(30 days)
Not Found
No
The document describes a physical medical device (vena cava filter) and its associated delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on the physical properties and handling of the device.
Yes
The device is indicated for the prevention of recurrent pulmonary embolism, which is a medical condition, making it a therapeutic device.
No
The OPTEASE Filter is indicated for the prevention of recurrent pulmonary embolism, acting as a physical barrier (filter) rather than a diagnostic tool. While it uses angiographic visualization, this is for guidance in placement, not for diagnosing a condition.
No
The device description clearly outlines physical components like a filter made of nickel titanium alloy, a storage tube, an introduction kit including a dilator, sheath introducer, and obturator, and a retrieval catheter. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent recurrent pulmonary embolism by physically filtering blood in the vena cava. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical filter designed for placement within a blood vessel.
- Lack of Diagnostic Function: The device does not perform any tests on samples taken from the body (like blood, urine, or tissue) to diagnose a condition. While it uses angiographic visualization for placement, the primary function is not diagnostic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated, .
- Failure of anticoagulant therapy for 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 OPTEASE® Filter may be retrieved according to the instructions supplied in the Section labeled: "Optional Procedure for Filter Retrieval".
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of the radiopaque contrast media to the vena cava.
Product codes
DTK
Device Description
The Cordis OPTEASE® Vena Cava Filter (Filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC). The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. The constrained filter is supplied in a unidirectional storage tube that is loaded as a system into the hemostasis valve of the sheath introducer. The subject device is comprised of the filter packaged within a unidirectional storage tube, introduction kit that includes angiographic vessel dilator, catheter sheath introducer and obturator. The OPTEASE® Retrieval catheter is packaged separately.
The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. Six straight struts connect the baskets. A single row of fixation barbs is present at the cranial end of the struts. These barbs are intended for the fixation to the vessel wall, and are extensions of the parallel struts. A hook is centrally located at the caudal basket extremity. The constrained filter is supplied in a unidirectional storage tube that is to be loaded as a system into the valve of the sheath introducer. The constrained filter is flexible and achieves its unconstrained diameter upon deployment in the inferior vena cava (IVC). Upon deployment, the filter imparts an outward radial force on the luminal surface of the Vena Cava to ensure proper positioning and stability.
The OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter is packaged with an Introduction Kit that contains the following components:
- . Filter packaged within unidirectional storage tube (containing the constrained OPTEASE Filter)
- . 6F BRITE TIP® Catheter Sheath Introducer
- VisEase™ Angiographic Vessel Dilator ●
- . Obturator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava, 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)
Design verification and validation testing data confirms that the Optease® Vena Cava Filter in a unidirectional storage tube performs according to its intended use and is equivalent in performance to the predicate device. Specifically, the following tests were performed on the proposed device to demonstrate substantial equivalence with the predicate device.
| Test | Conclusion |
|---|---|
| Human Factor Assessment | The proposed product |
| configuration was safer to use | |
| and better at mitigating the | |
| risk of incorrect insertion. | |
| Transfer filter into CSI | Meets Acceptance Criteria |
| Filter release from storage | |
| tube | |
| Fixation on mounting card | |
| Fixation in storage tube | |
| Dimensional Analysis | |
| Visual inspection and | |
| verification of packaging and | |
| labeling |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K140286 1/3 MAR - 7 2014
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92 in order to gain clearance to market the OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. The OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are identical in design and intended use to the predicate OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter. The change is to provide unique catalog numbers for the femoral-only, jugular-only, and jugular/antecubital-only approaches with dedicated OPTEASE® Vena Cava Filter packaged within a unidirectional storage tube according to the site specific deployment approach.
| APPLICANT | Cordis Corporation
A Johnson & Johnson Company
6500 Paseo Padre Parkway
Fremont, CA 94555
Tel.: 510-248-2961
Fax: 510-248-2533 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Shamsa Karimi
Manager, Regulatory Affairs
Phone:(510) 248-2896
Fax: (510) 248-2533
e-mail: SKarimi@ITS.JNJ.com |
| DATE PREPARED | February 04, 2014 |
| TRADE NAME | OPTEASE® Vena Cava Filter and OPTEASE®
Retrieval Catheter |
| COMMON NAME | Vena Cava Filter and Introduction Kit |
| CLASSIFICATION NAME | Filter, Intravascular, Cardiovascular |
| DEVICE CLASSIFICATION | 21 CFR §870.3375 |
| PRODUCT CODES | DTK |
| PREDICATE DEVICE | OPTEASE® Vena Cava Filter and OPTEASE®
Retrieval Catheter
Previously cleared under K034050 and again under
K091077 |
1
SUBSTANTIALLY EQUIVALENT TO:
The Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are substantially equivalent to the predicate Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter, previously cleared under K034050 and again under K091077.
- The OPTEASE® Vena Cava Filter (Filter) is identical in design and intended use to the . predicate OPTEASE® Filter.
- The packaging components of the Cordis OPTEASE® Vena Cava Filter and . OPTEASE® Retrieval Catheter are substantially equivalent to the predicate packaging components.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Cordis OPTEASE® Vena Cava Filter (Filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (IVC). The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. The constrained filter is supplied in a unidirectional storage tube that is loaded as a system into the hemostasis valve of the sheath introducer. The subject device is comprised of the filter packaged within a unidirectional storage tube, introduction kit that includes angiographic vessel dilator, catheter sheath introducer and obturator. The OPTEASE® Retrieval catheter is packaged separately.
INDICATIONS FOR USE:
.
The OPTEASE® Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated, .
- Failure of anticoagulant therapy for 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 OPTEASE® Filter may be retrieved according to the instructions supplied in the Section labeled: "Optional Procedure for Filter Retrieval".
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of the radiopaque contrast media to the vena cava.
TECHNICAL CHARACTERISTICS:
The self-centering OPTEASE® Filter is laser cut from nickel titanium alloy (Nitinol) tubing. The proximal and distal baskets of the OPTEASE® Filter, consisting of struts in a six-diamond shape configuration, are designed for optimal clot capture. Six straight struts connect the baskets. A single row of fixation barbs is present at the cranial end of the struts. These barbs are intended for the fixation to the vessel wall, and are extensions of the parallel struts. A hook is centrally
2
located at the caudal basket extremity. The constrained filter is supplied in a unidirectional storage tube that is to be loaded as a system into the valve of the sheath introducer. The constrained filter is flexible and achieves its unconstrained diameter upon deployment in the inferior vena cava (IVC). Upon deployment, the filter imparts an outward radial force on the luminal surface of the Vena Cava to ensure proper positioning and stability.
The OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter is packaged with an Introduction Kit that contains the following components:
- . Filter packaged within unidirectional storage tube (containing the constrained OPTEASE Filter)
- . 6F BRITE TIP® Catheter Sheath Introducer
- VisEase™ Angiographic Vessel Dilator ●
- . Obturator.
The OPTEASE® Retrieval catheter is packaged separately.
Performance Data:
Design verification and validation testing data confirms that the Optease® Vena Cava Filter in a unidirectional storage tube performs according to its intended use and is equivalent in performance to the predicate device. Specifically, the following tests were performed on the proposed device to demonstrate substantial equivalence with the predicate device.
| Test | Conclusion |
|---|---|
| Human Factor Assessment | The proposed product |
| configuration was safer to use | |
| and better at mitigating the | |
| risk of incorrect insertion. | |
| Transfer filter into CSI | Meets Acceptance Criteria |
| Filter release from storage | |
| tube | |
| Fixation on mounting card | |
| Fixation in storage tube | |
| Dimensional Analysis | |
| Visual inspection and | |
| verification of packaging and | |
| labeling |
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technical comparison and design verification and validation testing demonstrate that the subject OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter are substantially equivalent to the predicate.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a person with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Cordis Corporation, A Johnson & Johnson Co. Ms. Shamsa Karimi Manager, Regulatory Affairs 6500 Paseo Padre Parkway Fremont, CA 94555 US
Re: K140286
Trade/Device Name: OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter Regulation Number: 21 CFR 870.3375 Regulation Name: Vena Cava Filter and Introduction Kit, Filter, Intravascular, Cardiovascular Regulatory Class: Class II Product Code: DTK Dated: February 4, 2014 Received: February 5, 2014
Dear Ms. Karimi,
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 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
4
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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,
Kenneth J. Cavanaugh - S
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
..............................................................................................................................................................................
510(k) Number (if known): K140286
Device Name: Cordis OPTEASE® Vena Cava Filter and Optease Retrieval Catheter
Indications for Use:
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated, .
- Failure of anticoagulant therapy for 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 OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: "Optional Procedure for Filter Retrieval".
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of the radiopaque contrast media to the vena cava.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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