(29 days)
Not Found
No
The summary describes a mechanical filtration system and does not mention any AI/ML components or capabilities.
No.
The device is designed to contain and remove embolic material during a medical procedure, rather than directly treating a disease or condition itself. It serves as a tool within a therapeutic procedure.
No
The device is an embolic protection system designed to capture embolic material during procedures, not to diagnose medical conditions.
No
The device description explicitly lists physical components (BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter) and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Emboshield NAV Embolic Protection System is a physical device used within the body during a surgical procedure (angioplasty and stenting) to capture embolic material. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a procedural intervention within the carotid arteries, not a diagnostic test on a biological sample.
Therefore, the Emboshield NAV Embolic Protection System is a medical device, specifically an interventional device, but not an IVD.
N/A
Intended Use / Indications for Use
The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.
Product codes (comma separated list FDA assigned to the subject device)
NTE
Device Description
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components:
-
BareWire Filter Delivery Wire: .
The BareWire Filter Delivery Wire is a 0.014" PTFE coated stainless steel guidewire with a 3 cm (0.014") platinum/nickel radiopaque distal tip section. Three (3) BareWire designs are available as separately packaged items offering different support levels. The BareWire Workhorse is supplied with the Emboshield NAV6 Embolic Protection System and is available packaged separately in two lengths, 315 cm and 190 cm. -
. RX Delivery Catheter:
The RX Delivery Catheter usable length is 135 cm. The crossing profile is between 0.0365" and 0.0415", depending on Filtration Element size. A pull handle is used to deploy the loaded Filtration Element from the pod. Two (2) pairs of indicator bands are provided along the catheter shaft; a proximal pair (90 cm and 100 cm from the catheter tip) to indicate the catheter tip position during advancement through the guide catheter, and a distal pair to indicate the proximity of the RX exit port during catheter retraction. A radiopaque marker band is positioned proximal to the pod. -
Filtration Element: .
The Filtration Element consists of a nylon membrane with an internal nitinol support structure with radiopaque coils. There are two proximal triangular entry ports and multiple 120 micron distal perfusion pores. There is also a proximal and a distal marker band. The Filtration Element is available in two sizes; small (φ5.0 mm) to treat vessel diameters of 2.5 - 4.8 mm and large (φ7.2 mm) to treat vessel diameters of 4.0 to 7.0 mm. -
RX Retrieval Catheter: .
The RX Retrieval Catheter has a usable length of 139 cm and a molded expansile distal tip with a maximum outer diameter of 0.067''. A handle is situated at the proximal end. Two pairs of marker bands indicate the position of the Retrieval Catheter RX guidewire exit port and catheter tip.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was successfully completed on the Emboshield NAV6 Embolic Protection System. The following tests were conducted:
- . Biocompatibility
- o Cytotoxicity
- Sensitization o
- Hemocompatibility o
- Hemolysis
- . Complement Activation Test
- Material-Mediated Pyrogenicity o
- Bacterial Endotoxin o
- Intracutaneous Toxicity (Irritation) o
- O Acute Systemic Toxicity
- Simulated Use .
- Loading/Deployment/Retrieval Forces .
- Distal Preservation Flow (Flow Characteristics) .
- Tensile Strength .
- o Filtration Element Strength
- Frame Integrity O
- Catheter Coating Integrity .
- Filtration Element Coating Integrity (Congo Red Test) o
- Particulate Evaluation O
- Coating Delamination o
- Sterilization Validation .
- o Non-pyrogenic
- Shelf Life (2-year Accelerated Aging) .
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.
Emboshield NAV6 Embolic Protection System (K081523), Emboshield NAV6 Embolic Protection System (K090665)
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
:
.
2.0 510(k) Summary
APR 2 9 2011
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| Submitter's Name | Abbott Vascular |
|---|---|
| Submitter's Address | 3200 Lakeside Drive, Santa Clara, CA 95054 |
| Telephone | (408) 845-0865 |
| Fax | (408) 845-3743 |
| Contact Person | Cherece L. Jones |
| Date of Submission | March 25, 2011 |
| Device Trade Name | Emboshield NAV6 Embolic Protection System |
| Device Common Name | Embolic Protection System |
| Device Classification Name | Catheter, Carotid, Temporary, for Embolization |
| Capture | |
| Device Classification | Class II |
| Product Code | NTE |
| Predicate Device Names | Emboshield NAV6 Embolic Protection System |
| (K081523) | |
| Emboshield NAV6 Embolic Protection System | |
| (K090665) | |
| Summary of Substantial | |
| Equivalence | Abbott Vascular has submitted bench, |
| biocompatibility, sterilization and aging data to | |
| establish that the proposed Emboshield NAV6 | |
| Embolic Protection System is substantially | |
| equivalent to the predicate Emboshield NAV6 | |
| devices. | |
| The proposed Emboshield NAV6 Embolic | |
| Protection System has the same intended use as | |
| the predicate devices. Testing results have | |
| demonstrated that the Emboshield NAV6 Embolic | |
| Protection System is as safe, as effective, and | |
| performs as well as or better than the predicate | |
| devices. |
1
Device Description:
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components:
-
BareWire Filter Delivery Wire: .
The BareWire Filter Delivery Wire is a 0.014" PTFE coated stainless steel guidewire with a 3 cm (0.014") platinum/nickel radiopaque distal tip section. Three (3) BareWire designs are available as separately packaged items offering different support levels. The BareWire Workhorse is supplied with the Emboshield NAV6 Embolic Protection System and is available packaged separately in two lengths, 315 cm and 190 cm. -
. RX Delivery Catheter:
The RX Delivery Catheter usable length is 135 cm. The crossing profile is between 0.0365" and 0.0415", depending on Filtration Element size. A pull handle is used to deploy the loaded Filtration Element from the pod. Two (2) pairs of indicator bands are provided along the catheter shaft; a proximal pair (90 cm and 100 cm from the catheter tip) to indicate the catheter tip position during advancement through the guide catheter, and a distal pair to indicate the proximity of the RX exit port during catheter retraction. A radiopaque marker band is positioned proximal to the pod.
Filtration Element: .
The Filtration Element consists of a nylon membrane with an internal nitinol support structure with radiopaque coils. There are two proximal triangular entry ports and multiple 120 micron distal perfusion pores. There is also a proximal and a distal marker band. The Filtration Element is available in two sizes; small (φ5.0 mm) to treat vessel diameters of 2.5 - 4.8 mm and large (φ7.2 mm) to treat vessel diameters of 4.0 to 7.0 mm.
- RX Retrieval Catheter: .
The RX Retrieval Catheter has a usable length of 139 cm and a molded expansile distal tip with a maximum outer diameter of 0.067''. A handle is situated at the proximal end. Two pairs of marker bands indicate the position of the Retrieval Catheter RX guidewire exit port and catheter tip.
Indication for Use:
The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.
2
Technological Characteristics:
Comparisons to the predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.
Performance Data:
Performance testing was successfully completed on the Emboshield NAV6 Embolic Protection System. The following tests were conducted:
- . Biocompatibility
- o Cytotoxicity
- Sensitization o
- Hemocompatibility o
- Hemolysis
- . Complement Activation Test
- Material-Mediated Pyrogenicity o
- Bacterial Endotoxin o
- Intracutaneous Toxicity (Irritation) o
- O Acute Systemic Toxicity
- Simulated Use .
- Loading/Deployment/Retrieval Forces .
- Distal Preservation Flow (Flow Characteristics) .
- Tensile Strength .
- o Filtration Element Strength
- Frame Integrity O
- Catheter Coating Integrity .
- Filtration Element Coating Integrity (Congo Red Test) o
- Particulate Evaluation O
- Coating Delamination o
- Sterilization Validation .
- o Non-pyrogenic
- Shelf Life (2-year Accelerated Aging) .
3
Image /page/3/Picture/1 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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is positioned to the right of the text, and the entire logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Cherece L. Jones Regulatory Affairs Associate Abbott Vascular Inc. 3200 Lakeside Drive Santa Clara, CA 95054
APR 2 9 2011
Re: K110909
Trade/Device Name: Emboshield Nav Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: March 30, 2011 Received: March 31-2011 --
Dear Ms. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced 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 or any Federal statutes and regulations administered by other Federal agencies. You must
4
Page 2 – Ms. Cherece L. Jones
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 (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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram Zuckerman, M.D.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1.0 Indications for Use Statement
Indications for Use 510(k) Number (if known): K || 0909
Indications For Use:
The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.
Prescription Use
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
n of Cardiovascular Devices
510(k) Number K110609