(152 days)
No
The summary describes a mechanical catheter for accessing blood vessels and does not mention any computational or algorithmic functions, let alone AI/ML.
No.
The device facilitates placement of guidewires and infusion of diagnostic agents, but it does not directly treat a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device "may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic agents." This indicates it helps in delivering diagnostic agents, but the device itself is not performing the diagnostic function; it is a delivery tool for those agents.
No
The device description clearly details a physical catheter with lumens, marker bands, and positioning marks, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for accessing and facilitating procedures within the coronary and/or peripheral vasculature. This involves direct interaction with the patient's body for diagnostic and therapeutic purposes (facilitating guidewire placement, delivering diagnostic agents).
- Device Description: The description details a physical catheter designed to be inserted into blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform such analysis on specimens.
The device described is a medical device used for interventional procedures within the body.
N/A
Intended Use / Indications for Use
The Twin-Pass Torque catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Twin-Pass Torque is a dual lumen catheter consisting of an over-the-wire (OTW) lumen that runs the full length of the catheter, exiting just proximal to the distal tip, and a rapid exchange (RX) delivery lumen on the distal segment. The two exit ports are each marked by a radiopaque platinum-iridium marker band and the device shaft has two positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, which are not visible under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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 device design has been verified through the following tests:
- Kink resistance
- Guidewire insertion
- Tip flexibility
- Distal shaft flexibility
- Proximal shaft support
- Coating lubricity/Durability
- Radiopacity
- Guidewire deflection
- Distal tip length
- Torque control
- Torque transmission
- Tensile strength
- Torque strength
- Torque robustness
- Hub luer tests (air leak, burst, compatibility)
- Hydrophilic coating particulate
- Package integrity
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
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.
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
Image /page/0/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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2017
Vascular Solutions, Inc. Ms. Lisa Gallatin Director of Regulatory 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K162467
Trade/Device Name: Twin-Pass Torque Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 27, 2016 Received: December 28, 2016
Dear Ms. Gallatin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Aguel-S
for 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
510(k) Number (if known) K162467
Device Name Twin-Pass Torque
Indications for Use (Describe)
The Twin-Pass catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic agents.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: December 21, 2016
510(k) Number: __K162467
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Lisa Gallatin, RAC Director of Regulatory Tel: 763-656-4300 Fax: 763-656-4253
General Information
| Trade Name | Twin-Pass Torque |
|---|---|
| Common / Usual Name | Dual access catheter |
| Classification Name | Catheter, percutaneous |
| Predicate Device | K083784, Twin-Pass dual access catheter, Vascular Solutions, Inc. |
| Reference Device | K142065 and K151981, Turnpike catheter |
Device Description
The Twin-Pass Torque is a dual lumen catheter consisting of an over-the-wire (OTW) lumen that runs the full length of the catheter, exiting just proximal to the distal tip, and a rapid exchange (RX) delivery lumen on the distal segment. The two exit ports are each marked by a radiopaque platinum-iridium marker band and the device shaft has two positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, which are not visible under fluoroscopy.
Intended Use
The Twin-Pass Torque catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.
Technological Characteristics Comparison
Twin-Pass Torque is similar in design to the predicate device and both are dual lumen, percutaneous catheters intended to access discrete regions of the coronary and peripheral vasculature, facilitate placement and exchange of guidewires and subselectively infuse agents. With the exception of dimensional, material and package configuration differences, the Twin-Pass Torque is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests.
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Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The Twin-Pass dual access catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- . Kink resistance
- . Guidewire insertion
- . Tip flexibility
- . Distal shaft flexibility
- Proximal shaft support ●
- Coating lubricity/Durability ●
- Radiopacity
- Guidewire deflection ●
- Distal tip length ●
- . Torque control
- Torque transmission ●
- Tensile strength .
- . Torque strength
- Torque robustness
- Hub luer tests (air leak, burst, compatibility)
- Hydrophilic coating particulate
- . Package integrity
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- Sensitization
- . Irritation
- Systemic toxicity ●
- . Pyrogenicity
- . Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Twin-Pass Torque dual access catheter is substantially equivalent to the predicate device.