(120 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.
No
The device is described as a "Distal Access Catheter" used for the "introduction of interventional and/or diagnostic devices and fluid infusion," not for directly treating a condition or disease. It is a conduit, not a therapeutic agent itself.
No
The device is a distal access catheter indicated for the introduction of other devices and fluid infusion, not for diagnosis itself.
No
The device description clearly describes a physical catheter with a shaft, tip, and hub, indicating it is a hardware medical device.
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 "introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for procedures, not a device used to test samples outside the body.
- Device Description: The description details a catheter designed for insertion into blood vessels, consistent with its intended use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate procedures within the body, not to analyze samples.
N/A
Intended Use / Indications for Use
The Echo " Distal Access Catheter is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature.
The Nfocus Neuromedical Echo Distal Access Catheter Vessel is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Echo " Distal Access Catheter is a single-stiffness catheter with an atraumatic tip at the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. The Echo Distal Access Catheter is compatible with introducer sheaths having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire are required, but not provided with the Echo catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro 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)
In vitro bench testing and in vivo testing have been performed on the device materials and finished devices. Performance, sterilization and biocompatibility testing verified that the Echo Distal Access Catheter performs as designed and is suitable for its intended use.
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.
Not Found
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for NFOCUS neuromedical. The logo consists of a stylized "N" made up of triangles, followed by the word "NFOCUS" in bold, black letters. Below the word "NFOCUS" is the word "neuromedical" in a smaller, italicized font.
K0909118
JUL 30 2009
5. 510(K) SUMMARY
Date Prepared:
Trade Name:
Common Name:
Classification:
Applicant:
Contact Person:
Predicate Devices:
March 30, 2009
Echo™ Distal Access Catheter
Percutaneous Catheter
Class II, 21 CFR 870.1250, Product Code DQY
Nfocus™ Neuromedical 2191 E. Bayshore Road, Suite 100 Palo Alto, CA 94303 USA Tel: 650-845-3064 Fax: 650-813-1869
Bob Founds Director, Quality Assurance and Regulatory Affairs
Envoy Guiding Catheter, manufactured by Cordis Corporation Neuron Intracranial Access System, manufactured by Penumbra, Inc.
Device Description:
The Echo " Distal Access Catheter is a single-stiffness catheter with an atraumatic tip at the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. The Echo Distal Access Catheter is compatible with introducer sheaths having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire are required, but not provided with the Echo catheter.
Intended Use:
The Echo Distal Access Catheter is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature. The indicated use is substantially equivalent to that of the legally marketed predicate devices.
1
Image /page/1/Picture/0 description: The image shows the logo for NFOCUS neuromedical. The logo consists of a stylized letter N made up of three triangles, followed by the word "NFOCUS" in a bold, sans-serif font. Below the word "NFOCUS" is the word "neuromedical" in a smaller, italicized font. The logo is black and white.
Technological Characteristics of the Device Compared to the Predicate Device:
The Echo Distal Access Catheter uses similar technology, has similar intended use, functions, materials and method of operation as the following predicate device(s):
| Device | Nfocus Neuromedical
Echo Distal Access
Catheter (Subject
Device) | Cordis Endovascular
Systems ENVOY
Guiding Catheter | Penumbra Inc., Neuron
Intracranial Access
System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Echo Distal Access
Catheter is indicated for
the introduction of
interventional and/or
diagnostic devices and
fluid infusion into the
peripheral, coronary,
and neuro vasculature. | The Envoy Guiding
Catheter is intended for
use in the peripheral,
coronary, and
neurovasculature for the
introduction of
interventional /
diagnostic devices. | The Neuron Intracranial
Access System is
indicated for the
introduction of
interventional devices
into the peripheral,
coronary, and neuro
vasculature. |
| Design: | | | |
| Outer Diameter (OD) | 6 French | 6 French | 6 French |
| Inside Diameter (ID) | 0.070" | 0.070" | 0.070" |
| Working Length | 105cm | 90-100cm | 95-105cm |
| Catheter shaft | Transition in stiffness
from hub to tip | Transition in stiffness
from hub to tip | Transition in stiffness
from hub to tip |
| Materials | Predominantly PTFE,
Pebax, Stainless Steel,
Hydrophilic coating | Predominantly PTFE,
Nylon/polyurethane,
Stainless Steel, | Stainless Steel,
platinum, hydrophilic
coating |
Note: Materials in the predicate devices are not known with certainty. Material equivalence is demonstrated by in vivo performance tests and biocompatibility tests.
Summary of Studies:
In vitro bench testing and in vivo testing have been performed on the device materials and finished devices. Performance, sterilization and biocompatibility testing verified that the Echo Distal Access Catheter performs as designed and is suitable for its intended use.
Conclusion:
The data presented in this submission demonstrate that the Nfocus Neuromedical Echo Distal Access Catheter is substantially equivalent to the predicate devices identified in regards to device design, materials, and intended use.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" encircling the top portion of the seal. The eagle is stylized with thick, black lines, and the text is in a simple, sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nfocus™ Neuromedical c/o Mr. Bob Founds Director, Quality Assurance and Regulatory Affairs 2191 E. Bay Shore Road Suite 100 Palo Alto, Ca 94303
THE 30 2009
K090918 Re:
Trade/Device Name: EchoTM Distal Access Catheter Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: July 16, 2009 Received: July 21, 2009
Dear Mr. Founds:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Bob Founds
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.
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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R.Z. MP
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for NFocus Neuromedical. The logo consists of a stylized letter N made up of three triangles, followed by the word "NFOCUS" in bold, sans-serif font. Below the word "NFOCUS" is the word "neuromedical" in a smaller, italicized font.
INDICATIONS FOR USE STATEMENT 4.
510(K) Number (if known): KO90919
Device Name: Nfocus™ Neuromedical Echo™ Distal Access Catheter
Indications for Use:
The Nfocus Neuromedical Echo Distal Access Catheter Vessel is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) Division of Caralovascular Devices Kogog 510(k) Number