(29 days)
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 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.
The provided text describes the Cordis OptEase™ Permanent Vena Cava Filter, focusing on its safety and effectiveness studies. However, it does not include acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a numerical success rate) with corresponding thresholds. Instead, it details various in-vitro and in-vivo tests performed to demonstrate substantial equivalence to predicate devices.
Therefore, many of the requested items related to acceptance criteria, device performance against these criteria, and AI-specific study details cannot be extracted directly from this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical acceptance criteria with thresholds in the provided text. The overall "acceptance criterion" appears to be demonstrating substantial equivalence to predicate devices. | The device underwent a series of in-vitro and in-vivo tests to support its safety and effectiveness and its substantial equivalence to predicate devices such as the Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit, Günther Tulip Vena Cava MReye™ Filter set, and Vena Tech LGM Vena Cava Filter. |
| In-vitro Tests: | Pass (implied by substantial equivalence determination) |
| - Visual Inspection: Storage Tube | Performed |
| - Visual Inspection: Filter position in Storage Tube | Performed |
| - Visual Inspection: Filter | Performed |
| - Dimensional Inspection: Marker position obturator | Performed |
| - Dimensional Inspection: Storage Tube | Performed |
| - Dimensional Inspection: Measurement of expanded filter diameter | Performed |
| - Suitability: Pull strength / Friction test Storage Tube | Performed |
| - Simulated Deployment & Introducer / sheath Suitability incl. Kink resistance | Performed |
| - Resistance to Migration in-vitro-test Subject and Predicate Devices | Performed |
| In-vivo Tests: | Pass (implied by substantial equivalence determination) |
| - Animal Study - Part I: Filter implantation with simulated thrombo-embolic load | Performed |
| - Animal Study - Part II: Filter implantation without simulated thrombo-embolic load | Performed |
Note: The document implies that the device "passed" these tests by concluding substantial equivalence, but it does not provide specific numerical results or thresholds for these tests as "acceptance criteria." The focus is on demonstrating equivalence rather than meeting pre-defined specific performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number. The "test set" consists of the in-vitro tests and two animal studies. The number of samples/animals for these studies is not quantified in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin for the animal studies). The studies are labeled as in-vitro and in-vivo (animal studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for this medical device (a physical filter) is established through direct physical and biological testing (in-vitro and in-vivo animal studies), not by expert interpretation of images or other data that require "ground truthing" in the context of AI.
- Qualifications of Experts: Not applicable for establishing ground truth in this type of device submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are physical and biological measurements/observations, not interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This information is not present in the document. An MRMC study is typically performed for AI or diagnostic devices where human readers interpret data, and the AI's impact on their performance is evaluated. This document describes a physical medical device (vena cava filter).
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study or AI component is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Was it done? No. This document describes a physical medical device. There is no mention of an algorithm or an AI component that would have standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the device's performance is established through direct physical/functional measurements (e.g., dimensional inspection, pull strength, simulated deployment) and biological observations in animal models (filter implantation, simulated thrombo-embolic load). This is direct measurement and observation rather than expert consensus, pathology, or outcomes data in the usual sense for AI/diagnostic devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe an AI/ML device that requires a training set. The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for an AI/ML algorithm.
{0}------------------------------------------------
OCT 1 8 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-LJ RodenThe NetherlandsTelephone: +31 50 5022 321Fax +31 50 5022 456e-mail address Broossie@crdnl.jnj.com |
|---|---|
| ContactPerson: | Karen WilkManager, Regulatory AffairsCordis Corporation, a Johnson & Johnson Company7 Powder Horn DriveWarren, New Jersey 07059USATelephone: (908) 412-7257Fax (908) 412-3915e-mail address Kwilk@crdus.jnj.com |
| DatePrepared: | September 18, 2002 |
| GeneralProvisions: | |
| Trade Name Cordis OptEase™ Permanent Vena Cava FilterCommon Name Permanent Vena Cava Filter and Introduction KitClassification Name Cardiovascular Intravascular Filter (per 21 CFR 870.3375)Device-classification Class II | |
| PredicateDevices: | 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. |
| PerformanceStandards | As per 21 CFR 870.3375, the following special controls were established forcardiovascular intravascular filters:• Use of International Standards Organization's ISO-10993 'Biological Evaluation ofMedical Devices Part I: Evaluation and Testing,• FDA's Updated 510(k) Sterility Review Guidance (K90-1); Final Guiance forIndustry and FDA, August 30, 2002 , and• FDA's Guidance for Cardiovascular Intravascular Filter 510(k) Submissions |
| Indicationsfor Use | The Cordis OptEase Permanent Vena Cava Filter is indicated for the prevention ofrecurrent pulmonary embolism via percutaneous placement in the inferior vena cavain the following situations:• Pulmonary thromboembolism when anticoagulants are contraindicated,• Failure of anticoagulant therapy in thromboembolic diseases,• Emergency treatment following massive pulmonary embolism, where anticipatedbenefits of conventional therapy are reduced; and• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed oris 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 VenaCava Filter.The VisEase Angiographic Vessel Dilator is designed to provide angiographicvisualization and linear measurement of the vasculature when combined with thedelivery of radiopaque contrast media to the Vena Cava.This is the same intended use as for the VisEase Angiographic Vessel Dilatorfeatured with the predicate device. | |
| DeviceDescription | The subject device is a system that consists of a flexible, self-expanding vena cavafilter to be deployed in the infra-renal inferior vena cava via a 6F sheathed introductionkit. The filter is designed to trap large, life threatening emboli and therefore preventrecurrent pulmonary embolism, while maintaining caval patency. The OptEasePermanent Vena Cava Filter is packaged with a filter introduction kit that includes theVisEase Angiographic Vessel Dilator, a directional filter storage tube, catheter sheathintroducer and obturator for safe and accurate deployment of the filter.The modification to the design of the OptEase Vena Cava Filter with respect to thenumber and configuration of the fixation hooks and the introduction of a filterextension at the caudal end of the filter basket, do not affect the intended use or basicfundamental technology of the device. The subject device is substantially equivalentto the predicate devices, i.e., TrapEase permanent Vena Cava Filter, Günther TulipVena 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__________________________________________________________________________________________________________________________________________________________
§ 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.”