(7 days)
Not Found
No
The description focuses on the mechanical design and materials of the vena cava filter and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for the prevention and treatment of recurrent pulmonary embolism, which is a medical condition, making it a therapeutic device.
No
This device is designed to prevent pulmonary embolism by filtering clots, which is a therapeutic function, not a diagnostic one. While it uses angiographic visualization for placement, its primary purpose is intervention, not diagnosis. The "Angiographic Vessel Dilator" assists with "angiographic visualization and linear measurement," which are measurements used for placement, not for diagnosing a condition.
No
The device description clearly details physical components made of Nitinol, including struts, anchors, and a retrieval hook, which are implanted in the body. This is a hardware device, not software only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The device description clearly states that the Option™ELITE Filter is a physical device designed for percutaneous placement within the inferior vena cava (IVC) to prevent pulmonary embolism. It does not analyze blood, tissue, or any other bodily fluid or substance outside the body.
- The intended use is a therapeutic intervention. The indications for use describe conditions where the filter is placed within the body to treat or prevent a medical condition (pulmonary embolism). This is a direct medical intervention, not a diagnostic test performed on a sample.
- The device description focuses on physical characteristics and placement. The description details the material, design, delivery system, and mechanism of action of the filter within the blood vessel. This is consistent with a medical device intended for internal use.
Therefore, the Option™ELITE Filter is a medical device, specifically an implantable device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:
· Pulmonary thromboembolism when anticoagulants are contraindicated
• 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
The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.
The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
· Pulmonary thromboembolism when anticoagulants are contraindicated
· 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
The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).
The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.
The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.
The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.
The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker.
The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inferior vena cava (IVC)
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)
No new operating principles have been introduced with the subject device. The subject device operates using the identical fundamental scientific technology as the predicate device; therefore, no performance testing was necessary nor was any performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption and the PRESERVE study.
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
September 10, 2024
Argon Medical Devices, Inc. Scott Bishop VP Regulatory Affairs 1445 Flat Creek Road Athens, Texas 75751
Re: K242612
Trade/Device Name: Option ELITE Vena Cava Filter System and Option™ELITE Vena Cava Filter 100cm System Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: August 30, 2024 Received: September 3, 2024
Dear Scott Bishop:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Ariel G. Ash - Digitally signed by
shakoor -S
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242612
Device Name
Option™ELITE Vena Cava Filter System and Option™ELITE Vena Cava Filter 100cm System
Indications for Use (Describe)
The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:
· Pulmonary thromboembolism when anticoagulants are contraindicated
• 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
The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.
The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
· Pulmonary thromboembolism when anticoagulants are contraindicated
· 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
The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle with a small rectangle cut out of the bottom right corner. Below the triangle is the word "ARGON" in large, bold, blue letters. Underneath "ARGON" is the phrase "MEDICAL DEVICES" in smaller, gray letters.
Option Elite Vena Cava Filter System 510(k) Summary
Date Prepared:
Submitted Bv:
August 28, 2024
Argon Medical Devices Inc. 1445 Flat Creek Road Athens, TX 75751
| Contact: | Scott Bishop |
|---|---|
| Phone: | (469) 430-0546 |
| Email: | Scott.Bishop@argonmedical.com |
Device:
| Trade Name: | Option™ELITE Vena Cava Filter System |
|---|---|
| Option™ELITE Vena Cava Filter 100cm System | |
| Common Name: | Inferior Vena Cava Filter |
| Classification Name: | Filter, Intravascular, Cardiovascular |
| Regulation/Product Code: | 21 CFR Part 870.3375 / DTK |
| Classification / Panel: | Class II / Cardiovascular |
Predicate Devices:
The Option™ELITE Vena Cava Filter System (K133243, cleared Dec. 17, 2013) and the Option™ELITE Vena Cava Filter 100cm System (K143405, cleared April 16, 2015).
Summary of Change:
No changes have been made to the subject Option Elite Vena Cava Filter System or 100cm System. The purpose of the submission is to incorporate results from the PRESERVE study summary data into the IFU.
Device Description:
The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).
The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.
The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the
5
Image /page/5/Picture/0 description: The image is a logo for Argon Medical Devices. The logo features a stylized letter "A" in blue and gray, with the blue portion slightly overlapping the gray portion. Below the "A" is the word "ARGON" in large, bold, blue letters, and below that is the phrase "MEDICAL DEVICES" in smaller, gray letters.
vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.
The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.
The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker.
The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.
Intended Use:
Option™ELITE Vena Cava Filter
The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:
- Pulmonary thromboembolism when anticoagulants are contraindicated ●
- 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
The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.
Option™ELITE Vena Cava Filter (100cm)
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Image /page/6/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo consists of a blue triangle with a line through it, above the word "ARGON" in blue, block letters. Below "ARGON" is the phrase "MEDICAL DEVICES" in gray, block letters.
The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
- Pulmonary thromboembolism when anticoagulants are contraindicated
- 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
The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.
Comparison to Predicate Device:
Technological Comparison to Predicate Devices:
The technological characteristics of the subject devices, the Option™ ELITE Vena Cava Filter System & the Option Elite Vena Cava Filter 100cm System, are identical to the predicate devices, specifically:
- Intended Use = Identical ●
- Indication for Use = Identical ●
- Target Population = Identical ●
- Delivery System Design = Identical ●
- Filter Design and Material = Identical
- Fundamental scientific technology = Identical
- Packaging Configuration = Identical
- Method of Sterilization and SAL level = Identical ●
Performance Testing Summary:
No new operating principles have been introduced with the subject device. The subject device operates using the identical fundamental scientific technology as the predicate device; therefore, no performance testing was necessary nor was any performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption and the PRESERVE study.
Conclusion:
The Option™ ELITE Vena Cava Filter System & the Option Elite Vena Cava Filter 100cm System are substantially equipment to the legally marketed predicate devices. No changes have been made to the Option Elite Filter or delivery system. The purpose of the submission is to incorporate results from the PRESERVE study summary data into the IFU.