(144 days)
Not Found
No
The device description and performance studies focus on the physical properties and MR compatibility of the platinum coils, with no mention of AI or ML technology.
Yes
The device is described as being intended for "arterial and venous embolizations," which is a medical procedure to block blood vessels, indicating a direct therapeutic purpose.
No
The device is used for arterial and venous embolizations in the peripheral vasculature, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it consists of physical components like platinum-tungsten alloy coils, synthetic fibers, an introducer, and a coil plunger. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arterial and venous embolizations in the peripheral vasculature." This describes a therapeutic procedure performed within the patient's body to block blood vessels.
- Device Description: The description details physical coils made of platinum-tungsten alloy and synthetic fibers, along with tools for their delivery. This is consistent with an implantable or interventional device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to physically block blood vessels within the body.
N/A
Intended Use / Indications for Use
Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.
Product codes
KRD
Device Description
Boston Scientific's 0.018 Fibered Platinum Coils consist of platinum-tungsten alloy coils with synthetic fibers and are available in six different shapes; Vortx, Vortx Diamond, Complex Helical, Figure-8, Multi-Loop and Straight. The coil is provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. The coil plunger, supplied with the coil, is used to push the coil out of the introducer and into the microcatheter.
Boston Scientific VortX-35 and 2D Helical-35 Fibered Platinum Coils are helically-shaped platinum-tungstent alloy coils with synthetic fibers. The coils are provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. A coil plunger, supplied with the coil, is used to push the coil out of the introducer and into the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
Non-clinical testing demonstrates that the Vortx-18, Vortx Diamond-18, Straight-18, Figure 8-18, Multi-Loop-18, Complex Helical-18, Vortx-35 and 2D Helical-35 Fibered Platinum Coils will not present additional risk to a patient during a MRI procedure in comparison to risks imposed by gravitational, and other normal daily activities, or a temperature rise that is experienced during a feverish condition. The results of testing conducted under methods described by ASTM F2182-09, ASTM F2052-06e1, ASTM F2213-06 and ASTM F2119-07 have demonstrated that the Coils are MR Conditional and can be scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla in normal operating mode,and in a static magnetic field gradient less than 25 T/m. Testing at field strengths other than 1.5 Tesla or 3 Tesla has not been performed to evaluate coil migration or heating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
0
FEB 1 1 201
K | O 2714
- Summary 510(k) Summary
Section 2
ﺔ، ﻓ
i
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
| Submitter's Name and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Debbie McIntire
Senior Regulatory Affairs Specialist
Boston Scientific
Debbie.McIntire@bsci.com
Phone: (408) 935-4679
Fax: (763) 494-2222 |
| Classification Name | Vascular embolization device |
| Product Code | KRD |
| Common or Usual Name | 1) 0.018 Fibered Platinum Coils
2) 0.035 Fibered Platinum Coils |
| Proprietary Name | 1) VortX-18TM, VortXTM Diamond -18, Straight-18, Figure 8-18, Multi-Loop-18, Complex Helical-18 Fibered Platinum Coil
2) VortXTM-35, 2D Helical-35 Fibered Platinum Coils |
| Names of Predicate Devices | 1) Target Therapeutics Peripheral Coils (K914786)
2) Target Therapeutics Fibered Platinum Coils (K955293) |
| Reason for Submission | Modifications to the device labeling related to MRI compatibility |
| Device Description | Boston Scientific's 0.018 Fibered Platinum
1)
Coils consist of platinum-tungsten alloy coils
with synthetic fibers and are available in six
different shapes; Vortx, Vortx Diamond,
Complex Helical, Figure-8, Multi-Loop and
Straight. The coil is provided with an
introducer that is secured at both ends by a
retaining clip during shipping and storage.
The coil plunger, supplied with the coil, is
used to push the coil out of the introducer and
into the microcatheter. |
| | Boston Scientific VortX-35 and 2D Helical-35
2)
Fibered Platinum Coils are helically-shaped
platinum-tungstent alloy coils with synthetic
fibers. The coils are provided with an
introducer that is secured at both ends by a
retaining clip during shipping and storage. A
coil plunger, supplied with the coil, is used to
push the coil out of the introducer and into the
catheter. |
| Intended Use | Boston Scientific's 0.018 and 0.035 Fibered
Platinum Coils are intended for arterial and venous
embolizations in the peripheral vasculature. |
| Non-Clinical and Clinical Test
Summary | Non-clinical testing demonstrates that the Vortx-
18, Vortx Diamond-18, Straight-18, Figure 8-18,
Multi-Loop-18, Complex Helical-18, Vortx-35 and
2D Helical-35 Fibered Platinum Coils will not
present additional risk to a patient during a MRI
procedure in comparison to risks imposed by
gravitational, and other normal daily activities, or a
temperature rise that is experienced during a
feverish condition. The results of testing
conducted under methods described by ASTM
F2182-09, ASTM F2052-06e1, ASTM F2213-06
and ASTM F2119-07 have demonstrated that the
Coils are MR Conditional and can be scanned
safely under a static magnetic field of 1.5 Tesla or
3.0 Tesla in normal operating mode,and in a static
magnetic field gradient less than 25 T/m.
Testing at field strengths other than 1.5 Tesla or 3
Tesla has not been performed to evaluate coil
migration or heating. |
1
·
Date prepared: September 2010
.....
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corp. c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
FEB 1 1 201
Re: K102714
VortXTM-18, VortXTM Diamond-18, Straight-18, Figure 8-18, Multi-Loop-18, and Complex Helical-18 Febered Platinum Coils VortX™-35 and 2D Helical-35 Fibered Platinum Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Device, Embolization, Vascular Regulatory Class: Class II (two) Product Code: KRD Dated: January 6, 2011 Received: January 7, 2011
Dear Ms. Pettit:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave rovewod your occasion or (-) fe 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 encreated of the enactment date of the Medical Device Amendments, or to conninered print to 1125 20, 2017 11:12 provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelove, mains of the Act include requirements for annual registration, listing of genoral controls provisions practice, labeling, and prohibitions against misbranding and de rices, good mananablaring practice, and evaluate information related to contract liability addition. Ticasonote. ODAY as , 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 If your device is classified (500 above) and interest affecting your device can be
:
3
Page 2 -- Ms. Shannon Pettit
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 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 device-related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Dina R. Vahmir
A 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):
VortX-18TM , VortXTM Diamond -18, Straight-18, Figure 8-18, Multi-Device Name: Loop-18, Complex Helical-18 Fibered Platinum Coil and VortXTM-35, 2D Helical-35 Fibered Platinum Coils
Indications For Use:
Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.
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)
Duana R. Vihmer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K102714
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