(32 days)
Not Found
No
The description focuses on the mechanical and physical properties of the catheter and its manual control mechanism (rotating knob). There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a 'support catheter' for guiding wires and does not directly treat a disease or condition.
No
This device is a support catheter used to direct, steer, and control a guide wire for accessing specific regions of the coronary and peripheral vasculature. Its function is to facilitate the delivery of other instruments, not to diagnose medical conditions through evaluation or measurement.
No
The device description clearly outlines a physical catheter with a deflectable tip, guide wire lumen, proximal shaft, and a rotating knob for control. This 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 the device is for "directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical catheter with a deflectable tip and guide wire lumen, designed for manipulation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Anatomical Site: The anatomical site is the "coronary and peripheral vasculature," which are locations within the living body. IVDs typically analyze samples taken from the body (like blood, urine, tissue).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
In summary, the Venture™ Wire Control Catheter is an interventional medical device used for guiding and supporting guide wires within the circulatory system, not an IVD used for diagnostic testing of samples outside the body.
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 discretion regions of the coronary and peripheral vasculature.
Product codes
DQY
Device Description
The rapid exchange (RX) version of the Venture™ Wire Control Catheter is a single use support catheter consisting of a radiopaque deflectable tip, 30cm long guide wire lumen, and a proximal shaft (hypotube). A rotating knob at the handle controls the tip deflection angle. The tip can be deflected up to 90° from the catheter axis. The device is compatible with all 0.014" guide wires and 6 Fr or larger guide catheters. It is torqueable and can be used to instantaneously shape and control the curvature of the guide wire during use as well as provide support to the guide wire when needed.
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
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)
The Rapid Exchange Venture Wire Control Catheter passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the modifications incorporated to create the rapid exchange version of the Venture™ catheter no additional animal or clinical data was deemed necessary.
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).
0
Kob1843
ST. JUDE MEDICAL
AUG 0 1 2006
SECTION 6. 510(K) SUMMARY
6.1 APPLICANT INFORMATION
| Submitted by: | St. Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove, MN 55311 |
| --------------- | -------------------------------------------------------------------------------- |
|---|
Shannon Springer Contact Person: Telephone: 763-383-0900 763-322-8808 Fax:
29 June, 2006 Date Prepared:
6.2 DEVICE INFORMATION
| Trade Name: | Venture Wire Control Catheter |
|---|---|
| Model: | WCC |
| Version: | Rapid Exchange (RX) |
| Common Name: | Steerable Catheter |
| Classification Name: | Percutaneous Catheter |
| Classification: | Class II per CFR 870.1250 |
| Product Code: | DQY |
6.3 DEVICE DESCRIPTION
The rapid exchange (RX) version of the Venture™ Wire Control Catheter is a single use support catheter consisting of a radiopaque deflectable tip, 30cm long guide wire lumen, and a proximal shaft (hypotube). A rotating knob at the handle controls the tip deflection angle. The tip can be deflected up to 90° from the catheter axis.
The device is compatible with all 0.014" guide wires and 6 Fr or larger guide catheters. It is torqueable and can be used to instantaneously shape and control the curvature of the guide wire during use as well as provide support to the guide wire when needed.
6.4 INTENDED USE
The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discrete regions of the coronary and peripheral vasculature.
1
6.5 PREDICATE DEVICE COMPARISON / TECHNOLOGICAL CHARACTERISTICS
The Venture Wire Control Catheter included in this Special 510(k) submission is a modification of the current Venture Wire Control Catheter. A rapid exchange version of the Venture catheter was created by incorporating one primary design change; full length guide wire lumen replace with 30 cm guide wire lumen.
The Venture™ Wire Control Catheter device covered by this submission is similar in function, mechanism of action and intended use to market cleared predicate device, Venture™ Wire Control Catheter (K042910 - November 11, 2004).
6.6 TEST SUMMARY
The Rapid Exchange Venture Wire Control Catheter passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the modifications incorporated to create the rapid exchange version of the Venture™ catheter no additional animal or clinical data was deemed necessary.
6.7 SUBSTANTIAL EQUIVALENCE
The Venture™ Wire Control Catheter device covered by this submission is substantially equivalent to the previously cleared Venture™ Wire Control Catheter (K042910 - November 11, 2004).
The Venture™ Wire Control Catheter in this submission is substantially equivalent to the predicate device listed above given the similar technological characteristics, principles of operation and intended use.
6.8 CONCLUSION
The Venture™ Wire Control Catheter in this submission has the same fundamental indications for use, principles of operation, and technological characteristics as the previously cleared predicate device. The differences between this device and its predicate device do not raise new questions of safety or efficacy. Therefore, the rapid exchange version of the Venture Wire Control Catheter is substantially equivalent to the predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other. The figures are black and have a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG () 1 2006
St. Jude Medical c/o Ms. Shannon Springer Sr. Regulatory Affairs Associate 6550 Wedgwood Road N., Suite 150 Maple Grove, MN 55311
Re: K061843 Venture™ Wire Control Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: June 29, 2006 Received: June 30, 2006
Dear Ms. Springer:
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. Itsting 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 vour device in the Federal Register.
3
Page 2 - Ms. Shannon Springer
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 forth in the quality systems (QS) 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dittie R. Watson
( Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
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.
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)
DUAN
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K061843