(83 days)
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No
The document describes a physical medical device (a vena cava filter and retrieval system) and its intended use, without mentioning any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for the prevention of recurrent pulmonary embolism, which is a medical condition, and it achieves this by being placed in the vena cava to filter emboli.
No
The device, OPTEASE Filter, is indicated for prevention and treatment of pulmonary embolism and for retrieval of the filter, which are therapeutic and interventional actions. While it uses angiographic visualization, this is for guidance during placement and retrieval, not for diagnosing a condition.
No
The device description clearly outlines physical components including a vena cava filter, introduction kit, angiographic vessel dilator, catheter sheath introducer, obturator, and retrieval catheter. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for the prevention of pulmonary embolism by being placed in the vena cava. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical filter and associated delivery/retrieval catheters designed to be implanted in a blood vessel. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Anatomical Site: The device is placed in the inferior vena cava, which is an internal anatomical site. IVDs analyze samples taken from the body (like blood, urine, tissue), not devices placed directly within the body.
- No mention of analyzing biological samples: The description focuses on the mechanical function of the filter and its placement/retrieval. There is no mention of analyzing blood, tissue, or any other biological sample.
In summary, the OPTEASE Filter and its associated components are designed for therapeutic intervention within the body, not for diagnostic testing of biological samples outside the body.
N/A
Intended Use / Indications for Use
The Cordis OptEase 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, Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The OptEase Filter may be removed 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.
Product codes
DTK
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Inferior Vena Cava, vasculature
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Cordis OptEase Vena Cava Filter and the OptEase Retrieval Catheter have been demonstrated via data collected from 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.
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.
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)
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k)
Summary of Safety and Effectiveness
| Submitter: | Donna Marshall
Regulatory Affairs Associate II
Cordis Corporation
7 Powderhorn Drive
Warren, 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)
1
| 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
Guidance for Industry and FDA, August 30, 2002, andFDA's Guidance for Cardiovascular Intravascular Filter 510(k)
Submissions, dated November 26, 1999. |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use for
Filter: | The Cordis OptEase 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,Chronic, recurrent pulmonary embolism where anticoagulant therapy has
failed or is contraindicated.The OptEase Filter may be removed 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. |
| Indications for
Use for
Retrieval
Catheter: | 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. |
| Device
Description | 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). |
.
. . . .
2
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.
3
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.
4
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
5
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
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