(57 days)
Not Found
No
The device description focuses on the mechanical design and function of a catheter for guidewire manipulation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device facilitates a procedure by guiding wires but does not directly treat a condition or provide therapy.
No
The device is a dual-lumen catheter designed to facilitate the insertion and separate advancement of two guidewires into vessels during a procedure, which is a procedural aid, not a diagnostic function.
No
The device description clearly details a physical catheter with lumens, radiopaque markers, and a luer connector, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "For use during a two guidewire procedure." This describes a surgical or interventional procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a catheter designed for inserting and guiding wires within blood vessels. This is a medical device used in vivo (within the body), not in vitro (in glass/outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Visifiex Dual Lumen Catheter is a medical device used in interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visifiex Dual Lumen Catheter is intended for use during a two-guidewire procedure.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Visifiex Dual Lumen Catheter is designed to allow for the insertion of two guidewires into a single vessel, preventing them from crossing or entangling, and then allowing them to separately advance into different vessels. The Visifiex Dual Lumen Catheter consists of two lumens: one lumen allows the guidewire to advance along its length, and the second lumen allows separation and release of the second guidewire via two skives located 35cm apart and peeling along its length. There is a radiopaque marker near the tip of the catheter to provide visibility when placing the Visifiex Dual Lumen Catheter. There is also a radiopaque marker located at the proximal skive to aid in positioning of the catheter for advancement of a guidewire. The Visifiex Dual Lumen Catheter has an orientation feature that provides for proper positioning to aid in guidewire placement. The Visifiex Dual Lumen Catheter has a working length of 90cm and is compatible with a 9Fr introducer sheath. The proximal end of the catheter consists of a female luer connector.
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)
Not Found
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).
0
February 2008
·
510(k) Summary
A. Submitted By:
Annaliza Victoria Regulatory Affairs Specialist Endologix, Inc. 11 Studebaker Irvine, CA 92618 Tel (949) 595-7228 Fax (949) 595-7328
B. Date Prepared 07 February 2008
C. Device Name: Visiflex Dual Lumen Catheter Classified by FDA under 21 CFR 870.1250, Catheter, Percutaneous
D. Predicate Device:
Predicate device name: Manufacturer: 510(k) number:
Dual Lumen Catheter Endologix, Inc. K991601
E. Device Description:
The Visifiex Dual Lumen Catheter is designed to allow for the insertion of two guidewires into a single vessel, preventing them from crossing or entangling, and then allowing them to separately advance into different vessels. The Visifiex Dual Lumen Catheter consists of two lumens: one lumen allows the guidewire to advance along its length, and the second lumen allows separation and release of the second guidewire via two skives located 35cm apart and peeling along its length. There is a radiopaque marker near the tip of the catheter to provide visibility when placing the Visifiex Dual Lumen Catheter. There is also a radiopaque marker located at the proximal skive to aid in positioning of the catheter for advancement of a guidewire. The Visifiex Dual Lumen Catheter has an orientation feature that provides for proper positioning to aid in guidewire placement. The Visifiex Dual Lumen Catheter has a working length of 90cm and is compatible with a 9Fr introducer sheath. The proximal end of the catheter consists of a female luer connector.
F. Intended Use
The Visifiex Dual Lumen Catheter is intended for use during a two-guidewire procedure.
G. Substantial Equivalence
The Visifiex Dual Lumen Catheter is substantially equivalent to the predicate device, the Endologix Dual Lumen Catheter. The indications for use, materials, principles of operation, methods of manufacture, and performance specifications are substantially equivalent to the legally marketed device.
APR - 8 2008
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of a human figure, represented by three curved lines that suggest a head, body, and legs.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endologix, Inc. c/o Ms. Annaliza Victoria Regulatory Affairs Specialist 11 Studebaker Irvine, CA 92618
APR - 8 2008
Re: K080360
Visiflex Dual Lumen Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: March 20, 2008 Received: March 20, 2008
Dear Ms. Victoria:
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.
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Page 2 – Ms. Annaliza Victoria
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Dana R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) number (if known): K080360
Visiflex Dual Lumen Catheter Device Name:
Indications for Use:
For use during a two guidewire procedure
× Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
.
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dona R. Richter
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K080360
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