(121 days)
Not Found
No
The summary describes a mechanical delivery system and does not mention any AI or ML components or functions.
No
The device is described as a delivery system that facilitates the introduction of other devices, including therapeutic ones, into the body. It does not exert any therapeutic effect itself.
No
The device is described as a delivery system that provides a pathway for other devices, indicating a therapeutic or procedural function rather than a diagnostic one. Its purpose is to facilitate the introduction of devices, not to diagnose conditions.
No
The device description clearly outlines physical components like a catheter, loader, delivery wire, plastic vise, and hemostasis valve, indicating it is a hardware-based medical 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 "provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature." This describes a device used in vivo (within the body) for delivering other devices.
- Device Description: The description details a catheter system designed for introducing devices into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are typically used in laboratories or point-of-care settings to provide information about a patient's health status based on the analysis of biological samples.
This device is a medical device used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AMPLATZER TorqVue Low Profile Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Product codes
DQY
Device Description
The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components:
- . Delivery Catheter - used to deliver devices
- . Loader – used to help introduce the selected implantable device into the delivery catheter
- . Delivery Wire (optional) - attaches to the implantable device and facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.]
- . Plastic Vise (included with delivery wire) – a handle that is attached to the Delivery Wire by means of a set screw
- . Hemostasis Valve- used on the proximal end of the Loader to minimize bleeding from the Delivery Catheter and for flushing air from the system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers and coronary vasculature of the heart or in the 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
Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent to the predicate devices cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
Key Metrics
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
.
4 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
4.1 Applicant Information
| Date Prepared: | March XX, 2013 | ||
|---|---|---|---|
| Submitter: | AGA Medical Corporation | ||
| Address: | 5050 Nathan Lane North | ||
| Plymouth, MN 55442 | AUG 1 5 2013 | ||
| Establishment | |||
| Registration No: | 2135147 | ||
| Contact Person: | Heather M Taylor | ||
| Sr. Regulatory Affairs Specialist | |||
| Telephone Number: | (651) 756-5765 | ||
| Fax Number: | (763) 647-5932 | ||
| 4.2 | Device Information | ||
| Trade Name: | AMPLATZER® TorqVue® Low Profile Delivery System | ||
| Common Name: | Delivery System | ||
| Classification Name: | Catheter, Percutaneous | ||
| Classification: | Class II, 21 CFR 870.1250 | ||
| Product Code: | DQY | ||
| Predicate Devices: | AMPLATZER® TorqVue® Delivery System | ||
| 510(k) K072313, Reg. No. 870.1250; Product Code: DQY | |||
| Predicate Device Intended Use: The AMPLATZER® TorqVue® | |||
| Delivery System is intended to provide a pathway through | |||
| which devices are introduced within the chambers and | |||
| coronary vasculature of the heart or in the peripheral | |||
| vasculature. |
:
1
AMPLATZER® TorqVue® Low Profile Delivery System
510(k) K080757, Reg. No. 870.1250; Product Code: DQY
Predicate Device Intended Use: The AMPLATZER TorqVue LP delivery system is intended to provide a pathway through which devices are introduced into the peripheral vasculature.
Device Description: The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.
The catheter has a single lumen for passage of devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components:
- . Delivery Catheter - used to deliver devices
- . Loader – used to help introduce the selected implantable device into the delivery catheter
- . Delivery Wire (optional) - attaches to the implantable device and facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.]
- . Plastic Vise (included with delivery wire) – a handle that is attached to the Delivery Wire by means of a set screw
- . Hemostasis Valve- used on the proximal end of the Loader to minimize bleeding from the Delivery Catheter and for flushing air from the system
The AMPLATZER® TorgVue Low Profile Delivery System is Intended Use: intended to provide a pathway through which devices are
AMPLATZER® TorqVue® Low Profile Delivery System 510(k) Premarket Notification
2
introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Comparison to
The AMPLATZER TorqVue Low Profile Delivery System is Predicate Devices: substantially equivalent to the predicate devices cleared by K072313 and K080757. This submission seeks to add a cardiac indication to the already cleared K080757. All systems are handheld catheter systems designed to facilitate access and placement of specified implantable devices within the chambers and coronary vasculature of the heart. All three delivery catheters are single lumen design with a hemostasis valve. The device included in this submission is identical in design to the already cleared K080757, and is using the already cleared K072313 to support the cardiac indication for use. Test Data: Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent
to the predicate devices cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
Summary: Based on the technical information, intended use, laboratory verification tests and in vitro performance information provided, the AMPLATZER® TorqVue® Low Profile Delivery System is substantially equivalent to the currently marketed predicate devices.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal with text and a stylized symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Inside the circle is a symbol that resembles a stylized caduceus, with three wavy lines representing snakes intertwined around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 15, 2013
St. Jude Medical C/O Heather Taylor 5050 Nathan Lane North Plymouth, MN 55442 US
Re: K131063
Trade/Device Name: AMPLATZER TorqVue Low Profile Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: July 25, 2013 Received: July 26, 2013
Dear Ms. Taylor:
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
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,
M.S. Hillman
for
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
3 STATEMENT OF INDICATIONS FOR USE
K131063 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: AMPLATZER TorqVue Low Profile Delivery System
Indications for use:
The AMPLATZER TorqVue Low Profile Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
Prescription Use ______x (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 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)
M. A. Hilleman
(Division Sign-Off) AMPLATZER® TorqVue® Low Profile Delivery System Division Sign-Off)
510(k) Premarket Notification 510(k) Premarket Notification K131063 510(k) Number: