The Crux® Snare Filter Retrieval Set is an endovascular medical device indicated for the retrieval of the Crux® Vena Cava Filter (VCF) percutaneously via the jugular vein or femoral vein approach.

Device Description

The Crux® Snare Filter Retrieval Set consists of a 0.035" PTFE-coated guidewire, 18 gauge introducer needle, 8.2 F inner sheath with dilator, 10 F outer sheath, Crux Snare, introducer and torque tool. The components are designed to be used percutaneously to retrieve the Crux Vena Cava filter via either the jugular or femoral vein approach.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Crux® Snare Filter Retrieval Set. It details the device, its intended use, and a comparison to predicate and reference devices. However, the document does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria.

The document primarily focuses on:

Device identification and classification: Trade name, common name, product code, classification, and predicate/reference devices.
Device description: Components and how it's used.
Intended use: Retrieval of the Crux® Vena Cava Filter.
Performance data (Non-clinical): This section briefly mentions bench testing and biocompatibility testing.
- Bench Testing: Evaluated Visual, Dimensional, Hemostasis/Flushing/Compatibility, Radiopacity, Ability to access, and Bond Tensile against "known standards, product specification, or against the predicate device."
- Biocompatibility Testing: Successfully completed Cytotoxicity, Hemocompatibility (Hemolysis, PTT, Complement Activation, Platelet and Leukocyte Count, Thrombogenicity), Sensitization, Irritation, Systemic Toxicity, and Material Mediated Pyrogenicity.
Conclusion: The device is substantially equivalent to the predicate and reference device based on these tests.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these details are not present in the provided text.

The document states that bench testing was conducted against "known standards, product specification, or against the predicate device," but it does not elaborate on what those specific standards or specifications were, nor does it provide quantitative performance data against them.

Summary

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K133681

510(K) SUMMARY

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JAN 300 2014

SPONSOR:	Volcano Corporation2870 Kilgore RoadRancho Cordova, CA 95670
CONTACT/SUBMITTER:	Elisa HebbSr. Director Clinical DevelopmentVolcano CorporationTel: 858-720-4184
DATE OF SUBMISSION:	November 27, 2013
DEVICE:	Percutaneous Retrieval Device
Trade Name:	Crux® Snare Filter Retrieval Set
Common Name:	Vena Cava Filter Retrieval Set
Product Code:	MMX
Classification:	21 CFR 870.5150Class II Device
PREDICATE DEVICE:	Günther Tulip Vena Cava Filter Removal Set (K073374)
Reference Device:	Cook FourSnare Vascular Retrieval Snare (K112185)
DEVICE DESCRIPTION:	The Crux® Snare Filter Retrieval Set consists of a 0.035"PTFE-coated guidewire, 18 gauge introducer needle, 8.2 Finner sheath with dilator, 10 F outer sheath, Crux Snare,introducer and torque tool. The components are designedto be used percutaneously to retrieve the Crux Vena Cavafilter via either the jugular or femoral vein approach.
INTENDED USE:	The Crux® Snare Filter Retrieval Set is an endovascularmedical device indicated for the retrieval of the Crux® VenaCava Filter (VCF) percutaneously via the jugular vein orfemoral vein approach.

్లా శిశు

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Interactive Review

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COMPARISON OF CHARACTERISTICS:

PERFORMANCE DATA:

The Crux® Snare Filter Retrieval Set, its predicate and reference device are intended for the retrieval of vena cava filters. The subject and predicate devices are delivered via conventional venous access through dilators and flexible, coaxial polymeric catheters—sheaths— over a 0.035″ guidewire, to the filter's retrieval tail. Radiopaque features on the sheaths and snare provide the physician with visibility during angiography. The sheath/snare assembly is advanced to a position close to the filter's retrieval tail, and then the inner sheath, enclosing the snare, is advanced independently to an even closer position. The snare is advanced out of the inner sheath so that it can engage the filter. When the snare is appropriately positioned, the inner sheath is advanced to engage the filter (Crux) or, the snare is withdrawn into the sheath (predicate). The outer sheath is then advanced over the snare that has trapped the filter retrieval tail. The outer sheath is further advanced, collapsing and capturing the filter. The entire assembly is then withdrawn.

Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards, product specification, or against the predicate device and evaluated the following: Visual; Dimensional; Hemostasis/Flushing/Compatibility; Radiopacity; Ability to access; and Bond Tensile.

Biocompatibility testing was conducted on the device and the following tests were successfully completed:

. Cytotoxicity
Hemocompatibility, including .
- Hemolysis, ASTM Method, extract (human o blood)
- Hemolysis, direct contact (ASTM) o
- Partial Thromboplastin Time (PTT) o
- Complement Activation, both 3Ca and SC5b-9 o
- Platelet and Leukocyte Count PLC O
- Thrombogenicity (Sheep) o
Sensitization .
Irritation .
Systemic Toxicity, including .
- o Systemic Injection (ISO)

Interactive Review

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Material Mediated Pyrogenicity o

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Conclusion

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Completion of these tests concluded that the proposed Crux Snare Filter Retrieval Set is substantially equivalent to the predicate device and reference device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2014

Volcano Corporation Ms. Elisa Hebb Senior Director, Clinical Development - Peripheral Vascular 2870 Kilgore Road Rancho Cordova, CA 95670

Re: K133681

Trade/Device Name: Crux Snare Filter Retrieval Set Regulation Number: 21 CFR 870.5150 Regulation Name: Device, Percutaneous Retrieval Regulatory Class: Class II Product Code: MMX Dated: November 27, 2013 Received: December 2, 2013

Dear Ms. Hebb:

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.

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Page 2 - Ms. Elisa Hebb

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 -S

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 Statement

K133681 5l0(k) Number (if known)

Device Name Crux® Snare Retrieval Set

Indications for Use

The Crux® Snare Filter Retrieval Set is an endovascular medical device indicated for the retrieval of the Crux® Vena Cava Filter (VCF) percutaneously via the jugular vein or femoral vein approach.

Prescription Use × (Per 21 CFR 801.109)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of Center for Devices and Radiological Health (CDRH)

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Image /page/5/Picture/11 description: The image shows the name "Bram D. Zuckerman -S" in bold black font. Below the name is the date and time "2014.01.30 16:52:22 -05'00'" also in bold black font. In the background is a faded FDA logo.

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Regulation Number and Section

§ 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).