(56 days)
Not Found
No
The description focuses on the mechanical and material properties of a microcatheter for infusion, with no mention of AI or ML capabilities.
No
The device is a microcatheter used to deliver diagnostic, embolic, or therapeutic materials. It is a delivery tool, not a therapeutic device itself. Its therapeutic function is indirect, acting as a channel for other therapeutic agents.
Yes
The device description explicitly states, "the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium". This directly indicates its use in diagnostic procedures.
No
The device description clearly describes a physical catheter with specific dimensions, materials, and intended use for intravascular procedures, indicating it is a hardware medical device.
Based on the provided information, the Renegade Fiber Braided Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for accessing and infusing materials into blood vessels. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an in vivo device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is clearly intended for interventional procedures within the vascular system.
N/A
Intended Use / Indications for Use
The Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
Product codes
74 KRA
Device Description
The device is a 3.0F/2.5F, single lumen catheter constructed with progressively softer shaft characteristics from its proximal to its distal ends. The device is tracked coaxially over a selectively placed guide wire. To facilitate catheter introduction, the device incorporates a hydrophilic coating applied to the outer sufface of the shaft. Once the subselective region has been accessed, the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium, and therapeutic materials. The device is available in useable lengths of 130 cm and 150 cm and in distal segment lengths of 10cm, 20cm, and 30cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro, peripheral, and coronary vasculature
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)
Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical, biocompatibility and animal testing demonstrated that these differences do not adversely affect safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Evolution Microcatheter, Eddy Infusion, TurboTracker Infusion Catheter, Venture II™ Intravascular Infusion catheters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
NOV 19 1997
SUMMARY OF SAFETY AND EFFECTIVENESS K973645
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
| Owner Operator Submitting | Boston Scientific Corporation |
|---|---|
| this Premarket Notification: | One Boston Scientific Place |
| Natick, MA 01757 | |
| (508) 650.8174 | |
| Contact Person: | Wanda M. Carpinella |
| Regulatory Affairs Department | |
| Device Generic Name: | Intravascular Infusion Catheter |
| Device Classification: | 74 DQO Catheter, Intravascular, Diagnostic |
B. INDICATIONS FOR USE
The Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
C. DESCRIPTIVE CHARACTERISTICS
The device is a 3.0F/2.5F, single lumen catheter constructed with progressively softer shaft characteristics from its proximal to its distal ends. The device is tracked coaxially over a selectively placed guide wire. To facilitate catheter introduction, the device incorporates a hydrophilic coating applied to the outer sufface of the shaft. Once the subselective region has been accessed, the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium, and therapeutic materials. The device is available in useable lengths of 130 cm and 150 cm and in distal segment lengths of 10cm, 20cm, and 30cm.
D. SUBSTANTIAL EQUIVALENCE
The proposed microcatheter is substantially equivalent to the Evolution Microcatheter, and the Eddy Infusion, TurboTracker Infusion Catheter and Venture II™ Intravascular Infusion catheters. Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical, biocompatibility and animal testing demonstrated that these differences do not adversely affect safety and effectiveness.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
The proposed catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas.
F. CONCLUSION
Based on the information presented, Boston Scientific Corporation believes that the proposed infusion catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed intravscular infusion catheters.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1997
Ms. Wanda M. Carpinella Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
K973645 Re: Fiber-braided Microcatheter Requlatory Class: II (two) Product Code: 74 KRA Dated: September 22, 1997 Received: September 24, 1997
Dear Ms. Carpinella:
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 requlations 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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.
2
Page 2 - Ms. Wanda M. Carpinella
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 diagnostic 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K973645
Renegade™ Fiber Braided Microcatheter with Device Name: Hydropass™ Ccating
The Renegade Fiber Braided Microcatheter is Indications for Use: intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluaiton (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, nd Neurological Device : Number
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)