(113 days)
The Marksman™ Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
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.
The provided text is a 510(k) summary for the Marksman™ Catheter, detailing its design, indications for use, and a declaration of substantial equivalence to predicate devices. This document does not describe or include an acceptance criteria table, device performance data, or a description of a study proving device performance against acceptance criteria.
Instead, the document states:
- Substantial Equivalence Determination: The safety and effectiveness of the Marksman™ Catheter are based on its substantial equivalence to predicate endovascular catheters. The conclusion of substantial equivalence is drawn from comparisons in design, function, manufacturing, materials, indications, packaging, sterilization, and labeling.
- Clinical Evaluation: A clinical evaluation was conducted to show that "no new risks were identified and that the safety and effectiveness profile is similar to well-established predicate devices cleared for the market." This evaluation was performed in the neurovascular anatomy, considered the "worst case representation of the cardiac and peripheral vascular anatomies."
Since the document does not present specific quantitative acceptance criteria or detailed study results, I cannot fill in the requested table or provide information for most of the points about a specific performance study.
Here's what can be inferred or explicitly stated based on the provided text, acknowledging the limitations due to the lack of a detailed performance study section:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The device's safety and effectiveness are established through substantial equivalence to predicate devices, rather than meeting specific quantifiable performance criteria presented here. | Clinical Evaluation: "No new risks were identified and that the safety and effectiveness profile is similar to well-established predicate devices cleared for the market." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions a "clinical evaluation," but provides no details on participant numbers.
- Data Provenance: Not specified, but likely prospective as it refers to a "clinical evaluation" conducted to confirm safety and effectiveness for the specific device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The clinical evaluation focuses on comparing the device's safety and effectiveness profile to existing predicate devices.
4. Adjudication method for the test set:
- Not applicable. No details about an adjudication method are provided.
5. 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:
- Not applicable. This device is a catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used:
- Not explicitly stated as "ground truth" in the context of an accuracy study. The "clinical evaluation" aimed to demonstrate that the device's "safety and effectiveness profile is similar to well-established predicate devices." This implies that the 'truth' or benchmark was the known safety and effectiveness of existing, legally marketed catheters.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" in the context of an algorithmic or AI model.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of a "training set" or its ground truth.
{0}------------------------------------------------
5. 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. 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 27, 2009
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 intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
Marksman Catheter
CONFIDENTIAL
{1}------------------------------------------------
Substantial Equivalence Determination
The information presented in the 510k shows that the Marksman™ Catheter is substantially equivalent to predicate endovascular catheters in regards to the following aspects:
Design:
The subject and predicate devices are substantially equivalent with respect to design characteristics. The slight variations in flexibility, length of coated segments and lubricity are what differentiate these catheters. Each manufacturer optimizes these design variations towards a more specific application (e.g. infusion of diagnostic and therapeutic agents) or for the introduction of a specific devices such as embolic agents, coils and stents.
Function:
The subject and predicate devices are substantially equivalent with respect to functional characteristics.
Manufacturing: The subject and predicate devices are similar with respect to
Materials:
Indications:
Packaging:
technological manufacturing processes.
The subject and predicate devices are composed of similar materials, all of which have an extensive clinical history of safe use in medical devices.
The subject and predicate devices maintain similar indications.
The subject and predicate devices utilize similar packaging configurations.
Sterilization:
The subject and predicate devices are both sterilized utilizing a Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.
Labeling:
Both the subject and predicate devices have similar labeling.
Clinical evaluation was conducted to show that no new risks were identified and that the . safety and effectiveness profile is similar to well-established predicate devices cleared for the market. Evaluation was performed in the more complex and higher risk neurovascular anatomy, which is the worst case representation of the cardiac and peripheral vascular anatomies.
Marksman Catheter
CONFIDENTIAL
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
SEP 1 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Chestnut Medical Technologies, Inc. 1 C/O Daniel Cher, M.D. 173 Jefferson Dr. Menlo Park, CA 94025
Re: K091559
Trade/Device Name: Marksman™M Catheter Regulation Number: 21 CFR 870,1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: September 10, 2009 Received: September 11, 2009
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.
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
{3}------------------------------------------------
Page 2 - Daniel Cher, M.D.
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duma R. V. Achmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K091559
Device Name: Marksman™ Catheter.
Indications for Use:
The Marksman™ Catheter is intended 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)
Concurrence of CDRH, Office of Device Evaluation (ODE) oursel & pilmit
CONFIDENTIAL
(Division Sign Off) Division of Cardionascular Devices
510(K) Number_KO91559
Page 1 of 1
Marksman Catheter
§ 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).