(42 days)
No
The device description and intended use are purely mechanical, describing a balloon catheter for dilation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended for "balloon dilation" and "treatment of obstructive lesions," which directly involve treating a medical condition rather than just diagnostic imaging.
No
The device is described as a "PTA Catheter" used for "balloon dilation" and "treatment of obstructive lesions," indicating a therapeutic rather than a diagnostic purpose.
No
The device description clearly details a physical catheter with lumens, a balloon, and radiopaque markers, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for balloon dilation of blood vessels (iliac, femoral, popliteal, renal arteries) and treatment of obstructive lesions in dialysis fistulae. These are interventional procedures performed directly on the patient's body.
- Device Description: The description details a catheter with lumens, a balloon, and radiopaque markers, designed for insertion into the body for mechanical dilation. This aligns with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Advocate PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
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 15-300mm 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, renal arteries and arteriovenous dialysis fistulae
Indicated Patient Age Range
adult patient populations
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Extra Validation testing was done on the device to qualify the expanded indications for use.
The following is a list of testing that was successfully completed:
- Deliverability AVF Trackability
- Deliverability Pushability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 26, 2019
Merit Medical Systems, Inc. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K192907
Trade/Device Name: Advocate PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 10, 2019 Received: October 15, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192907
Device Name Advocate PTA Catheter
Indications for Use (Describe)
The Advocate PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Merit Medical Systems, Inc.
Merit Advocate PTA Catheter
Traditional Premarket Notification 510(k)
| General
| Provisions | 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 | |
| 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: | 3 October 2019 | |
| Registration Number: | 9616662 | |
| 510(k) Number: | K192907 | |
| Subject | ||
| Device | Trade Name: | Advocate PTA Catheter |
| Common/Usual Name: | Percutaneous Catheter | |
| Classification Name: | Catheter, Angioplasty, Peripheral, | |
| Transluminal | ||
| Premarket Notification Predicate: | ||
| Trade Name: | Advocate PTA Catheter | |
| Classification Name: | 21 CFR 870.1250 Percutaneous Catheter | |
| Premarket Notification: | K173621 | |
| Manufacturer: | Merit Medical | |
| Predicate | ||
| Device | Premarket Notification Reference Predicate: | |
| Trade Name: | Pirouette 018HP | |
| Classification Name: | 21 CFR 870.1250 Percutaneous Catheter | |
| Premarket Notification: | K172033 | |
| Manufacturer: | Arravasc |
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Merit Medical Systems, Inc.
Merit Advocate PTA Catheter
Traditional Premarket Notification 510(k)
| Classification | Class II
21 CFR § 870.1250
Product code: LIT
Division of Cardiovascular Devices |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Advocate PTA Catheter is intended for balloon dilation of the
iliac, femoral, popliteal, infra-popliteal, renal arteries and for the
treatment of obstructive lesions of native or synthetic arteriovenous
dialysis fistulae. |
| Intended Use | The Advocate PTA catheter is intended for use to treat vascular
stenoses, abnormal narrowing of a blood vessels, in various
clinical settings during endovascular procedures for adult patient
populations |
| 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 15-300mm 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. |
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Merit Medical Systems, Inc. Merit Advocate PTA Catheter Traditional Premarket Notification 510(k)
There are no technological differences between the subject and predicate devices. The changes to the device for this submission are as follows
- Indications for Use Change to: The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Comparison . Removal of the 1.25mm and 1.5mm Balloon diameters from to Predicate the list of applied 0.014 devices
- Change of Manufacturing location from Subcontractor at . Arravasc in Galway to Merit Medical in Galway, using the same processes as already qualified for the device.
The only difference between the two devices are the indications for use, the Manufacturing location and the removal of Devices with balloon diameters of 1.25mm and 1.5mm.
The existing Safety or Performance testing was not performed for the manufacturing location move as the process used is the same as already qualified by Arravasc Ltd when they acted as a subcontractor manufacturing location for the device. The processes were transferred into Merit Galway as is and were used to manufacture the devices that make up this submission. The process is the same as previously qualified under K173621.
Safety & Performance Tests
However, extra Validation testing was done on the device to qualify the expanded indications for use, that this change is introducing.
The following is a list of testing that was successfully completed:
- Deliverability AVF Trackability ●
- Deliverability Pushability .
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Merit Medical Systems, Inc.
Merit Advocate PTA Catheter
Traditional Premarket Notification 510(k)