(56 days)
Not Found
No
The device 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 indicate the use of AI/ML.
Yes
The device is described as "intended for the prevention of recurrent pulmonary embolism," indicating its purpose is to directly prevent a medical condition, which aligns with the definition of a therapeutic device.
No
The device, a vena cava filter system, is designed for the prevention of recurrent pulmonary embolism by physically capturing clots, not for diagnosing medical conditions. While it uses angiographic visualization, this is for guidance during placement of the therapeutic device, not for diagnostic purposes.
No
The device description clearly details physical components like a filter made of Nitinol, a catheter sheath introducer, a dilator, and a pusher, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Option™ ELITE Vena Cava Filter System is a physical implant designed to be placed directly into the vena cava to prevent blood clots from traveling to the lungs. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states its purpose is for the "prevention of recurrent pulmonary embolism via placement in the vena cava." This is a treatment/prevention function, not a diagnostic one.
- Device Description: The description details the physical components of the filter and its delivery system, all of which are designed for implantation and mechanical action within the body.
Therefore, the Option™ ELITE Vena Cava Filter System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Option (TM) ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolion (PE) via placement in the vena cava in the following conditions:
- · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
- · Failure of anticoagulant therapy in thromboembolic diseases;
- · Emergency treatment following massive pulmonary embolism when anticipated beaeffits of conventional therapy are realised;
- · Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated
The filter may be retrieved according to the instructions supplied in section entitled "Optional " in patients who no longer require a filter. Retrieval of the fitter can be performed only by 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 self-centering Option™ ELITE Filter is laser cut from nickel - itanium 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 proximal or 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 fi x 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 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
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)
Non-Clinical Performance Testing:
All testing performed on the Option™ ELITE Vena Cava Filter System was derived from the risk assessment which evaluated the safety and effectiveness of the design modifications to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
Results of bench testing and animal studies demonstrate Option TM ELITE Vena Cava Filter System is as safe and effective as the legally marketed predicate device.
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
REX MEDICAL
5 North I.n. Suite 50 Conshohocken, PA 19428 Special 510(k): Device Modification
Option™ ELITE Vena Cava Filter System
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
- Submitter: Rex Medical. L.P. 555 North Ln, Suite 5035 Conshohocken, PA 19428
- Contact Person: Erich Bressler Chief Engineer Phone: (610) 940-0665 x107 (610) 940-1590 Fax: Email: ebressler@rexmedical.com
| Date Prepared: | December 13, 2013 |
|---|---|
| Trade Name: | Option™ ELITE Vena Cava Filter System |
| Common Name: | Cardiovascular Intravascular Filter |
| (21 CFR 870.3375, Product Code DTK) |
Predicate Device(s):
Option "M Vena Cava Filter System K081410
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 self-centering Option™ ELITE Filter is laser cut from nickel - itanium 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 proximal or 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
1
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 fi x 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 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:
The Option 114 ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
- . Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
- Failure of anticoagulant therapy in thromboembolic diseases; .
- Emergency treatment following massive pulmonary embolism when anticipated benefits . of conventional therapy are reduced;
- . Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated
The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
This is the same intended use as previously cleared for the Option "" Vena Cava Filter System (K081410).
Technological Characteristics:
The Option™ ELITE Vena Cava Filter System is similar with regards to materials, intended use, principles of operation and technological characteristics to the predicate device. Results of bench testing and animal studies demonstrate Option TM ELITE Vena Cava Filter System is as safe and effective as the legally marketed predicate device.
Modifications to Existing Technology:
The Option™ ELITE consists of 6 small retention hooks identical to the Option™ small retention hooks compared to the Option" that has 3 small retention hooks and 3 large retention hooks. 3 small retention hooks provide an equal contribution to the retention force and stability as the 3 large retention hooks. Changing to a filter that has 6 small retention hooks instead of 3 small and 3 large retention hooks will allow a lower profile filter without any new issues of safety and efficacy.
The Option™ ELITE has a PTFE lined, 70cm spiral reinforced sheath made with a Pebax 6333/5533 Blend. The Option™ has a PTFE lined, 70cm braid reinforced sheath made with Pebax 7033. The inner diameter of the sheath has increased from .071" to .073". Changing the sheath from braided reinforcement to spiral reinforcement and increasing the inner diameter will facilitate the advancement of the Option vena cava filter delivery system into the IVC and advancement of the Option filter through the delivery system when encountering tortuous anatomy.
2
The Option™ ELITE has an alternate procedure for filter implantation where the physician can use the procedural guidewire and vessel dilator to deploy the filter instead of using the pusher to deploy the filter. This provides physicians with an additional technique to place the Option™ ELITE filter.
Non-Clinical Performance Testing:
All testing performed on the Option™ ELITE Vena Cava Filter System was derived from the risk assessment which evaluated the safety and effectiveness of the design modifications to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
Conclusion:
Rex Medical considers the Option™ ELITE Vena Cava Filter System to be substantially equivalent to the predicate device listed above. The conclusions are based on performance testing and similarities in indications for use, materials, technological characteristics, principle of operation and design features.
3
* DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2013
Rex Medical c/o Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 US
Re: K133243
Trade/Device Name: Option Elite Vena Cava Filter System Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: September 30, 2013 Received: October 22, 2013
Dear Ms. Goldstein-Falk:
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
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4
Page 2 - Susan Goldstein-Falk
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please.note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Option (TM) ELITE Vena Cava Filter System
Indications for Use (Describe)
The Option (TM) ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolion (PE) via placement in the vena cava in the following conditions:
- · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
- · Failure of anticoagulant therapy in thromboembolic diseases;
- · Emergency treatment following massive pulmonary embolism when anticipated beaeffits of conventional therapy are realised;
- · Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated
The filter may be retrieved according to the instructions supplied in section entitled "Optional " in patients who no longer require a filter. Retrieval of the fitter can be performed only by 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Heatth (CDRH) (Signature)
Image /page/5/Picture/20 description: The image shows a stylized logo or signature that appears to read "M. FDA". The letters "FDA" are drawn with a thick, outlined font, giving them a bold and prominent appearance. The "M" is written in a cursive style, contrasting with the blockier letters of "FDA". A line extends from the "A" in "FDA", underlining the entire logo and adding a sense of completion or signature to the design.
FORM FDA 3881 (9/13)
tat Services [30 ] +41-6740