which is a hardware device used to acquire images, not an algorithm that interprets images or makes diagnoses.

The "studies" mentioned are primarily bench and laboratory testing to demonstrate the functionality, safety, and effectiveness of the reprocessed catheter, ensuring it performs identically to a new, original catheter. These tests focus on aspects like cleaning, sterilization, mechanical characteristics, system compatibility, and biocompatibility, which are typical for reprocessed medical devices.

Therefore, many of the requested categories (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of device and its regulatory submission.

Here's a breakdown based on the available information, with explanations for why certain categories are not present:

Acceptance Criteria and Device Performance (Based on available information)

Characteristic/Test	Acceptance Criteria (Implied)	Reported Device Performance
Cleaning Validation	Demonstrated effective removal of visible soil and contaminants.	Performed and validated as effective.
Sterilization Validation	Validated to achieve specified sterility assurance levels.	Performed and validated.
Functional Testing	Device functions as intended, identical to predicate device.	Visual Inspection: AcceptableDimensional Verification: AcceptableSimulated Use: AcceptableMechanical Characteristics: AcceptableHydrophilic Coating: AcceptableSystem Compatibility: Acceptable (with Volcano s5 Series or CORE Series)
Drying Validation	Demonstrated effective drying process.	Performed and validated.
Packaging Validation	Maintained device integrity and sterility.	Performed and validated.
Biocompatibility	Demonstrated to be biocompatible, no adverse biological reactions.	Performed and validated.
Reprocessing Cycle Limit	Reprocessed no more than one (1) time.	Each device is marked and rejected from further reprocessing after max cycles.

Study Details and Data Provenance (Not Applicable in the typical sense for an AI/ML device)

Sample Size Used for the Test Set and Data Provenance:
- Not applicable for diagnostic performance as an algorithm. The "test set" here refers to the actual reprocessed catheters undergoing quality control. The document does not specify exact numbers of catheters tested for each validation section, but states "bench and laboratory testing was conducted," implying a sufficient sample size for these validation types. Data provenance is internal to Northeast Scientific, Inc.'s reprocessing and testing procedures.
Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a diagnostic algorithm is not generally established in this context. The "ground truth" for these tests would be established by validated test methods, reference standards, and specifications (e.g., a specific tensile strength, a certain level of microbial reduction, or successful image acquisition when connected to a compatible system). These are typically verified by qualified engineers and technicians, not clinical experts for diagnostic accuracy.
Adjudication method for the test set:
- Not applicable. Not a diagnostic study requiring expert adjudication. Test results are compared against predetermined specifications and validated methods.
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. This device is an IVUS catheter, not an AI or imaging interpretation algorithm. Therefore, no MRMC study, AI assistance performance, or human reader improvement metric is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; there is no standalone algorithm performance to evaluate.
The type of ground truth used:
- The "ground truth" for the reprocessed catheter's performance is its functional equivalence to the original, new device and compliance with established performance specifications. This is demonstrated through various engineering, mechanical, material, and biological tests (e.g., cleaning efficacy, tensile strength, sterility, biocompatibility standards), not clinical diagnostic ground truth like pathology or outcomes data.
The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

In summary: The submission for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter focuses on demonstrating that the reprocessed device is as safe and effective as the original predicate device through rigorous bench and laboratory testing. The criteria and studies are designed to prove manufacturing and functional equivalence of a reprocessed medical device, rather than the diagnostic interpretive performance of an AI/ML system.

Summary

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February 3, 2023

Northeast Scientific, Inc. Matt Farley Director of Product Development 2142 Thomaston Ave. Waterbury, Connecticut 06704

Re: K223026

Trade/Device Name: NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: November 30, 2022 Received: November 30, 2022

Dear Matt Farley:

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

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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); 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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The item numbers included in the scope of this submission are as follows:

Description	Item Number	French Size	Guide Wire	MinimumSheath	Length (cm)
Eagle Eye Platinum RXDigital IVUS Catheter	85900P	3.5F	0.014"	5F	150 cm

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223026

Device Name

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Indications for Use (Describe)

The NES Reprocessed Eagle Eve Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

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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SECTION 5: 510(k) SUMMARY

As required by 21 CFR 807.92(c)

Submitter's Name and Address:

Northeast Scientific, Inc. (NES) 2142 Thomaston Ave. Waterbury, CT 06704

Contact Name and Information:

Matt Farley Director of Product Development Northeast Scientific, Inc. 203-756-2111 (office) 203-757-5532 (fax) matt@smarthealth-care.com

Date Prepared:

November 30th, 2022

Device Information:

Trade/Proprietary Name:	NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Common or Usual Name:	Ultrasonic Imaging Catheter
Classification Name:	Diagnostic Intravascular Catheter
Review Panel:	Cardiovascular
Classification Number:	Class II, 21 CFR 870.1200
Product Code:	OWO. OBJ

Predicate Device:

510(k) Number	510(k) Title	Manufacturer	Applicant
K210655	Reprocessed Eagle Eye Platinum RXDigital IVUS Catheter	Northeast Scientific, Inc.	Innovative Health, LLC.
K200195	NES Reprocessed Visions PV .014p RXDigital IVUS Catheter	Northeast Scientific, Inc.	NortheastScientific, Inc.

Table 5.1 – Predicate Device

Device Description:

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The Eagle Eye catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

The item numbers in scope of this submission are as follows:
--------------------------------------------------------------	--

Description	Item Number	French Size	Guide Wire	MinimumSheath	Length (cm)
Eagle Eye Platinum RXDigital IVUS Catheter	85900P	3.5F	0.014"	5F	150 cm

Table 5.2 – Device Scope

Indications for Use:

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a crosssectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Northeast Scientific's reprocessing of the Catheter includes removal of visible soil and decontamination. Each device is inspected and functionally tested prior to packaging and labeling.

Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. This included the following:

. Cleaning Validation
. Sterilization Validation
Functional testing
- Visual Inspection O
- Dimensional Verification O
- o Simulated Use
- Mechanical Characteristics O
- o Hydrophilic Coating
- O System Compatibility
Drying Validation ●
Packaging Validation
Biocompatibility

K223026 Traditional 510(k)

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The catheter is reprocessed no more than one (1) time. Each device is marked during reprocessing. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Northeast Scientific. Northeast Scientific restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Northeast Scientific, Inc. concludes that the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).