(10 days)
Not Found
No
The 510(k) summary describes a mechanical embolic protection device and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in percutaneous transluminal coronary angioplasty or stenting procedures to contain and remove embolic material, which is a therapeutic intervention.
No
The device is described as an "embolic protection system to contain and remove embolic material" and "acts as the guidewire." Its purpose is to physically manage embolic material during procedures, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly details physical components like a Capture Wire, nitinol mesh filter, stainless steel wire, and a SpideRX Catheter, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- SpideRX™ Function: The SpideRX™ Embolic Protection Device is a medical device used inside the body during a surgical procedure (percutaneous transluminal coronary angioplasty or stenting). Its purpose is to physically capture and remove embolic material within blood vessels.
The description clearly indicates a device used for a therapeutic and protective purpose during an interventional procedure, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The SpideRX™ 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 (comma separated list FDA assigned to the subject device)
NFA
Device Description
The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
510(k) Summary SpideRXTM Embolic Protection Device
510(k) Number: K06220 |
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
| General Provisions: | |
|---|---|
| Submitter's Name | ev3 Inc. |
| 4600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Official Contact: | Brenda Johnson |
| Sr. Regulatory Affairs Specialist | |
| ev3 Inc. | |
| 9600 54th Avenue North | |
| Plymouth, MN 55442 | |
| Tel: (763) 398-7238 | |
| Fax: (763) 398-7200 | |
| brenda.johnson@ev3.net | |
| Trade Name: | SpideRXT™ Embolic Protection Device |
| Common Name/Usual Name: | Embolic Protection Device |
| Classification Name: | Catheter, Percutaneous |
| Class: | Class II, 21 CFR 870.1250 |
Predicate Devices:
SpideRX Embolic Protection Device (K053195)
Device Description:
The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.
1
Intended Use:
The SpideRX™ 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 Labeling Change:
The labeling has been modified to reflect use compatibility of the SpideRX Device with currently marketed drug-eluting stents.
2
Food and Drug Administrat. 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Ms. Brenda Johnson Senior Regulatory Affairs Specialist ev3 Inc. 4600 Nathan Lane North Plymouth, MN 55442-2920
Re: K062201
Trade/Device Name: ev3 Inc. SpideRX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Distal Embolic Protection Guidewire Regulatory Class: Class II Product Code: NFA Dated: July 27, 2006 Received: August 1, 2006
Dear Ms. Johnson
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 -- Ms. Brenda Johnson
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. product lauxiness on on 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 prorketed 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,
Bram D. Zuckerman, M.D.
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): _ KO6220)
Device Name: SpideRX™ Embolic Protection Device
Indications for Use:
The SpideRX 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 arotection system has not been established in the cerebral or peripheral vasculature.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 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)
Division of Cardiovascular Devices
510(k) Number. K062201
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