(113 days)
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.
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.
The provided text describes a 510(k) summary for the "Merit Microcatheter". This document focuses on demonstrating substantial equivalence to a predicate device through performance testing. It does not describe a study involving human readers, AI assistance, or complex ground truth establishment typical of diagnostic AI device evaluations.
Here's an analysis of the provided information in relation to your request:
Acceptance Criteria and Device Performance
The acceptance criteria for the Merit Microcatheter are based on a battery of physical and biological tests designed to ensure the safety and efficacy of the device as an intravascular catheter. The document states that the device "meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device," but does not provide a table with specific numerical acceptance criteria or reported device performance values. Instead, it lists the standards to which the tests were performed.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 10555-1: 1995 (Sterile, single-use intravascular catheters, Part 1. General requirements) | Device met acceptance criteria. |
| ISO 10555-2: 1996 (Sterile, single-use intravascular catheters, Part 2. Angiographic catheters) | Device met acceptance criteria. |
| ISO 594-2: 1998 (Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Device met acceptance criteria. |
| ISO 11135: 1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) | Device met acceptance criteria. |
| ISO 10993-1: 2003 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile) | Device met acceptance criteria. |
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for any of the performance tests.
- The provenance of the data is also not mentioned. These are likely in-house laboratory tests conducted by the manufacturer.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the described study is focused on physical and biological performance of a medical device (catheter), not a diagnostic device requiring expert interpretation for ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable as the study involves objective physical and biological tests, not subjective interpretations requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that either incorporate AI or aim to improve human interpretation. The Merit Microcatheter is a physical instrument.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this refers to an algorithm's performance. The Merit Microcatheter is a physical device, so this is not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests would be the specifications and requirements defined by the referenced ISO standards for catheter properties (e.g., burst pressure, tensile strength, sterility, biocompatibility). It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
-
The sample size for the training set:
- This is not applicable. The device is a physical product, not an AI algorithm that requires a training set.
-
How the ground truth for the training set was established:
- This is not applicable as there is no training set for an AI algorithm. The performance of the physical device is evaluated against engineering and biological standards.
{0}------------------------------------------------
DEC 3 0 2008
Section 5
510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4196(801) 253-6932Michaela RivkowichSeptember 5, 20081721504 |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | To be assignedMerit MicrocathetersContinuous Flush Catheter |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | RenegadeTM Fiber Braided Microcatheter withHydro PassTM Hydrophilic CoatingContinuous Flush CatheterK973645Boston Scientific Corporation |
| Classification | Class II21 CFR § 870.1210, 74 KRADivision 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. | |
| DeviceDescription | The Merit Microcatheter is available in 2.8/2.8 Fr and 2.8/2.4 Fr sizeswith lengths of 110, 130 and 150 cm. The outer surface of the distalsegment of the catheter shaft is coated with a hydrophilic coatingdesigned to facilitate the introduction of the catheter into the vessels.The Microcatheter has a radiopaque marker at the distal tip tofacilitate fluoroscopic visualization. | |
| Safety &PerformanceTests | No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. However, abattery of tests was performed according to protocols based on therequirements of the following documents, and were shown to meetthe acceptance criteria that were determined to be applicable to thesafety 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: Lockfittings• ISO 11135: 1994, Medical Devices - Validation and RoutineControl of Ethylene Oxide Sterilization• ISO 10993-1: 2003, Biological Evaluation of medical Devices Part1: Evaluation and Testing, and the FDA Modified ISO 10993 TestProfile | |
| Summary ofSubstantial | Based on the indications for use, design, and safety andperformance testing, the subject Merit Microcatheter meets theminimum 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
§ 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).