(95 days)
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.
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.
Here's an analysis of the provided information regarding the FiberNet® Embolic Protection System and its acceptance criteria and supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria with specific thresholds for the FiberNet® Embolic Protection System. Instead, it refers to meeting a "performance goal based on ARCHeR3."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable performance based on ARCHeR3 (Embolic Protection System rates) | FiberNet EPS rate met the performance goal based on ARCHeR3 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the exact sample size (number of patients) in the clinical study (EPIC Trial).
- Data Provenance: The EPIC Trial was a "non-randomized multi-center study." This indicates that the data was collected prospectively from multiple clinical sites. The country of origin is not specified, but typically for FDA submissions, studies are either conducted in the US or in countries with comparable regulatory and ethical standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications for establishing ground truth in the EPIC Trial. Clinical studies for such devices typically involve expert clinicians (e.g., interventional cardiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the document does not specify a separate "ground truth" establishment process by a distinct panel of experts.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set in the clinical study. Clinical trials typically have independent clinical events committees (CECs) to adjudicate adverse events, but this is not explicitly detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described (EPIC Trial) focused on the safety and performance of the FiberNet EPS itself, comparing its performance against a statistical performance goal derived from a predicate study (ARCHeR3), not a comparison between human readers with and without AI assistance or any multi-reader setup involving different interpretations.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the FiberNet® Embolic Protection System. This is a medical device (physical product), not an artificial intelligence algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
Given that this is a clinical trial for a physical medical device, the "ground truth" would be based on:
- Clinical Outcomes: Observed patient outcomes related to device safety (e.g., adverse events, stroke rates) and performance (e.g., successful embolic material capture and removal, procedural success).
- Imaging Interpretation: For assessing device placement and effectiveness, imaging (angiography, ultrasound) would be used, interpreted by the treating physicians and potentially reviewed by an independent core lab, though specifics are not provided.
- Pathology/Histology: If embolic material was retrieved, it would likely be sent for pathological analysis, but the document does not elaborate on this.
The primary "ground truth" for the overall device performance would be the clinically observed event rates and outcomes in the study population.
8. Sample Size for the Training Set
This question is not applicable as the FiberNet® Embolic Protection System is a physical medical device, not an AI/software product requiring a "training set." The clinical study (EPIC Trial) serves as the primary evidence for its safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this physical medical device.
{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 BrittleDirector 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 SystemK052659 SpideRX™ Embolic Protection SystemK072990 Guardwire SystemK071529 Xtract™ Aspiration Catheter |
| Intended Use: | The FiberNet® Embolic Protection System is indicated for use as aguidewire and emboli protection system to capture and remove embolicmaterial (thrombus/debris) produced while performing percutaneoustransluminal interventional procedures in carotid arteries in high surgicalrisk 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 withattachable actuator tool (capture wire) and a 0.014" guidewirecompatible aspiration catheter with attachable stopcock assembly (Xtractcatheter, K071529). System accessories included in the package consistof 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 benchand in animals. Test results verified the device is adequate for itsintended use and is equivalent to the predicate devices.Clinical: The EPIC Trial was a non-randomized multi-center studyassessing device safety and performance when used with commerciallyavailable carotid stent systems in high surgical risk patients. Statisticalanalysis confirmed the FiberNet EPS rate met the performance goalbased on ARCHeR3, demonstrating acceptable performance. Seriousadverse events were similar in frequency and type to other studies. |
| Conclusion: | The FiberNet Embolic Protection System is substantially equivalent tothe predicate embolic protection systems in technological characteristicsand 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
Page | of |
§ 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).