(83 days)
The AMPLATZER® TorqVue FX Delivery System is intended to provide a pathway through which devices are introduced within the chambers of the heart.
The AMPLATZER® TorqVue® FX Delivery Systems (also referred to herein as ITV FX) are general purpose delivery systems designed to provide a pathway through which devices are introduced within the chambers of the heart. The ITV FX Delivery Systems are an extension of the AMPLATZER TorqVue (ITV) Delivery System product line. The technological characteristics of the ITV FX are the same as the predicate devices, with the following differences: The TorqVue FX Delivery System contains a flex . delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve. The flex cable assembly provides rigidity for advancing devices through the sheath and allows the core wire to be extended out of the coil to provide flexibility for confirming correct placement of the deployed device. The Torq Vue FX Delivery System contains an 0.035" . compatible extension wire, which is only used for attaching to the delivery cable in vivo when there is a need to replace the sheath with a larger sheath. The standard ITV and ITV FX dilators fit over the extension wire and delivery cable core wire. The ITV FX Delivery System sheath will be offered with a 45° curve with a 60-cm useable length (6Fr, 7Fr, 8Fr) or 80-cm usable length (7Fr, 8Fr. 9Fr. 10Fr, 12Fr, 13Fr) and will be recommended for use with a subset of the AMPLATZER occluders that currently recommend the Torq Vue (45°) Delivery Systems. The ITV FX Delivery System includes a delivery sheath, dilator, delivery cable, extension wire, loader, delivery cable vise, two hemostasis valves, and for the 10, 12 and 13Fr products a flush adaptor to enable connection with syringes for flushing the sheath lumen. The sheaths are radiopaque for visibility under fluoroscopy.
The AMPLATZER® TorqVue® FX Delivery System is a catheter delivery system. The information provided describes the device's technical characteristics, its comparison to predicate devices, and the testing performed to demonstrate substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantified manner with corresponding "reported device performance." Instead, it states that "Results from testing of the proposed and predicate devices show the proposed device conforms to the requirements for its intended use." The testing performed serves as the basis for this conformance.
Here's a table summarizing the tests performed, which implicitly served as the "acceptance criteria" through successful completion:
| Acceptance Criteria (Functional/Safety Test Category) | Reported Device Performance (Implicitly Met) |
|---|---|
| Delivery Cable and Extension Wire Specific Tests | |
| Delivery Cable and Extension Wire Dimensional Tests | Conforms to dimensional requirements |
| Delivery Cable Vacuum Decay | Meets vacuum decay specifications |
| Extension Wire Connection Reliability | Demonstrates reliable connection |
| Delivery Cable Core Wire Distal Tip Flexibility | Meets flexibility requirements |
| Delivery Cable and Extension Wire Corrosion Testing | Demonstrates corrosion resistance |
| Delivery Cable Distal Torque to Failure | Meets torque to failure specifications |
| Delivery Cable Force Transmission | Demonstrates adequate force transmission |
| Delivery Cable Distal Core Tensile | Meets tensile strength requirements |
| Delivery Cable Core to Extension Wire Tensile | Meets tensile strength requirements |
| Delivery Cable Hub to Coil Tensile | Meets tensile strength requirements |
| Hemostasis Valve Leak Testing | Meets leak testing specifications |
| Device Interaction Testing with Other Components | |
| Advancement/Deployment Test | Successful advancement and deployment of devices |
| Recapture Test | Successful recapture of devices |
| Visual Inspection Post-Interaction Testing | No adverse visual changes post-interaction |
| Overall System Performance & Validation | |
| Design Validation Testing (animal study) | Successful performance in an animal model |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of units, number of tests for each type) used for the bench and laboratory testing. It broadly states "Bench and laboratory testing was performed."
The data provenance is from bench and laboratory testing, indicating controlled environments. There is one mention of an "animal study" for "Design Validation Testing." The country of origin for the data is not explicitly stated but is implied to be within the US, given the submitter's location (Plymouth, MN) and the FDA submission process. All studies appear to be prospective as they were conducted to support the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the described testing does not involve human interpretation or subjective assessment that would require expert consensus for ground truth. The tests are primarily engineering and performance-based, with results measured against predetermined specifications.
4. Adjudication method for the test set
This section is not applicable for the same reasons as #3. The testing involves objective measurements rather than subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a physical medical device (catheter delivery system), not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. As a physical medical device, the concept of "standalone algorithm performance" is not relevant. The device itself is the "standalone" entity whose physical and functional performance is being evaluated.
7. The type of ground truth used
The "ground truth" for the acceptance criteria is based on engineering specifications, design requirements, and established industry standards for medical device performance and safety. For example, a "Tensile Test" would have an established maximum force the component must withstand, which serves as its ground truth. The "animal study" would have defined success metrics related to device delivery and placement.
8. The sample size for the training set
This section is not applicable. This device is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reason as #8.
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4 510(K) SUMMARY
r
AUG 2 3 2012
K12161
| Submitter: | AGA Medical Corporation5050 Nathan LanePlymouth, MN |
|---|---|
| Contact Person: | Sherry KollmannSenior Regulatory Affairs SpecialistPhone: 651-756-5463Fax: 763-647-5932E-mail: skollmann@sjm.com |
| Date Prepared: | May 31, 2012 |
| Trade Name: | AMPLATZER® TorqVue® FX Delivery Systems |
| Common Name: | Catheter Delivery System |
| Classification: | Class II, 21 CFR 870.1250Catheter, Percutaneous |
| Product Code: | DQY |
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AMPLATZER® TorqVue® (45°) Delivery System (K072313) Predicate Device(s): AMPLATZER® TorqVue® 45°x45° Delivery Sheath (K083214) The AMPLATZER® TorqVue® FX Delivery Systems (also referred to Device Description: herein as ITV FX) are general purpose delivery systems designed to provide a pathway through which devices are introduced within the chambers of the heart. The ITV FX Delivery Systems are an extension of the AMPLATZER TorqVue (ITV) Delivery System product line. The technological characteristics of the ITV FX are the same as the predicate devices, with the following differences: The TorqVue FX Delivery System contains a flex . delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve. The flex cable assembly provides rigidity for advancing devices through the sheath and allows the core wire to be extended out of the coil to provide flexibility for confirming correct placement of the deployed device. The Torq Vue FX Delivery System contains an 0.035" . compatible extension wire, which is only used for attaching to the delivery cable in vivo when there is a need to replace the sheath with a larger sheath. The standard ITV and ITV FX dilators fit over the extension wire and delivery cable core wire. The ITV FX Delivery System sheath will be offered with a 45° curve with a 60-cm useable length (6Fr, 7Fr, 8Fr) or 80-cm usable length (7Fr, 8Fr. 9Fr. 10Fr, 12Fr, 13Fr) and will be recommended for use with a subset of the AMPLATZER occluders that currently recommend the Torq Vue (45°) Delivery Systems. The ITV FX Delivery System includes a delivery sheath, dilator, delivery cable, extension wire, loader, delivery cable vise, two hemostasis valves, and for the 10, 12 and 13Fr products a flush adaptor to enable connection with syringes for flushing the sheath lumen. The sheaths are radiopaque for visibility under fluoroscopy. The AMPLATZER TorqVue FX Delivery System is intended to Intended Use: provide a pathway through which devices are introduced within the chambers of the heart.
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| Comparison topredicate: | The AMPLATZER TorqVue FX Delivery System is substantiallyequivalent to the predicate devices cleared by K072313 and K083214,AMPLATZER TorqVue Delivery System (ITV) and AMPLATZERTorqVue 45°x45° Delivery Sheath (TV 45°x45°), respectively.With the exception of the delivery cable, extension wire, andhemostasis valves, the components used in the ITV FX are identical tothose used in ITV and/or TV 45°x45°.A high-level comparison of TorqVue FX Delivery Systemcomponents to the currently marketed predicate components isprovided in Table 1 below. |
|---|---|
| ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Table 1. | TV FX Comparison to Predicates |
|---|---|
| TorqVue FX Component | Comparison to Predicate Component |
| Hemostasis Valves | *New (equivalent to ITV) |
| Flush Adapter | Identical to TV 45°x45° |
| Loader | Identical to ITV |
| Sheath | Identical to ITV and Equivalent to TV45°x45° |
| Dilator | Identical to ITV and Equivalent to TV45°x45° |
| Delivery Cable | *New (equivalent to ITV) |
| Vise | Identical to ITV |
| Extension Wire | *New |
*Design verification testing was completed for new components, see Section 11.
The ITV FX contains a two-piece flex delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve. The coil component provides rigidity for advancing devices through the sheath and then the Nitinol core wire can be extended out of the coil to provide additional flexibility for confirming correct placement of the deployed device. The stainless steel coil is equivalent to ITV, and the Nitinol core wire concept is similar to the currently marketed AMPLATZER Vascular Plug II (AVP2) delivery wire.
A 0.035" compatible extension wire will also be packaged with the ITV FX Delivery System, and will only be used for attaching to the delivery cable in vivo when there is a need to replace the sheath with a new sheath. The standard ITV and ITV FX dilators fit over the extension wire and delivery cable core wire. The extension wire is similar in design and materials to the AVP2 delivery wire.
The modifications have not altered the fundamental scientific technology of the predicate device.
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| Functional andSafety Testing: | Bench and laboratory testing was performed to support adetermination of substantial equivalence to the predicate device.Results from testing of the proposed and predicate devices show theproposed device conforms to the requirements for its intended use.Testing performed on the proposed device (ITV FX Delivery Cableand Extension Wire) included the following:• Delivery Cable and Extension Wire Dimensional Tests• Delivery Cable Vacuum Decay• Extension Wire Connection Reliability• Delivery Cable Core Wire Distal Tip Flexibility• Delivery Cable and Extension Wire Corrosion Testing• Delivery Cable Distal Torque to Failure• Delivery Cable Force Transmission• Delivery Cable Distal Core Tensile• Delivery Cable Core to Extension Wire Tensile• Delivery Cable Hub to Coil Tensile• Design Validation Testing (animal study)• Device Interaction Testingo Advancement/Deployment Testo Recapture Testo Visual Inspection Post-Interaction Testing• Hemostasis Valve Leak Testing |
|---|---|
| Testing performed on the predicate devices (ITV Sheath and Dilator,TV 45°x45°) and leveraged for ITV FX included the following:• Sheath Surface Inspection• Dilator Surface Inspection• Sheath Tip Tensile Test• Dilator Hub Tensile Test• Sheath Hub Tensile Test• Loader Distal Luer Tensile• Loader Hub Tensile• Sheath Luer Leak Test (water and air)• Flush Adaptor Luer Leak• Sheath Torque to Failure | |
| Conclusion: | AGA Medical Corporation considers the AMPLATZER TorqVue FXDelivery Systems to be substantially equivalent to the predicatedevice listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials andindications for use. |
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings. The symbol is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AGA Medical Corporation % Sherry Kollmann 5050 Nathan Lane Plymouth, MN 55433 US
AUG 2 3 2012
Re: K121611
Trade/Device Name: Amplatzer TorqVue FX Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 19, 2012 Received: July 20, 2012
Dear Ms. Kollmann:
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
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Page 2 - Ms. Sherry Kollmann
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M.J. Killilea
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 Statement
510(k) Number (if known): K | Z | 6 | |
Device Name: AMPLATZER® TorqVue FX Delivery Systems
Indications for Use: The AMPLATZER® TorqVue FX Delivery System is 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)
Over-The-Counter Use AND/OR (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)
ghille
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KI 216 l
Page 1 of 1
§ 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).