(21 days)
The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.
The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 20-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.
The provided document is a 510(k) premarket notification decision letter from the FDA to Merit Medical Systems, Inc. regarding the Advocate PTA Catheter. It outlines the regulatory classification, intended use, and substantial equivalence to predicate devices.
Crucially, this document is for a physical medical device (a catheter for angioplasty), not a software or AI-based medical device. Therefore, the specific questions related to AI/software performance, such as acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, are not applicable to the information contained within this document.
The document explicitly states: "No Safety or Performance testing is required to establish the safety and efficacy of the subject device." This is because the device is being marketed as substantially equivalent to existing predicate devices (Pirouette 014, 018, and 035) with "no technological differences" and manufactured by the "same Manufacturer who makes the identical device under the Pirouette name." The only difference noted is the naming and labeling of the product.
Therefore, I cannot provide the requested information based on this document. The questions you posed are relevant for AI/software medical devices, which typically require extensive validation studies to demonstrate performance.
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December 13, 2017
Merit Medical Systems, Inc. Mr. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K173621
Trade/Device Name: Advocate PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 20, 2017 Received: November 22, 2017
Dear Mr. O'Sullivan:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
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
510(k) Number (if known) K173621
Device Name Advocate PTA Catheter
Indications for Use (Describe)
The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.
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 Name: | Merit Medical Systems, Inc. | |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | (+353) 91 703700 (Ext. 3061) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | Mark Mullaney | |
| Registration Number: | 1721504 | |
| GeneralProvisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| Address: | Parkmore Business ParkParkmore, Galway, Ireland | |
| Telephone Number: | (+353) 91 703700 (Ext. 3223) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | Michael O'Sullivan | |
| Date of Preparation: | 20 November 2017 | |
| Registration Number: | 9616662 | |
| SubjectDevice | Trade Name: | Advocate PTA Catheter |
| Common/Usual Name: | Percutaneous Catheter | |
| Classification Name: | Catheter, Angioplasty, Peripheral,Transluminal |
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| PredicateDevice | Premarket Notification Predicate #1:Trade Name: Pirouette 014Classification Name: 21 CFR 870.1250 Percutaneous CatheterPremarket Notification: K162316Manufacturer: Arravasc Limited |
|---|---|
| Premarket Notification Predicate #2:Trade Name: Pirouette 018Classification Name: 21 CFR 870.1250 Percutaneous CatheterPremarket Notification: K151153Manufacturer: Arravasc Limited | |
| Premarket Notification Predicate #3:Trade Name: Pirouette 035Classification Name: 21 CFR 870.1250 Percutaneous CatheterPremarket Notification: K161427Manufacturer: Arravasc Limited | |
| Classification | Class II21 CFR § 870.1250Product code: LITDivision of Cardiovascular Devices |
| Intended Use | The Advocate PTA Catheter is intended for balloon dilation ofthe iliac, femoral, popliteal, infra-popliteal, and renal arteries. |
| DeviceDescription | The Advocate PTA Catheter consists of two lumens, a compatibleguidewire lumen (0.014", 0.018" or 0.035") extending from guidewire port in the manifold to the catheter distal tip, and an inflationlumen extending from the proximal inflation port in the manifold tothe balloon interior. There are various size balloons in the productmatrix, ranging from 2.0-12.0mm in diameter and 20-300mm inlength. The catheter has two radiopaque marker bands that facilitatevisibility and location during the placement and inflation of theballoon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Frhaemostatic or non haemostatic introducer, depending on the modelselected. |
| Comparisonto Predicate | There are no technological differences between the subject andpredicate devices. They device is manufactured under contract bythe same Manufacturer who makes the identical device under thePirouette name. |
| The only difference between the two devices in in the naming andlabelling of the product, with the Merit product named and labelledas the "Advocate PTA Catheter". | |
| Safety &PerformanceTests | No Safety or Performance testing is required to establish the safetyand efficacy of the subject device |
| Summary ofSubstantialEquivalence | Based on the comparisons noted, the subject Merit Advocate PTACatheter meets the requirements that are considered essential forits intended use and is substantively equivalent to the threePredicate Devices, the Pirouette 014, 018 and 035 [K162316,K151153, K161427], manufactured by Arravasc Limited. |
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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).