(21 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. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to obstruct or reduce blood flow in the peripheral vasculature, which is a therapeutic intervention.
No
The device is an occlusion system designed to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one. While it is delivered using a "Diagnostic Catheter," the device itself does not diagnose conditions.
No
The device description clearly outlines physical components including a platinum-tungsten alloy coil, a delivery wire, and an 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 tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Interlock-35 Fibered IDC Occlusion System is a medical device designed to be implanted in the peripheral vasculature to obstruct blood flow. It is a physical device used for treatment, not a test performed on a sample outside the body.
- 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 therapeutic intervention, not a diagnostic test.
- Device Description: The description details a physical coil and delivery system, not reagents or equipment for analyzing biological samples.
- Input Imaging Modality: Fluoroscopy and MRI are used for guiding the placement of the device and assessing its effect, not for analyzing biological samples.
The information provided clearly describes a device used for a therapeutic procedure within the body, which is the opposite of an in vitro diagnostic.
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 (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing demonstrates that the Interlock-35 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 3.0 Tesla has not been performed to evaluate coil migration or heating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
长川之103
510(k) Summary
per 21 CFR §807.92 (c)
AUG 1 2 2011
per 21 CFR §807.92 (c)
:
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Harlan Jones
Regulatory Affairs Specialist II
Tel: 763-255-0027
Fax: 763-494-2222
E-mail: Harlan.Jones@bsci.com |
| Date Prepared | July 14, 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 Device | Interlock-35 Fibered
IDC Occlusion
System (Vascular
embolization device) K110295 SE: 3 Mar 2011 |
| Reason for
Submission | The reason for this premarket notification is to seek
clearance for a revision to the Directions for Use (DFU) for
Boston Scientific Corporation's (BSC) Interlock™-35
Fibered IDC™ Occlusion System (Vascular emolization
device). The device was previously cleared by FDA under
K110295 as Interlock™-35 Fibered IDC™ Occlusion System
(Vascular emolization device).
Accordingly, BSC is submitting this Premarket Notification
to incorporate results of non-clinical MRI testing in the DFU.
The proposed DFU revisions are described in Section 4.2.1,
Proposed MRI Labeling. The addition of MRI information is
not prompted by field events or complaints; the additional
information allows for safer and more effective use of the
device. The revision has no effect on the Indications for
Use, the Contraindications, or the device configuration. This
Premarket Notification represents no other device or
labeling changes |
:
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. |
| Non-Clinical
Performance
Data | Non-clinical testing demonstrates that the Interlock-35
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 3.0 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 Interlock-35 Fibered IDC Occlusion System
(K110295).
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. |
:
. .
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in uppercase letters and is evenly spaced around the perimeter of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation c/o Mr. Harlan Jones Regulatory Affairs Specialist II One Scimed Place Maple Grove. MN 55311
AUG 12 2011
Re: K112103
Trade/Device Name: Interlock™-35 Fibered IDC™ Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: July 21. 2011 Received: July 22, 2011
Dear Mr. Jones :
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
3
Page 2 - Mr. Harlan Jones
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/ReportalProblem/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 yours,
Bram D. Zuckerman, M.D.
Director Center for Devices and Radiological Health Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Interlock-35 Fibered IDC Occlusion System
Indications for Use
510(k) Number (if known): K112 (0 3
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 × AND/OR (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) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bivision Sign-Off) Division of Cardiovascular Devices
K112103 510(k) Number_
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