(102 days)
Not Found
Not Found
No
The description focuses on the physical construction and mechanical properties 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 dilatation catheters, not to provide a therapeutic effect itself. Its function is primarily assistive in a medical procedure.
No
The device is a guidewire intended to facilitate the placement of balloon dilatation catheters, which is a procedural/interventional tool, not a diagnostic one.
No
The device description clearly states it is a physical guidewire constructed from stainless steel with coatings, indicating it is a hardware device, not software.
Based on the provided information, 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 dilation catheters during PTCA and/or PTA procedures. These are medical procedures performed on a patient, not tests performed on samples taken from a patient.
- Device Description: The description details a physical guidewire used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) as a tool for a medical procedure.
N/A
Intended Use / Indications for Use
The Radius PTCA Guidewire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. Radius PTCA Guidewires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an .014 guidewire.
Product codes
LIT
Device Description
The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. Table 1 lists the key dimensional characteristics for the proposed device. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone 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 PTCA Guidewire:
-
- Tensile Strength
-
- Torque Strength
-
- Torqueability
-
- Tip Flexibility
-
- Coating Adherence/Integrity
In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
Biocompatibility testing was conducted on the proposed line of Radius PTCA Guidewires according to General Program Memorandum - #G95-1 issued May 1, 1995 from the ODE. Following is a summary of the tests performed:
- Coating Adherence/Integrity
-
- Cytotoxicity
- 2 Sensitization
-
- Intracutaneous Toxicity
-
- Acute systemic toxicity
-
- Material Mediated Pyrogenicity
-
- ASTM Hemolysis
All test results were acceptable.
- ASTM Hemolysis
Key Metrics
Not Found
Predicate Device(s)
ACS High Torque Guidewire family
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY 2 0 1997
瑞| 彩
510(K) SUMMARY
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Radius Medical Technologies, Inc. is I answited to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Radius Medical Technologies, Inc. chooses to submit a summary of information respecting safety and effectiveness.
GENERAL INFORMATION A.
| Submitter's Name: | Radius Medical Technologies, Inc. |
|---|---|
| Address: | 63 Great Road |
| Maynard, MA 01754 | |
| Contact Person: | Maureen A. Finlayson |
| Date of Preparation: | February 5, 1997 |
| Device Generic Name: | PTCA Guidewire |
| Device Trade Name: | Radius PTCA Guidewire |
| Classification Name: | Wire, Guide, Cardiovascular (74DQX) |
B. INDICATIONS
The Radius PTCA Guidewire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. Radius PTCA Guidewires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an .014 guidewire.
DESCRIPTIVE CHARACTERISTICS C.
The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. Table 1 lists the key dimensional characteristics for the proposed device. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
| Specification | |
|---|---|
| G/W Outer Diameter | .014" |
| G/W Overall Length | 180cm or 300cm |
| Overall Coil Length | 15cm to 30cm |
| Radiopaque Length | 3cm to 30cm |
| Floppy Tip Length | 2.5cm to 3cm |
| 1
4 DJ
25
18
| 1 |
|---|
| ---------------------------- |
1
COMPARATIVE INFORMATION D.
F
The Radius PTCA Guidewires are substantially equivalent to the currently marketed ACS High Torque Guidewire family. ACS High Torque Guidewires, marketed by:
Advanced Cardiovascular Systems, Inc. 26531 Ynez Road Temecula, California 92390-1856
E. PERFORMANCE TESTING
The following in vitro performance tests were performed on the Radius PTCA Guidewire:
-
- Tensile Strength
-
- Torque Strength
-
- Torqueability
-
- Tip Flexibility
-
- Coating Adherence/Integrity
In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
BIOCOMPATIBILITY F.
Biocompatibility testing was conducted on the proposed line of Radius PTCA Guidewires according to General Program Memorandum - #G95-1 issued May 1, 1995 from the ODE. Following is a summary of the tests performed:
-
- Cytotoxicity
- 2 Sensitization
-
- Intracutaneous Toxicity
-
- Acute systemic toxicity
-
- Material Mediated Pyrogenicity
-
- ASTM Hemolysis
All test results were acceptable.
CONCLUSION:
Based on the indications for use, technological characteristics, and safety and performance testing, the proposed Radius PTCA Guidewire meets the minimum requirements that are considered adequate for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Ms. Maureen A. Finlayson President Radius Medical Technologies, Inc. 63 Great Road Maynard, Massachusetts 01754
K970466 Re : Radius PTCA Guidewire Requlatory Class: II (two) Product Code: LIT Dated: April 23, 1997 Received: April 24, 1997
Dear Ms. Finlayson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions.
3
regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ 1 of . 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Radius PTCA Guidewire Device Name:
Indications for Use: -- ------------------------------------------------------------------------------------------------------------------------------------------------------
The Radius PTCA Guidewire is indicated to facilitate the 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)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K970466
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use