(30 days)
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.
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.
Acceptance Criteria and Study Analysis for Interlock™-35 Fibered IDCT™ Occlusion System (K113651)
This submission (K113651) is a 510(k) premarket notification seeking clearance for a revision to the Directions for Use (DFU) for the Interlock™-35 Fibered IDCT™ Occlusion System, not for a new device or significant modification to the existing device itself. Therefore, the information provided primarily addresses the regulatory implications of this labeling change rather than a study proving new device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this submission is for a DFU revision and explicitly states "Non-clinical performance data was not required since there were no changes made to the device," there are no specific acceptance criteria for device performance or reported device performance metrics in this document. The "acceptance criteria" here relate to the regulatory acceptance of the DFU changes.
| Acceptance Criteria (Regulatory) | Reported Device Performance (N/A for this submission) |
|---|---|
| Clarity of modified DFU | No performance data needed as device is unchanged |
| Consistency of DFU with intended use | No performance data needed as device is unchanged |
| No new contraindications introduced | No performance data needed as device is unchanged |
| Minor modifications to precaution and caution statements for clarity and consistency | No performance data needed as device is unchanged |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. As this submission is for a DFU revision, there was no "test set" of device performance data used. The modifications were purely textual to the labeling.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth for a test set was established for device performance in this submission. The "ground truth" for the DFU changes would be regulatory compliance and clarity, which would have been assessed internally by Boston Scientific's regulatory team and subsequently by the FDA.
4. Adjudication Method for the Test Set
Not applicable. There was no test set or adjudication process for device performance in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI assistance. This submission pertains to a physical embolization device and a labeling revision.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
Not applicable for device performance. The "ground truth" for the DFU revision was the clarity, accuracy, and regulatory compliance of the instructional language presented in the DFU, ensuring it accurately reflects the device and its intended use without introducing new risks or unclear information.
8. The Sample Size for the Training Set
Not applicable. There was no training set for an algorithm or device performance study in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set or associated ground truth establishment for this regulatory submission.
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长川3651
510(k) Summary
per 21 CFR §807.92 (c)
per 21 CFR §807.92 (c)
JAN 1 1 2012
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Nameand Information | Harlan JonesRegulatory Affairs Specialist IITel: 763-255-0027Fax: 763-494-2222E-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 FiberedIDC OcclusionSystem (Vascularembolization device)K112103 SE: 12 Aug 2011 |
| Reason forSubmission | The reason for this premarket notification is to seekclearance for a revision to the Directions for Use (DFU) forBoston Scientific Corporation's (BSC) Interlock™-35Fibered IDCT™ Occlusion System (Vascular embolizationdevice). The device was previously cleared by FDA underK112103 as Interlock™-35 Fibered IDCT™ Occlusion System(Vascular embolization device). |
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| DeviceDescription | The Interlock-35 Fibered IDC Occlusion System includes acoil manufactured from a platinum-tungsten alloy that ismechanically attached to a coil delivery wire. This assemblyis contained within an introducer sheath. The platinum coilcontains synthetic fibers for greater thrombogenicity. TheInterlock-35 Fibered IDC Occlusion System is designed tobe 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 deliverywire design allows the coil to be advanced and retractedbefore final placement in the vessel, thus aiding in morecontrolled delivery including the ability to withdraw the coilprior to deployment. |
|---|---|
| IntendedUse/Indicationsfor Use | The Interlock-35 Fibered IDC Occlusion System is indicatedfor obstructing or reducing blood flow in the peripheralvasculature during embolization procedures. This device isnot intended for neurovascular use. |
| Non-ClinicalPerformanceData | Non-clinical performance data was not required since therewere no changes made to the device. The modificationsmade to the DFU do not change the intended use of thedevice, but were made for clarity. |
| Conclusion | Modification of the Intended Use/Indications for Usestatement in the Interlock-35 DFU was made for clarity. Nocontraindications have been added or deleted. Instructionsfor use have been clarified and reworded. Minormodifications to precaution and caution statements werereworded for clarity and consistency. No other changes tolabeling have been made.Based on the minor labeling modifications, and no changesto the device, Boston Scientific determined that theInterlock-35 Fibered IDC Occlusion System continues to beappropriate for its intended use. |
:
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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
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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
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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 _
§ 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).