(27 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the embolization coil and delivery system, with no mention of AI or ML technologies.
Yes
The device is used to obstruct or reduce blood flow, which is a therapeutic intervention for certain medical conditions.
No
This device is designed for therapeutic embolization (obstructing or reducing blood flow) in the peripheral vasculature, not for diagnosis. It is an occlusion system.
No
The device description clearly outlines physical components made of platinum-tungsten alloy and synthetic fibers, delivered via a wire and sheath, indicating it is a hardware-based medical device.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a coil system used to obstruct or reduce blood flow within the peripheral vasculature during embolization procedures. This is an interventional procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Interlock-35 Fibered IDC Occlusion System is a medical device used for therapeutic intervention, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Interlock-35 Fibered IDC Occlusion Svstem is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. 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 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 (1.70 mm) OD (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic Catheter without side flushing holes. 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 following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Interlock-35 Fibered IDC Occlusion System met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- Interlocking Arm to Delivery Wire Tensile Strength .
- Delivery Wire Bend Resistance .
- Introducer Sheath Deliverability .
- Device Preparation .
- Corrosion Resistance o
- Device Removal From Carrier Tube
- Sterilization .
- Biocompatibility
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
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 Name and Information | Maureen Sundeen
Principal of Regulatory Affairs
Phone: 763-494-2903
Fax: 763-494-2222
Email: sundeenm@bsci.com |
| Date Prepared | October 16, 2013 |
| Proprietary Name | Interlock™ -35 Fibered IDC™ Occlusion System |
| Common Name | Vascular Embolization Devices |
| Classification | Class II per 21 CFR 870.3300
Product Code: KRD
Review Panel: Cardiovascular |
| Predicate Device | Interlock™ -35 Fibered IDC™ Occlusion System
(K113651, January 11, 2013) |
NOV 1 4 2013### Intended Use / Indications for Use
The Interlock-35 Fibered IDC Occlusion Svstem is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. This device is not intended for neurovascular use.
Device Description
The Interlock - 35 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 - 35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (1.70 mm) OD (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic Catheter without side flushing holes. 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.
1
Comparison of Technological Characteristics
The Interlock-35 Fibered IDC Occlusion System is similar in fundamental design, function, device materials, packaging, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device. The modifications from the predicate device include changes to the coil, delivery wire, introducer sheath and carrier hoop design and materials for added pushability, deliverability, and to facilitate coil hydration. In addition, the DFU will provide instructions for flushing the device using the hand-injection setup which is an additional method for hydrating the coil.
Performance Data
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Interlock-35 Fibered IDC Occlusion System met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- Interlocking Arm to Delivery Wire Tensile Strength .
- Delivery Wire Bend Resistance .
- Introducer Sheath Deliverability .
- Device Preparation .
- Corrosion Resistance o
- Device Removal From Carrier Tube �
- Sterilization .
- Biocompatibility �
Conclusion
. '
Boston Scientific has demonstrated that the modification made for the Interlock-35 Fibered IDC Occlusion System are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the predicate device, Interlock-35 Fibered IDC Occlusion System (K113651).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a person with their arms outstretched.
November 14, 2013
Boston Scientific Corp. Maureen Sundeen Principal of Regulatory Affairs One Scimed Place Maple Grove, MN 55311-1566 US
Re: K133208
Trade/Device Name: Interlock-35 Fibered IDC Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Devices Regulatory Class: Class II Product Code: KRD Dated: October 16, 2013 Received: October 18, 2013
Dear Ms. Sundeen:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
3
Page 2 - Maureen Sundeen
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 of medical devicerelated 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 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Notification Interlock™ -35 Fibered IDC™ Occlusion System
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 for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. 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)
Bram D. Zuckerman -S 2013.11.14 12:26:01 -05'00'
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