(41 days)
The Günther Tulip Filter implant is intended for the prevent 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 PE where anticipated benefits of conventional therapy are reduced; and
- · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.
The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.
The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.
The provided text is related to a 510(k) premarket notification for a medical device called the "Günther Tulip® Vena Cava Filter Set." This document focuses on demonstrating that the updated device is substantially equivalent to a previously cleared predicate device. It explicitly states that no performance testing was warranted for this submission because no changes were made to the device's design, manufacturing, sterilization, or principles of operation.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance results, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device's performance evaluation. The submission relies on the performance data from the predicate device (K172557).
To answer your request, if this were a submission requiring new performance testing for an AI/ML medical device, the following information would be necessary:
Hypothetical Study Information (Illustrative, NOT based on the provided document)
Since the provided document states "No performance testing was warranted," I cannot extract the requested information. However, if this were an AI/ML device requiring performance evaluation, the following is an example of what would be expected for a submission.
Acceptance Criteria and Device Performance (Hypothetical Example for an AI/ML Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Metric | Acceptance Threshold | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Sensitivity | ≥ 90% | 92.5% | Yes |
| Specificity | ≥ 85% | 88.2% | Yes |
| Positive Predictive Value (PPV) | ≥ 80% | 81.0% | Yes |
| Negative Predictive Value (NPV) | ≥ 95% | 96.8% | Yes |
| Area Under the ROC Curve (AUROC) | ≥ 0.90 | 0.93 | Yes |
| Algorithm Latency | < 5 seconds per image | 2.1 seconds per image | Yes |
2. Sample Size and Data Provenance
- Test Set Sample Size: 500 cases (e.g., medical images or patient records).
- Data Provenance: Retrospective, multi-center data collected from hospitals in the United States (40%), Europe (30%), and Asia (30%). Care was taken to include diverse patient demographics and disease prevalence.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: 3 independent expert readers.
- Qualifications: All experts were board-certified radiologists with at least 10 years of experience in the relevant modality (e.g., diagnostic imaging for venous thromboembolism) and had specific expertise in the condition being assessed.
4. Adjudication Method for the Test Set
- Adjudication Method: 2+1 Adjudication. Initial independent reads by two experts. If their assessments disagreed, a third, senior expert independently reviewed the case, and their decision served as the tie-breaker and final ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted: Yes.
- Effect Size of Human Reader Improvement:
- Average Sensitivity Improvement with AI Assistance: +8.5% (from 80% without AI to 88.5% with AI).
- Average Specificity Improvement with AI Assistance: +4.2% (from 85% without AI to 89.2% with AI).
- Average Reading Time Reduction with AI Assistance: 15% faster per case.
- Overall Diagnostic Accuracy Improvement (AUROC): Relative improvement of 5% in reader AUROC on challenging cases.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done: Yes. The "Reported Device Performance" in the table above reflects the standalone (algorithm-only) performance results on the independent test set.
7. Type of Ground Truth Used
- Type of Ground Truth: Consensus expert adjudication was the primary ground truth for the test set. For a subset of cases (e.g., 20%), pathological confirmation or long-term clinical outcomes data were also available and used to corroborate the expert consensus.
8. Sample Size for the Training Set
- Training Set Sample Size: 15,000 cases (medical images/records).
9. How Ground Truth for the Training Set was Established
- Training Set Ground Truth Establishment:
- Initial Annotation: Cases were initially annotated by a team of trained clinical annotators under the supervision of a senior radiologist.
- Expert Review/Validation: A subset of these annotations (approximately 20%) was randomly selected and reviewed by a board-certified radiologist to ensure quality and consistency.
- Automated Cross-Referencing: Where available, ground truth was further enriched or validated through cross-referencing with electronic health records (EHRs), surgical reports, or lab results (e.g., for confirmed diagnoses).
- Iterative Refinement: During the model development process, cases that frequently led to model errors were re-reviewed by experts to refine and confirm the ground truth labels.
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July 28, 2021
William Cook Europe ApS Mie Dyrholm, Director of Regulatory Affairs Sandet 6, Bjaeverskov, 4632 Denmark
Re: K211874
Trade/Device Name: Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip® Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: June 16, 2021 Received: June 17, 2021
Dear Mie Dyrholm:
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.
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211874
Device Name
Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach Günther Tulip® Vena Cava Filter Set for Jugular Vein Approach Günther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach
Indications for Use (Describe)
INTENDED USE
The Günther Tulip Filter implant is intended for the prevent 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 PE where anticipated benefits of conventional therapy are reduced; and
- · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.
The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.
The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
| 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 | K211874 |
|---|---|
| Date Prepared: | July 27, 2021 |
| Submitted By: | William Cook Europe ApS |
| Sandet 6 | |
| 4632 Bjaeverskov, Denmark | |
| Contact: | Mie Dyrholm |
| Phone: | +45 56 86 84 92 |
| Fax: | +45 56 86 85 68 |
| Email: | Mie.Dyrholm@CookMedical.com |
| Device: | |
| Trade Name: | Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach |
| Günther Tulip® Vena Cava Filter Set for Jugular Vein Approach | |
| Günther Tulip® Vena Cava Filter Set for Femoral and Jugular VeinApproach | |
| Common Name: | Inferior Vena Cava Filter |
| Classification Name: | Filter, Intravascular, Cardiovascular |
| Regulation/Product Code: | 21 CFR Part 870.3375 / DTK |
| Classification/Panel: | Class II / Cardiovascular |
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Predicate Devices:
The subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices, the Günther Tulip Vena Cava Filter Sets (K172557, cleared 20 November 2017).
Comparison to Predicate Device:
It has been demonstrated that the subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate Günther Tulip Vena Cava Filter Sets (K172557). The subject devices are identical to the predicate devices in terms of intended use, principles of operation, materials, design, manufacturing, packaging, and sterilization. The device labeling has been updated based on post-market surveillance information and updated documentation in the risk management system.
Device Description:
The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.
Indications for Use:
The Günther Tulip Filter implant 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 PE where anticipated benefits of ● conventional therapy are reduced; and
- . Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.
The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.
The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
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Performance Testing:
No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, no performance testing was not warranted, and the testing provided for the predicate submission (K172557) remains supportive.
Conclusion:
The subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices (K172557). No changes have been made to the IVC filter implant or the delivery systems. Only the device labeling has been updated based on post-market surveillance information and updated documentation in the risk management system.
§ 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.”