(381 days)
Not Found
No
The description focuses on the mechanical design and function of a physical medical device (a vena cava filter) and its delivery system. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is a vena cava filter used for the "prevention of recurrent pulmonary embolism," which is a therapeutic purpose aiming to treat or prevent a medical condition.
No
Explanation: The SafeFlo® Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism by physically filtering emboli in the inferior vena cava, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical medical device (vena cava filter) and its delivery system, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SafeFlo® Vena Cava Filter is a physical implant designed to be placed directly into the inferior vena cava within the body. It functions mechanically to prevent blood clots from traveling to the lungs.
- Intended Use: The intended use describes the prevention of pulmonary embolism by physically filtering blood within the vena cava. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the SafeFlo® Vena Cava Filter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated,
- Failure of anticoagulant therapy in thromboembolic diseases,
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Product codes
DTK
Device Description
The SafeFlo Filter is a Nitinol filter designed for simple, stable and safe implantation in the inferior vena cava to allow blood flow towards the heart while preventing the passage of emboli into the pulmonary arteries. The SafeFlo Filter set comprises the vena cava filter unit and a delivery system kit, provided in separate packages.
The SafeFlo Filter is inserted through a 6F (ID) delivery system. The filter is divided into two functional parts, the Double Ring Platform and the Filter Element. The Double Ring Platform is a fixator, which anchors itself in the vessel wall by over-sizing of the rings with respect to the circular diameter of the vessel. The Double Ring Platform has been designed to exit the delivery sheath and rotate through 90° to be positioned perpendicular to the vessel wall. This method of fixation does not utilize individual hooks and therefore vessel trauma is minimized and repositioning is possible.
The Filter Element is the functional unit of the filter; it is shaped from the continuation of the wires of the Double Ring Platform and is thereby supported securely within the bloodstream. The Filter Element's unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli. The Filter Element's size (diameter) is designed to be up to 3mm smaller than the diameter of the IVC.
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)
Data from bench, animal and clinical testing demonstrates that the SafeFlo Filter functioned as intended and results were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Simon Nitinol Filter (C.R. Bard, Inc.), OptEase Permanent Vena Cava Filter (Cordis Corp.)
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
p1/2
510(k) SUMMARY
Rafael Medical Technologies, Inc.'s SafeFlo® Vena Cava Filter
Submitter's Name, Address, Tclephone Number, Contact Person and Date Prepared
MAY - 7 2009
Rafael Medical Technologies, Inc. 3500 South Du Pont Highway Dover, Delaware 19901
Phone: +972-4-6270375 Facsimile: +972-4-6270376
Contact Person: Aaron Feldman
Date Prepared: April 17, 2008
Name of Device
SafeFlo® Vena Cava Filter
Common or Usual Name
Vena Cava Filter
Classification Name,
Cardiovascular Intravascular Filter
Predicate Devices
- . Simon Nitinol Filter (C.R. Bard, Inc.)
- OptEase Permanent Vena Cava Filter (Cordis Corp.) ●
Intended Use / Indications for Use
The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulants are contraindicated,
- . Failure of anticoagulant therapy in thromboembolic diseases,
- . Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has . failed or is contraindicated.
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Technological Characteristics
The SafeFlo Filter is a Nitinol filter designed for simple, stable and safe implantation in the inferior vena cava to allow blood flow towards the heart while preventing the passage of emboli into the pulmonary arteries. The SafeFlo Filter set comprises the vena cava filter unit and a delivery system kit, provided in separate packages.
The SafeFlo Filter is inserted through a 6F (ID) delivery system. The filter is divided into two functional parts, the Double Ring Platform and the Filter Element. The Double Ring Platform is a fixator, which anchors itself in the vessel wall by over-sizing of the rings with respect to the circular diameter of the vessel. The Double Ring Platform has been designed to exit the delivery sheath and rotate through 90° to be positioned perpendicular to the vessel wall. This method of fixation does not utilize individual hooks and therefore vessel trauma is minimized and repositioning is possible.
The Filter Element is the functional unit of the filter; it is shaped from the continuation of the wires of the Double Ring Platform and is thereby supported securely within the bloodstream. The Filter Element's unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli. The Filter Element's size (diameter) is designed to be up to 3mm smaller than the diameter of the IVC.
Performance Data
Data from bench, animal and clinical testing demonstrates that the SafeFlo Filter functioned as intended and results were as expected.
Substantial Equivalence
The SafeFlo Filter is as safe and effective as the Predicate Devices. The SafeFlo Filter has the same intended uses and indications as well as similar technological characteristics, and principles of operation as its Predicate Devices. The minor technological differences between the SafeFlo Filter and its Predicate Devices raise no new issues of safety or effectiveness. Performance data demonstrate that the SafeFlo Filter is as safe and effective as the Predicate Devices. Thus, the SafeFlo Filter is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2009
Rafael Medical Technologies, Inc. c/o Ms. Janice Hogan Hogan and Hartson LLP 1835 Market Street 28" Floor Philadelphia, PA 19103
Re: K081138
Trade/Device Name: SafeFlo Vena Cava Filter Regulation Number: 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II Product Code: DTK Dated: May 1, 2009 Received: May 1, 2009
Dear Ms. Hogan:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:
The safety and effectiveness of the SafeFlo Vena Cava Filter for use as a retrievable or temporary filter have not been established.
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Page 2 - Ms. Janice Hogan
Furthermore, the indication for permanent placement of the SafeFio Vena Cava Filter must be runnermore, the multion for permained ding pouch box, and carton labels, instructions for promiliently displayed in an harening, include proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I totas note that the act 10 hoursed before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate I ho i Dr rinding or basefication for your device and permits your device to proceed to the devreet . This letter will allow you to begin marketing your device as described in your Section niaker. " This letter will ation statement described above is added to your labeling.
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of actived that 12-11 bistian that your device complies with other requirements of the Act that I Dr has made a deter mailations administered by other Federal agencies. You must Or any I outlar the Act's requirements, including, but not limited to: registration and listing (21 oompry ... labeling (21 CFR Part 801); medical device reporting (reporting of medical OI K Fat 607), lacemig (21 CFR 803); good manufacturing practice requirements as set device related develop ovence) (2 regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (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 11 you don't speer for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 0156. Innov (21CFR Part 807.97). For questions regarding the reporting of adverse premation internetion (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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Page 3 - Ms. Janice Hogan
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.
Sinccrely yours,
Nil R.P. Ogden for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: SafeFlo® Vena Cava Filter
Indications for Use:
The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated, .
- Failure of anticoagulant therapy in thromboembolic diseases, .
- Emergency treatment following massive pulmonary embolism where . anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has ● failed or is contraindicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eemee
(Division Sign Off) Division of Cardiovascular Devices KOBII38 510(k) Number
Page of
\\PH - 070999/000060 - 36396 v1
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