(188 days)
Not Found
No
The description focuses on the mechanical design and function of a catheter for guidewire placement, with no mention of AI or ML technologies.
No
The device is indicated to "facilitate the placement of guidewires," which describes an assistive function rather than a direct therapeutic intervention for a disease or condition.
No
The device's intended use is to facilitate the placement of guidewires, which is a procedural/interventional function, not a diagnostic one. It does not gather information about a patient's health status.
No
The device description clearly details a physical catheter with specific dimensions, materials, and mechanical components (lumens, spring, sheath, knob, port). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of guidewires in bifurcations or any sidebranch vasculature." This describes a device used within the body for a procedural purpose (guiding other devices), not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a catheter with lumens, a deflectable tip, and features for guiding a guidewire. This is consistent with an interventional medical device used in procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural within the vascular system.
N/A
Intended Use / Indications for Use
The Edwards Directional Catheter is indicated to facilitate the placement of quidewires in bifurcations or any sidebranch vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Edwards Directional Catheter is 99 cm in length and 16F outer diameter. The body has two lumens, one for a deflectable spring, and the other to allow it to track on a 0.035" guidewire. The sheath on the subject device provides a smooth transition from the body to the tip of the catheter. The tip of the catheter is made from a soft material that offers flexibility. The body of the catheter is made from a higher durometer material that offers better torqueability. When the sheath of the device is retracted, the spring tip can be deflected using the knob located at the proximal end. The spring tip can be adjusted from approximately 0° to 180° by sliding the knob back and forth. There is also a port that allows a 0.035" guidewire to pass through the catheter and exit through the deflecting tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical testing was performed on the Edwards Directional Catheter including: Biocompatibility testing/chemical acceptability testing, Physical and mechanical specification testing, Sterilization testing, and Animal Studies. Based on the results, the device was determined to be acceptable in design and construction for its intended use. Clinical testing was not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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SEP = 3 2003
Image /page/0/Picture/2 description: The image shows a letter 'E' in a bold, sans-serif font. The letter is white and is set against a black background. The image has a grainy texture, which gives it a slightly distressed or vintage look.
Edwards Lifesciences
CONFIDENTIAL May not be reproduced without written permission from Edwards Lifesciences
510(k) Summary
A. Submitter Information
Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686, USA
Contact: Kevin Drisko, Senior Manager Regulatory Affairs Phone Number: (949) 250-2416 Fax Number: (949) 250-3630 Email address: kevin drisko@edwards.com
B. Device Information
-
- Trade Name: Edwards Directional Catheter
-
- Common or Usual Name: Percutaneous Catheter
-
- Device Classification and Classification Name: Class II (74 DQY, 21 CFR §870.1250)
5. Device Description:
The Edwards Directional Catheter is 99 cm in length and 16F outer diameter. The body has two lumens, one for a deflectable spring, and the other to allow it to track on a 0.035" guidewire. The sheath on the subject device provides a smooth transition from the body to the tip of the catheter. The tip of the catheter is made from a soft material that offers flexibility. The body of the catheter is made from a higher durometer material that offers better torqueability. When the sheath of the device is retracted, the spring tip can be deflected using the knob located at the proximal end. The spring tip can be adjusted from approximately 0° to 180° by sliding the knob back and forth. There is also a port that allows a 0.035" guidewire to pass through the catheter and exit through the deflecting tip.
-
- Intended Use:
The Edwards Directional Catheter is indicated to facilitate the placement of quidewires in bifurcations or any sidebranch vasculature.
- Intended Use:
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Image /page/1/Picture/1 description: The image shows the Edwards Lifesciences logo. The logo consists of a square graphic on the left and the text "Edwards Lifesciences" on the right. The graphic is a stylized letter "E" inside a square. The text is in a serif font.
CONFIDENTIAL May not be reproduced without written permission from Edwards Lifesciences
- Technological Comparison of Subject Device to Predicate Device: 7. The Edwards Directional Catheter is similar to the predicate devices in that all three provide access to the vasculature and facilitate the placement of guidewires, interventional devices, or therapeutic and diagnostic devices. Similar materials are used in each to enhance maneuverability of the devices and to prevent damage to vessels.
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- Summary of Non-Clinical Tests and Conclusions: The following non-clinical testing was performed on the Edwards Directional Catheter:
- Biocompatibility testing/chemical acceptability testing .
- Physical and mechanical specification testing .
- . Sterilization testing
- Animal Studies .
Based on the results of this testing, Edwards Lifesciences has determined that the Edwards Directional Catheter is acceptable in design and construction for its intended use.
-
- Summary of Clinical Tests and Conclusions: Clinical testing was not deemed necessary to establish the substantial equivalence of the subject device to the predicate devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2003
Edwards Lifesciences LLC c/o Kevin Drisko Senior Manager Regulatory Affairs One Edwards Way Irvine, CA 92614-5686
Re: K030630
Percutaneous Catheter Regulation Number: 870.1250 Regulation Name: Catheter percutaneous Regulatory Class: Class II Product Code: DQY Dated: June 24, 2003 Received: June 25, 2003
Dear Mr. Drisko:
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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 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
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Page 2 - Mr. Kevin Drisko
forth in the quality systems (OS) 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 (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of the company name, "Edwards Lifesciences", in a serif font. To the left of the name is a stylized graphic, possibly representing the letter "E" or a medical device.
Indications For Use
Page __ of l
510(k) Number (if known): K030630
Device Name: Edwards Directional Catheter
Indications for Use:
The Edwards Directional Catheter is indicated to facilitate the placement of guidewires in bifurcations or any sidebranch vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE
NOCeTA
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030630
Image /page/4/Picture/12 description: The image shows the text "Prescription Use (per 21 CFR 801.109)" with a symbol resembling an X over a line. The text indicates that the product is intended for prescription use, as defined by the Code of Federal Regulations (CFR) section 801.109. The symbol is placed to the right of the text.
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________