(58 days)
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.
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.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the AMPLATZER® TorqVue® Delivery Sheaths.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes various functional and safety tests performed on the AMPLATZER TorqVue Delivery Sheaths to demonstrate their substantial equivalence to a predicate device. The document does not explicitly state numerical "acceptance criteria" for each test but implies that the device "conforms to the requirements for its intended use" if the tests are passed.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Tests | Conformance to specified dimensions for various sheath sizes (9Fr, 10Fr, 12Fr, 13Fr, 14Fr), lengths (80 cm for TVLA, 100 cm for TV45x45), and curve geometries. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Trackability Test | Ability of the sheath to be maneuvered through the vascular system. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Kink Test | Resistance of the sheath to kinking during use. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Flushability Test | Ability to effectively flush the lumen of the sheath. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Handoff / Advancement Force Test | Acceptable forces required to advance the device. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Recapture Force Test | Acceptable forces required to recapture the device. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Visual Inspection | Absence of defects or inconsistencies upon visual examination. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Post-Interaction Testing | Maintenance of integrity and functionality after simulated interactions. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Tip Tensile Test | Resistance of the sheath tip to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Transition Tensile Test | Resistance of transitions within the sheath to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Surface Inspection | Absence of surface imperfections. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath torque to failure | Resistance of the sheath to torque until failure. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Dilator Hub Tensile Test | Resistance of the dilator hub to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Hub Tensile Test | Resistance of the sheath hub to tensile forces. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Sheath Luer Leak Test (water and air) | Absence of leaks in the luer connection with water and air. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
| Design validation testing (animal study) | Performance and safety of the device in a relevant biological model. | Not explicitly detailed, but stated that "Results from the testing show the proposed device conforms to the requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench and laboratory testing" and "Design validation testing (animal study)". However, it does not specify the sample size for the test set used for these various tests. It also does not provide data provenance (e.g., country of origin, retrospective or prospective) for any of the studies, beyond stating that they were "Bench and laboratory testing" and an "animal study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any of the described tests. The tests appear to be primarily engineering and animal model-based, rather than human expert-driven interpretation.
4. Adjudication Method for the Test Set:
Given the nature of the bench, laboratory, and animal studies described, an adjudication method is not mentioned and is likely not applicable in the same way it would be for studies involving human interpretation or clinical outcomes. The tests appear to have objective pass/fail criteria based on engineering specifications or physiological responses in the animal model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench, laboratory, and animal studies to demonstrate substantial equivalence, not a clinical study involving human readers and interpretations. Therefore, no effect size for human readers improving with or without AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a physical medical device (catheter delivery system), not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable.
7. The Type of Ground Truth Used:
The ground truth for the bench and laboratory tests would have been established by engineering specifications, material properties, and performance standards for medical devices of this type. For the "design validation testing (animal study)," the ground truth would be based on physiological responses, procedural success, and absence of adverse events observed in the animal model, as determined by veterinary experts and scientific observation.
8. The Sample Size for the Training Set:
This device is a physical medical device, and the described studies are for its functional and safety validation. There is no concept of a "training set" as would be used for machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the context of this device and its validation, this question is not applicable.
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K120120
P. 1 of 4
510(K) SUMMARY
MAR 1 5 2012
| Submitter: | AGA Medical Corporation5050 Nathan LanePlymouth, MN |
|---|---|
| Contact Person: | Rashmi Bhushan, PhDPrincipal Regulatory Affairs SpecialistPhone: 651-756-5767Fax: 763-647-5932E-mail: rbhushan@sjm.com |
| Date Prepared: | January 13, 2012 |
| Trade Name: | AMPLATZER® TorqVue® 45°x45° Delivery SheathAMPLATZER® TorqVue® LA1 Delivery SheathAMPLATZER® TorqVue® LA2 Delivery Sheath |
| Common Name: | Catheter Delivery System |
| Classification: | Class II, 21 CFR 870.1250Catheter, Percutaneous |
| Product Code: | DQY |
| Predicate Device(s): | AMPLATZER TorqVue 45°x45° Delivery Sheath (K083214) |
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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.
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:
.
| Comparison topredicate: | The predicate device, the TV45x45, is currently marketed underK083214 clearance for the 9, 10, 12, and 13Fr sizes. Designchanges 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 andSafety Testing: | Bench and laboratory testing was performed to support adetermination of substantial equivalence to the predicate device.Results from the testing show the proposed device conforms tothe requirements for its intended use. This included thefollowing 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) |
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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.
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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
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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
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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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§ 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).