(35 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 7.0 mm.
The FiberNet Embolic Protection System consists of a fiber filter on a 0.014" guide wire with attachable actuator tool and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer and a 40µm cell strainer cup.
The provided text describes a 510(k) summary for the FiberNet® Embolic Protection System. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility analysis, rather than setting specific performance acceptance criteria for a new clinical study or providing detailed results from such a study.
Therefore, many of the requested points regarding acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), and ground truth establishment for a new device performance study cannot be directly extracted from this document as it details a regulatory submission based on equivalence testing.
However, I can provide the information that is present:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria for each bench test, nor does it provide numerical results. Instead, it asserts that "The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Wall integrity/aspiration rate equivalent to predicate | Met (Equivalent to predicate device) |
| Push/track equivalent to predicate | Met (Equivalent to predicate device) |
| Stent crossing equivalent to predicate | Met (Equivalent to predicate device) |
| Torque response equivalent to predicate | Met (Equivalent to predicate device) |
| Tip stiffness equivalent to predicate | Met (Equivalent to predicate device) |
| Torque strength equivalent to predicate | Met (Equivalent to predicate device) |
| Liquid leakage under aspiration equivalent to predicate | Met (Equivalent to predicate device) |
| Liquid leakage pressure hub/catheter equivalent to predicate | Met (Equivalent to predicate device) |
| Kink resistance equivalent to predicate | Met (Equivalent to predicate device) |
| Tensile bonds and joints (catheter port and hub) equivalent to predicate | Met (Equivalent to predicate device) |
| Device retraction equivalent to predicate | Met (Equivalent to predicate device) |
| Biocompatibility equivalent to predicate (Cytotoxicity, Hemolysis, Complement Activation, Unactivated Partial Thromboplastin Time Assay, In vivo Thrombogenicity, Physical Chemical) | Met (Equivalent to predicate device, supported by material manufacturer data and additional tests) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document describes a pre-market submission based on bench testing and biocompatibility to establish substantial equivalence. It does not involve a clinical test set with human patients. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided.
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):
Not applicable. This was bench and biocompatibility testing, not human-read clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This was bench and biocompatibility testing, not human-read clinical data.
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:
Not applicable. This document is for an embolic protection system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a medical device that physically captures embolic material, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench testing, the "ground truth" would be established by standardized engineering measurements and defined performance specifications, often relative to the predicate device. For biocompatibility testing, the ground truth is established by recognized standards and scientific principles for assessing biological responses to materials.
8. The sample size for the training set:
Not applicable. This document describes testing for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/1 description: The image shows the words "LUMEN BIOMEDICAL" stacked on top of each other. The word "LUMEN" is on the top line, and the word "BIOMEDICAL" is on the bottom line. The text is black and has a rough, textured appearance. There are also some white lines going through the word "LUMEN".
AUG 177 2011
Lumen Biomedical, Inc.
10900 731d Avenue North, Suite 150 Maple Grove, MN 55369 (763) 577-9600 Business
(763) 557-1044 Fax
510(k) Summary
| Contact Person: | Michelle StraightDirector of Quality Assurance and Regulatory Affairs |
|---|---|
| Summary Date: | July 12, 2011 |
| Product Trade Name: | FiberNet® Embolic Protection System |
| Common Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Predicate(s): | FiberNet Embolic Protection System (K082348) |
| 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 7.0 mm. |
| Device Description: | The FiberNet Embolic Protection System consists of a fiber filter on a0.014" guide wire with attachable actuator tool and a 0.014" guidewirecompatible aspiration catheter with attachable stopcock assembly.System accessories included in the package consist of two 30 mlsyringes, a peel-away introducer and a 40µm cell strainer cup. |
| Indication for 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 7.0 mm. |
| TechnologicalCharacteristics | The FiberNet Embolic Protection System has the same technologicalcharacteristics as the predicate device except for the following:• Addition of antioxidants to the catheter material• Addition of a white colorant near the RX port• Change in the distal liner material to a material used in the midshaft of the catheter• Increase in the proximal shaft OD |
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The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device.
Bench tests performed included:
- Wall integrity/aspiration rate ●
- . Push/track
- . Stent crossing
- . Torque response
- Tip stiffness
- � Torque strength
- Liquid leakage under aspiration
- Liquid leakage pressure hub/catheter ●
Safety & Performance:
- . Kink resistance
- Tensile bonds and joints (catheter port and hub) .
- Device retraction ●
Biocompatibility was supported by material manufacturer data and the following additional tests:
- . Cytotoxicity
- Hemolysis (direct and extract) ◆
- Complement Activation .
- . Unactivated Partial Thromboplastin Time Assay (direct and indirect)
- . In vivo Thrombogenicity
- Physical Chemical .
Conclusion:
This product is substantially equivalent and acceptable for the intended use.
l This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Michelle Straight Director of Quality Assurance and Regulatory Affairs Lumen Biomedical, Inc. 10900 73rd Ave. N. Suite 150 Maple Grove, MN 55369
AUG 1 7 2011
Re: K111987
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: July 12, 2011 Received: July 13, 2011
Dear Ms. Straight:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Michelle Straight
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 forth in the quality systems (OS) 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.html 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram Zuckerman
r Bram 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
510(k) Number (if known): K1) 1987
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 (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 7.0 mm.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
_
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K111987
Confidential
Lumen Biomedical, Inc.
§ 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).