(22 days)
Not Found
No
The description focuses on the mechanical components and function of an embolic protection device, with no mention of AI or ML.
Yes
The device is described as an "Embolic Protection Device" used to "contain and remove embolic material (thrombus/debris)" during angioplasty and stenting, which are therapeutic interventions.
No
The device is described as an "Embolic Protection Device" used to "contain and remove embolic material." Its function is interventional, not to diagnose a condition or provide diagnostic information.
No
The device description clearly outlines physical components like a guidewire, nitinol mesh filter, and catheter, 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 describes a device used during a medical procedure (angioplasty and stenting) to physically capture and remove embolic material from carotid arteries. This is a therapeutic and interventional use, not a diagnostic one.
- Device Description: The description details a physical system (guidewire, filter, catheter) designed for mechanical intervention within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
This device is a medical device used for a therapeutic purpose within the body.
N/A
Intended Use / Indications for Use
The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire 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 3.0mm and 7.0mm.
Product codes
NTE
Device Description
The SpiderFXTM Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 190/320 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.
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 verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use.
Key Metrics
Not Found
Predicate Device(s)
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
SpiderFXTM Embolic Protection Device
510(k) Number: K063204
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
General Provisions:
| Submitter's Name | ev3 Inc.
9600 54th Avenue North
Plymouth, MN 55442 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tamima Itani, Ph.D., RAC
Vice President
Clinical & Regulatory Affairs
ev3 Inc.
9600 54th Avenue North
Plymouth, MN 55442
Tel: (763) 398-7050
Fax: (763) 398-7200
titani@ev3.net |
| Trade Name: | SpiderFXTM Embolic Protection Device |
| Common Name/Usual Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Class: | Class II, 21 CFR 870.1250 |
Predicate Devices:
SpideRXTM Embolic Protection Device (K052659)
Device Description:
The SpiderFXTM Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 190/320 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.
1
Intended Use:
The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire 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 3.0mm and 7.0mm.
Summary of Technological Characteristics:
The SpiderFX™ Embolic Protection Device is a rapid exchange distal embolic protection device that is compatible with 0.014"/0.018" primary guidewires and utilizes a nitinol mesh filter to capture debris. The SpiderFX Device is substantially equivalent to the SpideRX™ Device (K052659) with several modifications, including the addition of a 23 gauge blunt tip needle and a rapid exchange length (190 cm) Capture Wire, and modifications to the radiopaque mouth marker, flexible connector, and marking of the primary wire exit port.
Summary of Testing:
Non-clinical verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use.
Statement of Equivalence:
The SpiderFX™ Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K052659) in intended use, materials, technological characteristics and performance.
2
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 4 2006
ev3, Inc. c/o Tamima Itami, Ph.D. Vice President, Clinical & Regulatory Affairs 9600 54th Avenue North Plymouth, MN 55442
Re: K063204 SpyderFX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: NTE Dated: October 20, 2006 Received: October 23, 2006
Dear Dr. Itami:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is segmy and cate of the Medical Device Amendments, or 10 connineres phor to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have occh rechasined in assire approval of a premarket approval application (PMA). and Cosmetic Hot (rec) that to device, subject to the general controls provisions of the Act. The I ou may, mercloro, manel the Act include requirements for annual registration, listing of general controls proficiouring 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 If your device is olassified (600 a00 0) and . Existing major regulations affecting your device can may be subject to back as a such as a most of the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
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); 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Dmia R. Holmes
Bram D. 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): 166 3204
Device Name: SpiderFX™ Embolic Protection Device
Indications for Use:
The SpiderFXTM Embolic Protection Device is indicated for use as a guidewire 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 3.0mm and 7.0mm.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nura R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_£063204
Confidential
ev3 Inc.