(380 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and clinical performance of a physical filter, with no mention of AI or ML.
Yes
The device is intended for the prevention and treatment of pulmonary embolism, which are medical conditions, and it actively intervenes in the body's physiological processes by physically capturing clots in the vena cava.
No
The device, a vena cava filter, is designed for the prevention of pulmonary embolism by physically capturing clots, not for diagnosing conditions.
No
The device description clearly outlines a physical medical device made of nickel-titanium alloy (Nitinol) with struts, anchors, and a delivery system including a catheter sheath introducer, dilator, and pusher. This is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Option Vena Cava Filter is a physical device intended for placement within the vena cava (a blood vessel) to prevent blood clots from traveling to the lungs. It is an implantable device used for mechanical intervention, not for analyzing samples outside the body.
The information provided describes a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Option* Vena Cava Filter 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 anticoagulant 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.
Product codes
DTK
Device Description
The Rex Medical Option Vena Cava Filter System consists of a self-centering vena cava filter made from nickel-titanium alloy (Nitinol). The filter consists of shape memory nitinol struts emanating from a central location and designed for clot capture. Retention anchors are located at the caudal portion of the filter. These anchors are intended for filter fixation into the cava wall. The Option Filter is intended for use in cava diameters up to 30mm.
The delivery system consists of the filter preloaded in a filter cartridge, a 5French catheter sheath introducer, an openended angiographic vessel dilator which may be used for infusion of contrast solution during placement and a pusher with deployment marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Mechanical bench testing, in vivo animal testing and clinical testing were performed. In some instances, legally marketed vena cava filters were tested as control devices for the purpose of comparison with the Option Vena Cava Filter System.
In addition, testing was also performed in accordance with the following Special Controls for Cardiovascular Intravascular Filters (21 CFR 870.3375):
- International Standards Organization's ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing,
- FDA's Updated 510(k) Sterility Review Guidance (K90-. 1); Final Guidance for Industry and FDA, August 30,2002, and
- FDA's Guidance for Cardiovascular Intravascular Filter . 510(k) Submissions
Key Metrics
Not Found
Predicate Device(s)
K964284, K955396, K951508, K023116, K000062, K022236, K073090, K032426
Reference Device(s)
Not Found
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
JUN - 4 2009
Section 5
.
・
510(k) Summary : Rex Medical Option Vena Cava Filter System
| Submitter: | Rex Medical
1100 East Hector Street, Suite 245
Conshohocken, PA 19428
Phone: 610-940-0665
Fax: 610-940-1590 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leo Basta, Partner
Boston Biomedical Associates, LLC
Office: 508.351.8632 |
| Date Prepared: | June 2, 2009 |
| Trade Name: | Option* Vena Cava Filter System |
| Classification Name: | Cardiovascular Filter |
| Classification Number: | 21 CFR 870.3375 |
| Product Code: | DTK |
| Predicate Devices: | Boston Scientific Corporation's SS Greenfield Vena Cava
Filter - K964284, determined substantially equivalent on
January 6, 1997 (also K955396, K951508) |
| | Cordis Optease Vena Cava Filter - K023116 determined
substantially equivalent on October 18, 2002. |
| | Cordis Trapease Vena Cava Filter - K000062 determined
substantially equivalent on July 7, 2000 |
| | Bard Recovery Vena Cava Filter - K022236 determined
substantially equivalent on November 27, 2002 |
| | Recovery G2 Filter - K073090 determined substantially
equivalent on January 15, 2008 |
| | Gunther-Tulip Vena Cava Filter Set -- K032426 determined
substantially equivalent on October 31, 2003. |
| Device Description: | The Rex Medical Option Vena Cava Filter System consists of
a self-centering vena cava filter made from nickel-titanium |
1
alloy (Nitinol). The filter consists of shape memory nitinol struts emanating from a central location and designed for clot capture. Retention anchors are located at the caudal portion of the filter. These anchors are intended for filter fixation into the cava wall. The Option Filter is intended for use in cava diameters up to 30mm.
The delivery system consists of the filter preloaded in a filter cartridge, a 5French catheter sheath introducer, an openended angiographic vessel dilator which may be used for infusion of contrast solution during placement and a pusher with deployment marker.
The Option* Vena Cava Filter 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 anticoagulant 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.
Mechanical bench testing, in vivo animal testing and clinical testing were performed. In some instances, legally marketed vena cava filters were tested as control devices for the purpose of comparison with the Option Vena Cava Filter System.
In addition, testing was also performed in accordance with the following Special Controls for Cardiovascular Intravascular Filters (21 CFR 870.3375):
- . International Standards Organization's ISO-10993 Biological Evaluation of Medical Devices Part I: Evaluation and Testing,
Intended Use:
Functional Testing:
2
- FDA's Updated 510(k) Sterility Review Guidance (K90-. 1); Final Guidance for Industry and FDA, August 30,2002, and
- FDA's Guidance for Cardiovascular Intravascular Filter . 510(k) Submissions
Summary of Substantial Equivalence:
The design, material, components, fundamental technology and intended use of the Rex Medical Option Vena Cava Filter System for the permanent indication with the option for removal are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon not only descriptive characteristics of the various devices but also upon the safety and performance testing completed. Based upon this information, the Rex Option Vena Cava Filter System has been shown to be substantially equivalent to the predicate devices for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
N - 4 2009
Rex Medical c/o Mr. Leo L. Basta Boston Biomedical Associates, LLC 386 West Main Street, Suite #7 Northboro, MA 01532
Re: K081410
Trade/Device Name: Option Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II (Two) Product Code: DTK Dated: April 6, 2009 Received: April 7, 2009
Dear Mr. Basta:
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.
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.
4
Page 2 - Mr. Leo L. Basta
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 (OS) 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/cdrl/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Duna D. Vuhner
Image /page/4/Picture/6 description: The image shows a handwritten symbol or character that appears to be a stylized letter or abstract design. It consists of curved and angular lines, with a prominent loop at the top and a diagonal stroke extending downwards to the left. The symbol is positioned to the left of some blurred text, which is unreadable due to the image quality or focus.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE
KO81410 Not Assigned
510(k) Number (if known):
Device Name:
Option* Vena Cava Filter System
Indications for Use:
The Option* Vena Cava Filter 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 anticoagulant 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.
Prescription Use:
AND/OR
Over-The Counter Use:
(Per 21 CFR 801 Subpart D) ...................................................................................................................................................
(Per 21 CFR 801 SubpartC)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. V. huse
sion of Cardiovascular Devices
Page 1 of 1
510(k) number K081460