(504 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a catheter, with no mention of AI or ML capabilities.
No
The device is a catheter designed for the introduction of other interventional and/or diagnostic devices, not for therapeutic intervention itself.
No
This device is a guide catheter designed to facilitate the introduction of other interventional and/or diagnostic devices, but it does not perform diagnostic functions itself.
No
The device description clearly describes a physical catheter with specific material properties and dimensions, and the performance studies involve bench testing, biocompatibility testing, and in vivo testing on the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for introducing interventional and/or diagnostic devices into the peripheral and coronary vasculature. This is a procedure performed in vivo (within the living body).
- Device Description: The description details a catheter designed for physical manipulation within the body.
- Anatomical Site: The device is used in the peripheral and coronary vasculature, which are internal anatomical structures.
- Input Imaging Modality: Fluoroscopic evaluation is used to visualize the device's placement within the body.
- Performance Studies: The studies described (bench testing, biocompatibility, in vivo animal model) are typical for medical devices used in vivo.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not perform such analysis on specimens.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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:
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.
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.
Neuron Intracranial Access System, Envoy Guiding Catheter
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
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 Street | ||
| Campbell, CA 95008 | ||
| USA | ||
| Telephone: (408) 409-2455 | ||
| Fax: (408) 608-1999 | ||
| Contact Person: | Carrie Neuberger | |
| Vice-President, Regulatory and Clinical Affairs | ||
| and Quality Assurance | ||
| Predicate Devices: | Neuron Intracranial Access System, manufactured | |
| by Penumbra, Inc. |
Envoy Guiding Catheter, manufactured by Cordis
Corporation | |
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™.
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.
1
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 Funnel
Guide CatheterTM
(Subject Device) | Penumbra Inc.,
Neuron Intracranial
Access System | Cordis Endovascular
Systems ENVOY
Guiding Catheter |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Funnel Guide
CatheterTM is indicated
for use in the peripheral
and coronary
vasculature for the
introduction of
interventional and/or
diagnostic devices. | The Neuron
Intracranial Access
System is indicated for
the introduction of
interventional devices
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. |
| 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 stiffness
from hub to tip | Transition in stiffness
from hub to tip | Transition in stiffness
from 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, hydrophilic
coating | 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:
2
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 :
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wing strokes, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.
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
4
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
5
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