(108 days)
The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter/Straight Line™ System ("SNF/SL System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.
The cleared SNF/SL System and the proposed models of the SNF/SL System are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When placed in saline, the wires become soft and can be straightened to allow delivery through a small diameter catheter. The SN Filter reassumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava.
The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath ("sheath") and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava: the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed.
This 510(k) summary for the "Simon Nitinol Filter/Straight Line™ System" does not contain the information requested for acceptance criteria and a study proving those criteria are met.
The document primarily focuses on:
- Device identification: Names, classification, product code, and contact information.
- Predicate devices: Listing previously cleared versions of the device.
- Intended use: Preventing pulmonary embolisms.
- Device description and principle of operation: How the filter works and is deployed.
- Substantial equivalence claim: Arguing that the modifications (radiopaque markers, new delivery methods like antecubital and subclavian) do not raise new safety or effectiveness concerns compared to previously cleared versions.
There is no mention of:
- Acceptance criteria: Specific performance metrics (e.g., filter efficacy, complication rates, deployment success rates) that the device must achieve.
- A study or clinical trial: No data is presented from a study to demonstrate the device meets any particular performance criteria. The document states that the minor modifications "do not raise any new questions of safety or effectiveness," which is an argument for substantial equivalence, not a report of a new study to prove efficacy or safety against specific benchmarks.
- Specific performance numbers: There are no reported device performance values against which acceptance criteria could be compared.
- Sample sizes, data provenance, expert qualifications, ground truth methods, MRMC studies, or standalone performance. These details would typically be found in a study report.
Therefore, I cannot populate the requested table or provide the detailed information about a study based on the provided text. The document's purpose is to argue for substantial equivalence based on minor modifications, not to present a new clinical efficacy or safety study.
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”