(49 days)
No
The summary describes a physical medical device (vena cava filter and vessel dilator) and its intended uses, focusing on mechanical and functional aspects. There is no mention of AI, ML, image processing for analysis, or any software-driven decision-making based on data. The performance studies are based on physical testing, not algorithmic evaluation.
Yes
The device, specifically the Cordis TrapEase™ Permanent Vena Cava Filter, is indicated for the prevention of recurrent pulmonary embolism, which is a therapeutic intervention.
No.
The primary device, the TrapEase™ Permanent Vena Cava Filter, is for the prevention of recurrent pulmonary embolism. While the VisEase Angiographic Vessel Dilator component provides "angiographic visualization and linear measurement," these functions support the placement and use of the filter rather than diagnosing a condition.
No
The device description clearly states it is a physical medical device consisting of a vena cava filter and a vessel dilator, with mentions of physical testing like pull strength and flow rate.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for preventing pulmonary embolism by being placed in the inferior vena cava. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The description focuses on a vena cava filter and a vessel dilator used for angiographic visualization and measurement within the body.
- Lack of In Vitro Activities: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
- Input Imaging Modality: Angiographic visualization is an imaging technique performed on a living patient.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for treatment and visualization within the body.
N/A
Intended Use / Indications for Use
The Cordis TrapEase™ 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DTK, DRE, DQO
Device Description
The subject TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator most notably differs from the predicate TrapEase Permanent Vena Cava Filter and Introduction Kit with regards to the vessel dilator that is included as a component in the Introduction Kit. In addition to its original function as a vessel dilator, which was featured with the predicate Cordis TrapEase Introduction Kits, the subject VisEase Angiographic Vessel Dilator features new intended uses involving angiographic visualization and linear measurement. These new intended uses of the subject VisEase Angiographic Vessel Dilator are addressed in updated product labeling herein and are identical to the intended uses of the predicate Cordis Super Torque MB Angiographic Catheter (reference K992347, determined substantially equivalent on October 8, 1999). Besides the aforementioned changes in intended use for the VisEase Angiographic Vessel Dilator, the TrapEase Permanent Vena Cava Filter and all other components used with the subject device remain unchanged from #K000062, #K003964 and #K010083).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 TrapEase Permanent Vena Cava Data: Filter and VisEase Angiographic Vessel Dilator have been demonstrated via data collected from non-clinical design verification tests and analyses. The design verification testing consisted of the following: Visual and Dimensional Inspection, Catheter Sheath Introducer Compatibility, Flow Rate Testing, Hydrodynamic Testing, Pull Strength Testing.
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.
K000062, K003964, K010083, K992347, K914007, K983023, K984500
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.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, enclosed in a circle. The text is in bold, with "FDA" in a square.
October 24, 2018
Cordis Corp. Karen Wilk Manager, Regulatory Affairs 7 Powder Horn Dr. Warren, New Jersey 07059
Re: K020316
Trade/Device Name: Cordis TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Dilator Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK, DRE, DQO Dated: January 29, 2002 Received: January 30, 2002
Dear Karen Wilk:
This letter corrects our substantially equivalent letter of March 20, 2002.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Oilator ordis Corporation, a Johnson & Johnson Company Traditional 510(k) Premarket Notification
510(k) Number:
KC20316
Device Name:
Cordis TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Dilator
Indications for Use:
The Cordis TrapEase™ 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.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | |
|---|---|
| 510(k) Number | K000316 |
3
MAR 2 0 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
The Netherlands |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Karen Wilk
Manager, Regulatory Affairs
Cordis Corporation, a Johnson & Johnson Company
7 Powder Horn Drive
Warren, New Jersey 07059
Telephone: (908) 412-7257
Fax: (908) 412-3915 |
| Date
Prepared: | January 29, 2002 |
| General
Provisions: | Trade Name: Cordis TrapEase™ Permanent Vena Cava Filter with the
VisEase™ Angiographic Vessel Dilator
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 TrapEase Permanent Vena Cava Filter with the VisEase
Angiographic Vessel Dilator is substantially equivalent to:
Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit (510(k) #K000062, #K003964 and #K010083)Cordis 5F Super Torque MB Angiographic Catheter (510(k) #K992347).Cordis 5.2 F Super Torque Plus Angiographic Catheter (510(k) #K914007)Cordis Brite Tip Catheter Sheath Introducer & Vessel Dilator (510(k) #K983023 and #K984500) |
4
TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Dilator
Cordis Corporation, a Johnson & Johnson Company Traditional 510(k) Premarket Notification
| 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 510(k) Sterility Review Guidance and Revision of November 16,
2001 (K90-1), and
• FDA's Guidance for Cardiovascular Intravascular Filter 510(k)
Submissions
For the Angiographic Catheter and vessel Dilator performance standards
have not been established by the FDA under section 514 of the Food, Drug
and Cosmetic Act. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | [Unchanged from the predicate devices:] The Cordis TrapEase™
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.
[New:] 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. |
| Device
Description | The subject TrapEase Permanent Vena Cava Filter with the VisEase
Angiographic Vessel Dilator most notably differs from the predicate TrapEase
Permanent Vena Cava Filter and Introduction Kit with regards to the vessel
dilator that is included as a component in the Introduction Kit. In addition to
its original function as a vessel dilator, which was featured with the predicate
Cordis TrapEase Introduction Kits, the subject VisEase Angiographic Vessel
Dilator features new intended uses involving angiographic visualization and
linear measurement. These new intended uses of the subject VisEase
Angiographic Vessel Dilator are addressed in updated product labeling
herein and are identical to the intended uses of the predicate Cordis Super
Torque MB Angiographic Catheter (reference K992347, determined
substantially equivalent on October 8, 1999).
Besides the aforementioned changes in intended use for the VisEase
Angiographic Vessel Dilator, the TrapEase Permanent Vena Cava Filter and
all other components used with the subject device remain unchanged from |
#K000062, #K003964 and #K010083).
5
Performance The safety and effectiveness of the Cordis TrapEase Permanent Vena Cava Data: Filter and VisEase Angiographic Vessel Dilator have been demonstrated via data collected from non-clinical design verification tests and analyses. The design verification testing consisted of the following: Visual and Dimensional Inspection ● Catheter Sheath Introducer Compatibility . ● Flow Rate Testing Hydrodynamic Testing . . Pull Strength Testing Summary of The design, material, components, fundamental technology and intended use Substantial featured with the Cordis TrapEase Permanent Vena Cava are substantially equivalent to those featured with the predecessor Cordis TrapEase Equivalence Permanent Vena Cava Filter and Introduction Kit (reference 510(k) #K000062, #K003964 and #K010083). The design, material and new intended uses of the VisEase Angiographic Vessel Dilator are substantially equivalent to those featured with the predicate Cordis Super Torque MB
Torque Plus Angiographic Catheter (510(k) #K914007).
Angiographic Catheter (reference 510(k) #K992347) and Cordis 5.2 F Super