(31 days)
The AMPLATZER® TorqVue® Low Profile Delivery System is indicated to provide a pathway through which devices are introduced into the peripheral vasculature.
The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous 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 transvenous 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
Here's an analysis of the provided text regarding the acceptance criteria and study for the AMPLATZER® TorqVue® Low Profile Delivery System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Characteristics) | Reported Device Performance |
|---|---|
| Catheter integrity | Confirmed substantially equivalent to predicate device |
| Catheter kink resistance | Confirmed substantially equivalent to predicate device |
| Leak resistance | Confirmed substantially equivalent to predicate device |
| Hub strength | Confirmed substantially equivalent to predicate device |
| Ability to deliver various implantable devices | Confirmed substantially equivalent to predicate device |
Explanation: The document explicitly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices." The specific numerical acceptance criteria (e.g., "kink resistance must withstand X N of force") and the exact performance values (e.g., "kink resistance withstood Y N") are not provided in this summary. The evaluation is made against a predicate device, seeking "substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Verification and validation testing" and "laboratory verification tests and in vitro performance information."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are primarily laboratory and in vitro performance tests, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided as the described tests are laboratory and in vitro performance assessments, not studies requiring human expert adjudication of results.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant to this device. This device is a medical delivery system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
A standalone performance evaluation in the context of an algorithm or AI was not performed or described. This is a medical device, not a software algorithm. The "standalone" performance here refers to the device's functional characteristics tested in a lab setting, which were indeed conducted without human operator variables, beyond basic operation.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests was established through objective laboratory measurements and in vitro performance evaluations against pre-defined engineering and performance specifications, likely derived from the predicate device's characteristics or internal design requirements. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A training set typically refers to data used to train machine learning models, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as there is no mention of a training set or machine learning in the context of this device.
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4 510(k) Summary
Applicant Information 4.1
| Date Prepared: | April 10, 2008 |
|---|---|
| Submitter: | AGA Medical Corporation |
| Address: | 5050 Nathan Lane NorthPlymouth, MN 55442 |
| EstablishmentRegistration No: | 2135147 |
| Contact Person: | Rashmi G BhushanSr. Regulatory Affairs Specialist |
| Telephone Number: | (763) 531-3066 |
| 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 Device: | AMPLATZER® TorqVue® Delivery System510(k) K072313, Reg. No. 870.1250; Product Code: DQY |
| Predicate Device Intended Use: The AMPLATZER®TorqVue® Delivery System is intended to provide apathway through which devices are introduced within thechambers and coronary vasculature of the heart or in theperipheral vasculature. | |
| Device Description: | The AMPLATZER TorqVue Low Profile Delivery Systemis a sterile, single-use device designed to facilitate theintroduction of devices to a location within the peripheralvasculature. |
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| The catheter has a single lumen for passage of transvenousdevices with maximum outer diameters of 4 and 5 French.The catheters will be provided in 60 cm and 80 cm usablelengths. The system includes the following components: | |
|---|---|
| • | Delivery Catheter - used to deliver transvenous devices |
| • | Loader- used to help introduce the selected implantabledevice into the delivery catheter |
| • | Delivery Wire (optional) – attaches to the implantabledevice and facilitates advancement through the catheter,placement and, if desired, recapture of the specifiedimplantable device. [If this surgical accessory (ProductCode = DWS) is included, the labeling will specifycompatibility with the appropriate implantable devices.] |
| • | Plastic Vise (included with delivery wire) – a handlethat is attached to the Delivery Wire by means of a setscrew |
| • | Hemostasis Valve- used on the proximal end of theLoader to minimize bleeding from the DeliveryCatheter and for flushing air from the system |
| Intended Use: | The AMPLATZER® TorqVue® Low Profile DeliverySystem is intended to provide a pathway through whichdevices are introduced into the peripheral vasculature. |
| Comparison toPredicate Device: | The AMPLATZER® TorqVue® Low Profile DeliverySystem is substantially equivalent to the predicate devicecleared by K072313. The two systems are both handheldcatheter systems designed to facilitate access andplacement of specified implantable devices into theperipheral vasculature. Both delivery catheters are singlelumen design with a hemostasis valve. The AMPLATZERTorqVue Low Profile Delivery System was created fromthe existing TorqVue Delivery System and onlyincorporates modifications to the design and materials thatallow for the modified system to be manufactured in a 4and 5 French size. The modifications have not altered thefundamental scientific technology of the predicate device. |
| Test Data: | Verification and validation testing confirms that thefunctional characteristics of the AMPLATZER® TorqVue®Low Profile Delivery Systems are substantially equivalent |
:
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to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
Based on the technical information, intended use, Summary: laboratory verification tests and in vitro performance information provided, the AMPLATZER® TorqVue® Low Profile Delivery System is substantially equivalent to the currently marketed predicate device.
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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2008
AGA Medical Corp. c/o Mr. Rashmi Bhushan Senior Regulatory Affairs Specialist 5050 Nathan Lane North Plymouth, MN 55442-3209
Re: K080757
AMPLATZER TorqVue Profile Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: II Product Code: DQY Dated: March 17, 2008 Received: March 18, 2008
Dear Mr. 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 such additional controls. Existing major regulations affecting your device can he 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.
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Pagc 2 - Mr. Rashmi Bhushan
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
R. Vahner
o 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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510(k) Number: _ ¥080757
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 into 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 T NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oulma R. W. Hines
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ko80757
§ 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).