(83 days)
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. .
- . 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 indicated for the retrieval of the Cordis OptEase Vena Cava Filter from the inferior vena cava. Retrieval of the OptEase Filter is possible only from the femoral vein approach.
The subject OptEase Filter is identical to the predicate OptEase Permanent Vena Cava Filter with the exception of the addition of the retrievability option to the labeling. The OptEase 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.
The subject OptEase Filter is substantially equivalent to the predicate devices (i.e., OptEase Permanent Vena Cava Filter, TrapEase Permanent Vena Cava Filter, Recovery Filter System, and Günther Tulip™ Vena Cava Filter and Retrieval Set).
The subject OptEase Retrieval Catheter is an 80 cm long, 10F catheter with radiopaque tip. The subject device is packaged separately and is intended for the percutaneous retrieval of the OptEase Filter from the inferior vena cava when used with an appropriate Endovascular snare. The subject device is substantially equivalent to the predicates devices (i.e., the Günther Tulip™ Vena Cava Filter and Retrieval Set and the VISTA BRITE TIP® Guiding Catheter).
Here's a breakdown of the acceptance criteria and the study that proves the Cordis OptEase™ Vena Cava Filter and OptEase™ Retrieval Catheter met those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (as per provided text) | Reported Device Performance |
|---|---|---|
| Filter: Indication for Use - Prevention of recurrent pulmonary embolism in specific situations | - Pulmonary thromboembolism when anticoagulants are contraindicated - Failure of anticoagulant therapy in thromboembolic diseases - Emergency treatment following massive pulmonary embolism where anticipated - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated | The reported indications for use of the Cordis OptEase Vena Cava Filter are identical to the acceptance criteria, indicating the device performs as intended for these specific situations. |
| Retrieval Catheter: Indication for Use - Retrieval of the Cordis OptEase Vena Cava Filter from inferior vena cava via femoral vein approach | - Retrieval of the Cordis OptEase Vena Cava Filter from the inferior vena cava. - Retrieval possible only from the femoral vein approach. | The reported indications for use of the Cordis OptEase Retrieval Catheter are identical to the acceptance criteria, indicating the device performs as intended for this specific retrieval method. |
| Retrieval Safety & Effectiveness | (Implied through "safety and effectiveness... demonstrated via data collected from in-vitro, animal and clinical testing and analyses" for retrieval) | - Prospective Clinical Study: 21 retrieval patients. Time to retrieval: 5-14 days (mean 11.1 ± 1.8 days). - Retrospective Clinical Experience: 40 retrieval patients. Time to retrieval: 3-48 days in 29 patients (mean 16.4 ± 7.2 days). - 11 patients in retrospective study had filter captured and redeployed (4-30 days, mean 13.8 ± 6.1 days) and subsequently retrieved. |
| Substantial Equivalence (General) | Based on comparison to predicate devices for design, material, components, fundamental technology, and intended use. | - OptEase Filter: Substantially equivalent to OptEase Permanent Vena Cava Filter (except for retrievability option), TrapEase Permanent Vena Cava Filter, Recovery Filter System, and Günther Tulip™ Vena Cava Filter and Retrieval Set. - OptEase Retrieval Catheter: Substantially equivalent to Günther Tulip™ Vena Cava Filter and Retrieval Set and VISTA BRITE TIP® Guiding Catheter. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data for Retrieval Safety and Effectiveness):
- Sample Size:
- Prospective Clinical Study: n = 21 retrieval patients
- Retrospective Clinical Experience: n = 40 retrieval patients
- Data Provenance: The document does not explicitly state the country of origin.
- Prospective Clinical Study: Prospective
- Retrospective Clinical Experience: Retrospective
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on the number of experts used to establish ground truth for the clinical studies, nor their qualifications. The clinical data appears to be observational (retrieval attempts) rather than a consensus-based ground truth establishment by experts for specific outcomes.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set. The data presented are reported outcomes of retrieval procedures.
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
This section is not applicable. The device is a medical implant (vena cava filter) and its associated retrieval catheter, not an AI or imaging diagnosis system that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
For the clinical studies on retrieval, the "ground truth" is the observed clinical outcome of the retrieval procedure (e.g., successful retrieval, time to retrieval, filter capture and redeployment). It is not based on expert consensus, pathology, or separate outcomes data in the traditional sense of diagnostic studies. The safety and effectiveness are derived directly from the reported performance in patient cases.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The term "training set" is typically used for developing algorithms. In this context, the device's design, materials, and initial performance (in-vitro, animal testing) would constitute the development and validation phase, prior to clinical testing.
9. How the Ground Truth for the Training Set was Established
As there's no mention of a "training set" in the context of an algorithm, this question is not applicable. The development and design of the physical device would have been guided by engineering specifications, material science, and pre-clinical testing, rather than a "ground truth" derived from patient data in a training set.
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510(k)
Summary of Safety and Effectiveness
| Submitter: | Donna MarshallRegulatory Affairs Associate IICordis Corporation7 Powderhorn DriveWarren, NJ 07059 |
|---|---|
| Telephone: | 908-412-3844 |
| Fax | 908-412-3915 |
| e-mail address | dmarshal@crdus.jnj.com |
| Date Prepared: | December 29, 2003 |
General Provisions:
| Trade Name: | Cordis OptEase™ Vena Cava Filter |
|---|---|
| Common Name: | 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 Vena Cava Filter is substantially equivalent to:
- Cordis OptEase Permanent Vena Cava Filter and Introduction Kit (#K023116)
- Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit (#K000062 and #K020316)
- Recovery Filter System, Bard Peripheral Vascular, C.R. Bard, Inc. (#K031328)
- Günther Tulip™ Vena Cava Filter and Retrieval set, Cook Incorporated (#K032426)
- Cordis VISTA BRITE TIP® Guiding Catheter (#K965211)
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| 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 Updated 510(k) Sterility Review Guidance (K90-1); FinalGuidance for Industry and FDA, August 30, 2002, andFDA's Guidance for Cardiovascular Intravascular Filter 510(k)Submissions, dated November 26, 1999. |
|---|---|
| Indicationsfor Use forFilter: | The Cordis OptEase Vena Cava Filter is indicated for the prevention ofrecurrent pulmonary embolism via percutaneous placement in the inferiorvena cava in the following situations:Pulmonary thromboembolism when anticoagulants are contraindicated,Failure of anticoagulant therapy in thromboembolic diseases,Emergency treatment following massive pulmonary embolism whereanticipated,Chronic, recurrent pulmonary embolism where anticoagulant therapy hasfailed or is contraindicated.The OptEase Filter may be removed according to the instructions supplied inthe Section labeled: Optional Procedure for Filter Retrieval.The Angiographic Vessel Dilator is designed to provide angiographicvisualization and linear measurement of the vasculature when combined withthe delivery of radiopaque contrast media to the Vena Cava. |
| Indications forUse forRetrievalCatheter: | The Cordis OptEase Retrieval Catheter is indicated for the retrieval of theCordis OptEase Vena Cava Filter from the inferior vena cava. Retrieval of theOptEase Filter is possible only from the femoral vein approach. |
| DeviceDescription | The subject OptEase Filter is identical to the predicate OptEase PermanentVena Cava Filter with the exception of the addition of the retrievability optionto the labeling. The OptEase Vena Cava Filter is packaged with a filterintroduction kit that includes the Angiographic Vessel Dilator, a directionalfilter storage tube, catheter sheath introducer and obturator for safe andaccurate deployment of the filter.The subject OptEase Filter is substantially equivalent to the predicate devices(i.e., OptEase Permanent Vena Cava Filter, TrapEase Permanent Vena CavaFilter, Recovery Filter System, and Günther Tulip™ Vena Cava Filter andRetrieval Set). |
.
. . . .
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The subject OptEase Retrieval Catheter is an 80 cm long, 10F catheter with Device radiopaque tip. The subject device is packaged separately and is intended for Description the percutaneous retrieval of the OptEase Filter from the inferior vena cava (continued) when used with an appropriate Endovascular snare. The subject device is substantially equivalent to the predicates devices (i.e., the Günther Tulip™ Vena Cava Filter and Retrieval Set and the VISTA BRITE TIP® Guiding Catheter).
The safety and effectiveness of the Cordis OptEase Vena Cava Filter and the Performance OptEase Retrieval Catheter have been demonstrated via data collected from Data: in-vitro, animal and clinical testing and analyses. The safety of retrieval of the OptEase Filter was evaluated in a prospective clinical study (n = 21 retrieval patients) and in a retrospective clinical experience (n = 40 retrieval patients). In the prospective clinical study, the time to retrieval ranged from 5 - 14 days (mean implantation time of 11.1 ± 1.8 days). In the retrospective clinical experience, the time to retrieval ranged from 3 - 48 days in 29 patients (mean implantation time of 16.4 ± 7.2 days). Eleven patients in the retrospective clinical experience had their filter captured from the vessel wall and then redeployed at the different location within the inferior vena cava (capture time ranged from 4 - 30 days, mean of 13.8 ± 6.1 days). The OptEase Filter was subsequently retrieved from this subset of patients.
The design, material, components, and fundamental technology featured with Summary of the Cordis OptEase Vena Cava are substantially equivalent to those featured Substantial with the predecessor Cordis OptEase Permanent Vena Cava Filter and Equivalence Introduction Kit and the Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit. In addition, the intended use for the OptEase Vena Cava Filter is substantially equivalent with the Recovery Filter System and the Günther Tulip Vena Cava Filter and Retrieval Set.
The design and materials of the OptEase Retrieval Catheter are substantially equivalent to the VISTA BRITE TIP Guiding Catheter. The intended use for OptEase Retrieval Catheter is substantially equivalent to the Günther Tulip Vena Cava Filter and Retrieval Set.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Cordis Corporation c/o Ms. Donna Marshall Regulatory Affairs Associate II 7 Powder Horn Drive Warren, NJ 07059
Re: K034050
Trade Name: Cordis OptEase™ Vena Cava Filter and Optease TM Retrievable Catheter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: II (two) Product Code: DTK Dated: December 29, 2003 Received: December 30, 2003
Dear Ms. Marshall:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Donna Marshall
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. La due
W. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K034050
Device Name: Cordis OptEase™ Vena Cava Filter and OptEase™ Retrieval Catheter
Indications 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. .
- . 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna P. Lodine.
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number Lo34 050
Page 1 of 1
§ 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.”