(58 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a delivery sheath, with no mention of AI or ML capabilities.
No
The device is a delivery sheath, providing a pathway for other devices into the heart, rather than directly treating a medical condition itself.
No
The device is described as a delivery sheath intended to provide a pathway for introducing other devices into the heart chambers, not to diagnose a condition. Its function is to facilitate the delivery of other medical devices.
No
The device description clearly details physical components like sheaths, dilators, and flush adaptors, indicating it is a hardware 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 of the heart." This describes a device used in vivo (within a living organism) for delivering other devices.
- Device Description: The description details a physical sheath, dilator, and flush adaptor designed for accessing and delivering devices to the heart chambers. This is consistent with an interventional medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with or deliver devices into the body.
N/A
Intended Use / Indications for Use
The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The AMPLATZER TorqVue LA and AMPLATZER TorqVue 45x45 Delivery Sheaths are general purpose delivery sheaths designed to access and deliver a device to the chambers of the heart. The TV45x45 Delivery Sheath is curved approximately 45° in two dimensions resulting in a three-dimensional geometry. The TVLA1 provides a single 45° curve on the distal end of the sheath. The TVLA2 provides the same 45° curve as the TVLA1 with a second superior curve at the distal tip of 20-30°.
The sheaths are offered in five sizes each (9Fr, 10Fr, 12Fr, 13FR, and 14Fr). The TVLA sheaths and are 80 cm in length and the TV45x45 sheath is 100 cm in length.
The devices include a sheath to enable device delivery, a dilator to ease entrance into and through the vasculature, and a flush adaptor for the 10, 12, 13, and 14Fr sizes to enable connection with syringes for flushing the sheath lumen. The sheaths and dilators are radiopaque for visibility under fluoroscopy. For added visibility, the sheaths also have a radiopaque marker band near the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart
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)
Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing show the proposed device conforms to the requirements for its intended use. This included the following testing: Dimensional Tests Trackability Test Kink Test Flushability Test Handoff / Advancement Force Test Recapture Force Test Visual Inspection Post-Interaction Testing Sheath Tip Tensile Test Sheath Transition Tensile Test Sheath Surface Inspection Sheath torque to failure Dilator Hub Tensile Test Sheath Hub Tensile Test Sheath Luer Leak Test (water and air) Design validation testing (animal study)
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.
AMPLATZER TorqVue 45°x45° Delivery Sheath (K083214)
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
K120120
P. 1 of 4
510(K) SUMMARY
MAR 1 5 2012
| Submitter: | AGA Medical Corporation
5050 Nathan Lane
Plymouth, MN |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rashmi Bhushan, PhD
Principal Regulatory Affairs Specialist
Phone: 651-756-5767
Fax: 763-647-5932
E-mail: rbhushan@sjm.com |
| Date Prepared: | January 13, 2012 |
| Trade Name: | AMPLATZER® TorqVue® 45°x45° Delivery Sheath
AMPLATZER® TorqVue® LA1 Delivery Sheath
AMPLATZER® TorqVue® LA2 Delivery Sheath |
| Common Name: | Catheter Delivery System |
| Classification: | Class II, 21 CFR 870.1250
Catheter, Percutaneous |
| Product Code: | DQY |
| Predicate Device(s): | AMPLATZER TorqVue 45°x45° Delivery Sheath (K083214) |
1
Device Description: The AMPLATZER TorqVue LA and AMPLATZER TorqVue 45x45 Delivery Sheaths are general purpose delivery sheaths designed to access and deliver a device to the chambers of the heart. The TV45x45 Delivery Sheath is curved approximately 45° in two dimensions resulting in a three-dimensional geometry. The TVLA1 provides a single 45° curve on the distal end of the sheath. The TVLA2 provides the same 45° curve as the TVLA1 with a second superior curve at the distal tip of 20-30°.
The sheaths are offered in five sizes each (9Fr, 10Fr, 12Fr, 13FR, and 14Fr). The TVLA sheaths and are 80 cm in length and the TV45x45 sheath is 100 cm in length.
The devices include a sheath to enable device delivery, a dilator to ease entrance into and through the vasculature, and a flush adaptor for the 10, 12, 13, and 14Fr sizes to enable connection with syringes for flushing the sheath lumen. The sheaths and dilators are radiopaque for visibility under fluoroscopy. For added visibility, the sheaths also have a radiopaque marker band near the distal tip.
Intended Use: The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.
2
:
.
| Comparison to
predicate: | The predicate device, the TV45x45, is currently marketed under
K083214 clearance for the 9, 10, 12, and 13Fr sizes. Design
changes were made to the predicate, which included: |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 14Fr TV45x45 Delivery Sheath Addition of larger sheath size Change to flush adapter (14Fr devices only) Addition of additional backing card to packaging (14Fr devices only) TVLA Delivery Sheaths Addition of larger sheath size Change to device length Change to sheath distal curve geometry Change to flush adapter (14Fr devices only) Addition of additional backing card to packaging (14Fr devices only) |
| Functional and
Safety Testing: | Bench and laboratory testing was performed to support a
determination of substantial equivalence to the predicate device.
Results from the testing show the proposed device conforms to
the requirements for its intended use. This included the
following testing: Dimensional Tests Trackability Test Kink Test Flushability Test Handoff / Advancement Force Test Recapture Force Test Visual Inspection Post-Interaction Testing Sheath Tip Tensile Test Sheath Transition Tensile Test Sheath Surface Inspection Sheath torque to failure Dilator Hub Tensile Test Sheath Hub Tensile Test Sheath Luer Leak Test (water and air) Design validation testing (animal study) |
3
AGA Medical Corporation considers the 14Fr AMPLATZER Conclusion: TorqVue 45°x45° Delivery Sheath, 9-14Fr AMPLATZER TorqVue LA1 Delivery Sheaths, and 9-14Fr AMPLATZER TorqVue LA2 Delivery Sheaths to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a central symbol. The symbol consists of three stylized shapes that resemble a person with outstretched arms, representing health and human services. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 5 2012
AGA Medical Corporation c/o Rashmi Bhushan, Ph.D. Principal Regulatory Affairs Specialist 5050 Nathan Lane Plymouth, MN 55433
Re: K120120
Trade/Device Name: AMPLATZER® TorqVue® 45°x45° Delivery Sheath AMPLATZER® TorqVue® LA1 Delivery Sheath AMPLATZER® TorqVue® LA2Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: February 22, 2012 Received: February 23, 2012
Dear Dr. Bhushan:
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 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
5
Page 2 – Dr. Rashmi Bhushan
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21CFR 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram Ø. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number:
K 120120 --
Device Name:
AMPLATZER TorqVue 45°x45° Delivery Sheath AMPLATZER TorqVue LA1 Delivery Sheath AMPLATZER TorqVue LA2 Delivery Sheath
Indications for Use:
The AMPLATZER TorqVue 45°x45°, LA1, and LA2 Delivery Sheaths are intended to provide a pathway through which devices are introduced within the chambers of the heart.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2 Devices
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