(30 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.
The provided text describes a 510(k) submission for the "Interlock™-35 Fibered IDC™ Occlusion System," a vascular embolization device. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
Therefore, the information you requested about acceptance criteria and associated studies is not directly applicable to this type of device submission as it is typically presented for AI/ML device clearances.
Here's why and what can be extracted:
- No "Acceptance Criteria" for Clinical Performance: This submission is for a modified device, not a new one requiring extensive clinical trials to establish its own performance metrics. The goal is to show it's as safe and effective as its predicate.
- No "Device Performance" Metrics in the AI/ML Sense: The device is a physical medical implant (an embolization coil), not a diagnostic or therapeutic AI algorithm. Therefore, "device performance" here refers to mechanical and material properties, not accuracy, sensitivity, or specificity.
- No "Study that Proves the Device Meets Acceptance Criteria" in the AI/ML Sense: The "study" is a collection of non-clinical, bench-top tests designed to demonstrate that the modifications to the device do not negatively impact its safety and performance compared to the predicate.
Given this context, I will address your points by extracting the relevant information about the non-clinical performance data and explaining why other points are not present.
Acceptance Criteria and Device Performance (Non-Clinical)
Since this is a physical medical device and not an AI/ML diagnostic, the "acceptance criteria" relate to engineering and material specifications, and "device performance" refers to the results of non-clinical tests. The text indicates that all testing performed and data demonstrate passing results according to executed verification protocols. This implies that the acceptance criteria for each test were met.
| Acceptance Criterion (Implicit: "Passing Results per verification protocols") | Reported Device Performance (Summary) |
|---|---|
| Coil Geometry | Demonstrated passing results per executed verification protocols. |
| Stretch Resistance | Demonstrated passing results per executed verification protocols. |
| Deployment | Demonstrated passing results per executed verification protocols. |
| Atraumatic Embolic Coil Tip | Demonstrated passing results per executed verification protocols. |
| Fiber Retention | Demonstrated passing results per executed verification protocols. |
| Interlocking Arm to Embolic Coil Tensile Strength | Demonstrated passing results per executed verification protocols. |
| Embolic Coil Corrosion Resistance | Demonstrated passing results per executed verification protocols. |
| Radial Force | Demonstrated passing results per executed verification protocols. |
| Atraumatic Delivery Wire Tip | Demonstrated passing results per executed verification protocols. |
| Interlocking Arm to Delivery Wire Tensile Strength | Demonstrated passing results per executed verification protocols. |
| Corrosion Resistance | Demonstrated passing results per executed verification protocols. |
| Delivery Wire Coating Fracture | Demonstrated passing results per executed verification protocols. |
| Delivery Wire Coating Flexure | Demonstrated passing results per executed verification protocols. |
| Delivery Wire OD | Demonstrated passing results per executed verification protocols. |
| Delivery Wire Length | Demonstrated passing results per executed verification protocols. |
| Introducer Sheath Interface | Demonstrated passing results per executed verification protocols. |
| Introducer Sheath Deliverability | Demonstrated passing results per executed verification protocols. |
| Delivery Catheter Compatibility | Demonstrated passing results per executed verification protocols. |
| Rotating Hemostatic Valve (RHV) Compatibility | Demonstrated passing results per executed verification protocols. |
Information Not Applicable/Provided for This Type of Submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for non-clinical bench testing of a physical device. There isn't an "image test set." The tests are performed on manufactured device samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on engineering specifications and validated test methods, not expert consensus on images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to non-clinical bench testing.
- 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 is not an AI-enabled device nor one requiring evaluation of human reader performance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and material science standards, measurement techniques, and specifications. Not clinical outcomes or pathology.
- The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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510(k) Summary
per 21 CFR §807.92 (c)
per 21 CFR §807.92 (c)
:
| K110295 | |
|---|---|
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
| Contact Nameand Information | Shannon PettitSenior Regulatory Affairs SpecialistTel: 763-494-2833Fax: 763-494-2222E-mail: Shannon.Pettit@bsci.com |
| Date Prepared | January 31, 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) |
| PredicateDevices | Boston ScientificK060078 SE: 31 Jan 2006Interlock Fibered IDCOcclusion System |
| Fibered PlatinumK955293 SE: 6 Feb 1996.035" Type OcclusionCoils | |
| Reason forSubmission | To gain clearance for a modified fibered interlockingdetachable coil embolization system based on the currentlymarketed Fibered IDC Occlusion System cleared underK060078 |
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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. |
| Comparison ofTechnologicalCharacteristics | The proposed Interlock-35 Fibered IDC Occlusion Systemis a modification to existing designs/shapes currentlymarketed by Boston Scientific. It is important to note thateach of the Interlock-35 Fibered IDC Occlusion Systemdevice characteristics is currently available on BSC legallymarketed devices and no changes in fundamental scientifictechnology have been made. Additionally, the performancecharacteristics of the Interlock-35 Fibered IDC OcclusionSystem are substantially equivalent to the currentlymarketed devices. |
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Non-Clinical Performance Data
Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical performance data submitted in support of substantial equivalence is based on the Failure Modes/Effects Analysis (FMEA) risk analysis method completed for the Interlock-35 Fibered IDC Occlusion System to demonstrate that the proposed devices are suitable for their intended use.
All testing performed and data demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device.
The following performance tests were performed:
- Coil Geometry .
- Stretch Resistance .
- Deployment .
- Atraumatic Embolic Coil Tip .
- Fiber Retention
- . Interlocking Arm to Embolic Coil Tensile Strength
- Embolic Coil Corrosion Resistance ●
- Radial Force .
- . Atraumatic Delivery Wire Tip
- Interlocking Arm to Delivery Wire Tensile Strength .
- Corrosion Resistance .
- Delivery Wire Coating Fracture .
- . Delivery Wire Coating Flexure
- Delivery Wire OD .
- . Delivery Wire Length
- Introducer Sheath Interface .
- Introducer Sheath Deliverability .
- Delivery Catheter Compatibility .
- Rotating Hemostatic Valve (RHV) Compatibility .
Clinical · Performance Data
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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Conclusion
The modifications do not affect the intended use or alter the fundamental scientific technology of the predicate Boston Scientific Interlock Fibered IDC Occlusion System (K060078).
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.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 3 2011
Boston Scientific Corporation c/o Ms. Shannon Pettit Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K110295
K110295
Trade/Device Name: Interlock™-35 Fibered IDC™ Occlusion System
Trade/Device Name: 11, OFF 970, 2300 Frade/Don Number: 21 CFR 870.3300 Regulation Namber: 21 Cr Creation Device Regulatory Class: Class II Product Code: KRD Dated: January 31, 2011 Received: February 1, 2011
Dear Ms. Pettit:
Dour new reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(t) premarket notification in them to makes in the indications
referenced above and have devel is substantially equivalent (for the indicatio referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medice Amendments, or to commerce prior to May 28, 1976, the enactment of the Pederal Food, Drug, es that have been recassified in accordance with the proval application (PMA).
devices that have been require approval of a prematies approval application (PMA).
The Act (A genese and the Act (Act) that do not require approval of a previsions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The and Controls, market the Act include requirements for amual registration, listing of
general controls provises of the Act include requirements for annual registrations and reneral controls provisions of the Act include requirentelity to annual 1992
devices, good manufacturing practice, labeling, and problibitions against misbranding and devices, good manufacturing practice, labeling, and promotion related to contract liability
adulteration. Please not evaluate information related to contract in the de read, good
wantines of the major and ther class II (Special Controls) or class III (PMA), it
form of the may of the classesses - Existing major regulations affecting your device can be If your device is classified (see above) into either class II (Special Controlly)
may be subject to additional controls. Existing major regulations affecting your device can
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Page 2 - Ms. Shannon Pettit
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Duma R. Holmes
Image /page/5/Picture/8 description: The image shows a black and white drawing of a wavy line. The line has several peaks and valleys, creating a pattern that resembles a simplified waveform. The drawing is simple and lacks any shading or additional details.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
Prescription Use X (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Palmer
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number_K 110295
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).