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).

AI/ML Overview

The provided text describes the 510(k) submission for the NHancer™ guidewire support catheter. The device is a traditional guidewire support catheter, not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device submissions are not directly applicable.

However, I can extract the performance criteria and the study approach used to demonstrate substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the NHancer™ guidewire support catheter met all acceptance criteria. Specific quantitative acceptance criteria are not detailed in the provided text. Instead, the document focuses on demonstrating that the NHancer™ performed similarly or was substantially equivalent to the predicate device, the Spectranetics QuickCross® Support Catheter, for a range of performance characteristics.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (NHancer™)
Crossability (in-vitro & in-vivo)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Guidewire friction (in-vitro)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Guidewire Torqueability (in-vitro & in-vivo)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Flow rate (in-vitro)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Marker visibility (in-vivo)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Guidewire exchangeability (in-vivo)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Contrast medium administration (in-vivo)	Substantially equivalent to predicate	Met acceptance criteria (similar to predicate)
Usable length	Defined specification met	Met acceptance criteria
Length of coated part	Defined specification met	Met acceptance criteria
Tip inner diameter	Defined specification met	Met acceptance criteria
Tip length	Defined specification met	Met acceptance criteria
Outer diameter	Defined specification met	Met acceptance criteria
Pull strength after 5 rotations	Defined specification met	Met acceptance criteria
Burst strength after 5 rotations	Defined specification met	Met acceptance criteria
Flow rate testing (bench)	Defined specification met	Met acceptance criteria
System Burst testing	Defined specification met	Met acceptance criteria
6% taper Luer testing	Defined specification met	Met acceptance criteria
Screw connection Luer testing	Defined specification met	Met acceptance criteria
Female Hub	Defined specification met	Met acceptance criteria
Exit marker location	Defined specification met	Met acceptance criteria
Radiopaque marker location	Defined specification met	Met acceptance criteria
Visual appearance	Defined specification met	Met acceptance criteria
Force at break: shaft	Defined specification met	Met acceptance criteria
Force at break: shaft/hub connection	Defined specification met	Met acceptance criteria
Force at break: tip/shaft connection	Defined specification met	Met acceptance criteria
Outer diameter radiopaque marker	Defined specification met	Met acceptance criteria
Dimensions of packaging box	Defined specification met	Met acceptance criteria
Product integrity after simulated transportation test	Defined specification met	Met acceptance criteria
Pouch bubble test	Defined specification met	Met acceptance criteria
Liquid dye test	Defined specification met	Met acceptance criteria
Pouch seal strength	Defined specification met	Met acceptance criteria
Pouch seal width	Defined specification met	Met acceptance criteria
Label adhesive retention	Defined specification met	Met acceptance criteria
Legibility of product information	Defined specification met	Met acceptance criteria
Pouch delamination assessment after opening	Defined specification met	Met acceptance criteria
Kink resistance	Defined specification met	Met acceptance criteria
Torque testing	Defined specification met	Met acceptance criteria
Coating Integrity and Particulate Evaluation	Defined specification met	Met acceptance criteria
Biocompatibility (Thrombosis, Hemolysis, Cytotoxicity, Irritation, Sensitization, Systemic Toxicity)	Passed all tests	Successfully passed all tests
Sterility (SAL of 10^-6)	Meets ISO 11137 and 11737 standards	Validated in accordance with standards
Non-pyrogenicity	Endotoxin Kinetic Turbidimetric test passed	Successfully passed Endotoxin Turbidimetric test

2. Sample Size Used for the Test Set and Data Provenance:

The document details performance testing for both the NHancer™ and a predicate device. However, it does not specify the sample sizes used for the in-vitro and in-vivo tests. It only states that "Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter" and that various "bench tests were performed on NHancer™ guidewire support catheter."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based (in-vitro) and animal studies (in-vivo) conducted prospectively for the purpose of demonstrating regulatory compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically a concept used in the evaluation of AI/ML diagnostic or prognostic devices, where human expert labels are used to train and validate AI algorithms. For a guidewire support catheter, the "ground truth" is determined by objective performance measurements against engineering specifications and predicate device performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in AI/ML studies to resolve disagreements among human labelers for establishing ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with/without AI Assistance:

This information is not applicable as the NHancer™ is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, there are no "human readers" interpreting data with or without AI assistance, and no MRMC study would be conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

This information is not applicable as the NHancer™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the NHancer, the "ground truth" is based on:

Engineering specifications: For various dimensions, material properties, and functional tests (e.g., usable length, outer diameter, pull strength, burst strength, flow rate).
Performance relative to a predicate device: For clinical performance characteristics like crossability, guidewire friction, torqueability, marker visibility, guidewire exchangeability, and contrast administration. The predicate device's established performance serves as the benchmark.
International Standards: For biocompatibility (ISO 10993), sterility (ISO 11137, ISO 11737), and non-pyrogenicity (Ph. Eur. Chapter 2.6.14 Method C, USP).

8. The Sample Size for the Training Set:

This information is not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. The NHancer™ is a physical device and does not involve AI/ML.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

Summary

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TraditIonal 510(k) Submission for NHancer

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005_510(k) Summary

DEC 2 1 2012

A. Manufacturer - and Contact Information

Manufacturer:	IMDS Operations B.V.Ceintuurbaan Noord 1509301 NZ RodenThe NetherlandsTelephone: +31 50 8200 230Fax: +31 50 8200 231
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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

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E. Intended Use

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.

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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 QuickCrossSupport CatheterModel Number: 518-032	IMDS NHancer™ guidewiresupport catheterModel 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 screwconform ISO 594-1 and -2.	Female, 6% taper and screwconform ISO 594-1 and -2.
4	Number of radiopaque markers	3	1
6	Radiopaque marker material	Platinum	Platinum / Irridium
7	Effective Length or UsableLength	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 / PVPhydrophilic coating

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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

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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.

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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

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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

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Traditional 510(k) Submission for NHancer

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004_Indications for Use Statement

510(k) Number (if known): K121077

Device Name:

NHancer (model number: 8101-B140P)

Indications For Use:

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) Number	K121077
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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).