(7 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a guidewire intended to facilitate the placement of balloon dilation catheters, rather than directly providing therapy itself.
No
The device is described as a guidewire intended to facilitate the placement of balloon dilatation catheters, which is a procedural aid, not a diagnostic tool.
No
The device description clearly details physical components (stainless steel, Nitinol core, coil, PTFE coating, hydrophilic coating) and manufacturing processes (packaging, sterilization), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement of balloon dilitation catheters during PTCA and/or PTA." This is a procedure performed in vivo (within the body) to treat cardiovascular conditions.
- Device Description: The description details the physical construction of a guidewire used in a medical procedure, not a device used to analyze samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly in a medical procedure.
N/A
Intended Use / Indications for Use
The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.
Product codes
DQX
Device Description
The Radius .018 Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
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
The following in vitro performance tests were performed on the Radius .018 Cougar Wire:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Adherence/Integrity
Key Metrics
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.
0
JUL 1 7 2003
Attachment 6 510(k) Summary of Safety and Effectiveness July 9, 2003
GENERAL INFORMATION A.
| Submitter's Name: | Radius Medical Technologies, Inc. |
|---|---|
| Address: | 15 Craig Road |
| Acton, MA 01720 | |
| Contact Person: | Maureen A. Finlayson |
| Device Generic Name: | PTCA Guidewire |
| Device Trade Name: | Radius .018 Cougar Wire |
| Classification Name: | Wire, Guide, Cardiovascular (74DQX) |
INDICATIONS B.
The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.
DESCRIPTIVE CHARACTERISTICS C.
The Radius .018 Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
COMPARATIVE INFORMATION D.
The Radius .018 Cougar Wire is substantially equivalent to the currently marketed Radius Cougar Guidewire (K011287).
E. PERFORMANCE TESTING
The following in vitro performance tests were performed on the Radius .018 Cougar Wire:
-
- Tensile Strength
-
- Torque Strength
-
- Torqueability
-
- Tip Flexibility
-
- Coating Adherence/Integrity
CONCLUSION:
Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Radius .018 Cougar Wire meets the minimum requirements that are considered adequate for its intended use.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Radius Medical Technologies, Inc. c/o Debbie Iampiedro 7 Tiffany Trail Hopkinton, MA 01748
Re: K032129
Radius 018 Cougar Wire Regulation Number: 870.1330 Regulation Name: Cardiovascular Guidewire Regulatory Class: Class II Product Code: DQX Dated: July 9, 2003 Received: July 10, 2003
Dear Ms. Iampiedro:
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.
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
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Page 2 - Debbie Iampietro
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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Radius .018 Cougar Wire Device Name:
Indications For Use:
Radius .018 Cougar Wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) 510(k