The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Device Description

The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories.

AI/ML Overview

The provided 510(k) summary for the Terumo Runthrough NS guide wire describes a device intended to facilitate placement of balloon dilatation catheters. It's important to note that this submission focuses on demonstrating substantial equivalence to a predicate device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445), rather than proving the device meets a set of clinical performance acceptance criteria in the way an AI/software device would.

Therefore, many of the requested categories related to AI performance, such as sample size for training/test sets, ground truth establishment for AI, expert consensus, MRMC studies, and standalone AI performance, are not applicable to this type of device submission. The "acceptance criteria" here are defined by demonstrating equivalence through a series of engineering/physical tests.

Here's the information that can be extracted or inferred from the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating that the Runthrough NS performs equivalently to the predicate device across a range of physical and mechanical characteristics. The "performance" is reported as "substantial equivalence" based on the results of the verification tests.

Acceptance Criteria (Implicitly, Equivalence to Predicate)	Reported Device Performance (Runthrough NS)
Dimensional Accuracy	Performed Dimensional Inspection
Resistance to Tip Sliding	Performed Tip sliding resistance test
Tip Tensile Strength	Performed Tensile strength of tip
Tip Butting Load	Performed Tip butting load
Shaft Tensile Strength	Performed Tensile strength of shaft
Wire Stability in Holder Loop	Performed Wire stability in holder loop
Bend Strength	Performed Bend strength
Seal Strength of Packaging	Performed Seal strength of packaging
Reshapability	Performed Reshapability
Torque Strength	Performed Torque Strength
Torqueability	Performed Torqueability
Tip Flexibility	Performed Tip Flexibility
Coating Adherence/Integrity	Performed Coating Adherence/Integrity
Biocompatibility	Tested according to ISO-10993
Sterility Assurance Level (SAL)	Validated to SAL of 10-6 per ANSI/AAMI/ISO 11135

The document states: "None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness. Therefore the performance of the modified Runthrough NS is substantially equivalent to the performance of the predicate device..."

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

Sample Size for Test Set: Not specified in terms of clinical or imaging data. The "test set" refers to physical samples of the device undergoing engineering verification tests. The number of physical units tested for each criterion is not disclosed.
Data Provenance: Not applicable in the context of clinical data. The performance data comes from internal laboratory testing of the device itself.

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

Not applicable. Ground truth in the context of AI refers to labels or diagnoses provided by experts. For this medical device, "ground truth" would be the known physical properties and performance of the predicate device, against which the modified device's performance is compared through engineering tests. The "experts" involved would be the engineers and technicians performing and assessing these tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to human readers reviewing clinical cases for ground truth establishment. Here, the "adjudication" is based on comparing engineering test results of the new device against established benchmarks or the predicate device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a guide wire.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical guide wire, not a software algorithm.

7. Type of Ground Truth Used

For the engineering performance tests, the "ground truth" is implicitly the known and acceptable performance specifications for a guide wire of this type, often derived from prior knowledge of the predicate device and relevant industry standards. For biocompatibility, the ground truth is established by the specified ISO-10993 standards. For sterility, it's defined by ANSI / AAMI / ISO 11135-1994.

8. Sample Size for the Training Set

Not applicable. This refers to AI/machine learning.

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

Not applicable. This refers to AI/machine learning.

Summary

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Kd63695

SECTION II. 510(K) SUMMARY

A. Device Name

APR 2 7 2007

Proprietary Name	Runthrough NS
Classification Name	Wire, Guide, Catheter
Common Name	Guide Wire

B. Intended Use

The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Note: This is the same intended use as the predicate device - Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445.

C. Device Description

D. Principle Of Operation / Technology

The Runthrough NS is operated manually or by a manual process.

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E. Design / Materials

Differences in materials between the modified device and the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil cleared under K961445 raise no new issues of safety and effectiveness.

F. Specifications

Feature	Modified Runthrough NS	Unmodified DeviceRadifocus® Glidewirefor Coronary Use withPlatinum or Gold Coilcleared under K961445
Available diameter	0.014" ( 0.36mm )	0.014" ( 0.36mm )
Available length	180cm, 300cm	180cm, 300cm
Tip marker length	30mm	20mm
Accessory Devices	Torque Device, Inserter,Stylet	Torque Device, Inserter
Shelf life	36 months	24 months

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G. Performance

The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS) to the unmodified device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445).

. Dimensional Inspection
Tip sliding resistance test
Tensile strength of tip .
Tip butting load ●
Tensile strength of shaft .
Wire stability in holder loop .
Bend strength ●
Seal strength of packaging .
Reshapability .
Torque Strength ●
Torqueability .
Tip Flexibility .
Coating Adherence/Integrity .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Therefore the performance of the modified Runthrough NS is substantially equivalent to the performance of the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445.

H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

The guide wire is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (< 24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.

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Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994, Medical Devices – Validation and routine control of ethylene oxide sterilization and EN 550. The device is sterilized to a SAL of 10-6.

H. Substantial Equivalence

The modified Runthrough NS is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445. Differences between the two devices do not raise any significant issues of safety or effectiveness.

I. Submitter Information

Prepared By:	Mr. Mark UnterreinerSr. Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com
Date Prepared:	December 12, 2006

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2007

Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K063695 Runthrough NS Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: II (two) Product Code: DQX Dated: April 4, 2007 Received: April 5, 2007

Dear Mr. Unterreiner:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Mark Unterreiner

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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna R. Lachner

Image /page/5/Picture/5 description: The image contains a signature and the words "Brian" and "Director". The signature is a stylized, illegible mark, possibly initials. The text is in a simple, sans-serif font and is positioned to the right of the signature.

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

Enclosure

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Indications for Use

510(k) Number (if known): _ Ko (e 3695

Device Name:__________________________________________________________________________________________________________________________________________________________________ Runthrough NS

Indications For Use:

The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the contraction of the comments of the comments of the contribution of

Duna R. Vechner

Jivision Sign-Off) wision of Cardiovascular Device

10(k) Number_Ko63695

00005

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.