(127 days)
Not Found
No
The description focuses on mechanical components and manual operation for filter retrieval, with no mention of AI or ML capabilities.
No
The device is described as a "retrieval set" for implanted filters, indicating its purpose is to remove, rather than treat, a condition or disease.
No
The device is described as a retrieval set for vena cava filters, which is a therapeutic rather than a diagnostic function. There is no indication of it being used for diagnosis of any condition.
No
The device description explicitly lists multiple hardware components (retrieval loop system, sheath system, needle, wire guide, dilator, radiopaque band).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the retrieval of implanted medical devices (vena cava filters) from within the patient's body. This is a therapeutic or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device components (retrieval loop, sheath, needle, wire guide, dilator) are all designed for physical manipulation and removal of an implanted object within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside that definition.
N/A
Intended Use / Indications for Use
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
The Günther Tulip Vena Cava Filter Retrieval Set consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath.
The Günther Tulip Vena Cava Filter Retrieval Set is supplied sterile in a peel-open package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vena Cava
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 dimensional change, packaging change, and 3-year shelf life extension were supported by the following performance testing which demonstrated that the Günther Tulip Vena Cava Filter Retrieval Set met applicable design and performance requirements and support a determination of substantial equivalence:
- Performance testing (dimensional, functionality, and tensile testing)
- Distribution testing
- Performance testing (dimensional, functionality, and tensile testing) and package integrity and seal strength testing on 3-year accelerated aged devices
- Simulated use testing on 3-year accelerated aged devices
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 6, 2018
Cook Incorporated Dr. Jennifer Brown, PhD, RAC Director, Global Regulatory Science, Vascular Division 1 Geddes Way West Lafayette, Indiana 47906
Re: K181757
Trade/Device Name: Günther Tulip Vena Cava Filter Retrieval Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: October 4, 2018 Received: October 5, 2018
Dear Dr. Brown:
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.
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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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, Date: 2018.11.06 Eleni Whatley 10:30:36 -05'00' For 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) K181757
Device Name
Günther Tulip Vena Cava Filter Retrieval Set
Indications for Use (Describe)
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) Number: | K181757 |
|---|---|
| Date Prepared: | 29 June 2018 |
| Submitted By: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact: | Jennifer Brown, Ph.D., RAC |
| Director, Global Regulatory Science, Vascular Division | |
| Phone: | (765) 463-7537 |
| Fax: | (765) 497-0641 |
| Email: | JenniferA.Brown@CookMedical.com |
Device:
| Trade Name: | Günther Tulip® Vena Cava Filter Retrieval Set |
|---|---|
| Common Name: | Inferior Vena Cava Filter Retrieval Set |
| Review Panel: | Cardiovascular |
| Classification Name: | Device, Percutaneous Retrieval (21 CFR 870.5150, |
| Product Code MMX) | |
| Classification: | Class II |
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Indications for Use:
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
Predicate Device:
The Günther Tulip Vena Cava Filter Retrieval Set is substantially equivalent to the predicate device:
- . Günther Tulip Vena Cava Filter Retrieval Set cleared under K073374 on 07 March 2008.
Comparison to Predicate Device:
It has been demonstrated that the subject Günther Tulip Vena Cava Filter Retrieval Set is substantially equivalent to the predicate Günther Tulip Vena Cava Filter Retrieval Set (K073374). Minor changes have been made to the Günther Tulip Vena Cava Filter Retrieval Set; specifically, the dimensions and material of the core wire of the braided platinum wire loop have changed, the outer packaging materials were updated, and the shelf life was extended from 2 years to 3 years. Otherwise, the Günther Tulip Vena Cava Filter Retrieval Set is identical to the predicate device in terms of indications for use, principles of operation, overall design, manufacturing process, sterilization process, and basic technological characteristics. In addition, this submission describes updates to device labeling based on safety and performance information gathered from post-market experience and to align with current international and regulatory standards.
Device Description:
The Günther Tulip Vena Cava Filter Retrieval Set consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath.
The Günther Tulip Vena Cava Filter Retrieval Set is supplied sterile in a peel-open package.
Performance Testing:
The dimensional change, packaging change, and 3-year shelf life extension were supported by the following performance testing which demonstrated that the Günther Tulip Vena Cava Filter
5
Retrieval Set met applicable design and performance requirements and support a determination of substantial equivalence:
- Performance testing (dimensional, functionality, and tensile testing) ●
- . Distribution testing
- Performance testing (dimensional, functionality, and tensile testing) and package . integrity and seal strength testing on 3-year accelerated aged devices
- . Simulated use testing on 3-year accelerated aged devices
The material change to the core wire, which is associated with a long history of clinical use in vascular applications and is non-patient contacting, did not require additional performance testing in excess of the performance testing discussed above. No changes to the overall design, manufacturing, sterilization, or principles of operation have been introduced with the subject device; therefore, no additional performance testing was considered necessary.
Summary of Device Labeling Changes:
Device labeling changes were made to reflect added or changed safety information based on post-market surveillance, clinical study data, and information published in regulatory communications and the international test standard on vena cava filters (ISO 25539:2011). The following sections of the Instructions for Use (IFU) were impacted by the labeling changes: Device Description, Warnings, Precautions, Potential Adverse Events, Clinical Studies, step-bystep Instructions for Use, and References.
Conclusion:
The Günther Tulip Vena Cava Filter Retrieval Set is substantially equivalent to the predicate device. The changes being made include a dimensional and material change to the core of the braided platinum loop, an outer material packaging change, an extension of the device shelf life, and updates to device labeling.