(96 days)
Not Found
No
The description focuses on the mechanical components and performance of a physical retrieval device, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is intended to manipulate and retrieve foreign objects within the cardiovascular system, which is a direct treatment or intervention for a medical condition.
No
The device is described as a "Vascular Retrieval Snare" intended to "manipulate and retrieve foreign objects" in the cardiovascular system, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components made of nitinol and tantalum, a coaxial sheath system, and a dilator. The performance studies also focus on physical properties and performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in the cardiovascular system to manipulate and retrieve foreign objects." This describes a procedure performed within the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (snare, sheaths, dilator) designed for mechanical manipulation within the cardiovascular system. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical retrieval within the body.
N/A
Intended Use / Indications for Use
The Vascular Retrieval Snare is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including, but not limited to, wire guides, coils, balloons, catheters, and filters.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
The Vascular Retrieval Snare consists of four petals composed of nitinol and tantalum. It is packaged with a coaxial sheath system and a dilator. Each of the sheaths of the coaxial system has radiopaque tips incorporated to identify the location of the distal tip of each sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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 following tests were performed to demonstrate that the Vascular Retrieval Snare meets applicable design and performance requirements and supports a determination of substantial equivalence. Additionally, appropriate engineering tests were also performed on aged product to ensure that the Vascular Retrieval Snare meets the performance requirements throughout the duration of shelf life.
- Tensile Strength Testing shows the tensile strength during proper clinical use should not fracture or rupture the sheaths, catheter, or dilator. In conformance with the applicable sections of ISO 11070 and ISO 10555-1, the predetermined acceptance criteria were met.
- Liquid Leakage Testing shows there would be no liquid leakage from the catheter and sheath during proper clinical use. In conformance with the applicable sections of ISO 11070, the predetermined acceptance criteria were met.
- Deployment and Retrieval Testing shows the device can grab and grasp foreign objects from a model and retrieves them in simulated clinical use. The predetermined acceptance criteria were met.
- Kink Testing shows the catheter, dilator, and sheaths should not kink during proper clinical use. The predetermined acceptance criteria were met.
- Opening and Closing Measurement Testing shows the device can repeatedly open and close the basket width during proper clinical use. The predetermined acceptance criteria were met.
- Retraction Force Testing shows the snare can be retracted during proper clinical use. The predetermined acceptance criteria were met.
- Radiopacity Testing shows that the applicable portions of the device shall be radiopaque during proper clinical use.
- Packaging Validation Testing shows the packaging system shall maintain packaging integrity. The predetermined acceptance criteria were met.
- Biocompatibility Testing shows the device is biocompatible. In conformance with the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate devices and supports a determination of substantial equivalence.
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
Cook Incorporated FourSnare Vascular Retrieval Snare Traditional 510(k) 12 October 2011
K112185 page 1 of 3
46
NOV - 2 2011
1. 510(k) Summary
FourSnare™ Vascular Retrieval Snare 510(k) Summary 21 CFR 807.92
1. Submitter Information:
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47402 | |
| Phone Number: | (800) 468-1379 |
| Fax Number: | (812) 332-0281 |
Molly Busenbark, MA, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47402 812-339-2235 Ext. 2162 812-332-0281
2. Device Information:
Contact Phone Number:
Contact Fax Number:
Contact:
Contact Address:
| Trade name: | FourSnare™ Vascular Retrieval Snare |
|---|---|
| Common name: | Embolectomy catheter |
| Classification: | Class II |
| Regulation: | 21 CFR 870.5150 |
| Product Code: | MMX |
3. Predicate Device:
Cook Incorporated's FourSnare "Vascular Retrieval Snare, hereafter referred to as Vascular Retrieval Snare, or VRS, is substantially equivalent to the EN Snare Endovascular Snare System originally manufactured by Merit Medical under 510(k) clearance number K092343 and the Gunther Tulip Vena Cava Filter Retrieval Set originally manufactured by Cook Incorporated under 510(k) clearance number K073374.
4. Comparison to Predicate Device:
It has been demonstrated that the Vascular Retrieval Snare is comparable to the predicate devices in terms of design, intended use, materials, fundamental technology, and principal of operation.
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K112185 page 2 of $\frac{47}{3}$
Cook Incorporated FourSnare Vascular Retrieval Snare Traditional 510(k) 12 October 2011
5. Device Description:
The Vascular Retrieval Snare consists of four petals composed of nitinol and tantalum. It is packaged with a coaxial sheath system and a dilator. Each of the sheaths of the coaxial system has radiopaque tips incorporated to identify the location of the distal tip of each sheath.
6. Intended Use:
The Vascular Retrieval Snare is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including, but not limited to, wire guides, coils, balloons, catheters, and filters.
7. Technological Characteristics:
The proposed Vascular Retrieval Snare contains a nitinol/tantalum snare basket (consisting of four loops) encased in a radiopaque TFE snare catheter, a nylon radiopaque inner sheath with radiopaque marker bands, a vinyl outer sheath with radiopaque marker bands and a polyethylene dilator. The nitinol/tantalum snare basket is used to manipulate and retrieve foreign objects from the vasculature. The technical characteristics of the VRS are substantially equivalent to the EN Snare Endovascular Snare System and the Günther Tulip Vena Cava Filter Retrieval Set because all three devices have components that function to manipulate and retrieve foreign objects from the vasculature.
The proposed Vascular Retrieval Snare was subjected to applicable testing to assure reliable design and performance under the testing parameters.
8. Test Data:
The following tests were performed to demonstrate that the Vascular Retrieval Snare meets applicable design and performance requirements and supports a determination of substantial equivalence. Additionally, appropriate engineering tests were also performed on aged product to ensure that the Vascular Retrieval Snare meets the performance requirements throughout the duration of shelf life.
- Tensile Strength Testing shows the tensile strength during proper clinical use ୍ତ should not fracture or rupture the sheaths, catheter, or dilator. In conformance with
2
K112185 page 3 of 3
48
Cook Incorporated Cook Incorporated
FourSnare Vascular Retrieval Snare Traditional 510(k) 12 October 2011
the applicable sections of ISO 11070 and ISO 10555-1, the predetermined acceptance criteria were met.
- Cincha were mor.
Liquid Leakage Testing shows there would be no liquid leakage from the catheter 。 Liquid Leasure - Forming and 10 mm
and sheath during proper clinical use. In conformance with the applicable sections of ISO 11070, the predetermined acceptance criteria were met. - 150 11070, the proceterialited and grasp foreign objects from a model . to simulated Ober I use. The predetermined acceptance criteria were met.
- to shindiate eningar abows the catheter, dilator, and sheaths should not kink during . proper clinical use. The predetermined acceptance criteria were met.
- propor enmined asset with Testing shows the device can repeatedly . Opening and close the basket width during proper clinical use. The predetermined acceptance criteria were met. .
- accopained critical with the snare can be retracted during proper � clinical use. The predetermined acceptance criteria were met.
- omnour also! Testing shows that the applicable portions of the device shall be . radiopaque during proper clinical use.
- Packaging Validation Testing shows the packaging system shall maintain packaging . integrity. The predetermined acceptance criteria were met.
- micegny. The prodoterains and the device is biocompatible. In conformance with . Diocompanismly - February - 1 county - 1 the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe III concrusion, are reviews and supports a determination of substantial equivalence.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 2 2011
Cook Inc. c/o Ms. Molly Busenbark 750 Daniels Way Bloomington, IN 47402
Re: K112185
Trade/Device Name: Four Snare Vascular Retrieval Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II (two) Product Code: MMX Dated: October 12, 2011 Received: October 13, 2011
Dear Ms. Busenbark:
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. 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
4
Page 2 – Ms. Molly Busenbark
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
//
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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K112185 page 1 of 1
Cook Incorporated Cook Incorporated
FourSnare Vascular Retrieval Snare Traditional 510(k) 12 October 2011
- Indications for Use Statement
510(k) Number (if known): ≤112185
Device Name: FourSnare™ Vascular Retrieval Snare
Indications for Use:
్ర
The Vascular Retrieval Snare is intended for use in the cardiovascular system to manipulate and I he Vascular Retrieval Share is mossess.
retrieve foreign objects, including, but not limited to, wire guides, coils, balloons, catheters, and filters.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off)
| Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | K112185 |
Concurrence of CDRH, Office of Device Evaluation (ODE)