The Funnel Guide Catheter" is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices.

Device Description

The Lazarus Effect Funnel Guide Catheter" (Funnel Guide Catheter") is a single-lumen, variable-stiffness catheter with an atraumatic nitinol wire braided funnel distal tip to facilitate the passage of other interventional and/or diagnostic devices. Device dimensions and configuration are shown on the product label. The Funnel Guide Catheter" is compatible with introducer sheaths and guide catheters having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire may be used, but are not provided with the Funnel Guide Catheter™.

AI/ML Overview

The provided text describes a medical device, the "Funnel Guide Catheter™," and its regulatory submission (510(k) summary). This is a physical medical device, not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML specific criteria (such as AI assistance effect size, standalone algorithm performance, ground truth for training/test sets, sample size for training/test sets, and expert qualifications for ground truth establishment) are not applicable to this submission.

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices through various performance tests.

Here's an interpretation of the requested information based on the provided text, while noting the non-applicability of certain AI/ML specific points:

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

The document does not explicitly state quantitative "acceptance criteria" with specific pass/fail thresholds for each test, as would be common for AI/ML performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" are implied by the successful completion of a battery of tests demonstrating the device's safety and effectiveness and its substantial equivalence to predicate devices. The "reported device performance" is a general statement that the device met these criteria.

Acceptance Criteria Category (Implied)	Reported Device Performance
Bench Testing:	Verified as designed
- Dimensional measurement	Verified as designed
- Visual examination	Verified as designed
- Fluoroscopic evaluation	Verified as designed
- Kink resistance	Verified as designed
- Simulated use	Verified as designed
- Torque transmission	Verified as designed
- Repeated use	Verified as designed
- Navigation and insertion force	Verified as designed
- Air and fluid leak	Verified as designed
- Corrosion resistance	Verified as designed
- Tensile testing (force at break)	Verified as designed
- Fluid flow rate	Verified as designed
- Burst pressure	Verified as designed
- Product and packaging stability	Verified as designed
- Packaging integrity	Verified as designed
Biocompatibility Testing:	Verified as designed
- Cytotoxicity	Verified as designed
- Sensitization assay	Verified as designed
- Intracutaneous reactivity	Verified as designed
- Pyrogen	Verified as designed
- Systemic toxicity	Verified as designed
- Hemolysis	Verified as designed
- Thromboresistance	Verified as designed
- Complement Activation	Verified as designed
- Sterilization	Verified as designed
In-vivo Testing:	Verified as designed
- Simulated use (porcine model)	Verified as designed
Overall Conclusion:	Substantially equivalent to predicate devices, performs as designed and is suitable for its intended use.

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

The text mentions "in vivo testing in the animal model" using a "simulated use porcine model." The exact sample size (number of pigs) is not specified. This would be a prospective animal study. Data provenance (country of origin) is not stated for the animal model. Bench testing and biocompatibility testing were also performed, but these do not typically involve "test sets" in the same way an AI/ML model would, and specific sample sizes for these tests are generally detailed in the full test reports, not typically summarized in a 510(k) summary.

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 is not applicable. For a physical medical device like a catheter, "ground truth" is established through engineering specifications, validated test methods (bench, biocompatibility), and animal studies, not through expert consensus on diagnostic images. The performance of the device itself (e.g., its navigated path, ability to deliver other devices, material integrity) is the "ground truth" being assessed.

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

This is not applicable. Adjudication methods are relevant for subjective interpretations of data, particularly in clinical trials or AI/ML evaluations. For performance testing of a physical device, results are typically objectively measured against specifications or observed in controlled environments (e.g., kink resistance, burst pressure). Any observations during the porcine model would likely be recorded by researchers/veterinarians involved in the study.

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 is not applicable. This device is a physical catheter, not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant.

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

This is not applicable. This device is a physical medical instrument and does not involve an algorithm.

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

For this physical device, the "ground truth" is primarily established through:

Engineering Specifications: For benchmark and dimensional measurements.
Validated Test Methods: For biocompatibility, mechanical properties (e.g., tensile strength, burst pressure), and functional performance (e.g., simulated use, torque transmission).
Biological Response in Animal Models: For in-vivo assessment of tissue reaction (histology) and visibility (fluoroscopic visibility) in a porcine model.

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device. This term applies to machine learning models.

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

This is not applicable. There is no "training set."

Summary

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JAN 1 2 2012

5. 510(K) SUMMARY

Date Prepared:	August 25, 2010
Trade Name:	Funnel Guide Catheter™
Common Name:	Percutaneous Catheter
Classification:	Class II, 21 CFR 870.1250, Product Code DQY
Applicant:	Lazarus Effect, Inc.560 Division StreetCampbell, CA 95008USATelephone: (408) 409-2455Fax: (408) 608-1999
Contact Person:	Carrie NeubergerVice-President, Regulatory and Clinical Affairsand Quality Assurance
Predicate Devices:	Neuron Intracranial Access System, manufacturedby Penumbra, Inc.Envoy Guiding Catheter, manufactured by CordisCorporation

Device Description:

Intended Use:

The Funnel Guide Catheter™ is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices. 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 Devices:

The Funnel Guide Catheter" is intended for use in interventional radiological procedures. It is substantially equivalent to other interventional radiological devices currently on the market. The Funnel Guide Catheter" is substantially equivalent to the identified predicate devices with regard to device design, materials, patient population and anatomical site. The intended use for the Funnel Guide Catheter has been revised and is a subset of the intended use for the predicate devices. This change, and any differences due to the technological characteristics of the Funnel Guide Catheter" compared to its predicate devices do not raise new issues of safety or effectiveness.

Device	Lazarus Effect FunnelGuide CatheterTM(Subject Device)	Penumbra Inc.,Neuron IntracranialAccess System	Cordis EndovascularSystems ENVOYGuiding Catheter
Intended Use	The Funnel GuideCatheterTM is indicatedfor use in the peripheraland coronaryvasculature for theintroduction ofinterventional and/ordiagnostic devices.	The NeuronIntracranial AccessSystem is indicated forthe introduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	The Envoy GuidingCatheter is intended foruse in the peripheral,coronary, andneurovasculature forthe introduction ofinterventional /diagnostic devices.
Design:
Outer Diameter(OD)	6 French	6 French	6 French
Inside Diameter(ID)	0.062in	0.070in and 0.053in	0.070in
Working Length	102cm	95-115cm	90-100cm
Catheter shaft	Transition in stiffnessfrom hub to tip	Transition in stiffnessfrom hub to tip	Transition in stiffnessfrom hub to tip
Wire Compatibility	0.035in/.038in	0.035in/.038in	0.035in/.038in
Materials	Predominantly PTFE,Stainless Steel,platinum, Pebax, Nitinol	Stainless Steel,platinum, hydrophiliccoating	Predominantly PTFE,Stainless Steel,Nylon/polyurethane

Materials in the predicate devices are not known with certainty. Material Note: equivalence is demonstrated by performance tests and biocompatibility tests.

Summary of Studies:

Bench testing, biocompatibility testing and in vivo testing in the animal model were performed on the device materials and on finished devices. These tests included:

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Bench Testing:

Dimensional measurement .
Visual examination .
. Fluoroscopic evaluation
Kink resistance ●
Simulated use
. Torque transmission
. Repeated use
Navigation and insertion force
. Air and fluid leak
. Corrosion resistance
. Tensile testing (force at break)
. Fluid flow rate
Burst pressure ●
Product and packaging stability (shelf-life) .
Packaging integrity (seal strength and puncture resistance) .

Biocompatibility Testing:

Cytotoxicity .
. Sensitization assay
Intracutaneous reactivity .
. Pyrogen
Systemic toxicity .
. Hemolysis
Thromboresistance .
Complement Activation ●
Sterilization .

In-vivo Testing:

Simulated use porcine model (including histology and fluoroscopic visibility) .
The results of the performance, biocompatibility, and in-vivo tests verified that the Funnel Guide Catheter™ performs as designed and is suitable for its intended use.

Conclusion:

The data contained in this submission demonstrate that the Lazarus Effect Funnel Guide Catheter" is substantially equivalent to the identified predicate devices in regards to device design, materials, patient population, anatomical site, and intended use :

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 2 2012

Lazarus Effect, Inc. c/o Ms. Carrie Neuberger Vice President, Regulatory and Clinical Affairs and Quality Assurance 560 Division Street Campbell, CA 95008

Re: K102439

Trade/Device Name: Funnel Guide Catheter™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 29, 2011 Received: November 30, 2011

Dear Ms. Neuberger:

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 misoranding 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 of 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

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Page 2 - Ms. Carrie Neuberger

(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 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/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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, .

M.A. Killebrew

Gram 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): K102439

Device Name: Lazarus Effect - Funnel Guide Catheter™

Indications for Use:

The Funnel Guide Catheter" is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices.

AND/OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use

(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. A. Hillhouse

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K102439

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).