(134 days)
Not Found
No
The device description and intended use focus on a mechanical coil and delivery system, with no mention of AI or ML capabilities. The performance studies are related to MRI compatibility, not algorithmic performance.
Yes
The device is intended to obstruct or reduce blood flow in the peripheral vasculature, which is a therapeutic intervention for medical conditions.
No
The device is an IDC Coil, indicated to obstruct or reduce blood flow in the peripheral vasculature. It is a therapeutic device for embolization, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly outlines physical components made of platinum-tungsten alloy, a delivery wire, and an introducer sheath. It is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the IDC Coil is a physical device (a coil made of platinum-tungsten alloy) designed to be delivered into the peripheral vasculature to obstruct blood flow. It is an implantable or interventional device, not a test performed on a sample outside the body.
- Intended Use: The intended use is to "obstruct or reduce rate of blood flow in the peripheral vasculature," which is a therapeutic or interventional procedure, not a diagnostic test.
Therefore, the IDC Coil falls under the category of a medical device used for treatment or intervention within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The IDC Coil is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
Product codes
KRD
Device Description
The IDC Coil includes a standard or soft coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The IDC Coil is designed to be delivered under fluoroscopy with a 0.53 mm (0.021 in) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one radiopaque (RO) tip marker. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
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)
The MRI testing results conducted under methods described by ASTM F2182-02a, ASTM F2052-06e1, ASTM F2213-06 and ASTM F2119-07 have demonstrated that the peripheral coils are to be MR Conditional and can be scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla.
Testing at field strengths other than 1.5 Tesla or 3.0 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they appear to be emerging from a single point. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2014
Boston Scientific Corporation Liz Johnston Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K141378
Trade/Device Name: IDC Interlocking Detachable Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 15, 2014 Received: August 18, 2014
Dear Liz Johnston:
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. We remind you, however, 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.
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141378
Device Name IDCTM Interlocking Detachable Coil
Indications for Use (Describe)
The IDC Coil is a modified interlocking detachable coll indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Per 21 CFR §807.92
| Submitter's Name and Address: | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
USA | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Information: | Liz Johnston
Regulatory Affairs Specialist II
Phone: 763-494-1676
Fax: 763-494-2222
Email: Liz.Johnston@bsci.com | |
| Date Prepared: | 23May2014 | |
| Proprietary Name: | IDC™ Interlocking Detachable Coil | |
| Common Name: | Vascular embolization device | |
| Classification: | Class II
Product Code: KRD
Review Panel: Cardiovascular | |
| Predicate Device: | Interlocking Detachable Coil System (IDC)
K040342 - April 13, 2004 | |
Intended Use / Indications for Use:
The IDC Coil is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
Device Description:
The IDC Coil includes a standard or soft coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The IDC Coil is designed to be delivered under fluoroscopy with a 0.53 mm (0.021 in) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one radiopaque (RO) tip marker. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.
4
Comparison of Technological Characteristics:
The IDC Interlocking Detachable Coil are similar in fundamental design, function, device materials, packaging, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device.
Performance Data:
The MRI testing results conducted under methods described by ASTM F2182-02a, ASTM F2052-06e1, ASTM F2213-06 and ASTM F2119-07 have demonstrated that the peripheral coils are to be MR Conditional and can be scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla.
Testing at field strengths other than 1.5 Tesla or 3.0 Tesla has not been performed to evaluate coil migration or heating.
Conclusion:
The modifications do not affect the intended use or alter the fundamental scientific technology of the predicate Boston Scientific Interlocking Detachable Coil System (K040342).
Based on the Indications for Use, unaltered technological characteristics, and submitted nonclinical performance data supporting this modification, the Boston Scientific IDC Interlocking Detachable Coil is shown to be appropriate for its intended use and demonstrates that the device is as safe, as effective, and performs as well as the predicate device.