(32 days)
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.
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.
The provided text is a 510(k) summary for the St. Jude Medical Venture™ Wire Control Catheter (Rapid Exchange version). It describes design modifications and demonstrates substantial equivalence to a previously cleared predicate device. This document focuses on the regulatory submission process and does not contain information about acceptance criteria for device performance in the context of a study that uses a "test set" or "ground truth" to evaluate an algorithm or AI.
The "Test Summary" section explicitly states: "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."
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance: The document mentions "verification specification criteria" but does not detail them or present specific performance data in a tabular format as would be expected for a clinical or AI-based study.
- Sample size used for the test set and the data provenance: No test set in the context of AI evaluation is mentioned. The testing performed was engineering verification and validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth in the context of expert consensus or diagnostic accuracy is mentioned.
- Adjudication method for the test set: Not applicable as there is no "test set" in the AI or diagnostic sense.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document states "no additional animal or clinical data was deemed necessary," indicating no MRMC study was performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as it's a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable as no ground truth in the diagnostic sense was established. The "ground truth" for this device's performance would be the engineering specifications and whether the device met them.
- The sample size for the training set: Not applicable as it's a physical medical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
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Kob1843
ST. JUDE MEDICAL
AUG 0 1 2006
SECTION 6. 510(K) SUMMARY
6.1 APPLICANT INFORMATION
| Submitted by: | St. Jude Medical6550 Wedgwood Rd. N.Suite 150Maple 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.
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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.
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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.
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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
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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
§ 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).