(77 days)
Not Found
No
The device description and performance studies focus on mechanical components and their function, with no mention of AI or ML.
Yes
The device is described as an "Embolic Protection System" used to "contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures," which directly addresses a disease state (embolism) and restores normal function (blood flow through arteries).
No
The device is described as an embolic protection system used to contain and remove embolic material during angioplasty and stenting procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple physical components including a guidewire, filter basket, delivery system, and recovery catheters, 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:
- Intended Use: The intended use clearly describes a device used within the body during a surgical procedure (angioplasty and stenting in carotid arteries) to physically capture embolic material.
- Device Description: The description details a physical system of catheters, guide wires, and a filter basket designed for mechanical intervention within the circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings for testing and analysis.
This device is a medical device used for therapeutic and protective purposes during an interventional procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The RX Accunet® LP Embolic Protection System is indicated for use as a quidewire 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 site of filter basket placement should be between 3.25mm to 7.0mm.
Product codes (comma separated list FDA assigned to the subject device)
NTE
Device Description
The RX ACCUNET® LP Embolic Protection System is a low profile filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET® LP Delivery System, the RX ACCUNET® Recovery Catheter - Shapeable Tip Design and the RX ACCUNET® 2 Recovery Catheter - Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET® LP Guide Wire with Filter Basket is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.
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)
The results of the bench, in vivo, sterilization qualification and packaging validation studies have demonstrated the substantial equivalence of the proposed RX ACCUNET® LP Embolic Protection System.
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.
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
Abbott Vascular
RX Accunet® LP Embolic Protection System
Confidential
Traditional 510(k)
510(k) SUMMARY
AUG 1 9 2008
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Abbott Vascular Inc. |
|---|---|
| Submitter's Address: | 3200 Lakeside Drive |
| Santa Clara, CA 95052 | |
| Telephone: | |
| Fax: | 408-845-0633 |
| 408-845-0921 | |
| Contact Person: | Virginia Singer |
| Regulatory Affairs Advisor | |
| Date Prepared: | May 7, 2008 |
| Device Trade Name: | RX ACCUNET® LP Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification Name: | Embolic Protection System |
| Device Classification: | Class II, NTE |
Summary of Substantial Equivalence:
The proposed RX ACCUNET® LP Embolic Protection Systemis substantially equivalent to the currently marketed RX ACCUNET® Embolic Protection System cleared in K052166 and K052165, respectively, on August 18, 2005.
Device Description:
The RX ACCUNET® LP Embolic Protection System is a low profile filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET® LP Delivery System, the RX ACCUNET® Recovery Catheter - Shapeable Tip Design and the RX ACCUNET® 2 Recovery Catheter - Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET® LP Guide Wire with Filter Basket is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.
1
Abbott Vascular
RX Accunet® LP Embolic Protection System
Confidential
Traditional 510(k)
Indication for Use:
The RX ACCUNET® LP 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 site of filter basket placement should be between 3.25 mm and 7.0 mm.
Technological Characteristics:
The RX ACCUNET®LP Embolic Protection System is substantially equivalent to the RX ACCUNET® Embolic Protection Systems (K052166 and K052165) with regard to device design, principles of operation, materials, and indications for use. The following design attributes are the same or similar for both the subject device and the predicate devices:
- Rapid exchange systems .
- t Filter based technology
- t Polvurethane filter membrane
- . Nitinol filter/basket component
- Compatibility with .014" guidewires .
- Compatibility with 6F guide sheaths and 8F guide catheters .
- Accommodates same vessel sizes .
- . Radiopaque guidewire tips and/or delivery sheath tips
- . Radiopaque markers on filter
- . Delivery System /Recovery Catheter compatability
Comparisons of the subject and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices.
Performance Data:
The results of the bench, in vivo, sterilization qualification and packaging validation studies have demonstrated the substantial equivalence of the proposed RX ACCUNET® LP Embolic Protection System.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around it. The eagle is depicted in a simple, modern style, with bold lines and a sense of movement. The text is written in capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2008
Abbott Vascular Inc. c/o Ms. Danielle Taylor Regulatory Affairs Manager 3200 Lakeside Drive Santa Clara, CA 95054
Re: K081549
Trade/Device Name: RX Accunet® LP Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: August 6, 2008 Received: August 7, 2008
Dear Ms. Taylor:
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
3
Page 2 - Ms. Danielle Taylor
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); 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 clectronic 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 Biometrics' (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
impe
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Abbott Vascular
Confidential
Traditional 510(k)
Indications for Use
Not known 15081549 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ RX Accunet® LP Embolic Protection System
Indications for Use:
The RX Accunet® LP Embolic Protection System is indicated for use as a quidewire 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 site of filter basket placement should be between 3.25mm to 7.0mm.
Prescription Use × (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)
emal
n of Cardiovascular Devices
510(k) Number_korl 549
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