(70 days)
No
The device description and performance studies focus on mechanical components and their function, with no mention of AI or ML.
Yes
The device is indicated for the prevention and treatment of pulmonary embolism, which are therapeutic interventions addressing a medical condition.
No
The device is a vena cava filter system indicated for the prevention of pulmonary embolism, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a vena cava filter, introducer system, dilators, sheath, and catheter, 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 medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is a physical implant designed to be placed directly into the inferior vena cava within the patient's body. Its purpose is to physically prevent blood clots from traveling to the lungs.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body in vitro. It is a therapeutic device that acts directly on the patient's circulatory system.
Therefore, based on the provided information, this device falls under the category of an implantable medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the following situations:
- Venous thrombosis or pulmonary thromboembolism when anticoagulants are . contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism.
- Failure of anticoagulant therapy in thromboembolic disease. .
- Emergency treatment following massive pulmonary embolism where anticipated benefits . of conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is . contraindicated.
Product codes
Not Found
Device Description
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System consists of sequential vascular dilators for percutaneous access; a guide the Introducer Sheath and Dilator into place; an Introducer Sheath and Dilator to create a passageway to guide the Introducer Catheter to the implant site; and an Introducer Catheter to transport the pre-loaded fitter through the sheath and over the guidewire to the implant site for fifter deployment .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inferior vena cava
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and Animal testing were performed and the data supported the substantial equivalence of the proposed guidewire for the jugular Stainless Steel Greenfield ® Vena Cava Filter with 12F Introducer System to the current quidewire of the jugular Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
K964284
JAN 4, 1997
510(k) Summary
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification " . . . adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| Trade Name: | Stainless Steel Greenfield®
Vena Cava Filter with
12F Introducer System |
|---------------|-------------------------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation
480 Pleasant Street
Watertown, MA 02172 |
Device Generic Name:
Guidewire for Vena Cava Filter System
Classification:
According to Section 513 of the Federal Food, Drug and Cosmetic Act, FDA has classified cardiovascular intravesuciar fitters in Class III, 21 CFR § 870.3375, under guidance by the Circulatory Systems Devices Panel. Although 21 CFR § 870.3375 requires premarket approval for cardiovascular intravascualr filters, no effective date has been established for the reqirement of PMA's for these devices at this time.
Predicate Device:
Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System
Device Description:
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System consists of sequential vascular dilators for percutaneous access; a guide the Introducer Sheath and Dilator into place; an Introducer Sheath and Dilator to create a passageway to guide the Introducer Catheter to the implant site; and an Introducer Catheter to transport the pre-loaded fitter through the sheath and over the guidewire to the implant site for fifter deployment .
Indications For Use:
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the following situations:
Image /page/0/Picture/16 description: The image shows the logo for Boston Scientific Corporation. The words "Boston Scientific" are stacked on top of each other in a bold, sans-serif font. The word "Corporation" is placed below "Boston Scientific" in a similar font, but slightly smaller and bolder. The logo is black and white.
One Boston Scientific Place Natick, MA 01760-1537 508.650.8000
1
- Venous thrombosis or pulmonary thromboembolism when anticoagulants are . contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism.
- Failure of anticoagulant therapy in thromboembolic disease. .
- Emergency treatment following massive pulmonary embolism where anticipated benefits . of conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is . contraindicated.
Contraindications:
Patients in whom the diameter of the inferior vena cava exceeds 28 mm are contraindicated for the placement of the Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System.
- Presence of thrombus at the femoral puncture site, in the iliac vein, or in the inferior . vena cava risks the dislodgement of thrombus during catheter manipulation.
- . Patients in whom pregnancy has been confirmed.
Safety and Performance:
Bench and Animal testing were performed and the data supported the substantial equivalence of the proposed guidewire for the jugular Stainless Steel Greenfield ® Vena Cava Filter with 12F Introducer System to the current quidewire of the jugular Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System.
The biocompatibility of the Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System (K912036) was previously established through biocompatibility testing performed on the predicate in accordance with the Tripertite Biocompatibility Guidance (#G87-1). This testing is also in accordance with blue book memorandum #395-1, "Use of International Standard ISC-10993, Biologicaly Evaluation of Medical Devices Part 1: Evaluation and Testing with FDAmodified matrix.
Conclusion:
Based upon the indications for use, technological characteristics, and safety and performance testing, the guidewire for the Jugular Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System meets the requirements for its intended use.