(296 days)
Not Found
No
The description focuses on the mechanical function of a vena cava filter and its delivery system. There is no mention of AI/ML terms, image processing for analysis, or data sets for training/testing.
Yes.
The device (vena cava filter) is indicated for the prevention and treatment of recurrent pulmonary embolism, which are conditions affecting the patient's health.
No
The device, a vena cava filter system, is designed for the prevention of pulmonary embolism by trapping emboli. While it uses angiographic visualization for placement, its primary function is therapeutic (prevention) rather than diagnostic (identifying or characterizing a disease).
No
The device description clearly outlines a physical vena cava filter, introduction kit, and retrieval catheter, which are hardware components. The summary does not mention any software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The OPTEASE Vena Cava Filter is an implantable medical device designed to be placed inside the body (in the inferior vena cava) to physically prevent blood clots from traveling to the lungs. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states its purpose is for the "prevention of recurrent pulmonary embolism" by trapping emboli within the vena cava. This is a treatment/prevention function, not a diagnostic one.
- Device Description: The description details a physical filter and its delivery system, not equipment for analyzing biological samples.
- Input Imaging Modality: Angiographic visualization is used to guide the placement of the device within the body, not to analyze a specimen.
The device is a therapeutic implant used for the prevention of pulmonary embolism.
N/A
Intended Use / Indications for Use
The OPTEASE Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations: 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 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 radiopaque contrast media to the vena cava.
The Cordis OPTEASE Retrieval Catheter is has been designed for retrieval of an implanted OPTEASE Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by femoral approach.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The subject device is a system that consists of a flexible, self-expanding vena cava filter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introduction kit. The filter is designed to trap large, life threatening emboli and therefore prevent recurrent pulmonary embolism, while maintaining caval patency. The OptEase Permanent Vena Cava Filter is packaged with a filter introduction kit that includes the Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inferior vena cava, 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)
Not Found
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
K091077
FEB - 4 2010
510(k) Summary
| Applicant | Cordis Corporation, a Johnson & Johnson Company
430 Rt. 22 East
Bridgewater, New Jersey 08807
Telephone: 908-541-4888
Fax: 908-541-4559 | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Contact | Joan Martin, Manager, Regulatory Affairs | |
| Date | April 13, 2009 | |
| Subject Device | Trade Name: | OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter |
| | Common or Usual Name: | Cardiovascular Intravascular Filter (per 21 CFR 870.3375) |
| | Classification: | Class II |
| | Classification Panel | Cardiovascular |
| Name of Predicate Devices | The device is substantially equivalent to:
Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter (ref. 510(k) K034050) G2 EXPRESS Filter System, Bard Peripheral Vascular, Inc. (ref. 510(k) K082305) | |
| Performance Standards | As per 21 CFR 870.3375, the following special controls were established for cardiovascular intravascular filters:
Use of 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, dated November 26, 1999 | |
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| Indications for
| Use for Filter | The OPTEASE Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations: 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 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 radiopaque contrast media to the vena cava. |
|---|---|
| Indications for | |
| Use for | |
| Retrieval | |
| Catheter | The Cordis OPTEASE Retrieval Catheter is has been designed for retrieval of an implanted OPTEASE Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by femoral approach. |
| Device | |
| Description | The subject device is a system that consists of a flexible, self-expanding vena cava filter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introduction kit. The filter is designed to trap large, life threatening emboli and therefore prevent recurrent pulmonary embolism, while maintaining caval patency. The OptEase Permanent Vena Cava Filter is packaged with a filter introduction kit that includes the Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter. |
| Summary of | |
| Substantial | |
| Equivalence | The subject OPTEASE Vena Cava Filter is substantially equivalent to the predicate devices, the OPTEASE Vena Cava Filter and the G2 EXPRESS Filter System in terms of intended use, application and user application. The change to the predicate devices, OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter, only affects the labeling. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services. The symbol consists of a series of curved lines that form a wing-like shape, suggesting care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB - 4 2010
Cordis Corporation c/o Ms. Joan Martin 430 Rt. 22 East Bridgewater, NJ 08807
Re: K091077
OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: January 4, 2010 Received: January 5, 2010
Dear Ms. Martin:
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 use in the prevention of recurrent pulmonary embolism 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 resporancing 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.
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Page 2 - Ms. Joan Martin
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Dina R. Lehner
E
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Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Cordis Corporation, a Johnson & Johnson Company OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter
SPECIAL 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K091077
Device Name: OPTEASE® Vena Cava Filter and OPTEASE Retrieval Catheter
Indication 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 radiopague 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vihunen
(Division Sign-Off) (Division Sign of Cardiovascular Devices
510(k) Number_10 9 10 7