(153 days)
No
The device description focuses on the mechanical and material properties of the coil and delivery system, with no mention of AI or ML. The performance studies are related to MRI compatibility, not algorithmic performance.
Yes.
This device is designed to obstruct or reduce blood flow in the peripheral vasculature to treat medical conditions, which falls under the definition of a therapeutic device.
No
This device is an occlusion system designed to obstruct blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components including a coil, delivery wire, and introducer sheath, 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Interlock™ Fibered IDC™ Occlusion System is a medical device designed to be implanted in the peripheral vasculature to physically obstruct or reduce blood flow. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "obstruct[ing] or reduce[ing] rate of blood flow in the peripheral vasculature." This is a treatment, not a diagnostic test.
- Device Description: The description details a physical coil and delivery system, not a test kit or analytical instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the Interlock™ Fibered IDC™ Occlusion System is a therapeutic medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Interlock™ Fibered IDC™ Occlusion System 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 Interlock Fibered IDC Occlusion System includes a coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.0 21 in (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. 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
Non-clinical testing demonstrates that the Interlock Fibered IDC Occlusion System 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 F2182-02a, 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. Testing at field strengths other than 1.5 Tesla or 3 Tesla has not been performed to evaluate coil migration or heating.
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)
Fibered Interlocking Detachable Coil (Fibered IDC Occlusion System) (K060078)
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
MAR - 3 2011
Premarket Notification 510(k) Detachable Platinum Coils
Section 2
510(k) Summary
(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 | Fibered IDC |
| Proprietary Name | Interlock™ Fibered IDC™ Occlusion System |
| Name of Predicate Device | Fibered Interlocking Detachable Coil (Fibered IDC
Occlusion System) (K060078) |
| | |
| Device Description | The Interlock Fibered IDC Occlusion System
includes a coil (manufactured from platinum-
tungsten alloy) that is mechanically attached to a
coil delivery wire. This assembly is contained
within an introducer sheath. The platinum coil
contains synthetic fibers for greater
thrombogenicity. The Interlock Fibered IDC
Occlusion Coil is designed to be delivered under
fluoroscopy with a 0.0 21 in (0.53 mm) inner
diameter (I.D.) microcatheter (e.g. Renegade™
Microcatheter) with one or two radiopaque (RO)
tip markers. 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. |
| Intended Use | The Interlock Fibered IDC Occlusion System 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. |
| Non-Clinical and Clinical Test
Summary | Non-clinical testing demonstrates that the Interlock
Fibered IDC Occlusion System 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 F2182-02a, 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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
MAR - 3 2011
Re: K102912
Trade/Device Name: Interlock™ Fibered IDC™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: February 18, 2011 Received: February 22, 2011
Dear Ms. Pettit:
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 indives 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 Fedral 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, list in 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 micleading.
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
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 is 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dana R. Bohmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 1
Indications for Use Statement
510(k) Number (if known): K102912
Device Name: Interlock™ Fibered IDC™ Occlusion System
Indications for Use:
The Interlock™ Fibered IDC™ Occlusion System 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.
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 OF NEEDED)
ه سربه مارك Concentrance of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Nighfiggpian (ng Doginean Do Boston Scientific Corporation