(29 days)
Not Found
No
The description focuses on the mechanical function of the device (filter, guidewire, catheter) and does not mention any computational or algorithmic components related to AI/ML.
Yes
The device is indicated for use as an embolic protection system during percutaneous transluminal coronary angioplasty or stenting procedures, which are therapeutic interventions.
No.
The device is an embolic protection system designed to contain and remove embolic material during angioplasty or stenting procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components like a Capture Wire, nitinol mesh filter, stainless steel guidewire, and a dual-ended 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 in vivo (within the body) during a medical procedure (percutaneous transluminal coronary angioplasty or stenting). It is designed to physically capture embolic material within blood vessels.
- Device Description: The description details a percutaneously delivered system with a guidewire, filter, and catheter. These are components used for interventional procedures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic and protective device used directly within the patient's circulatory system during a procedure.
N/A
Intended Use / Indications for Use
The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.
Product codes
NFA
Device Description
The SpiderFX™ 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 320/190 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
coronary saphenous vein bypass grafts
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 the predicate device 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:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
General Provisions:
| Submitter's Name | ev3
9600 54th Avenue North
Plymouth, MN 55442 | JAN 1 9 2007 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact: | David Worrell, MS, RAC
Manager, Regulatory Affairs
ev3
9600 54th Avenue North
Plymouth, MN 55442
Tel: (763) 398-7000
Fax: (763) 398-7200
dworrell@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 Device:
SpideRXTM Embolic Protection Device (K062201)
Device Description:
The SpiderFX™ 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 320/190 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 an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.
Summary of Technological Characteristics:
The SpiderFXTM Embolic Protection Device is a rapid exchange distal embolic protection device that is compatible with 0.014" primary guidewires and utilizes a nitinol mesh filter to capture debris. The SpiderFX Device is substantially equivalent to the SpideRX™ Embolic Protection Device (K062201) 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 the predicate device and is adequate for its intended use.
Statement of Equivalence:
The SpiderFXTM Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K062201) in intended use, materials, technological characteristics and performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ev3, Inc. c/o Mr. David Worrell Manager, Regulatory Affairs 9600 54th Avenue North Plymouth, MN 55442-2111
JAN 1 9 2007
Re: K063785
SpiderFXTM Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: NFA Dated: December 19, 2006 Received: December 21, 2006
Dear Mr. Worrell:
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.
3
Page 2 - Mr. David Worrell
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,
una R. h. hmes
Image /page/3/Picture/5 description: The image contains a handwritten signature or symbol on the left, followed by the words "Br" and "Di" stacked vertically on the right. The signature appears to be a stylized, looping design. The text is simple and straightforward, suggesting it might be part of a name or title.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: SpiderFXTM Embolic Protection Device
Indications for Use:
The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.
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)
Duna R. Vachner
(Division Sign-Off)
ാസിടിഠന ഗ്രീപ്പ് വിട്ടിം വിരുന്ന
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n Number_K063785
Confidential
ev3 Inc.