(21 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device, a guide wire, facilitates the placement of other therapeutic devices (balloon dilatation catheters) but is not itself performing a therapeutic function. It is an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
The provided text describes a guide wire used to facilitate the placement of other medical devices for therapeutic procedures (angioplasty), not for diagnosing a condition or disease.
No
The device description clearly outlines physical components made of Ni/Ti alloy, stainless steel, and Pt/Ni alloy, along with coatings and accessories, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA)." This describes a device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical guide wire with components like a core wire, tip coil, and coatings. It's designed to be inserted into the vasculature.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device described is a medical device used in interventional cardiology and radiology procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Runthrough NS Extension Wire are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Product codes
DQX
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 surface-coated 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. An extension wire is available to connect to the proximal end of the 180cm wire when the physician wants to convert from a monorail catheter system to an over the wire system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS Extension Wire) to the unmodified device (Runthrough NS K063695).
- Dimensional Inspection.
- Tensile strength of tip
- Extension wire connection strength
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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SECTION II. 510(K) SUMMARY
A. Device Name
| Proprietary Name | Runthrough NS Extension Wire |
|---|---|
| Classification Name | Wire, Guide, Catheter |
| Common Name | Guide Wire |
B. Intended Use
The Runthrouh NS Extension Wire are used to facilitate the 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 - Runthrough NS K063695
C. 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. An extension wire is available to connect to the proximal end of the 180cm wire when the physician wants to convert from a monorail catheter system to an over the wire system.
D. Principle Of Operation / Technology
The Runthrough NS and Runthrough NS Extension wire are operated manually or by a manual process.
1
Terumo Corporation
Special 510k – Runthrough NS Extension Wire Section II. 510(k) Summary
E. Design / Materials
Differences in materials between the modified device and the predicate device the Runthrough NS cleared under K063695 raise no new issues of safety and effectiveness.
F. Specifications
| Feature | Runthrough NS | Runthrough NS
Extension Wire |
|--------------------|------------------------------------|--------------------------------------------------------------|
| Available diameter | 0.014" ( 0.36mm ) | 0.014" ( 0.36mm ) |
| Available length | 180cm, 300cm | 120-165cm which docs
into the 180cm
Runthrough NS wire |
| Tip marker length | 30mm | none |
| Accessory Devices | Torque Device, Inserter,
Stylet | Torque Device, Inserter |
| Shelf life | 36 months | 36 months |
2
G. Performance
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS Extension Wire) to the unmodified device (Runthrough NS K063695).
- Dimensional Inspection .
- . Tensile strength of tip
- . Extension wire connection strength
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 Extension Wire is substantially equivalent to the performance of the predicate device the unmondified Runthrough NS K063695.
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.
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 106.
H. Substantial Equivalence
The modified Runthrough NS Extension Wire is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Runthrough NS K063695. Differences between the two devices do not raise any significant issues of safety or effectiveness.
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I. Submitter Information
·
| Prepared By: | Mr. Mark Unterreiner
Sr. Regulatory Affairs Specialist |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
Phone: (410) 392-7213
Fax: (410) 398-6079
Email: mark.unterreiner@terumomedical.com |
| Date Prepared: | February 26, 2008 |
Ten Similar Andrews Andrews Comments of the Same Children Children Children Children Children Children Children Children Children Children Children Children Children Children
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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in a minimalist, abstract design.
MAR 2 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Medical Corporation c/o Mr. Mark Unterreiner Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921
Re: K080563
Runthrough NS Extension Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide Catheter Regulatory Class: II Product Code: DQX Dated: February 26, 2008 Received: February 28, 2008
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Bhimnma for
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
Koros63 510(k) Number (if known): ___
Runthrough NS Extension Wire Device Name:
Indications For Use:
The Runthrough NS Extension Wire are used to facilitate the 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)
Bhummer
Division of Cardiovascular Devices
510(k) Number K08056