NHancer Rx

K200324 · Imds Operations B.V. · DQY · Aug 6, 2020 · Cardiovascular

Device Facts

• Record ID: K200324
• Device Name: NHancer Rx
• Applicant: Imds Operations B.V.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

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 Story

NHancer Rx is a dual-lumen, rapid-exchange (Rx) guidewire support catheter; 135 cm length; compatible with 0.014" guidewires. Features an over-the-wire (OTW) lumen and a distal rapid-exchange lumen; includes a removable stylet for loading assistance. Distal shaft features hydrophilic coating; internal lumens feature MDX (silicone) coating. Used in clinical settings (e.g., cath lab) by physicians to facilitate vascular access, guidewire exchange, and contrast agent infusion. Radiopaque markers at distal tip and 8 mm from tip aid positioning. Device provides mechanical support for guidewires, enabling navigation through coronary/peripheral vasculature; improves procedural efficiency during wire exchanges.

Clinical Evidence

Bench testing only. Verification testing included kink resistance, flexibility, guidewire insertion, radiopacity, tensile strength, burst pressure, flow rate, leak testing, and coating integrity/lubricity. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility. All tests met acceptance criteria.

Technological Characteristics

Dual-lumen percutaneous catheter; polymeric shaft with stainless steel reinforcement. 135 cm effective length; 0.014" guidewire compatibility. Hydrophilic coating (PUR/PVP) on distal 15 cm; hydrophobic MDX (silicone) inner lumen coating. Tungsten radiopaque markers. Hub/Luer lock conforms to NEN EN ISO 80369-7. Max injection pressure 300 psi. Removable stylet included. Sterilization method not specified.

Indications for Use

Indicated for patients requiring coronary or peripheral vascular access for guidewire support, guidewire exchange, or diagnostic contrast agent delivery. Contraindicated for use in neurovasculature.

Regulatory Classification

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.

Predicate Devices

• Twin-Pass torque, dual access catheter (K162467)

Reference Devices

• NHancer guidewire support catheter (K121077)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known) K200324

Device Name NHancer Rx

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) Summary

[As required by 21 CFR 807.92]

#### Date Prepared: August 6th, 2020

| <b>Submitter's Name / Contact Person</b> | |
|------------------------------------------|------------------------------------|
| <b>Manufacturer</b> | <b>Contact Person</b> |
| IMDS Operations BV | Florence Wagter |
| Ceintuurbaan Noord 150 | Director of Quality and Regulatory |
| 9301 NZ Roden, The Netherlands | Tel: [phone] |
| Establishment Registration #3007740583 | Fax: [phone] |

#### 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<br>solutions, Inc. |
| Reference Device | K121077, NHancer guidewire support catheter |

#### 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

#### 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.

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

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| 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<br>NEN EN ISO 80369-7 | Female, 6% taper and screw conform<br>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<br>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.

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#### 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
- 2) Guide wire insertion
- 3) Radiopacity
- 4) Distal tip length
- 5) Tensile strength
- 6) Catheter body burst
- 7) Contrast medium flow rate
- 8) Leak testing
- 9) Effective length
- 10) Shaft inner diameter
- 11) Outer diameter
- 12) Surface coating lubricity
- 13) Coating Integrity
- 14) Coating Particulate Evaluation
- 15) 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.