(21 days)
Not Found
No
The description focuses on the mechanical components and function of a balloon catheter, with no mention of AI or ML technologies.
Yes
The device is used for “balloon dilation of the iliac, femoral, popliteal, and renal arteries,” which is a therapeutic intervention.
No
The device description clearly states its intended use is for "balloon dilation," which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines physical components like lumens, a guidewire port, an inflation port, a balloon, and radiopaque marker bands, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "balloon dilation of the iliac, femoral, popliteal, and renal arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon designed for mechanical dilation within blood vessels. This is a physical intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic device used for a physical intervention.
N/A
Intended Use / Indications for Use
The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.
Product codes
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal, and renal arteries.
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
No Safety or Performance testing is required to establish the safety and efficacy of the subject device
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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 Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (+353) 91 703700 (Ext. 3061) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | Mark Mullaney | |
| Registration Number: | 1721504 | |
| General | ||
| Provisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| Address: | Parkmore Business Park | |
| Parkmore, 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 | |
| Subject | ||
| Device | Trade Name: | Advocate PTA Catheter |
| Common/Usual Name: | Percutaneous Catheter | |
| Classification Name: | Catheter, Angioplasty, Peripheral, | |
| Transluminal |
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| Predicate
Device | Premarket Notification Predicate #1:
Trade Name: Pirouette 014
Classification Name: 21 CFR 870.1250 Percutaneous Catheter
Premarket Notification: K162316
Manufacturer: Arravasc Limited |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Premarket Notification Predicate #2:
Trade Name: Pirouette 018
Classification Name: 21 CFR 870.1250 Percutaneous Catheter
Premarket Notification: K151153
Manufacturer: Arravasc Limited |
| | Premarket Notification Predicate #3:
Trade Name: Pirouette 035
Classification Name: 21 CFR 870.1250 Percutaneous Catheter
Premarket Notification: K161427
Manufacturer: Arravasc Limited |
| Classification | Class II
21 CFR § 870.1250
Product code: LIT
Division of Cardiovascular Devices |
| Intended Use | The Advocate PTA Catheter is intended for balloon dilation of
the iliac, femoral, popliteal, infra-popliteal, and renal arteries. |
| Device
Description | 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. |
| Comparison
to Predicate | There are no technological differences between the subject and
predicate devices. They device is manufactured under contract by
the same Manufacturer who makes the identical device under the
Pirouette name. |
| | The only difference between the two devices in in the naming and
labelling of the product, with the Merit product named and labelled
as the "Advocate PTA Catheter". |
| Safety &
Performance
Tests | No Safety or Performance testing is required to establish the safety
and efficacy of the subject device |
| Summary of
Substantial
Equivalence | Based on the comparisons noted, the subject Merit Advocate PTA
Catheter meets the requirements that are considered essential for
its intended use and is substantively equivalent to the three
Predicate Devices, the Pirouette 014, 018 and 035 [K162316,
K151153, K161427], manufactured by Arravasc Limited. |
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