(297 days)
Not Found
No
The summary describes a physical medical device (a vena cava filter) and its mechanical properties and performance, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is intended for the prevention of recurrent pulmonary embolism, treating a medical condition and aimed at restoring health.
No
The device, a vena cava filter, is designed for the prevention of pulmonary embolism by physically filtering blood, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable filter constructed from a biocompatible alloy, intended for percutaneous placement. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems.
- Device Description: The Cook Celect Vena Cava Filter is a physical implantable device designed to be placed directly into the vena cava to filter blood and prevent pulmonary embolism. It does not examine specimens outside the body.
- Intended Use: The intended use is for the prevention of recurrent pulmonary embolism by physically filtering blood within the vena cava. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, the Cook Celect Vena Cava Filter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cook Celect Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
- Failure of anticoagulant therapy in thromboembolic diseases; .
- Emergency treatment following massive pulmonary embolism when . anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism when anticoagulant therapy has . failed or is contraindicated.
The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary thromboembolism. The filter is compatible with placement in vena cava diameters between 15 and 30 mm.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The Cook Celect Vena Cava Filter is an inferior vena cava filter, intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm. The Cook Celect Vena Cava Filter is constructed from a biocompatible alloy. The filter is 46 mm long along its main axis, and, when unrestrained, the legs will expand radially to a base diameter of over 32 mm. The design of the Cook Celect Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs. The secondary legs are the filter wires, distributed to catch thrombi in the caval bloodstream and they are shaped to assist in promote centering of the filter within the vena cava.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava, IVC (inferior vena cava), jugular vein, femoral vein
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 testing that has been conducted on the Cook Celect Vena Cava Filter has demonstrated that this device is substantially equivalent to the predicate device. Bench and animal testing has been performed using the Cook Celect Vena Cava Filter, and the results have been compared with the predicate device. Both devices were tested for mechanical properties as well as the safety and performance of these devices, in vitro and in vivo. All the testing conducted demonstrates that the Cook Celect Vena Cava Filter exhibits the same safety and performance qualities of the predicate device.
The following bench testing has been performed:
-
- Mechanical characteristics
-
- Performance characteristics
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.
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.
Not Found
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
§ 870.3375 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
COOK Celect TM Vena Cava Filter 510(k) - Premarket Notification
K061815
p. 1 of 3
Cook Incorporated
P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
APR 2 0 2007
510(k) Summary
510(k) Owner: Address:
Phone Number: Fax Number:
Contact: Contact Address:
Contact Phone Number: Contact Fax Number:
Date 510(k) Summary Prepared:
Trade name: Common name: Classification name: William Cook Europe, ApS Sandet 6, DK-4632 Bjaeverskov, Denmark
011-45-56-86-86-86 011-45-56-86-86-96
Thalia Brine Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 812-339-2235 812-332-0281
26 June 2006
Cook Celect™ Vena Cava Filter Inferior Vena Cava Filter Cardiovascular intravascular filter 21 CFR 870.3375, Product Code DTK
Substantial Equivalence:
The Cook Celect Vena Cava Filter is substantially equivalent to the Günther Tulip Vena Cava Filter (#K000855, cleared on 18 October 2000), which is currently marketed. The Cook Celect Vena Cava Filter, the subject of this submission, is based on the design of the Gunther Tulip Vena Cava Filter, with key similarities to the Tulip design. The similar indications for use, principles of operation, technological characteristics and results of performance testing of the Cook Celect Vena Cava Filter as compared to the predicate device support a determination of substantial equivalence.
1
COOK Celect TM Vena Cava Filter 510(k) - Premarket Notification
Device Description:
The Cook Celect Vena Cava Filter is an inferior vena cava filter, intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm. The Cook Celect Vena Cava Filter is constructed from a biocompatible alloy. The filter is 46 mm long along its main axis, and, when unrestrained, the legs will expand radially to a base diameter of over 32 mm. The design of the Cook Celect Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs. The secondary legs are the filter wires, distributed to catch thrombi in the caval bloodstream and they are shaped to assist in promote centering of the filter within the vena cava.
Intended Use:
The Cook Celect Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulant therapy is contraindicated; �
- Failure of anticoagulant therapy in thromboembolic diseases; .
- Emergency treatment following massive pulmonary embolism when . anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism when anticoagulant therapy has . failed or is contraindicated.
The filter is intended for percutaneous placement via either the jugular vein or femoral vein. The filter is compatible with placement in vena cava with measured diameters in the range of 15 mm to 30 mm. The filter is intended for one time use.
Technological Characteristics:
Key Similarities:
The majority of the Cook Celect Vena Cava Filter components are identical to the predicate device and the design of the filter is substantially similar.
Key Differences:
The design of the secondary legs of the Cook Celect filter has been modified.
Non-clinical Testing:
The testing that has been conducted on the Cook Celect Vena Cava Filter has demonstrated that this device is substantially equivalent to the predicate device. Bench and animal testing has been performed using the Cook Celect Vena Cava
2
Filter, and the results have been compared with the predicate device. Both devices were tested for mechanical properties as well as the safety and performance of these devices, in vitro and in vivo. All the testing conducted demonstrates that the Cook Celect Vena Cava Filter exhibits the same safety and performance qualities of the predicate device.
The following bench testing has been performed:
-
- Mechanical characteristics
-
- Performance characteristics
3
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2007
Cook Incorporated c/o Ms. Thalia Brine Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402-0489
Re: K061815
Trade/Device Name: Cook Celect™ Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: April 10, 2007 Received: April 11, 2007
Dear Ms. Brine:
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.
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
4
Page 2 - Ms. Thalia Brine
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D . Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
COOK Celect ™ Vena Cava Filter 510(k) - Premarket Notification
4. Indications for Use Statement
510(k) Number (if known): K061815
Device Name: Cook Celect™ Vena Cava Filter
Indications for Use:
The Cook Celect Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
- Failure of anticoagulant therapy in thromboembolic diseases; .
- Emergency treatment following massive pulmonary embolism when . anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism when anticoagulant therapy has . failed or is contraindicated.
The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary thromboembolism. The filter is compatible with placement in vena cava diameters between 15 and 30 mm.
Prescription Use X (Per 21 CFR 801 Subpart D) OR Over-the-Counter Use (Per 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)
Meka Mun
(Division Sign-Off) /
Division of Cardiovascular Devices
510(k) Number K061815