(147 days)
Not Found
No
The summary describes a standard ultrasound catheter and its physical characteristics, intended use, and compatibility with imaging systems. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used for imaging and evaluation of vascular morphology, not for treating conditions.
Yes
The device is designed for "evaluation of vascular morphology" and provides "a cross-sectional image of such vessels," which are diagnostic functions. It generates "real-time images of the coronary and peripheral vessels," aiding in the diagnosis of vascular conditions.
No
The device description clearly details a physical catheter with an ultrasound transducer array, guide wire lumen, radiopaque markers, and a hydrophilic coating. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels." This is a direct imaging and diagnostic procedure performed in vivo (within the living body).
- Device Description: The description details an ultrasound catheter that is introduced into the vascular system to generate real-time images. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs typically involve reagents, assays, or other methods for analyzing samples.
Therefore, the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
OWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
The item numbers included in the scope of this 510(k) submission are as follows:
| Description | Item
Number | French
Size | Guide
Wire | Minimum
Sheath | Length (cm) |
|-----------------------------------------------------------------|----------------|----------------|---------------|-------------------|-------------|
| NES Reprocessed
Visions PV .014P RX
Digital IVUS Catheter | 014R | 3.5F | 0.014" | 5F | 150 cm |
3
Indications for Use
510(k) Number (if known) K200195
Device Name
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Indications for Use (Describe)
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.
| 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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4
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:
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.
5
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 | Minimum
Sheath | Length (cm) |
|---------------------------------------------|-------------|-------------|------------|-------------------|-------------|
| Visions PV.014P RX
Digital 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.
6
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.
7
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 RX | |||||
| Digital IVUS Catheter | 014R | 3.5F | 0.014" | 5F | 150 cm |
Table 1: Device Description