The NES Reprocessed Visions PV .014P 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 cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed .014P 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 Visions PV .014P 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 Visions PV .014P 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 tip. 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 VISIONS PV .014P 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

This document is a 510(k) premarket notification for a reprocessed medical device, specifically an Intravascular Ultrasound (IVUS) Catheter. The primary objective of this submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets new acceptance criteria for a novel technology through a clinical study with AI components.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device or a device with new performance claims are not applicable to this specific 510(k) submission.

This submission focuses on demonstrating that the reprocessed device maintains the same safety and effectiveness as the original, new device (predicate device). The "proof" relies on bench and laboratory testing, not on a clinical effectiveness study with human readers or AI.

Here's a breakdown of the requested information and why most of it is not explicitly addressed in this 510(k) summary:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not presented in a tabular format with specific numerical thresholds for clinical performance. The acceptance criteria for this reprocessed device revolve around demonstrating that its functional and safety characteristics are equivalent to the predicate device after reprocessing. This is shown through various tests of physical and functional integrity.
- Reported Device Performance: The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter." A list of tests is provided (e.g., Cleaning Validation, Sterilization Validation, Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility, Drying Validation, Packaging Validation, Biocompatibility). However, the specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria are not detailed in this summary. The conclusion is that the reprocessed device is "as safe and effective" as the predicate based on these tests.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each test. The testing involves reprocessed units of the IVUS catheter.
- Data Provenance: Not applicable in the context of clinical data for performance evaluation. The data comes from internal lab testing conducted by Northeast Scientific, Inc. It is not clinical patient data, therefore, retrospective/prospective or country of origin of data is not relevant here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable: This is not a study requiring expert readers to establish ground truth for clinical cases (e.g., image interpretation). The "ground truth" for this submission is established through validated engineering and biological testing methodologies (e.g., confirming sterility, dimensional accuracy, mechanical integrity).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: As above, this applies to studies with human readers interpreting data, which is not the nature of the testing described in this 510(k) summary.
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 is not a study assessing the effectiveness of an AI component or the improvement of human readers. This device is an IVUS catheter, an imaging tool; there is no mention of an associated AI component to assist readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: There is no algorithm or AI component discussed for standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" for this submission is derived from benchmarks and specifications of the original new device and validated test methods (e.g., sterility testing, dimensional measurements, mechanical force testing). The reprocessed device is tested to ensure it meets these established engineering and biological standards, demonstrating equivalence to the predicate.
The sample size for the training set:
- Not Applicable: This is not a machine learning/AI device, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable: No training set exists for this device.

In summary, for this particular 510(k) submission for a reprocessed IVUS catheter, the "acceptance criteria" and "proof" primarily revolve around demonstrating that the reprocessed device performs equivalently to the original, new device through a battery of non-clinical, benchtop, and laboratory tests. The summary provided does not contain the detailed numerical results or specific sample sizes for these tests, but merely lists the categories of testing performed to support the claim of substantial equivalence. The questions regarding AI, human readers, and clinical ground truth are not relevant to this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 22, 2020

Northeast Scientific, Inc. Matthew Farley Director, Regulatory & Quality 2142 Thomaston Ave. Waterbury, Connecticut 06704

Re: K200195

Trade/Device Name: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: May 21, 2020 Received: May 22, 2020

Dear Matthew 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 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

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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.

Mark S.
Fellman -S

Mark Fellman 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 510(k) submission are as follows:

Description	ItemNumber	FrenchSize	GuideWire	MinimumSheath	Length (cm)
NES ReprocessedVisions PV .014P RXDigital IVUS Catheter	014R	3.5F	0.014"	5F	150 cm

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Indications for Use

510(k) Number (if known) K200195

Device Name

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Indications for Use (Describe)

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

× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Farlev Director, Regulatory & Quality Northeast Scientific, Inc. 203-756-2111 (office) 203-757-5532 (fax) matt@smarthealth-care.com

Date Prepared: December 30th, 2019

Device Information:

Trade/Proprietary Name:	NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Common or Usual Name:	Ultrasonic Imaging Catheter
Classification Name:	Diagnostic Intravascular Catheter
Classification Number:	Class II, 21 CFR 870.1200
Product Code:	OWQ
510(k) Number:	K200195

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K152829	Visions PV.014P RX Digital IVUS Catheter	Volcano Corporation

Table 5.1 – Predicate Device

Device Description:

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The VISIONS PV .014P 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.

Description	Item Number	French Size	Guide Wire	MinimumSheath	Length (cm)
Visions PV.014P RXDigital IVUS Catheter	014R	3.5F	0.014"	5F	150 cm

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

Table 5.2 - Device Scope

Indications for Use:

The NES Reprocessed Visions PV .014P 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 Visions PV .014P 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 Visions PV .014P RX Digital IVUS Catheter. This included the following:

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

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.

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Conclusion:

Northeast Scientific, Inc. concludes that the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein.

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

Description	Item Number	French Size	Guide Wire	Minimum Sheath	Length (cm)
Visions PV.014P RXDigital IVUS Catheter	014R	3.5F	0.014"	5F	150 cm

Table 1: Device Description

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).