(231 days)
Not Found
No
The 510(k) summary describes a physical catheter used for mechanical support and delivery of fluids. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device facilitates other procedures by supporting a guidewire, assisting in guidewire exchange, and delivering solutions, rather than directly treating a medical condition itself.
No
The device is a support catheter used during vascular interventions, primarily for guidewire support, exchange, and delivery of solutions/agents. While it can deliver "diagnostic contrast agents," its function is not to diagnose conditions itself, but rather to facilitate procedures where diagnostic imaging may be performed using those agents. The device itself does not perform any diagnostic function.
No
The device description clearly identifies it as a physical catheter, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spectranetics Support Catheter is an intravascular catheter. It is used within the body to support a guidewire, assist in guidewire placement, and deliver solutions. It does not analyze specimens taken from the body.
The description clearly indicates it's a device used directly in a vascular intervention procedure, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.
Product codes
DQY
Device Description
The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary intravascular
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)
Design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints, tracking, visibility, flow rate, wire movement, sterility and biocompatibility including hemolysis, MEM cytotoxicity and dermal sensitization. Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated.
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
§ 870.1250 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).
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NOV I 6 1999
Image /page/0/Picture/1 description: The image shows the word "Spectranetics" in a bold, sans-serif font. The word is in all capital letters and is black. There is a horizontal line underneath the word. The line is thin and black.
K99 1059
BRILLIANCE IN INTERVENTIONAL THERAPY
Submitted By: Adrian E. Elfe. CQM, RAC Vice President, Quality Assurance and Regulatory Affairs Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907 Signature and Date:
510(k) Summary
Device Trade Name:
The device trade name is Spectranetics Support Catheter. The generic name for this device is percutaneous catheter.
The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention. Predicate devices of this type with similar intended uses have been classified into Class II.
Substantial Equivalence:
This product is similar in design, composition, and function to the Medtronic Buchbinder Transfer Catheters, 510(k) K935425.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92.
The Spectranetics Support Catheters are similar in basic design, construction, mechanical safety, indications, target population, risk analysis, performance and materials to the predicate device. Spectranetics New Product Introduction procedure has been faithfully followed in concert with the quality systems regulations for new production. The design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints. tracking, visibility, flow rate, wire movement, sterility and biocompatibility including hemolysis, MEM cytotoxicity and dermal sensitization. Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated.
THE SPECTRANETICS CORPORATION 96 TALAMINE COURT • COLORADO SPRINGS, COLORADO 80907-5186 TEL 719.633.8333 · 800.6333.0960 · FAX 719.633.2248
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 6 1999
Mr. Michael J. Quinn Director of Requlatory Affairs Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907-5186
Re: K991059 Spectranetics Support Catheter Trade Name: Regulatory Class: II Product Code: DQY Dated: October 21, 1999 October 22, 1999 Received:
Dear Mr. Quinn:
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 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). 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 Requlations. Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 obliqation
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Page 2 - Mr. Michael J. Quinn
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 requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christopher Martin
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BRILLIANCE IN INTERVENTIONAL THERAPY
| Applicant: | Spectranetics Corporation |
|---|---|
| 96 Talamine Court | |
| Colorado Springs, CO 80907 |
510(k):
Spectranetics Support Catheter Device Name:
Statement of Indications for Use Spectranetics Support Catheter
The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.
Christopher Arthur Witten
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 199117 510(k) Number
Support Catheter Page 7