(32 days)
No
The description focuses on the mechanical components and function of a catheter delivery system, with no mention of AI or ML capabilities.
No
The device is described as a delivery catheter intended to provide a pathway for other devices; it does not itself provide a therapeutic effect.
No
The device is a delivery catheter intended to provide a pathway for introducing other devices into the heart's chambers and coronary vasculature, or peripheral vasculature. It is not described as diagnosing a condition.
No
The device description clearly outlines physical components such as a catheter, loader, and hemostasis valves, 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: 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 medical devices.
- Device Description: The description details a catheter and associated components for delivering devices within the body. There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Anatomical Site: The anatomical sites are within the heart and peripheral vasculature, indicating use within the living organism.
- Input Imaging Modality: Fluoroscopy is used for visualization during the procedure, not for analyzing samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AMPLATZER™ TorqVue™ LP Catheter 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.
Product codes
DQY
Device Description
The AMPLATZER TorqVue Low Profile Delivery Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing: The components of the TVLPC are identical to the 510(k) cleared predicate TVLP and A VP4 devices. Design Verification and Design Validation testing has been performed and has been provided in cleared applications for the predicate TVLP (K131063) and A VP4 (K113658) devices. Separate packaging validation has been completed on the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AMPLATZER TorqVue Low Profile Delivery System (K131063)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
AGA Medical Corporation (wholly owned by St. Jude Medical Corporation) Mary Johnson Specialist I, Regulatory Affairs 5050 Nathan Lane Plymouth. Minnesota 55442
Re: K16228
Trade/Device Name: AMPLATZER TorqVue Low Profile Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 5, 2016 Received: August 8, 2016
Dear Mary Johnson:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
AMPLATZER TorqVue Low Profile Delivery Catheter
Indications for Use (Describe)
The AMPLATZER™ TorqVue™ LP Catheter 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Submitter: | AGA Medical Corporation
A wholly owned subsidiary of St. Jude Medical
5050 Nathan Lane
Plymouth, MN |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Johnson,
Regulatory Affairs Specialist I
Phone: 651-756-2213
Fax: 651-756-5744
E-mail: mjohnson16@sjm.com |
| Date Prepared: | August 5, 2016 |
| Trade Name: | AMPLATZER® TorqVue® Low Profile Delivery Catheter |
| Common Name: | Catheter Delivery System |
| Classification: | Class II, 21 CFR 870.1250
Catheter, Percutaneous |
| 510(k) Number: | K162228 |
| Product Code: | DQY |
| Predicate Device(s): | AMPLATZER TorqVue Low Profile Delivery System (K131063) |
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AMPLATZER TorqVue Low Profile Delivery Catheter
The AMPLATZER TorqVue Low Profile Delivery Catheter (TVLPC) is an extension of Device Description: the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters. Figure 1. TVLPC Components Self-Sealing Tuohy-Borst Hemostasis Valve Hemostasis Valve
Intended Use: The AMPLATZER TorqVue LP Catheter is intended to provide a pathway through
Catheter
which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
5
AMPLATZER TorqVue Low Profile Delivery Catheter
The AMPLATZER TorqVue LP Catheter is an extension of the AMPLATZER TorqVue Comparison to predicate: Low Profile Delivery System (K131063) product line. The predicate TorqVue LP Delivery System includes a catheter, loader, Tuohy-Borst hemostasis valve, delivery wire, and plastic vise for the delivery of AMPLATZER occlusion devices, while the Torq Vue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The self-sealing hemostasis valve (referred to as hemostasis valve in AVP4 documentation) is identical to the one included with the currently marketed AMPLATZER Vascular Plug 4 (K113658).
The TVLPC differs from the TVLP in the following ways:
- . TVLPC Device only offered in 4 Fr size
- Removal of Delivery Wire ●
- Addition of Self-Sealing Hemostasis Valve
Table 1 summarizes the included components for each device.
| TVLPC | TVLP | AVP4 | |
|---|---|---|---|
| Catheter | ✓ | ✓ | |
| Loader | ✓ | ✓ | |
| Tuohy-Borst hemostasis valve | ✓ | ✓ | |
| Delivery Wire | ✓ | ||
| Vise | ✓ | ||
| Self-sealing hemostasis valve | ✓ | 4 Fr | ✓ |
| Sizes offered | 4Fr | 5 Fr | n/a |
Table 1. TVLPC vs. TVLP and AVP 4 Component Summarv
- Functional and The components of the TVLPC are identical to the 510(k) cleared predicate TVLP and Safety Testing: A VP4 devices. Design Verification and Design Validation testing has been performed and has been provided in cleared applications for the predicate TVLP (K131063) and A VP4 (K113658) devices. Separate packaging validation has been completed on the subject device.
- AGA Medical Corporation considers the 4 Fr AMPLATZER TorqVue Low Profile Conclusion: Delivery Catheter to be substantially equivalent to the TorqVue Low Profile Delivery System. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use as identical components merely packaged differently from predicate devices.