(113 days)
Not Found
No
The summary describes a physical medical device (microcatheter) and its intended use for delivering materials within blood vessels. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on physical and biological properties, not algorithmic performance.
Yes
The device is used for the controlled and selective infusion of "therapeutic materials" into vessels.
Yes
The intended use explicitly states that the microcatheter can be used for the controlled and selective infusion of "diagnostic" materials into vessels.
No
The device description clearly describes a physical catheter with a hydrophilic coating and a radiopaque marker, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use, including peripheral and coronary vasculature" and for the "controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels." This describes a device used within the body for direct intervention and delivery of substances, not for testing samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a hydrophilic coating and a radiopaque marker for visualization during insertion. This aligns with an in-vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or treatment.
Therefore, the Merit Microcatheter is an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Merit Microcatheter is available in 2.8/2.8 Fr and 2.8/2.4 Fr sizes with lengths of 110, 130 and 150 cm. The outer surface of the distal segment of the catheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the catheter into the vessels. The Microcatheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 acceptance criteria that were determined to be applicable to the safety and efficacy of the device:
• ISO 10555-1: 1995, Sterile, single-use intravascular catheters, Part 1. General requirements.
• ISO 10555-2: 1996, Sterile, single-use intravascular catheters, Part 2. Angiographic catheters
• ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 11135: 1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
• ISO 10993-1: 2003, Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
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.
Not Found
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
DEC 3 0 2008
Section 5
510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4196
(801) 253-6932
Michaela Rivkowich
September 5, 2008
1721504 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | To be assigned
Merit Microcatheters
Continuous Flush Catheter |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | RenegadeTM Fiber Braided Microcatheter with
Hydro PassTM Hydrophilic Coating
Continuous Flush Catheter
K973645
Boston Scientific Corporation |
| Classification | Class II
21 CFR § 870.1210, 74 KRA
Division of Cardiovascular, Respiratory and Neurological Devices | |
| Intended Use | The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. | |
| Device
Description | The Merit Microcatheter is available in 2.8/2.8 Fr and 2.8/2.4 Fr sizes
with lengths of 110, 130 and 150 cm. The outer surface of the distal
segment of the catheter shaft is coated with a hydrophilic coating
designed to facilitate the introduction of the catheter into the vessels.
The Microcatheter has a radiopaque marker at the distal tip to
facilitate fluoroscopic visualization. | |
| 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 acceptance criteria that were determined to be applicable to the
safety and efficacy of the device:
• ISO 10555-1: 1995, Sterile, single-use intravascular catheters,
Part 1. General requirements.
• ISO 10555-2: 1996, Sterile, single-use intravascular catheters,
Part 2. Angiographic catheters
• ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 2: Lock
fittings
• ISO 11135: 1994, Medical Devices - Validation and Routine
Control of Ethylene Oxide Sterilization
• ISO 10993-1: 2003, Biological Evaluation of medical Devices Part
1: Evaluation and Testing, and the FDA Modified ISO 10993 Test
Profile | |
| Summary of
Substantial | Based on the indications for use, design, and safety and
performance testing, the subject Merit Microcatheter meets the
minimum requirements that are considered essential for its intended | |
1
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2008
Merit Medical Systems, Inc. c/o Mr. Glenn Norton Director of Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095
Re: K082613
Trade/Device Name: Merit Microcatheter Common Name: catheter, continuous flush Regulation Number: 21 CFR 870.1210 Regulatory Class: II Product Code: KRA Dated: December 19, 2008 Received: December 22, 2008
Dear Mr. Norton:
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 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); 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.
3
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's) 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. A. Killennan
ﻣﺮ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K082613
Device Name: Merit Microcatheters
Indications for Use:
The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
Prescription Use X
. 1988
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)
M. G. Hillebert
vascular Devices
510(k) Number K082613