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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Echo™ Distal Access Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through extensive clinical trials with specific acceptance criteria and detailed study designs as might be found for a novel device or a PMA submission.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training data) is not applicable or not provided in this type of regulatory document.

However, I can extract the information that is present and indicate where the requested details are not available.

1. A table of acceptance criteria and the reported device performance

This information is typically not presented as a formal table with acceptance criteria in a 510(k) summary for a device like a catheter. Substantial equivalence is demonstrated by comparing technological characteristics and intended use to predicate devices and showing that the new device is as safe and effective.

Characteristic	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Echo™ Distal Access Catheter)
Intended Use	Must be substantially equivalent to predicate devices.	"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." (Identical to predicates or within acceptable variation for substantial equivalence).
Outer Diameter (OD)	6 French	6 French
Inside Diameter (ID)	0.070"	0.070"
Working Length	Must be within the range of predicate devices (90-105cm).	105cm (within the range of 90-105cm of predicates)
Catheter Shaft	Must have a transition in stiffness from hub to tip.	Transition in stiffness from hub to tip.
Materials	Must use materials that are either similar or proven equivalent in vivo performance and biocompatibility to predicate devices.	Predominantly PTFE, Pebax, Stainless Steel, Hydrophilic coating (These are common materials; material equivalence claimed to be demonstrated by in vivo performance and biocompatibility tests)
Performance	Must perform as designed and be suitable for its intended use (verified by in vitro bench testing and in vivo testing).	"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."
Biocompatibility	Must meet biocompatibility standards.	Biocompatibility testing verified the device suitability.
Sterilization	Must meet sterilization standards.	Sterilization testing verified the device suitability.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For a 510(k) for a device like a catheter, the "test set" typically refers to the physical devices subjected to bench and in vivo (animal) testing, not a clinical data set of patients. The exact number of devices tested is not detailed, nor is the "provenance" in terms of clinical data. The tests are "in vitro bench testing" and "in vivo testing," implying laboratory and potentially animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" concept, often used for AI/ML performance evaluation against expert consensus, does not apply to the regulatory submission for this physical device. The testing involved engineering and biological assessments, not expert interpretation of diagnostic images or outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for studies where human expert disagreement on interpretation of data is present (e.g., radiology reads). This device submission relies on engineering performance, material science, and in vivo biological response.

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

This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic systems, especially those with AI components, and how they impact human reader performance. The Echo™ Distal Access Catheter is a physical medical device (catheter) for delivery, not a diagnostic imaging or AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This question is relevant to AI/ML software. The Echo™ Distal Access Catheter is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this device's performance would be established by physical measurements matching design specifications, material properties meeting regulatory standards, and biological compatibility (lack of adverse reaction in in vivo tests).

8. The sample size for the training set

This information is not applicable and not provided. This question is relevant to AI/ML software. The Echo™ Distal Access Catheter does not involve a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering principles and iterative testing, not by training an algorithm on a 'training set' of data.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reasons as #8.

Summary

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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:

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.

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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 NeuromedicalEcho Distal AccessCatheter (SubjectDevice)	Cordis EndovascularSystems ENVOYGuiding Catheter	Penumbra Inc., NeuronIntracranial AccessSystem
Intended Use	The Echo Distal AccessCatheter is indicated forthe introduction ofinterventional and/ordiagnostic devices andfluid infusion into theperipheral, coronary,and neuro vasculature.	The Envoy GuidingCatheter is intended foruse in the peripheral,coronary, andneurovasculature for theintroduction ofinterventional /diagnostic devices.	The Neuron IntracranialAccess System isindicated for theintroduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.
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 stiffnessfrom hub to tip	Transition in stiffnessfrom hub to tip	Transition in stiffnessfrom hub to tip
Materials	Predominantly PTFE,Pebax, Stainless Steel,Hydrophilic coating	Predominantly PTFE,Nylon/polyurethane,Stainless Steel,	Stainless Steel,platinum, hydrophiliccoating

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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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

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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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INDICATIONS FOR USE STATEMENT 4.

510(K) Number (if known): KO90919

Device Name: Nfocus™ Neuromedical Echo™ Distal Access Catheter

Indications for Use:

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

Regulation Number and Section

§ 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).