(127 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Günther Tulip Vena Cava Filter Retrieval Set:
Based on the provided text, this submission (K181757) is for minor changes to an already cleared device, not an entirely new device requiring extensive clinical trials to prove effectiveness/safety. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the modified device remains substantially equivalent to its predicate device (K073374) despite the changes. There isn't a table of specific clinical acceptance criteria (like sensitivity/specificity for an AI device) because this is a mechanical device update, not a diagnostic algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical/Physical Integrity & Functionality: Device maintains intended design and operational characteristics despite dimensional/material changes to core wire. | Performance testing (dimensional, functionality, and tensile testing): Demonstrated that the Günther Tulip Vena Cava Filter Retrieval Set met applicable design and performance requirements. The material change to the core wire was associated with a long history of clinical use in vascular applications and is non-patient contacting; no additional performance testing beyond the generic tests was deemed necessary as no changes to overall design, manufacturing, sterilization, or principles of operation were introduced. |
| Packaging Integrity: Outer packaging material change does not compromise sterility or device integrity. | Distribution testing: Confirmed packaging effectiveness. Package integrity and seal strength testing: Performed on 3-year accelerated aged devices, demonstrating suitable integrity. |
| Shelf Life Extension: Device maintains performance and sterility over an extended shelf life of 3 years. | Performance testing (dimensional, functionality, and tensile testing) and package integrity and seal strength testing on 3-year accelerated aged devices: These tests demonstrated the device maintained its required performance and sterility over the extended shelf life. Simulated use testing on 3-year accelerated aged devices: Further supported the extended shelf life by showing the device functioned as intended after accelerated aging. |
| Labeling Adequacy: Updated labeling reflects current safety/performance information and regulatory standards. | 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). Impacted sections include Device Description, Warnings, Precautions, Potential Adverse Events, Clinical Studies, step-by-step Instructions for Use, and References. This indicates that the labeling was updated to meet current standards and reflect available data. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not applicable in the context of human data. The "test set" here refers to the physical devices undergoing various engineering and accelerated aging tests. The text does not specify the exact number of devices tested for each performance test (dimensional, functionality, tensile, distribution, package integrity, simulated use).
- Data Provenance: Not applicable in the context of human data. The tests described are laboratory/benchtop performance tests on the physical device. The material change to the core wire is noted to have a "long history of clinical use in vascular applications," which refers to general material knowledge rather than specific data provenance for this device modification study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. This study focuses on engineering and benchtop performance of a physical medical device, not on interpreting images or patient data to establish a ground truth that would require medical experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This study involves objective performance testing of a physical device. There is no subjective interpretation requiring an adjudication process.
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
- MRMC Study: No, an MRMC study was not done. The device is a physical medical instrument (vena cava filter retrieval set), not an AI algorithm or a diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, this is not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is based on accepted engineering standards, predetermined design specifications, and performance requirements for medical devices. For example, the ground truth for tensile strength would be a minimum force it must withstand, or for package integrity, it would be a "pass/fail" based on established testing protocols. The "long history of clinical use" for the core wire material serves as a form of "ground truth" regarding its safety and suitability for vascular applications.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI device or a study involving a "training set" in the machine learning sense. The device is a physical instrument.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. There is no training set mentioned or implied in this submission, as it is not an AI/machine learning device.
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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
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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 Incorporated750 Daniels WayBloomington, IN 47404 |
| Contact: | Jennifer Brown, Ph.D., RACDirector, 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
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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.
§ 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).