(50 days)
The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" outer diameter guidewire. The CanaliZer is not intended for use in the coronary arteries.
The guidewires are constructed from a Nitinol core coated with Tecoflex EG85-A polyurethane to provide a wire with a maximum OD of 0.035" or 0.038". The polyurethane formulation contains BaSO4 for radiopacity. A hydrophilic coating is applied to the distal portion of the guidewire to facilitate wire movement within 0.035" or 0.038" diameter devices. The guidewires are available in lengths of 150, 180 and 260 cm. Two tip shapes are also available, straight and angled. Both tip shapes are provided on wires of standard stiffness, and a stiffer design. The family of guidewires has a CE mark and is in commercial distribution in Europe.
The provided text refers to a premarket notification for a medical device called the "InterV® brand CanaliZer Hydrophilic Guide Wire." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, the requested information regarding acceptance criteria, a study proving performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided text.
The document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on comparing the technological characteristics of the new device to a predicate device, and often includes bench testing to confirm compliance with recognized standards or demonstrate equivalence, but not necessarily a full clinical study with acceptance criteria and reported performance in the way a new drug or a novel high-risk device might.
The relevant sections provided are:
- Premarket Notification [510(K)] Summary: This section describes the device, its intended use, and technological characteristics, and identifies predicate devices.
- FDA Review Letter: This letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to predicate devices for its stated indications for use.
- Indications for Use: This section reiterates the intended use of the device.
In summary, the provided content is for a 510(k) submission, which does not typically include the detailed study information as requested.
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May, 2005 Koso873 p. L of 2
MAY 2 6 2005
TAB 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
February, 2005
| Trade Name: | InterV® brand CanaliZer Hydrophilic Guide Wire |
|---|---|
| Common Name: | Guidewire |
| Classification Name: | Catheter guide wire (per 21 CFR section 870.1330) |
| Manufacturer's Name: | Medical Device Technologies, Inc.3600 SW 47" AvenueGainesville, FL 32608 |
| Corresponding Official: | Kristine LiberackiQuality Manager, MD Technologies, Inc.3600 Southwest 47th Ave.Gainesvill, FL 32608Phone: (800) 338-0440 ext, 350Fax: (352) 33-0662 |
| Predicate Device(s): | Terumo Radifocus Glidewire GT and GOLD, K955801Terumo Radifocus Guidewire, K924204Terumo Radifocus Guidewire M, K863138B |
| Device Description: | The guidewires are constructed from a Nitinol core coatedwith Tecoflex EG85-A polyurethane to provide a wire with amaximum OD of 0.035" or 0.038". The polyurethaneformulation contains BaSO4 for radiopacity. A hydrophiliccoating is applied to the distal portion of the guidewire tofacilitate wire movement within 0.035" or 0.038" diameterdevices. The guidewires are available in lengths of 150, 180and 260 cm. Two tip shapes are also available, straight andangled. Both tip shapes are provided on wires of standardstiffness, and a stiffer design. The family of guidewires has aCE mark and is in commercial distribution in Europe. |
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CONFIDENTIAL
This document and the information contained herein may not be reproduced, used or disclosed without written permission from Medical Device Technologies, Inc.
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Medical Device Technologies, Inc. Traditional 510(k) CanaliZer Hydrophilic Guide Wire
May, 2005
KOSO813 p. 2062
| Intended Use: | The CanaliZer Hydrophilic Guide Wire is designed for use inthe peripheral vasculature with medical devices requiring a0.035" or 0.038" outer diameter guidewire. The CanaliZer isnot intended for use in the coronary arteries. . |
|---|---|
| TechnologicalCharacteristics: | The guidewires are available in two families, regular and stiffshaft, each in two tip configurations; straight and angled.Each combination is available in 150, 180 and 260 cmlengths. |
CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from Medical Device Technologies, Inc.
.
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Image /page/2/Picture/2 description: The image shows a black and white seal for 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 image of an eagle.
MAY 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Technologies, Inc. c/o Ms. Kristine Liberacki Quality Manager 3600 SW 47th Avenue Gainesville, FL 32608
Re: K050873
CanaliZer Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: February 18, 2005 Received: April 6, 2005
Dear Ms. Liberacki:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 9 re(s) pecifical is substantially equivalent (for the indications ferenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the encrosule) to tegans actment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food, Drug. devices that have occh recalism in accessfied in accessor and of a premarket approval application (PMA). and Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devices, boojeet to annual registration. Ilsting of general controls provisions of the ties 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 If your device is classified (see above) the existing major regulations affecting your device can Inay be subject to such additional connotions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean r load be actived that i bromination 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 t 21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF and 0077, abouting (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) ار premarket notification. The FDA finding of substantial equivalence of your device to a legally premiuner nodicate 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), picase contact the Office of Compliance at (240) 276-__ 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dama R. V. Jones
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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Medical Device Technologies, Inc. Traditional 510(k) CanaliZer Hydrophilic Guide Wire
TAB 3
INDICATIONS FOR USE
510(k) Number: _ Koso813
Device Name: Medical Device Technologies InterV® brand CanaliZer® Hydrophilic Guide Wire
Indications for Use: The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" m the perpherar vacuvire. The CanaliZer is not intended for use in the coronary arteries.
× Prescription Use (per 21 CFR 801 Subpart D) or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dama R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K050873
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CONFIDENTIAL This document and the information contained herein may not be reproduced, used or disclosed without written permission from Medical Device Technologies, Inc.
§ 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.