(49 days)
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.
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).
The provided document is a 510(k) premarket notification for the "Cordis TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vessel Dilator." This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or AI device might.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not typically found in this type of regulatory submission because they are not required to demonstrate substantial equivalence for this conventional medical device.
However, I can extract the information that is present and indicate what is not applicable based on the document.
1. A table of acceptance criteria and the reported device performance
For this device, "acceptance criteria" are primarily related to conforming to established standards and demonstrating functional performance through non-clinical testing. The document states that the safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses."
| Acceptance Criteria (Standards/Tests Applied) | Reported Device Performance/Compliance |
|---|---|
| For Cardiovascular Intravascular Filters (21 CFR 870.3375): | |
| ISO-10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing' | Implied compliance through the statement: "The safety and effectiveness...have been demonstrated via data collected from non-clinical design verification tests and analyses." This is a regulatory requirement for filters. |
| FDA's 510(k) Sterility Review Guidance and Revision of November 16, 2001 (K90-1) | Implied compliance through the statement: "The safety and effectiveness...have been demonstrated via data collected from non-clinical design verification tests and analyses." This is a regulatory requirement for filters. |
| FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions | Implied compliance through the statement: "The safety and effectiveness...have been demonstrated via data collected from non-clinical design verification tests and analyses." This is a regulatory requirement for filters. |
| Design Verification Testing (Non-clinical): | |
| Visual and Dimensional Inspection | Demonstrated through "data collected from non-clinical design verification tests and analyses." Specific pass/fail criteria or measurements are not provided in this summary. The summary states: "The design, material, components, fundamental technology and intended use featured with the Cordis TrapEase Permanent Vena Cava are substantially equivalent to those featured with the predecessor Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit..." |
| Catheter Sheath Introducer Compatibility | Demonstrated through "data collected from non-clinical design verification tests and analyses." No specific quantitative results are provided in this summary. |
| Flow Rate Testing | Demonstrated through "data collected from non-clinical design verification tests and analyses." No specific quantitative results are provided in this summary. |
| Hydrodynamic Testing | Demonstrated through "data collected from non-clinical design verification tests and analyses." No specific quantitative results are provided in this summary. |
| Pull Strength Testing | Demonstrated through "data collected from non-clinical design verification tests and analyses." No specific quantitative results are provided in this summary. |
| For Angiographic Catheter and Vessel Dilator: | No performance standards established by the FDA under section 514. Substantial equivalence for the VisEase Angiographic Vessel Dilator is based on its similarity to existing cleared devices (Cordis Super Torque MB Angiographic Catheter and Cordis 5.2 F Super Torque Plus Angiographic Catheter). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it's a 510(k) summary relying on non-clinical engineering and bench testing, not human subject data for "test sets" in the typical sense. Data provenance is not specified for the non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable for this type of submission, as ground truth is not established by human experts for non-clinical bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for this type of submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable to this device, as it is a physical medical device (vena cava filter and dilator), not an AI diagnostic tool or system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that the testing consisted of "non-clinical design verification tests and analyses" (Visual and Dimensional Inspection, Catheter Sheath Introducer Compatibility, Flow Rate Testing, Hydrodynamic Testing, Pull Strength Testing), the "ground truth" would be established by engineering specifications, material science standards, and performance metrics defined for the device during its design and development, rather than medical ground truths like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable as this is a physical medical device and not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device and not an AI algorithm.
{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 AffairsCordis Europa, N.V., a Johnson & Johnson CompanyOosteinde 8NL-9301-LJThe Netherlands |
|---|---|
| ContactPerson: | Karen WilkManager, Regulatory AffairsCordis Corporation, a Johnson & Johnson Company7 Powder Horn DriveWarren, New Jersey 07059Telephone: (908) 412-7257Fax: (908) 412-3915 |
| DatePrepared: | January 29, 2002 |
| GeneralProvisions: | Trade Name: Cordis TrapEase™ Permanent Vena Cava Filter with theVisEase™ Angiographic Vessel DilatorCommon Name: Permanent Vena Cava Filter and Introduction KitClassification Name: Cardiovascular Intravascular Filter (per 21 CFR 870.3375)Device Classification: Class II |
| PredicateDevices: | The subject TrapEase Permanent Vena Cava Filter with the VisEaseAngiographic 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
| PerformanceStandards | As per 21 CFR 870.3375, the following special controls were established forcardiovascular intravascular filters:• Use of International Standards Organization's ISO-10993 'BiologicalEvaluation 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)SubmissionsFor the Angiographic Catheter and vessel Dilator performance standardshave not been established by the FDA under section 514 of the Food, Drugand Cosmetic Act. |
|---|---|
| Indicationsfor Use | [Unchanged from the predicate devices:] The Cordis TrapEase™Permanent Vena Cava Filter is indicated for the prevention of recurrentpulmonary embolism via percutaneous placement in the inferior vena cava inthe following situations:• Pulmonary thromboembolism when anticoagulants are contraindicated,• failure of anticoagulant therapy in thromboembolic diseases,• emergency treatment following massive pulmonary embolism, whereanticipated benefits of conventional therapy are reduced and• chronic, recurrent pulmonary embolism where anticoagulant therapy hasfailed or is contraindicated.[New:] The VisEase Angiographic Vessel Dilator is designed to provideangiographic visualization and linear measurement of the vasculature whencombined with the delivery of radiopaque contrast media to the vena cava. |
| DeviceDescription | The subject TrapEase Permanent Vena Cava Filter with the VisEaseAngiographic Vessel Dilator most notably differs from the predicate TrapEasePermanent Vena Cava Filter and Introduction Kit with regards to the vesseldilator that is included as a component in the Introduction Kit. In addition toits original function as a vessel dilator, which was featured with the predicateCordis TrapEase Introduction Kits, the subject VisEase Angiographic VesselDilator features new intended uses involving angiographic visualization andlinear measurement. These new intended uses of the subject VisEaseAngiographic Vessel Dilator are addressed in updated product labelingherein and are identical to the intended uses of the predicate Cordis SuperTorque MB Angiographic Catheter (reference K992347, determinedsubstantially equivalent on October 8, 1999).Besides the aforementioned changes in intended use for the VisEaseAngiographic Vessel Dilator, the TrapEase Permanent Vena Cava Filter andall 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
§ 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).