(28 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the coil and delivery system, with no mention of AI or ML.
Yes
The device is indicated to "obstruct or reduce rate of blood flow in the peripheral vasculature," which describes a therapeutic action to treat a medical condition.
No
The device, the Interlock Fibered IDC Occlusion System, is an interventional device designed to obstruct blood flow in the peripheral vasculature. Its intended use is therapeutic (occlusion) rather than diagnostic (identifying a condition or disease).
No
The device description clearly outlines physical components including a coil, delivery wire, and introducer sheath, all made of physical materials. The performance studies also focus on bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obstruct or reduce rate of blood flow in the peripheral vasculature." This is a therapeutic intervention performed directly on the patient's circulatory system.
- Device Description: The device is a physical coil designed to be implanted within blood vessels.
- Mechanism of Action: The device works by physically blocking blood flow and promoting clot formation within the vessel.
- Lack of In Vitro Testing: While there are performance studies, they are focused on the physical properties and biocompatibility of the device itself, not on analyzing biological samples in vitro (outside the body).
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
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 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is a product line consisting of 0.018 inch (0.457 mm) system compatible fibered interlocking detachable coils. 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 0.021 inch (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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Determination of substantial equivalence for the 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System bench testing is based on an assessment of non-clinical bench and biocompatibility testing. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and chemical characterization tests were completed on the 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System:
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated Pyrogenicity
USP Physicochemical
Partial Thromboplastin Time
Hemolysis (Extract Method)
Complement Activation
Implantation
Genotoxicity (Ames Assay and Mouse Lymphoma)
Subacute Toxicity (IP and IV)
Latex
The following in-vitro performance tests were completed on the 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System:
Anchorability
Fiber Retention
Microcatheter Compatibility (lumen)
Deliverability/Pushability
Stretch Resistance
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
25-78
SEP 1 3 2013
. :
510(k) Summary
r
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
763-494-2222
Fax: | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Contact Name
and
Information | Todd Kornmann
Principal Regulatory Affairs Specialist
Phone: 763-494-1348
763-494-2222
Fax:
e-mail: todd.kornmann@bsci.com | |
| Date Prepared | 15 August 2013 | |
| Proprietary
Name | Interlock™ 018 Fibered IDC ™ Occlusion System | |
| Common Name | Vascular embolization device | |
| Product Code | KRD | |
| Classification | Class II, 21 CFR Part 870.3300 | |
| Predicate
Devices | K102912, March 3, 2011
Interlock -18 Fibered IDC
K060078, January 31, 2006
Occlusion System | |
| Device
Description | The 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is a
product line consisting of 0.018 inch (0.457 mm) system compatible
fibered interlocking detachable coils. 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 0.021 inch (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/
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. | |
| Comparison of
Technological
Characteristics | The proposed line extension of the 018 Spiral / Helical 2D Interlock
Fibered IDC Occlusion System incorporates substantially equivalent
design, packaging, fundamental technology, manufacturing processes,
sterilization process and intended use as those featured in the predicate
BSC Interlock Fibered IDC Occlusion System. | |
| Performance
Data | Determination of substantial equivalence for the 018 Spiral / Helical 2D
Interlock Fibered IDC Occlusion System bench testing is based on an
assessment of non-clinical bench and biocompatibility testing. The resultsof these tests provide reasonable assurance that the proposed device has
been designed and tested to assure conformance to the requirements for
its intended use. No new safety or performance issues were raised during
the testing and, therefore, these devices may be considered substantially
equivalent to the predicate devices. | |
| | The following biocompatibility and chemical characterization tests were
completed on the 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion
System: | |
| | Cytotoxicity | Hemolysis (Extract Method) |
| | Sensitization | Complement Activation |
| | Intracutaneous Reactivity | Implantation |
| | Acute Systemic Toxicity | Genotoxicity (Ames Assay and
Mouse Lymphoma) |
| | Materials Mediated Pyrogenicity | Subacute Toxicity (IP and IV) |
| | USP Physicochemical | Latex |
| | Partial Thromboplastin Time | |
| | The following in-vitro performance tests were completed on the 018 Spiral
/ Helical 2D Interlock Fibered IDC Occlusion System: | |
| | Anchorability | Deliverability/Pushability |
| | Fiber Retention | Stretch Resistance |
| | Microcatheter Compatibility (lumen) | |
| Conclusion | The modifications do not affect the intended use or alter the fundamental
scientific technology of the predicate Boston Scientific Interlock Fibered
IDC Occlusion System (K102912, cleared March 3, 2011 and K060078,
cleared January 31, 2006). | |
| | Based on the indications for use, technological characteristics, safety and
performance testing, the proposed line extension of the 018 Spiral /
Helical 2D Interlock Fibered IDC Occlusion System is appropriate for the
intended uses and are considered to be substantially equivalent to the
predicate Interlock Fibered IDC Occlusion Systems (K102912, cleared
March 3, 2011 and K060078, cleared January 31, 2006). | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, rendered in a bold, flowing line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Go05 Silver Spring, MD 20993-0002
September 13, 2013
Boston Scientific Corporation C/O Todd Kornmann One Scimed Place Maple Grove, MN 55311
Re: K132578
Trade/Device Name: Interlock™ - 18 Fibered ICD™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 15, 2013 Received: August 16, 2013
Dear Mr. Kornmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have to to to to the determined the 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 enotiment date of the Medical Device Amendments. or to continered prof to may 2011 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 cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 complics with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of any I cachar statues and regionnents. including, but not limited to: registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set ocelection in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic (200 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Todd Kornmann
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,
Melissa A. Torres -S
Bram D. Zuckerman, M.D. For Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): _ K132578
Device Name: Interlock™ -18 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 × (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)