(375 days)
No
The summary describes a mechanical catheter for removing emboli and thrombi. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making. The performance studies focus on physical and mechanical properties and biocompatibility.
Yes
The device is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system, which is a therapeutic intervention.
No
The device is described as an embolectomy catheter intended for the mechanical removal of emboli and thrombi from vessels, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical catheter with specific dimensions, materials (radiopaque marker band), and mechanical properties (stiffness, kink resistance). The performance studies also focus on physical and mechanical testing of the hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Merit Embolectomy Catheter is a surgical device used within the body to physically remove emboli and thrombi from blood vessels. It is a therapeutic device, not a diagnostic one.
The description clearly outlines a catheter designed for a physical intervention within the arterial system, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system.
Not for use in cerebral vasculature.
Product codes
OEZ, DXE
Device Description
The Merit Embolectomy Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100 cm, and 110 cm proximal of the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vessels of the arterial system. Not for use in cerebral vasculature.
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
A battery of tests was performed according to protocols based on the requirements of the following documents, and were shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device:
@ ISO 10555-1, Sterile, single-use intravascular catheters, Part 1. General requirements.
@ ISO 10555-2, Sterile, single-use intravascular catheters, Part 2. Angiographic catheters
@ ISO 594-2, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
@ ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
@ ISO 10993-1, Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
Significant testing successfully completed:
Surface Condition
Force at Break
Freedom from Leakage 1 - Leak under Pressure
Freedom from Leakage 2- Aspiration Leak
Dimensional Verification
. Outside Diameter
- . Effective Length
- . Usable Length
- . Depth Marks
- . Tip Angle
Radio-detectability
Visual
Aspiration
Flow
Lubricious Coating Effectiveness - Coating Lubricity and Durability Test and Accelerated Aging Assessment
Coating Integrity- Dye Test
Lubricious Coating Length
Guide Wire Compatibility
Stiffness- Proximal, Mid, Distal Section
Kink Test- Proximal, Mid, Distal Section
Marker Band Retention
Rapid Exchange Lumen Attachment
Simulated Use Testing:
Tortuous Path- Tracking
Tortuous Path- Guide Wire
Tortuous Path- Crossing a deployed stent
Tortuous Path- Soft emboli aspiration
Biocompatibility Tests - . Cytotoxicity
- Sensitization
- . Irritation
- Acute Systemic Toxicity
- . Pyrogenicity
- . Genotoxicity
- Hemocompatibility .
Packaging performance before and after exposure to accelerated aging and simulated shipping and handling conditions - . bubble emission
- . dye penetration
- . seal peel tensile strength
- . burst strength
- . visual inspection
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
February 8, 2021
Merit Medical Systems, Inc. Lindsay Martin Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K100569
Trade/Device Name: Merit Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ
Dear Lindsay Martin:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 11, 2011. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.02.08 07:54:50 -05'00'
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
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Merit Medical Systems, Inc. c/o Ms. Lindsay Martin 1600 West Merit Parkway South Jordan, UT 84095
Re: K100569
Trade Name: Merit Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: February 26, 2011 Received: March 1, 2011
MAR 1 1 2011
Dear Ms. Martin:
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. Iisting 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
2
Page 2 - Ms. Linday Martin
device-related adverse events) (21 CFR 803); 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.
ff 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
3
| 510(k) Number (if known): | K100569 |
|---|---|
| Device Name: | Merit Embolectomy Catheter |
Indications for Use:
The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system.
Not for use in cerebral vasculature.
| Prescription Use | X | AND/OR | Over-The-Counter Use | _________________ |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
}
Anna R. Vahmen
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number_K1 0 0569
4
Section 5 510(k) Summary for K100569
General Provisions
| Submitter Name: | Merit Medical Systems, Inc. |
|---|---|
| Address: | 1600 West Merit Parkway, South Jordan, UT 84095 |
| Telephone Number: | (801) 208-4187 |
| Fax Number: | (801) 253-6905 |
| Contact Person: | Lindsay Martin |
| Date of Preparation: | February 26, 2010 |
| Registration Number: | 1721504 |
Subject Device
Trade Name: ASAP Catheter Common/Usual Name: Merit ASAP Embolectomy Catheter Classification Name: Catheter, Embolectomy
Predicate Device
| Trade Name: | Pronto V3 Extraction Catheter, Model 5003 |
|---|---|
| Classification Name: | Catheter, Embolectomy |
| Premarket Notification: | K063371 |
| Manufacturer: | Vascular Solutions, Inc. |
Classification
Class II per 21 CFR § 870.5150 DXE Product Code: Division of Cardiovascular Devices Review Branch:
Intended Use
The intended use of the Merit Embolectomy Catheter is to remove or aspirate fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.
Device Description
The Merit Embolectomy Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100 cm, and 110 cm proximal of the distal tip.
Safety & Performance Tests
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of the following documents, and were shown to meet the
5
acceptance criteria that were determined to be applicable to the safety and efficacy of the device:
@ ISO 10555-1, Sterile, single-use intravascular catheters, Part 1. General requirements.
@ ISO 10555-2, Sterile, single-use intravascular catheters, Part 2. Angiographic catheters
@ ISO 594-2, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
@ ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
@ ISO 10993-1, Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
[The following is a list of all significant testing that was successfully completed:
Surface Condition
Force at Break
Freedom from Leakage 1 - Leak under Pressure
Freedom from Leakage 2- Aspiration Leak
Dimensional Verification
. Outside Diameter
- . Effective Length
- . Usable Length
- . Depth Marks
- . Tip Angle
Radio-detectability
Visual
Aspiration
Flow
Lubricious Coating Effectiveness - Coating Lubricity and Durability Test and Accelerated Aging Assessment
Coating Integrity- Dye Test
Lubricious Coating Length
Guide Wire Compatibility
Stiffness- Proximal, Mid, Distal Section
Kink Test- Proximal, Mid, Distal Section
Marker Band Retention
Rapid Exchange Lumen Attachment
Simulated Use Testing:
Tortuous Path- Tracking
Tortuous Path- Guide Wire
Tortuous Path- Crossing a deployed stent
Tortuous Path- Soft emboli aspiration
Biocompatibility Tests
- . Cytotoxicity
- Sensitization
- . Irritation
- Acute Systemic Toxicity
- . Pyrogenicity
- . Genotoxicity
- Hemocompatibility .
6
Packaging performance before and after exposure to accelerated aging and simulated shipping and handling conditions
- . bubble emission
- . dye penetration
- . seal peel tensile strength
- . burst strength
- . visual inspection
Summary of Substantial Equivalence
Based on the indications for use, design, and safety and performance test results, the subject Merit Embolectomy Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Pronto V3 Embolectomy Catheter manufactured by Vascular Solutions, Inc.