(108 days)
None
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheter, with no mention of AI or ML.
No.
The device is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents. It is a delivery system, not a therapeutic device itself.
No
The device is described as facilitating the introduction of diagnostic or therapeutic agents and interventional devices, as well as providing visualization, but it does not independently perform diagnostic analysis or provide a diagnosis itself.
No
The device description clearly details a physical catheter with material properties, coatings, a PTFE liner, and a radiopaque marker, indicating it is a hardware device, not software-only.
Based on the provided information, the Marksman™ Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature." This describes a device used within the body for procedures, not for testing samples outside the body.
- Device Description: The description details a catheter designed for accessing blood vessels and facilitating the passage of other devices or substances. This aligns with an interventional medical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Marksman™ Catheter's function is to facilitate procedures within the vascular system.
N/A
Intended Use / Indications for Use
The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
Product codes
KRA
Device Description
The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Marksman™ Catheter
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 6 2011
8. 510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Submitted by:
Chestnut Medical Technologies, Inc., an ev3 Company 173 Jefferson Drive Menlo Park, CA 94025 Tel.: (650) 566-0057 Fax: (650) 566-0072
Contact Person: Daniel Cher, M.D.
Date summary prepared: May 12, 2011
Trade Name: Marksman™ Catheter
Common Name: Catheter
Classification Name: Catheter, Continuous Flush (21 CFR 870.1210, Product Code KRA)
Device Description:
The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.
Indications for Use:
The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
Special 510(k) Marksman Catheter
1
Substantial Equivalence Determination
バ
The information presented in this Special 510k shows that the Marksman™ Catheter with
the alternative Biocoat™ coating is substantially equivalent to the predicate Marksman™
- ﺗ
| Design: | SAME: The subject and predicate device are substantially
equivalent with respect to design characteristics. |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function: | SAME: The subject and predicate device are substantially
equivalent with respect to functional characteristics. |
| Manufacturing: | The subject and predicate device are the same with respect to
technological manufacturing processes with the exception of the
hydrophilic coating. |
| Materials: | The subject and predicate devices are composed of exactly the
same materials, with the exception of the hydrophilic coating. All
the materials have an extensive clinical history of safe use in
medical devices. |
| Indications: | SAME: The subject and predicate device maintain the same
indication. |
| Packaging: | SAME: The subject and predicate devices utilize the same
packaging configurations. |
| Sterilization: | SAME: The subject and predicate devices are both sterilized
utilizing the same Ethylene Oxide sterilization cycle validated in
accordance with ISO 11135 - Medical Devices - Validation and
Routine Control of Ethylene Oxide Sterilization. |
| Labeling: | SAME: Both the subject and predicate devices have the same
labeling. |
| Shelf life: | SAME: The subject and predicate device maintain the same shelf
life indication. |
| Biocompatibility: | SAME: Biocompatibility testing of the Marksman™ Catheter was
performed according to the relevant sections of standard EN ISO
10993-1: 2009. Tests were performed by Toxikon (Bedford, MA),
a laboratory certified to EN/ISO/IEC 17025:2005 (Title: General
Requirements for the Competence of Testing and Calibration
Laboratories). When evaluated according to the above listed
biocompatibility standards, the Marksman™ Catheter utilizing the
alternative hydrophilic Biocoat™ is not toxic (local or systemic), |
| | |
| | sensitizing, locally irritating or otherwise harmful. All test results obtained were acceptable for the device's intended use. The MarksmanTM Catheter with BiocoatTM coating meets the requirements for biocompatibility. The BiocoatTM coating is a widely used coating in the industry Micro Therapeutics, Inc./ev3 Inc.'s Rebar Micro Catheter's coating (Ref. 510K # K993672) & (Ref. Special 510k # K001966-Rebar Micro Catheter). |
| Risk: | SAME: A risk evaluation was conducted to show that no new risks were identified and that the safety and effectiveness profile is similar to the well-established predicate device cleared for the market. As an alternative coating, BiocoatTM, the team has determined that no new risks have been identified. This well-established coating is currently used by many of our products for the same purpose and confirmatory tests show there we no new risks specifically associated with coating of the MarksmanTM Catheter. |
| Safety and
Performance
Verification
Tests: | SAME: Verification testing for changes implemented in the MarksmanTM Catheters included dimensional inspection, material and component verification, access/tractability /coating durability, and particulate testing. These tests yielded acceptable results substantially equivalent to the predicate device. |
2
ﺰ
:
Special 510(k) Marksman Catheter .
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle with outstretched wings, overlaid with a caduceus symbol. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ev3. Inc. c/o Dr. Daniel Cher Vice President of Clinical and Regulatory Affairs 173 Jefferson Drive Menlo Park, CA 94025
Re: K111490
Trade/Device Name: Marksman™ Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: August 25. 2011 Received: August 26, 2011
SEP 16 66
Dear Dr. Cher:
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
4
Page 2 – Dr. Daniel Cher
device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If 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/CDRHOtfices/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/ReportalProblem/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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K-111490
Device Name: Marksman™ Catheter.
Indications for Use:
The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) の 2006年には、 2005年には、 1000年には、 2005年には、 2005年には、 2005年には、 2005年に、 1000年に、 1000年に、 1000年に、 1000
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510/k) Number_
Page 1 of 1
Special 510(k) Marksman Catheter
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