(29 days)
DTK
Not Found
No
The description focuses on the mechanical design and function of a vena cava filter and its delivery system, with no mention of AI or ML capabilities for image analysis, decision support, or any other function.
Yes
The device is intended for the prevention of recurrent pulmonary embolism and treats thromboembolic diseases, which are therapeutic functions.
No
The device is a vena cava filter designed to prevent pulmonary embolism by trapping emboli. While it involves angiographic visualization during placement, its primary function is therapeutic (preventing blood clots from reaching the lungs), not diagnostic (identifying or characterizing a disease). The angiographic visualization is for procedural guidance, not for diagnosing the patient's condition.
No
The device description clearly states it is a "system that consists of a flexible, self-expanding vena cava filter" and an "introduction kit" which are physical hardware components. There is no mention of software being the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the Cordis OptEase™ Permanent Vena Cava Filter is a physical device designed to be implanted in the inferior vena cava to trap blood clots and prevent pulmonary embolism. It is a therapeutic device, not a diagnostic one that analyzes biological samples.
- Intended Use: The intended use focuses on preventing recurrent pulmonary embolism by physically filtering the blood flow within the vena cava.
- Components: The components described (filter, introduction kit, dilator) are all related to the physical placement and function of the filter within the body.
- Testing: The performance studies mentioned involve in-vitro and in-vivo testing related to the physical properties and performance of the filter and its deployment system, not the analysis of biological samples.
The VisEase Angiographic Vessel Dilator, while used for visualization, is part of the delivery system for the filter and its function is to aid in the placement of the filter, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cordis OptEase™ Permanent Vena Cava Filter 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.
This is the same intended use as for the filter featured with the predicate devices: TrapEas, Günther Tulip Vena Cava MReye Filter set, and Vena Tech LGM Vena Cava Filter.
The VisEase 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.
This is the same intended use as for the VisEase Angiographic Vessel Dilator featured with the predicate device.
The OptEase™ is indicated for the prevention of recurrent pulmonary embolism via permanent, 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 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 VisEase Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath introducer and obturator for safe and accurate deployment of the filter.
The modification to the design of the OptEase Vena Cava Filter with respect to the number and configuration of the fixation hooks and the introduction of a filter extension at the caudal end of the filter basket, do not affect the intended use or basic fundamental technology of the device. The subject device is substantially equivalent to the predicate devices, i.e., TrapEase permanent Vena Cava Filter, Günther Tulip Vena Cava MReye Filter and the Vena Tech LGM Vena Cava Filter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization and linear measurement
Anatomical Site
inferior vena cava, vasculature, 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)
The safety and effectiveness of the Cordis OptEase Permanent Vena Cava Filter Performance have been demonstrated via data collected from in-vitro and in-vivo testing and Data: analyses conducted on the OptEase Permanent Vena Cava Filter.
The following in-vitro tests have been performed on the OptEase Permanent Vena Cava Filter:
- -Visual Inspection: Storage Tube
- -Visual Inspection: Filter position in Storage tube
- Visual Inspection: Filter -
- -Dimensional Inspection: Marker position obturator
- Dimensional Inspection Storage Tube -
- Dimensional Inspection: Measurement of expanded filter diameter -
- Suitability: Pull strength / Friction test Storage Tube -
- Simulated Deployment & Introducer / sheath Suitability incl. Kink resistance
- Resistance to Migration in-vitro-test Subject and Predicate Devices -
The following in-vivo have been performed:
- -Animal Study - Part I: Filter implantation with simulated thrombo-embolic load.
- Animal Study Part II: Filter implantation without simulated thrombo-embolic load.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit, Cordis TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator, Günther Tulip Vena Cava MReye™ Filter set, Cook Incorporated, Vena Tech LGM 30 CJ/U & 30 D/U Vena Cava Filter.
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
OCT 1 8 2002
510(k)
Summary of Safety and Effectiveness
| Submitter: | Bert Roossien, Ph.D.
Manager, Regulatory Affairs
Cordis Europa, N.V., a Johnson & Johnson Company
Oosteinde 8
NL-9301-LJ Roden
The Netherlands
Telephone: +31 50 5022 321
Fax +31 50 5022 456
e-mail address Broossie@crdnl.jnj.com |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Karen Wilk
Manager, Regulatory Affairs
Cordis Corporation, a Johnson & Johnson Company
7 Powder Horn Drive
Warren, New Jersey 07059
USA
Telephone: (908) 412-7257
Fax (908) 412-3915
e-mail address Kwilk@crdus.jnj.com |
| Date
Prepared: | September 18, 2002 |
| General
Provisions: | |
| | Trade Name Cordis OptEase™ Permanent Vena Cava Filter
Common Name Permanent Vena Cava Filter and Introduction Kit
Classification Name Cardiovascular Intravascular Filter (per 21 CFR 870.3375)
Device-classification Class II |
| Predicate
Devices: | The subject Cordis OptEase Permanent Vena Cava Filter is substantially equivalent to:
Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit, Cordis TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator, Günther Tulip Vena Cava MReye™ Filter set, Cook Incorporated, Vena Tech LGM 30 CJ/U & 30 D/U Vena Cava Filter. |
| 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 Guiance for
Industry and FDA, August 30, 2002 , and
• FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions |
| Indications
for Use | The Cordis OptEase Permanent Vena Cava Filter 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. |
| | This is the same intended use as for the filter featured with the predicate devices:
TrapEas, Günther Tulip Vena Cava MReye Filter set, and Vena Tech LGM Vena
Cava Filter.
The VisEase 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.
This is the same intended use as for the VisEase Angiographic Vessel Dilator
featured with the predicate device. |
| 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
VisEase Angiographic Vessel Dilator, a directional filter storage tube, catheter sheath
introducer and obturator for safe and accurate deployment of the filter.
The modification to the design of the OptEase Vena Cava Filter with respect to the
number and configuration of the fixation hooks and the introduction of a filter
extension at the caudal end of the filter basket, do not affect the intended use or basic
fundamental technology of the device. The subject device is substantially equivalent
to the predicate devices, i.e., TrapEase permanent Vena Cava Filter, Günther Tulip
Vena Cava MReye Filter and the Vena Tech LGM Vena Cava Filter. |
1
:
2
The safety and effectiveness of the Cordis OptEase Permanent Vena Cava Filter Performance have been demonstrated via data collected from in-vitro and in-vivo testing and Data: analyses conducted on the OptEase Permanent Vena Cava Filter.
The following in-vitro tests have been performed on the OptEase Permanent Vena Cava Filter:
- -Visual Inspection: Storage Tube
- -Visual Inspection: Filter position in Storage tube
- Visual Inspection: Filter -
- -Dimensional Inspection: Marker position obturator
- Dimensional Inspection Storage Tube -
- Dimensional Inspection: Measurement of expanded filter diameter -
- Suitability: Pull strength / Friction test Storage Tube -
- Simulated Deployment & Introducer / sheath Suitability incl. Kink resistance
- Resistance to Migration in-vitro-test Subject and Predicate Devices -
The following in-vivo have been performed:
- -Animal Study - Part I: Filter implantation with simulated thrombo-embolic load.
- Animal Study Part II: Filter implantation without simulated thrombo-embolic load.
Summary of The design, material, components, fundamental technology and intended use featured with the Cordis OptEase Permanent Vena Cava are substantially equivalent Substantial to those featured with the predecessor Cordis TrapEase Permanent Vena Cava Filter Equivalence and Introduction Kit and the Cordis TrapEase Permanent Vena Cava with the VisEase Angiographic Vessel Dilator. In addition, the design of the OptEase Permanent Vena Cava Filter is substantially equivalent with the Günther Tulip Vena Cava MReye Filter set and the Vena Tech LGM Vena Cava Filter.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2002
Bert Roossien, Ph.D. Manager, Regulatory Affairs Cordis Europa, N.V. Oosteinde 8 NL-9301-LJ Roden The Netherlands
Re: K023116
Trade/Device Name: Cordis OptEase™ Permanent Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II (two) Product Code: DTK Dated: September 18, 2002 Received: September 19, 2002
Dear Dr. Roossien:
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 Precautions section of the device's labeling and promotional materials:
The safety and effectiveness of the OptEase™ Filter for use as a retrievable or temporary filter have not been established.
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
4
Page 2 - Bert Roossien, Ph.D.
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); 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David C. Sabol, M.D.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known):_K203116
Device Name: Cordis OptEase™ Permanent Vena Cava Filter
FDA's Statement of the Indications For Use for device: The OptEase™ is indicated for the prevention of recurrent pulmonary embolism via permanent, 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.
Division of Cardiovascular & Respiratory Devices
510(k) Number K023116
Prescription Use_ X_ (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________