K Number

Device Name

NHancer Rx

Manufacturer

IMDS Operations B.V.

Date Cleared

2020-08-06

(178 days)

Product Code

DQY

Regulation Number

870.1250

Intended Use

The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

Device Description

The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014" Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014"/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen. To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the entire lumens of the NHancer Rx are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162467

Reference Devices

K121077

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is described as a catheter intended to support a guidewire, allow for guidewire exchange, and deliver diagnostic contrast agents during vascular access procedures, rather than directly treating a disease or condition.

Diagnostic

The device is intended to deliver diagnostic contrast agents, not to perform diagnostics itself. It is a support catheter for guide wires and agent delivery.

SaMD (Software as a Medical Device)

The device description clearly details a physical catheter with lumens, coatings, markers, and a stylet, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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 supporting a guide wire, exchanging guide wires, and delivering diagnostic contrast agents within the coronary and/or peripheral vasculature. This is an in vivo application, meaning it's used inside the living body.
Device Description: The description details a catheter designed for insertion into blood vessels.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body for interventional procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DQY

Device Description

To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the entire lumens of the NHancer Rx are coated with MDX (silicone) coating.

To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and/or 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)

The device design has been verified through the following tests:

1. Kind resistance/ flexibility
1. Guide wire insertion
1. Radiopacity
1. Distal tip length
1. Tensile strength
1. Catheter body burst
1. Contrast medium flow rate
1. Leak testing
1. Effective length
1. Shaft inner diameter
1. Outer diameter
1. Surface coating lubricity
1. Coating Integrity
1. Coating Particulate Evaluation
1. Packaging integrity

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

Cytotoxicity
Sensitization
Irritation
Systemic toxicity
Pyrogenicity
Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162467

Reference Device(s)

K121077

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

August 6, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 Roden, 9301 NA NI

Re: K200324

Trade/Device Name: NHancer Rx Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 2, 2020 Received: July 6, 2020

Dear Edwin Schulting:

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 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 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.

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K200324

Device Name NHancer Rx

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]

Date Prepared: August 6th, 2020

Submitter's Name / Contact Person
Manufacturer	Contact Person
IMDS Operations BV	Florence Wagter
Ceintuurbaan Noord 150	Director of Quality and Regulatory
9301 NZ Roden, The Netherlands	Tel: 0031651453880
Establishment Registration #3007740583	Fax: 0031508200231

General Information

Trade Name	NHancer Rx
Common/Usual Name	Dual lumen catheter
Classification Name	Catheter, percutaneous
Predicate Device	K162467, Twin-Pass torque, dual access catheter, Vascular
solutions, Inc.
Reference Device	K121077, NHancer guidewire support catheter

Device Description

To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen

Intended Use

Technological Characteristics Comparison

The NHancer Rx is similar in design to the predicate device and both are dual lumen, percutaneous catheters intended to access discrete regions of the coronary and peripheral vasculature, facilitate placement and exchange of guidewires and sub selectively infuse agents.

| # | Item | NHancer Rx
dual lumen guidewire support
catheter | Twin-Pass Torque dual access
catheter |
|---|-----------------------|--------------------------------------------------------|------------------------------------------|
| | Model number | NRX1413518 | 5201 |
| 1 | Type clinically based | Dual lumen guidewire support catheter | Dual lumen guidewire support catheter |
| 2 | Shaft material | Polymeric | Polymeric |

3	Shaft reinforcement	Stainless steel	Stainless steel
4	OTW Guidewire lumens	1	1
5	Rapid Exchange guidewire lumens	1	1
6	Number of guidewire distal exit ports	2	2
7	Strain Relief	present	present
8	Hub and Luer Lock	Female, 6% taper and screw conform
NEN EN ISO 80369-7	Female, 6% taper and screw conform
NEN EN ISO 80369-7
9	Radiopaque marker material	Tungsten	Pt/Ir
10	Effective Length or Usable Length	135 cm	135 cm
11	Exit Marker location (from tip)	95 and 105 cm	95 and 105 cm
12	Guidewire compatibility	0.014 inch	0.014 inch
13	Maximum injection pressure	300 psi	300 psi
14	Minimum Guiding Catheter size	5 Fr	5 Fr
15	Tip design / shape	Straight	Straight
16	Tip material	Polymeric	Polymeric
17	Hydrophilic coating distal shaft	present	present
18	Hydrophilic coating material	PUR / PVP
hydrophilic coating	Not known
19	Inner lumen coating	Hydrophobic	Not known
20	Removable stylet in OTW lumen	Yes	No
21	Distal shaft design	Oval	Round

With the exception of dimensional, material and package configuration differences, the NHancer Rx is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests.

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The NHancer Rx dual lumen catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

1. Kind resistance/ flexibility
1. Guide wire insertion
1. Radiopacity
1. Distal tip length
1. Tensile strength
1. Catheter body burst
1. Contrast medium flow rate
1. Leak testing
1. Effective length
1. Shaft inner diameter
1. Outer diameter
1. Surface coating lubricity
1. Coating Integrity
1. Coating Particulate Evaluation
1. Packaging integrity

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

Cytotoxicity ●
Sensitization
Irritation ●
Systemic toxicity
Pyrogenicity
Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.

Therefore, the NHancer Rx dual lumen catheter is substantially equivalent to the predicate device.