(32 days)
Not Found
No
The description focuses on mechanical control and physical properties of the catheter, with no mention of AI/ML terms or functionalities.
No
The device is described as a support catheter used to direct, steer, control, and support a guide wire, and for manual delivery of saline or contrast agents. Its functions are diagnostic and interventional support, not therapeutic treatment of a disease or condition.
No
The device is primarily intended for directing, steering, controlling, and supporting a guide wire, and for delivery of saline or contrast agents, which are procedural support functions rather than diagnostic functions.
No
The device description clearly outlines a physical catheter with a deflectable tip, a rotating knob, and a luer attachment, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for directing, steering, controlling, and supporting a guide wire within the coronary and peripheral vasculature. It also mentions manual delivery of saline or contrast agents, which are also administered in vivo.
- Device Description: The description details a physical catheter with a deflectable tip, a handle, and a luer attachment for injection. These are characteristics of a device used directly on a patient.
- Anatomical Site: The specified anatomical site is the coronary and peripheral vasculature, which are parts of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, or tissue. The device's function is entirely focused on manipulating instruments within the patient's circulatory system.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
Product codes
DQY
Device Description
The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque deflectable tip. A rotating knob at the handle controls the tip deflection angle. The tip can be deflected continuously up to about 90° from the catheter axis.
The device is compatible with all 0.014" guidewires. It is torqueable and can be use to instantaneously shape, and control the curvature of the guidewire while in use as well as provide support to the guidewire when needed. A luer attachment is also provided to allow for the manual injection of dye through the guidewire lumen of the catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 summary of the performance test data is provided in the 510(k) submission. The performance data demonstrates that the device complies with the applicable sections of: ISO 10555 (Part 1 and Part 4), ISO 10993-1, Product specification ASTM D-4169 (Packaging Integrity Testing) ISO 11607 (Packaging for terminally sterilized medical devices) ISO 11135: 1994(E) (Validation and routine control of ETO sterilization)
Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices.
Key Metrics
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).
0
Ko42910
NOV 2 2 2004
SECTION 3. 510(K) SUMMARY
3.1 ADMINISTRATIVE INFORMATION
Name and address 3.1.1
| Submitted by: | Velocimed Inc
11400 73rd Avenue North, Suite 134
Minneapolis, MN 55369 |
| --------------- | ------------------------------------------------------------------------------ |
|---|
| Contact Person: | John Carline |
|---|---|
| Telephone No.: | 763-463-4742 |
| Facsimile No.: | 763-488-9780 |
Date Prepared: Oct 19, 2004
3.1.2 Device Name
| Trade Name | Venture Wire Control Catheter |
|---|---|
| Common Name | Catheter Steerable |
| Classification Name | Catheter, Intravascular |
| Classification | Class II |
| Model | DRA, DQY |
| WCC |
3.1.3 Applicant
| Applicant's Name: | Velocimed Inc |
|---|---|
| 11400 73rd Avenue North, Suite 134 | |
| Minneapolis, MN 55369 |
3.2 INDICATION FOR USE
The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
3.3 DEVICE DESCRIPTION
The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque deflectable tip. A rotating knob at the handle controls the tip deflection angle. The tip can be deflected continuously up to about 90° from the catheter axis.
The device is compatible with all 0.014" guidewires. It is torqueable and can be use to instantaneously shape, and control the curvature of the guidewire while in use as well as provide
1
support to the guidewire when needed. A luer attachment is also provided to allow for the manual injection of dye through the guidewire lumen of the catheter
3.4 SUBSTANTIAL EQUIVALENCE
The Venture™ Wire Control Catheter device covered by this submission is substantially equivalent to previous Venture Wire Control Catheter (K040922).
The Venture™ in this submission has the same indication for use, principles of operation, and technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy.
3.5 PERFORMANCE DATA
The summary of the performance test data is provided in the 510(k) submission. The performance data demonstrates that the device complies with the applicable sections of: ISO 10555 (Part 1 and Part 4), ISO 10993-1, Product specification ASTM D-4169 (Packaging Integrity Testing) ISO 11607 (Packaging for terminally sterilized medical devices) ISO 11135: 1994(E) (Validation and routine control of ETO sterilization)
Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and converge, resembling a human figure in profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
Velocimed, Inc. c/o Mr. John Carline RA Specialist 11400 7310 Avenue North, Suite 134 Minneapolis, MN 55369
Re: K042910
Trade/Device Name: Venture Wire Control Catheter, Model WCC Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 19, 2004 Received: October 25, 2004
Dear Mr. Carline:
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 devive can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, EDA enay 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 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
3
Page 2 - Mr. John Carline
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decloils on a vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of worldwige to Aggil This letter will anow you to ought marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of Sabsanalian of 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 If you desire specific davice for Jour avoiled. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Misoranding by reference to premainteries in the Act from the Division of Small other general information on your response 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,
inna R. Lochner
( / Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 2. INDICATION FOR USE
510(k) Number: K642910 _______________________________________________________________________________________________________________________________________________________
Venture Wire Control Catheter Device Name:
Indication for Use
The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
Prescription Use: X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Vuchner
(Division Sign-Off) (Division Olgil-Six)
Division of Cardiovascular Devices
510(k) Number_K042910_________________________________________________________________________________________________________________________________________________________