(293 days)
Not Found
No
The summary describes a mechanical retrieval device and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The explicit function of the device is for the retrieval of an implanted filter, not for treating a disease or condition itself. While removing the filter might be part of a larger therapeutic process, the device's direct action is mechanical retrieval.
No
The device description clearly states its purpose is for "retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters," which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (retrieval loop system, sheath system, needle, wire guide, dilator) and describes physical testing (biocompatibility, dimensional verification, leakage, tensile) which are characteristic of a hardware medical device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Günther Tulip Vena Cava Filter Retrieval Set." Its intended use is to physically retrieve an implanted medical device (a vena cava filter) from within the patient's body.
- No Sample Analysis: The device does not involve the analysis of any biological samples taken from the patient. It is a surgical tool used for a physical procedure.
Therefore, based on the provided information, this device falls under the category of a surgical or interventional medical device, not an in vitro diagnostic.
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
MMX
Device Description
The Günther Tulip Vena Cava Filter Retrieval Set is composed 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 intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter.
The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.
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)
No performance standards have been established under section 514 performance standards, of the Food, Drug and Cosmetic Act for these devices. However, nonclinical tests identified to assess the impact of proposed material and additive changes were performed on the Günther Tulip Vena Cava Filter Retrieval Set to demonstrate that the device meets continues to meet critical design specifications. The Günther Tulip Vena Cava Filter Retrieval Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Biocompatibility Testing Testing was performed in accordance with BS EN ISO . 10993-1:2009. The materials and methods used to manufacture the subject device are non-toxic and met the acceptance criteria for their intended use. Testing included: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility
- Dimensional Verification Testing .
- . Leakage Testing (Time Zero and 3-year Accelerated Aged)
- Tensile Testing .
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 16, 2023
Cook Incorporated Daniel Corbin Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K222254
Trade/Device Name: Gunther Tulip Vena Cava Filter Retrieval Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: MMX Dated: April 6, 2023 Received: April 7, 2023
Dear Daniel Corbin:
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
1
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 medical devices and radiation-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,
Digitally signed by
Gregory W. Gregory W. O'connell -
S
O'connell -S Date: 2023.05.16
10:00:11 -04'00'
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
2
Indications for Use
510(k) Number (if known) K22254
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font. Below "COOK" is the word "MEDICAL" in white, sans-serif font, set against a black background.
510(k) SUMMARY
Submitted Bv:
COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Daniel Corbin Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 325-4172 Fax: (812) 332-0281 Date Prepared: July 26, 2022
Device:
| Trade Name: | Günther Tulip Vena Cava Filter Retrieval
Set |
|----------------------|----------------------------------------------------------|
| Common Name: | Inferior Vena Cava Filter Retrieval Set |
| Classification Name: | Device, Percutaneous Retrieval
MMX (21 CFR §870.5150) |
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 K181757 on 06 November 2018.
Comparison to Predicate Device:
It has been demonstrated that the Günther Tulip Vena Cava Filter Retrieval Set is substantially equivalent to the predicate device Günther Tulip Vena Cava Filter Retrieval Set (K181757) in terms of intended use, principles of operation, and basic technological characteristics.
4
Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters, stacked on top of the word "MEDICAL" in smaller, white, block letters. The words are set against a red background. The bottom left corner of the red background is cut off at an angle.
O DANIELS WAY, P.O. BOX MINGTON IN 47402-0489 II S 12.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.CO
Modifications from the predicate device include: a change to the material used to construct the dilator, and a change from a latex to silicone for the o-ring in the side-arm fitting assembly. The substantially equivalent safety and effectiveness outcomes of the subject device are supported by performance and biocompatibility testing.
Device Description:
The Günther Tulip Vena Cava Filter Retrieval Set is composed 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 intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter.
The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.
There are no prior submissions for the subject device.
Performance Test Data (non-clinical):
No performance standards have been established under section 514 performance standards, of the Food, Drug and Cosmetic Act for these devices. However, nonclinical tests identified to assess the impact of proposed material and additive changes were performed on the Günther Tulip Vena Cava Filter Retrieval Set to demonstrate that the device meets continues to meet critical design specifications. The Günther Tulip Vena Cava Filter Retrieval Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Biocompatibility Testing Testing was performed in accordance with BS EN ISO . 10993-1:2009. The materials and methods used to manufacture the subject device are non-toxic and met the acceptance criteria for their intended use. Testing included: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility
- Dimensional Verification Testing .
- . Leakage Testing (Time Zero and 3-year Accelerated Aged)
- Tensile Testing .
5
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, above the word "MEDICAL" in white, sans-serif font. Both words are on a red background. The word "COOK" has a registered trademark symbol after it.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
Summary of Substantial Equivalence:
Based on the indications for use, design, safety and performance testing the Günther Tulip Vena Cava Filter Retrieval Set meet the requirements for its intended use and are substantially equivalent to the predicate device (K181757).