(30 days)
Not Found
No
The device description and performance studies section do not mention any AI or ML components. The device is a mechanical embolization coil.
Yes
The device is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures, which is a therapeutic intervention.
No
The device is an occlusion system used for therapeutic embolization by obstructing blood flow, not for diagnosing conditions.
No
The device description clearly details physical components like a coil, delivery wire, and introducer sheath, indicating it is a hardware 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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Interlock-35 Fibered IDC Occlusion System is a medical device used within the body (in vivo) to physically obstruct blood flow in blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "obstructing or reducing blood flow in the peripheral vasculature during embolization procedures." 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 Information: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the Interlock-35 Fibered IDC Occlusion System is a therapeutic medical device, not an in vitro diagnostic.
N/A
Intended Use / 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.
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 (1.70 mm) (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic. 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 was not required since there were no changes made to the device. The modifications made to the DFU do not change the intended use of the device, but were made for clarity.
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
长川3651
510(k) Summary
per 21 CFR §807.92 (c)
per 21 CFR §807.92 (c)
JAN 1 1 2012
| 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 | December 08, 2011 |
| Trade Name | Interlock™-35 Fibered IDCT™ 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)
K112103 SE: 12 Aug 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 IDCT™ Occlusion System (Vascular embolization
device). The device was previously cleared by FDA under
K112103 as Interlock™-35 Fibered IDCT™ Occlusion System
(Vascular embolization device). |
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 (1.70 mm)
(0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen)
Imager™ II Selective Diagnostic. 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-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. |
| Non-Clinical
Performance
Data | Non-clinical performance data was not required since there
were no changes made to the device. The modifications
made to the DFU do not change the intended use of the
device, but were made for clarity. |
| Conclusion | Modification of the Intended Use/Indications for Use
statement in the Interlock-35 DFU was made for clarity. No
contraindications have been added or deleted. Instructions
for use have been clarified and reworded. Minor
modifications to precaution and caution statements were
reworded for clarity and consistency. No other changes to
labeling have been made.
Based on the minor labeling modifications, and no changes
to the device, Boston Scientific determined that the
Interlock-35 Fibered IDC Occlusion System continues to be
appropriate for its intended use. |
:
2
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 1 2012
Boston Scientific Corporation c/o Mr. Harlan Jones Regulatory Affairs Specialist II One Scimed Place Maple Grove, MN 55311
Re: K113651
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: December 9, 2011 Received: December 12, 2011
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass band in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conmisered prices 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 I ou may, merelors, manel a et include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Thease noter u, 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 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 I lease be devised that I Drivination that your device complies with other requirements of the Act that I Dri has made a availations administered by other Federal agencies. You must or any I cuently statures and regularents, including, but not limited to: registration and listing (21 Comply will an the Not 8 requirements (01); 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Killham
Jan D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Proposed Intended Use/Indications for Use
510(k) Number (if known): _K113651
Device Name: Interlock-35™ Fibered IDC™ Occlusion System
Proposed Intended Use/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 _ 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M Z Killham
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KIL 36 ST
Page 1 of _ 1 _