(21 days)
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.
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.
This 510(k) submission describes the Interlock™-35 Fibered IDC™ Occlusion System, which is a vascular embolization device. The submission is for a revision to the Directions for Use (DFU) to include results of non-clinical MRI testing, demonstrating the device's MR Conditional status. It's important to note that this submission is not for a new device but for an updated label based on non-clinical testing. Therefore, the traditional acceptance criteria and study design focused on clinical performance metrics (like sensitivity, specificity, accuracy) are not applicable here.
Instead, the acceptance criteria relate to the device's compatibility with MRI environments, and the study in question is a non-clinical (i.e., benchtop) evaluation.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Device will not present additional risk to a patient during a MRI procedure due to gravitational or daily activities. | "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..." (Implied: Device movement/dislodgement is acceptable) |
| Device will not cause a temperature rise in a MRI procedure that exceeds a feverish condition. | "...or a temperature rise that is experienced during a feverish condition." (Implied: Device heating is acceptable within specified limits) |
| Device is MR Conditional under specific static magnetic field strengths. | "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." (Explicitly states MR Conditional status at 1.5T and 3.0T). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of devices tested. The studies were non-clinical, so "sample size" would refer to the number of devices or coils subjected to MRI testing. The document refers to "the Coils."
- Data Provenance: The studies were non-clinical benchtop testing, not involving human or animal subjects. Therefore, there's no country of origin or retrospective/prospective nature in the typical sense. The testing was performed in a laboratory setting according to specified ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical safety evaluation for MRI compatibility, not a diagnostic or performance study requiring expert interpretation of results to establish ground truth. The "ground truth" was determined by adherence to established ASTM standards and measurement of physical parameters (e.g., temperature rise, magnetic susceptibility artifacts, force).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As this was a non-clinical, objective assessment based on ASTM standards, there was no subjective interpretation or adjudication process involving multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This submission describes a medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective measurements based on recognized ASTM standards. The "ground truth" for MRI compatibility is defined by the parameters and limits stipulated in the following ASTM standards:
- ASTM F2182-02a (Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)
- ASTM F2052-06e1 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2213-06 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2119-07 (Standard Test Method for Quantitative Measurement and Assessment of Magnetically Induced Distortion of an MR Image by a Medical Device)
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a non-clinical evaluation of a physical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or "ground truth" for a training set in this context.
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长川之103
510(k) Summary
per 21 CFR §807.92 (c)
AUG 1 2 2011
per 21 CFR §807.92 (c)
:
| 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 | 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 FiberedIDC OcclusionSystem (Vascularembolization device) K110295 SE: 3 Mar 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 IDC™ Occlusion System (Vascular emolizationdevice). The device was previously cleared by FDA underK110295 as Interlock™-35 Fibered IDC™ Occlusion System(Vascular emolization device).Accordingly, BSC is submitting this Premarket Notificationto 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 isnot prompted by field events or complaints; the additionalinformation allows for safer and more effective use of thedevice. The revision has no effect on the Indications forUse, the Contraindications, or the device configuration. ThisPremarket Notification represents no other device orlabeling changes |
:
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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 (0.035 in [0.89mm] or 0.038 in [0.97 mm] inner lumen) Diagnostic Catheter(e.g. Imager™ II Diagnostic Catheter). The interlockingdelivery wire design allows the coil to be advanced andretracted before final placement in the vessel, thus aiding inmore controlled delivery including the ability to withdraw thecoil prior to deployment. |
|---|---|
| Indications forUse | The Interlock-35 Fibered IDC Occlusion System is indicatedto obstruct or reduce rate of blood flow in the peripheralvasculature. This device is not intended for neurovascularuse. |
| Non-ClinicalPerformanceData | Non-clinical testing demonstrates that the Interlock-35Fibered IDC Occlusion System will not present additionalrisk to a patient during a MRI procedure in comparison torisks imposed by gravitational, and other normal dailyactivities, or a temperature rise that is experienced during afeverish condition. The results of testing conducted undermethods described by ASTM F2182-02a, ASTM F2052-06e1, ASTM F2213-06 and ASTM F2119-07 havedemonstrated that the Coils are MR Conditional and can bescanned safely under a static magnetic field of 1.5 Tesla or3.0 Tesla. |
| Testing at field strengths other than 1.5 Tesla or 3.0 Teslahas not been performed to evaluate coil migration orheating. | |
| Conclusion | The modifications do not affect the intended use or alter thefundamental scientific technology of the predicate BostonScientific Interlock-35 Fibered IDC Occlusion System(K110295).Based on the Indications for Use, unaltered technologicalcharacteristics, and submitted non-clinical performance datasupporting this modification, the Boston Scientific Interlock-35 Fibered IDC Occlusion System is shown to beappropriate for its intended use and demonstrates that thedevice is as safe, as effective, and performs as well as thepredicate device. |
:
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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
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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/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
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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_
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).