(95 days)
No
The device description and performance studies focus on mechanical components and clinical trial outcomes, with no mention of AI/ML technologies.
Yes
The device is used to capture and remove embolic material during medical procedures to improve patient outcomes, which is a therapeutic function.
No
The device is an embolic protection system designed to capture and remove embolic material during interventional procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a guidewire, fiber filter, actuator tool, aspiration catheter, syringes, introducer, actuation template, and cell strainer cup. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body during a percutaneous transluminal interventional procedure in carotid arteries. This is an in vivo application.
- Device Description: The description details a guidewire, filter, aspiration catheter, and related accessories used for capturing and removing embolic material from within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures during a procedure.
N/A
Intended Use / Indications for Use
The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0mm.
Product codes
NTE
Device Description
The system consists of a fiber filter on a 0.014" guidewire with attachable actuator tool (capture wire) and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529). System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40µm cell strainer cup.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
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
Non-Clinical: In vitro testing consisted of biocompatibility, sterilization, packaging, and product shelf life, and performance testing on the bench and in animals. Test results verified the device is adequate for its intended use and is equivalent to the predicate devices.
Clinical: The EPIC Trial was a non-randomized multi-center study assessing device safety and performance when used with commercially available carotid stent systems in high surgical risk patients. Statistical analysis confirmed the FiberNet EPS rate met the performance goal based on ARCHeR3, demonstrating acceptable performance. Serious adverse events were similar in frequency and type to other studies.
Key Metrics
Not Found
Predicate Device(s)
K032884, K052659, K072990, K071529
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 8 2008
Lumen Biomedical, Inc.
14505 21* Avenue North, Suite 212 Plymouth, MN 55447
(763) 577-9600 Business
(763) 577-1044 Fax
| Contact Person: | Maria Brittle
Director Regulatory Affairs |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Date: | August 14, 2008 |
| Product Trade Name: | FiberNet® Embolic Protection System |
| Common Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Predicate(s): | K032884 FilterWire EZ™ Embolic Protection System
K052659 SpideRX™ Embolic Protection System
K072990 Guardwire System
K071529 Xtract™ Aspiration Catheter |
| Intended Use: | The FiberNet® Embolic Protection System is indicated for use as a
guidewire and emboli protection system to capture and remove embolic
material (thrombus/debris) produced while performing percutaneous
transluminal interventional procedures in carotid arteries in high surgical
risk patients with reference vessel diameters of 3.5 to 7.0mm. |
| Device Description: | The system consists of a fiber filter on a 0.014" guidewire with
attachable actuator tool (capture wire) and a 0.014" guidewire
compatible aspiration catheter with attachable stopcock assembly (Xtract
catheter, K071529). System accessories included in the package consist
of two 30 ml syringes, a peel-away introducer, an actuation template,
and a 40µm cell strainer cup. |
| Safety & Performance: | Non-Clinical: In vitro testing consisted of biocompatibility, sterilization,
packaging, and product shelf life, and performance testing on the bench
and in animals. Test results verified the device is adequate for its
intended use and is equivalent to the predicate devices.
Clinical: The EPIC Trial was a non-randomized multi-center study
assessing device safety and performance when used with commercially
available carotid stent systems in high surgical risk patients. Statistical
analysis confirmed the FiberNet EPS rate met the performance goal
based on ARCHeR3, demonstrating acceptable performance. Serious
adverse events were similar in frequency and type to other studies. |
| Conclusion: | The FiberNet Embolic Protection System is substantially equivalent to
the predicate embolic protection systems in technological characteristics
and performance |
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2008
Lumen Biomedical, Inc. c/o Maria E. Brittle, PhD, RAC Director, Regulatory Affairs 14505 21st Avenue North, Suite 212 Plymouth, MN 55447
Re: K082348
Trade/Device Name: FiberNet Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: November 13, 2008 Received: November 14, 2008
Dear Dr. Brittle:
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 such 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);
2
Page 2 - Dr. Maria E. Brittle
labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
Donna R. Kirchner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K082348
FiberNet® Embolic Protection System · Device Name:
Indications for Use:
The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombuseded is) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.
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)
vina D. balmer
(Division Sir ... - Off) Division on Cardiovascular Devices
510(k) Number_K082348
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