(30 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and thrombogenicity of the coil, with no mention of AI or ML algorithms for image analysis, diagnosis, or treatment planning.
Yes
The device is indicated to "obstruct or reduce rate of blood flow in the peripheral vasculature," which is a treatment for a medical condition.
No
This device is an occlusion system designed to obstruct or reduce blood flow in the peripheral vasculature, which is a therapeutic function, not a diagnostic one. It is delivered using a diagnostic catheter, but the device itself is not diagnostic.
No
The device description clearly outlines physical components such as a platinum-tungsten alloy coil, delivery wire, and introducer sheath, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Interlock-35 Fibered IDC Occlusion System is a device used to obstruct or reduce blood flow within the peripheral vasculature. This is an interventional procedure performed inside the body.
- Lack of Specimen Testing: There is no mention of collecting or testing any biological specimens.
- Input Imaging Modality: The device is used with fluoroscopy, which is an imaging technique used during procedures performed inside the body.
Therefore, based on the provided information, the Interlock-35 Fibered IDC Occlusion System is a medical device used for an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Interlock-35 Fibered IDC Occlusion System is 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-35 Fibered IDC Occlusion System includes a coil manufactured from a 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-35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Diagnostic Catheter (e.g. Imager™ II Diagnostic Catheter). 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
Non-Clinical Performance Data: Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical performance data submitted in support of substantial equivalence is based on the Failure Modes/Effects Analysis (FMEA) risk analysis method completed for the Interlock-35 Fibered IDC Occlusion System to demonstrate that the proposed devices are suitable for their intended use. All testing performed and data demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device.
The following performance tests were performed:
- Coil Geometry
- Stretch Resistance
- Deployment
- Atraumatic Embolic Coil Tip
- Fiber Retention
- Interlocking Arm to Embolic Coil Tensile Strength
- Embolic Coil Corrosion Resistance
- Radial Force
- Atraumatic Delivery Wire Tip
- Interlocking Arm to Delivery Wire Tensile Strength
- Corrosion Resistance
- Delivery Wire Coating Fracture
- Delivery Wire Coating Flexure
- Delivery Wire OD
- Delivery Wire Length
- Introducer Sheath Interface
- Introducer Sheath Deliverability
- Delivery Catheter Compatibility
- Rotating Hemostatic Valve (RHV) Compatibility
Clinical Performance Data: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
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
510(k) Summary
per 21 CFR §807.92 (c)
per 21 CFR §807.92 (c)
:
| K110295 | |
|---|---|
| Submitter's | |
| Name and | |
| Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311 | |
| Contact Name | |
| and Information | Shannon Pettit |
| Senior Regulatory Affairs Specialist | |
| Tel: 763-494-2833 | |
| Fax: 763-494-2222 | |
| E-mail: Shannon.Pettit@bsci.com | |
| Date Prepared | January 31, 2011 |
| Trade Name | Interlock™-35 Fibered IDC™ Occlusion System |
| Common Name | Vascular embolization device |
| Classification | Class II |
| Product Code | KRD, Vascular embolization devices |
| (21 CFR 870.3300) | |
| Predicate | |
| Devices | Boston Scientific |
| K060078 SE: 31 Jan 2006 | |
| Interlock Fibered IDC | |
| Occlusion System | |
| Fibered Platinum | |
| K955293 SE: 6 Feb 1996 | |
| .035" Type Occlusion | |
| Coils | |
| Reason for | |
| Submission | To gain clearance for a modified fibered interlocking |
| detachable coil embolization system based on the currently | |
| marketed Fibered IDC Occlusion System cleared under | |
| K060078 |
1
| Device
Description | The Interlock-35 Fibered IDC Occlusion System includes a
coil manufactured from a 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-35 Fibered IDC Occlusion System is designed to
be delivered under fluoroscopy through a 5F (0.035 in [0.89
mm] or 0.038 in [0.97 mm] inner lumen) Diagnostic Catheter
(e.g. Imager™ II Diagnostic Catheter). 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. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Interlock-35 Fibered IDC Occlusion System is 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 Interlock-35 Fibered IDC Occlusion System
is a modification to existing designs/shapes currently
marketed by Boston Scientific. It is important to note that
each of the Interlock-35 Fibered IDC Occlusion System
device characteristics is currently available on BSC legally
marketed devices and no changes in fundamental scientific
technology have been made. Additionally, the performance
characteristics of the Interlock-35 Fibered IDC Occlusion
System are substantially equivalent to the currently
marketed devices. |
・
:
. . . . . .
.
.
2
Non-Clinical Performance Data
Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical performance data submitted in support of substantial equivalence is based on the Failure Modes/Effects Analysis (FMEA) risk analysis method completed for the Interlock-35 Fibered IDC Occlusion System to demonstrate that the proposed devices are suitable for their intended use.
All testing performed and data demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device.
The following performance tests were performed:
- Coil Geometry .
- Stretch Resistance .
- Deployment .
- Atraumatic Embolic Coil Tip .
- Fiber Retention
- . Interlocking Arm to Embolic Coil Tensile Strength
- Embolic Coil Corrosion Resistance ●
- Radial Force .
- . Atraumatic Delivery Wire Tip
- Interlocking Arm to Delivery Wire Tensile Strength .
- Corrosion Resistance .
- Delivery Wire Coating Fracture .
- . Delivery Wire Coating Flexure
- Delivery Wire OD .
- . Delivery Wire Length
- Introducer Sheath Interface .
- Introducer Sheath Deliverability .
- Delivery Catheter Compatibility .
- Rotating Hemostatic Valve (RHV) Compatibility .
Clinical · Performance Data
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
3
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 (K060078).
Based on the Indications for Use, unaltered technological characteristics, and submitted non-clinical performance data supporting this modification, the Boston Scientific Interlock-35 Fibered IDC Occlusion System 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 3 2011
Boston Scientific Corporation c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K110295
K110295
Trade/Device Name: Interlock™-35 Fibered IDC™ Occlusion System
Trade/Device Name: 11, OFF 970, 2300 Frade/Don Number: 21 CFR 870.3300 Regulation Namber: 21 Cr Creation Device Regulatory Class: Class II Product Code: KRD Dated: January 31, 2011 Received: February 1, 2011
Dear Ms. Pettit:
Dour new reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(t) premarket notification in them to makes in the indications
referenced above and have devel is substantially equivalent (for the indicatio referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medice Amendments, or to commerce prior to May 28, 1976, the enactment of the Pederal Food, Drug, es that have been recassified in accordance with the proval application (PMA).
devices that have been require approval of a prematies approval application (PMA).
The Act (A genese and the Act (Act) that do not require approval of a previsions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The and Controls, market the Act include requirements for amual registration, listing of
general controls provises of the Act include requirements for annual registrations and reneral controls provisions of the Act include requirentelity to annual 1992
devices, good manufacturing practice, labeling, and problibitions against misbranding and devices, good manufacturing practice, labeling, and promotion related to contract liability
adulteration. Please not evaluate information related to contract in the de read, good
wantines of the major and ther class II (Special Controls) or class III (PMA), it
form of the may of the classesses - Existing major regulations affecting your device can be If your device is classified (see above) into either class II (Special Controlly)
may be subject to additional controls. Existing major regulations affecting your device can
5
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/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,
Duma R. Holmes
Image /page/5/Picture/8 description: The image shows a black and white drawing of a wavy line. The line has several peaks and valleys, creating a pattern that resembles a simplified waveform. The drawing is simple and lacks any shading or additional details.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Interlock-35™ Fibered IDC™ Occlusion System
Indications for Use:
The Interlock-35 Fibered IDC Occlusion System is 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Palmer
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number_K 110295
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