(199 days)
No
The device description and performance studies focus on mechanical components and clinical outcomes, with no mention of AI or ML.
No
The device is an embolic protection system designed to contain and remove embolic material, which is a supportive function during interventional procedures, not a direct therapeutic treatment itself.
No
The device is an embolic protection system designed to contain and remove embolic material during procedures in arteries of the lower extremities, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components like a capture wire, nitinol mesh filter, stainless steel guidewire, and a catheter, indicating it is a hardware 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 in vivo (within the body) to physically capture and remove embolic material during a medical procedure in the lower extremities. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor medical conditions.
- Device Description: The description details a physical device (guidewire, filter, catheter) designed for percutaneous delivery and mechanical action within the circulatory system. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the SpiderFX Embolic Protection Device is an interventional medical device, not an IVD.
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 in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.
Product codes
NTE
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 dualended SpiderFX Catheter for delivery and recovery. The SpiderFX® Embolic Protection Device uses the following materials: pebax, grilamid, platinum/iridium, nitinol, stainless steel, PTFE coating, gold tungsten, and hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries of the lower extremities
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
To demonstrate substantial equivalence of the subject SpiderFX® Embolic Protection Device to the predicate device, the technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Analysis procedures, the following tests were performed:
- Stent Compatibility ●
- Filter Efficiency .
- Radial Outward Force .
- Simulated Use ●
- Deployment/Retrieval Forces .
- In Vivo Animal Studies .
The following testing was leveraged from the predicate SpiderFX® and SpideRX® Embolic Protection Device submissions. Test results met the specified acceptance criteria and were included in K063204 or K052659:
- Embolic Capture Efficiency and Retrieval Ability ●
- Simulated Use .
- Deployment/Retrieval Forces .
- Filter Capacity .
- Resistance to Filter Rupture During Removal of a Fully Loaded Filter .
- Flow Characteristics .
- Tip Flexibility .
- Tensile Strength ●
- Torque Strength .
- Torque Response ●
- Kink Resistance .
- Dimensional Verification .
- Package Integrity ◆
- Sterilization ●
- Shelf Life ●
The results from these tests demonstrate that the technological characteristics and performance criteria of the SpiderFX® Embolic Protection Device are comparable to the predicate device and that the SpiderFX® Embolic Protection Device performs in a manner equivalent to the predicate device currently on the market for the same intended use.
Clinical Summary:
The DEFINITIVE Cat + study was a prospective, multi-center, non-randomized, single-arm study comparing the SilverHawk TurboHawk and the SpiderFX to performance goals derived from an observational multi-center registry (TALON) of subjects with lower extremity PAD who underwent revascularization with catheter-based plaque excision. The purpose of this study was to evaluate the safety and effectiveness of the SilverHawk/TurboHawk and the SpiderFX for the treatment of moderate to severely calcified peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries.
Key Metrics
The primary safety endpoint of the DEFINITIVE Ca* study was freedom from major adverse event (MAE) rate. MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven TVR, through 30 days post-procedure, as adjudicated by the clinical events committee (CEC). The 30-day freedom from MAE rate was 93.1% (122/131). The 95% lower confidence limit was 88.3% (as calculated by the Exact method), greater than the performance goal of 85.5%. Therefore, the primary safety endpoint was met.
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).
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K111010
p. 1 of 4
OCT 2 7 2011
510(k) Summary
SpiderFX® Embolic Protection Device
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R § 807.92.
1. Submitter Information
| Applicant | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441-2651
Tel: 763-398-7000
Fax: 763-591-3248 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brenda Johnson
Principal Regulatory Affairs Specialist |
| Date Prepared | October 26, 2011 |
| 2.
Subject Device | |
| Device Trade Name | SpiderFX® Embolic Protection Device |
| Device Common Name | Embolic Protection Device |
| Classification Name | Temporary Carotid Catheter for Embolic Capture
21 CFR 870.1250, Product Code NTE |
| Classification Panel | Cardiovascular |
| 3. Predicate Devices | |
| Device Trade Name | SpiderFX® Embolic Protection Device;
SpideRX® Embolic Protection Device
Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture
Feature |
| 510(k) Number | K063204; K052659; K090364 |
| 510(k) Clearance Date | November 14, 2006; February 17, 2006; March 23, 2010 |
4. 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 dualended SpiderFX Catheter for delivery and recovery. The SpiderFX® Embolic Protection Device uses the following materials: pebax, grilamid, platinum/iridium, nitinol, stainless steel, PTFE coating, gold tungsten, and hydrophilic coating.
1
5. 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 in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.
6. Comparison of Technological Characteristics
The SpiderFX Embolic Protection Device is the identical device as the currently marketed SpiderFX Embolic Protection Device (K063204). The SpiderFX Embolic Protection Device for peripheral use and the predicate SpiderFX Embolic Protection Device for carotid use share the following technological characteristics:
- Intended use .
- Fundamental scientific technology and operating principle �
- � Design & Dimensions
- . Materials
- . Manufacturing site and methods
- Sterilization site, method, parameters, and sterility assurance level .
- Packaging .
- . Shelf Life
Additionally, the Indications for Use, labeling, and Instructions For Use are similar between the proposed and marketed devices. The differences include a revised sizing matrix for use during interventions in lower extremity vessels, allowing use of the SpiderFX Device with atherectomy interventional devices, and allowing use of commercially available catheters, that are minimally 0.035" guide wire compatible, for delivery and/or recovery of the SpiderFX Capture Wire. Bench and animal testing was performed to demonstrate the proposed use of the device met pre-determined acceptance criteria.
7. Biocompatibility Testing
Device materials in the proposed SpiderFX® Embolic Protection Device are identical to the materials in the commercially available SpiderFX® and SpideRX® Embolic Protection Devices. Biocompatibility testing was leveraged from the predicate SpiderFX® and SpideRX® Embolic Protection Device submissions and included cytotoxicity, sensitization, intracutaneous injection, systemic injection, hemolysis, pyrogen, complement activation, and thrombogenicity. The SpideRX Catheter and Capture Wire from the predicate SpideRX Device (K052659) meet the requirements for biocompatibility testing outlined in ISO 10993-1 Part 1: 2003 "Biological Evaluation of Medical Devices".
2
8. Performance Testing Summary
To demonstrate substantial equivalence of the subject SpiderFX® Embolic Protection Device to the predicate device, the technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Analysis procedures, the following tests were performed:
- Stent Compatibility ●
- Filter Efficiency .
- Radial Outward Force .
- Simulated Use ●
- Deployment/Retrieval Forces .
- In Vivo Animal Studies .
The following testing was leveraged from the predicate SpiderFX® and SpideRX® Embolic Protection Device submissions. Test results met the specified acceptance criteria and were included in K063204 or K052659:
- Embolic Capture Efficiency and Retrieval Ability ●
- Simulated Use .
- Deployment/Retrieval Forces .
- Filter Capacity .
- Resistance to Filter Rupture During Removal of a Fully Loaded Filter .
- Flow Characteristics .
- Tip Flexibility .
- Tensile Strength ●
- Torque Strength .
- Torque Response ●
- Kink Resistance .
- Dimensional Verification .
- Package Integrity ◆
- Sterilization ●
- Shelf Life ●
The results from these tests demonstrate that the technological characteristics and performance criteria of the SpiderFX® Embolic Protection Device are comparable to the predicate device and that the SpiderFX® Embolic Protection Device performs in a manner equivalent to the predicate device currently on the market for the same intended use.
9. Clinical Summary
DEFINITIVE Cat + was a prospective, multi-center, non-randomized, single-arm study to compare the SilverHawk TurboHawk and the SpiderFX to performance goals derived from an observational multi-center registry (TALON) of subjects with lower extremity PAD who underwent revascularization with catheter-based plaque excision. The purpose of this study was to evaluate the safety and effectiveness of the SilverHawk/TurboHawk and the SpiderFX for the treatment of moderate to severely calcified peripheral arterial disease (PAD) in the superficial femoral and/or the popliteal arteries.
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P. 4 of 4
The primary safety endpoint of the DEFINITIVE Ca* study was freedom from major adverse event (MAE) rate. MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven TVR, through 30 days post-procedure, as adjudicated by the clinical events committee (CEC). The 30-day freedom from MAE rate was 93.1% (122/131). The 95% lower confidence limit was 88.3% (as calculated by the Exact method), greater than the performance goal of 85.5%. Therefore, the primary safety endpoint was met.
10. Conclusions
Based on the intended use, technological characteristics, safety and performance testing included in this submission, ev3 considers the proposed SpiderFX® Embolic Protection Device to be substantially equivalent to its predicates.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 7 2011
ev3. Inc. c/o Ms. Brenda Johnson Principal Regulatory Affairs Specialist 3033 Campus Drive Plymouth, MN 55441
Re: K11010
Trade/Device Name: SpiderFX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: September 30, 2011
Received: October 3, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you 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.
5
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
KK
/R/ Z
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K111010
Device Name: SpiderFX® Embolic Protection Device
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 in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
LL
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number K111010