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K Number
K121077
Device Name
NHANCER
Manufacturer
IMDS OPERATIONS B.V.
Date Cleared
2012-12-21

(256 days)

Product Code
DQY
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.
Device Description
The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).
More Information

K033678

K033678

No
The description focuses on the physical components and mechanical function of a guidewire support catheter, with no mention of AI or ML.

No.
The device is a guidewire support catheter designed to facilitate guidewire placement and exchange, and for diagnostic contrast delivery, rather than directly treating a disease or condition. Its purpose is procedural assistance.

Yes

The intended use explicitly states that the device "provides a conduit for the delivery of diagnostic contrast agents," indicating a diagnostic function.

No

The device description clearly outlines a physical medical device (catheter, shaft, tip, luer, torquer, etc.) and the performance studies involve bench testing and in-vivo testing of these physical components. There is no mention of software as the primary or sole component.

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 guidewire, exchanging guidewires, and delivering diagnostic contrast agents within the vascular system. This is an interventional procedure performed directly on the patient.
  • Device Description: The description details a physical catheter designed for use within the body.
  • 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.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used to perform tests on samples taken from the body, while this device is used directly within the body during a medical procedure.

N/A

Intended Use / Indications for Use

The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

Product codes

DQY

Device Description

The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vascular system

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 NHancer™ guidewire support catheter in this submission and the Spectranetics QuickCross® Support Catheter, cleared under K033678, have similar performance characteristics. The following performance tests were conducted on these catheters. Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter.

    1. Crossability (both in-vitro as well as in-vivo)
    1. Guide wire friction (in-vitro)
    1. Guidewire Torqueability (both in-vitro as well as in-vivo)
    1. Flow rate (in-vitro)
  • Marker visibility (in-vivo)
    1. Guidewire exchangeability (in-vivo)
    1. Contrast medium administration (in-vivo)

The performance of the NHancer™ guidewire support catheter is substantially equivalent to the performance of the predicate device (Spectranetics QuickCross® Support Catheter). The performance of the NHancer™ guidewire support catheter met all the acceptance criteria.

In addition, the following bench tests were performed on NHancer™ guidewire support catheter to assure proper performance. All test results met the acceptance criteria.

    1. Usable length
    1. Length of coated part
  • Tip inner diameter
    1. Tip length
  • Outer diameter
  • Pull strength after 5 rotations
  • Burst strength after 5 rotations
    1. Flow rate testing
  • System Burst testing
    1. 6% taper Luer testing
    1. Screw connection Luer testing
    1. Female Hub
    1. Exit marker location
    1. Radiopaque marker location
    1. Visual appearance
    1. Force at break: shaft
    1. Force at break: shaft/hub connection
    1. Force at break: tip/shaft connection
    1. Outer diameter radiopaque marker
    1. Dimensions of packaging box
    1. Product integrity after simulated transportation test
    1. Pouch bubble test
    1. Liquid dye test
    1. Pouch seal strength
  • 25} Pouch seal width
    1. Label adhesive retention
    1. Legibility of product information
    1. Pouch delamination assessment after opening
    1. Kink resistance
    1. Torque testing
    1. Coating Integrity and Particulate Evaluation

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

Not Found

Predicate Device(s)

K033678

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

TraditIonal 510(k) Submission for NHancer

Image /page/0/Picture/1 description: The image shows the text "K121077 Page 1 of 5 IMDS". The text appears to be handwritten. The letters are in black ink on a white background. The word "IMDS" is in a different font than the rest of the text.

005_510(k) Summary

DEC 2 1 2012

A. Manufacturer - and Contact Information

| Manufacturer: | IMDS Operations B.V.
Ceintuurbaan Noord 150
9301 NZ Roden
The Netherlands
Telephone: +31 50 8200 230
Fax: +31 50 8200 231 |

---------------------------------------------------------------------------------------------------------------------------------------------------------

Contact Person: Mr. E. Schulting Managing Director Telephone: +31 50 8200 230 e-mail: eschulting@imds.nl

Date of preparation: 04 April 2012

B. Reason for Premarket Notification

This Premarket Notification is being submitted for the NHancer™ guidewire support catheter which is a new device being manufactured by IMDS Operations B.V.

C. Device Information

Trade Name:NHancerTM
Common Name:0.014" guidewire support catheter
Classification Name:Percutaneous Catheter (21 CFR 870.1250, product Code DQY)

D. Device Description

The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).

1

Image /page/1/Picture/1 description: The image shows the text "K121077 Page 2 of 5 IMDS". The text appears to be handwritten. The letters and numbers are black against a white background. There is a logo next to the word "of".

E. Intended Use

The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

F. Principle of Operation / Technology

The NHancer™ guidewire support catheter is operated manually or by manual process.

During an interventional procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then a guiding catheter or sheath would be advanced over the guide wire. Next, the NHancer™ guidewire support catheter would be inserted over the guide wire and through the hemostasis valve of the guiding catheter or sheath. The guide wire and NHancer™ guidewire support catheter would then be advanced to the target vessel. The NHancer™ guidewire support catheter can then be used for support and exchange of guide wires or for injection of contrast media.

G. Statement of Equivalence

The NHancer™ guidewire support catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology, principles of operation, materials and performance to the Spectranetics QuickCross® Support Catheters, cleared under K033678.

2

K121077 Page 3 of 5
IMDS

H. Design / Materials / Specifications

The NHancer™ guidewire support catheter in this submission uses a similar design, similar materials and specifications as the predicate device: Spectranetics QuickCross® Support Catheter. Differences in design, materials and/or specifications between the devices do not raise any issues of safety and effectiveness. Below is a table with a comparison of the design, materials and specifications between the NHancer™ guidewire support catheter and the predicate devices.

| # | Item | Predicate Device:
Spectranetics QuickCross
Support Catheter
Model Number: 518-032 | IMDS NHancer™ guidewire
support catheter
Model Number: 8101-B140P |
|----|--------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 1 | Design / construction | OTW, single lumen | OTW, single lumen |
| 2 | Shaft material | Polyethylene | Pebax / Polyethylene |
| 3 | Strain Relief | present | present |
| 4 | Luer Lock or Hub | Female, 6% taper and screw
conform ISO 594-1 and -2. | Female, 6% taper and screw
conform ISO 594-1 and -2. |
| 4 | Number of radiopaque markers | 3 | 1 |
| 6 | Radiopaque marker material | Platinum | Platinum / Irridium |
| 7 | Effective Length or Usable
Length | 135 cm | 140 cm |
| 8 | Exit Marker location | none | 95 and 105 cm |
| 9 | Guide wire compatibility | 0.014 inch | 0.014 inch |
| 10 | Maximum Injection pressure | 300 psi | 300 psi |
| 11 | Outer Diameter Shaft | 0.76 mm | 0.75 mm |
| 12 | Minimum Guiding Catheter | 5 Fr | 5 Fr |
| 13 | Tip design / shape | Straight | Straight |
| 14 | Hydrophilic coating length | Distal 40 cm | Distal 25 cm |
| 15 | Hydrophilic coating material | not known | PU / PVP
hydrophilic coating |

3

K121077 Page 4 of 5

IMDS

ﻟــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ Performance

The NHancer™ guidewire support catheter in this submission and the Spectranetics QuickCross® Support Catheter, cleared under K033678, have similar performance characteristics. The following performance tests were conducted on these catheters. Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter.

    1. Crossability (both in-vitro as well as in-vivo)
    1. Guide wire friction (in-vitro)
    1. Guidewire Torqueability (both in-vitro as well as in-vivo)
    1. Flow rate (in-vitro)
  • Marker visibility (in-vivo) ട)
    1. Guidewire exchangeability (in-vivo)
    1. Contrast medium administration (in-vivo)

The performance of the NHancer™ guidewire support catheter is substantially equivalent to the performance of the predicate device (Spectranetics QuickCross® Support Catheter). The performance of the NHancer™ guidewire support catheter met all the acceptance criteria.

In addition, the following bench tests were performed on NHancer™ guidewire support catheter to assure proper performance. All test results met the acceptance criteria.

    1. Usable length
    1. Length of coated part
  • Tip inner diameter 3)
    1. Tip length
  • Outer diameter 5)
  • Pull strength after 5 rotations 6)
  • Burst strength after 5 rotations 7)
    1. Flow rate testing
  • System Burst testing 9)
    1. 6% taper Luer testing
    1. Screw connection Luer testing
    1. Female Hub
    1. Exit marker location
    1. Radiopaque marker location
    1. Visual appearance
    1. Force at break: shaft
    1. Force at break: shaft/hub connection
    1. Force at break: tip/shaft connection
    1. Outer diameter radiopaque marker
    1. Dimensions of packaging box
    1. Product integrity after simulated transportation test
    1. Pouch bubble test
    1. Liquid dye test
    1. Pouch seal strength
  • 25} Pouch seal width
    1. Label adhesive retention
    1. Legibility of product information
    1. Pouch delamination assessment after opening
    1. Kink resistance
    1. Torque testing
    1. Coating Integrity and Particulate Evaluation

4

K 121077 Page 5 of 5

IMDS

J. Additional Safety Information

Biocompatibility testing was performed in accordance with the Blue Book Memorandum, G95-1. Use of International Standard ISO 10993, and Biological Evaluation of Medical Devices part 1: Evaluation and Testing. The NHancer™ guidewire support catheter is classified as an externally communication device. circulating blood, limited contact (up to 24 hrs), which resulted in the following tests:

    1. Thrombosis testing
    1. Hemolysis testing
    1. Cytotoxicity (Growth Inhibition test)
    1. Irritation {Intracutaneous Reactivity}
    1. Sensitation (Local Lymph Node Assy)
  • ର୍ଚ୍ଚ Systemic Toxicity (Acute Systemic Toxicity)

The NHancer " guidewire support catheter successfully passed all above listed biocompatibility tests.

The NHancer®1 guidewire support catheter is sterilized by means of irradiation (gamma irradiation). The sterility has been validated in accordance with the applicable parts of the ISO 11137 standard (part 1: 2006, part 2: 2006) and ISO 11737 standard (part 1: 2006, part 2: 2009) to provide a Sterility Assurance Level (SAL) of 10to.

The NHancer™ guidewire support catheter is certified to be non-pyrogenic in the unopened and undamaged package. An Endotoxin Kinetic Turbidimetric test has been performed and will be performed for future production batches in accordance with current Ph. Eur. Chapter 2.6.14 Method C, kinetic turbidimetric test, as well as current USP, the harmonized part of chapter 15 and chapter 161. Initial production batches of the NHancer™ guidewire support catheter successfully passed the Endotoxin Turbidimetric test.

K. Substantial Equivalence

The NHancer™ guidewire support catheter submitted in this 510(k) is substantially equivalent in the general intended use, design, materials, specifications, principles of operation / technology, and performance to the Spectranetics QuickCross Support Catheter cleared under K033678. Differences between the devices do not raise any issue of safety or effectiveness.

5

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a human figure embracing a bird or other winged creature. The image is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 2 1 2012

IMDS Operations B.V. c/o Mr. E. Schulting Managing Director Ceintuurbann Noord 150 9301 NZ Roden The Netherlands

Re: K121077

Trade/Device Name: NHancer guidewire support catheter Regulation Number: 21 CFR 870.1250 . Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 22, 2012 Received: November 26, 2012

Dear Mr. 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. 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 (IPMA), 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

6

Page 2 - Mr. Schulting

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Matthew G. Hillebrenner

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

7

Traditional 510(k) Submission for NHancer

Image /page/7/Picture/1 description: The image shows a logo with the letters "IMDS" in bold, sans-serif font. Above the letters is a stylized graphic of an animal, possibly a badger or similar creature, rendered in black and white. The animal is depicted in a simplified, almost abstract manner, with its head and upper body visible.

004_Indications for Use Statement

510(k) Number (if known): K121077

Device Name:

NHancer (model number: 8101-B140P)

Indications For Use:

The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

Prescription Use X

AND/OR

Over-The-Counter Use N/A

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . .

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) NumberK121077
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