CRUX SNARE FILTER RETRIEVAL SET

K133681 · Volcano Corporation · MMX · Jan 30, 2014 · Cardiovascular

Device Facts

• Record ID: K133681
• Device Name: CRUX SNARE FILTER RETRIEVAL SET
• Applicant: Volcano Corporation
• Product Code: MMX · Cardiovascular
• Decision Date: Jan 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2

Intended 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.

Device Story

The Crux Snare Filter Retrieval Set is a percutaneous endovascular tool used by physicians to retrieve the Crux Vena Cava Filter. The system includes a 0.035" PTFE-coated guidewire, 18 gauge introducer needle, 8.2 F inner sheath with dilator, 10 F outer sheath, snare, introducer, and torque tool. During the procedure, the physician uses the assembly to access the filter's retrieval tail via the jugular or femoral vein. Radiopaque markers on the sheaths and snare assist with visualization under angiography. The snare engages the filter tail, and the outer sheath is advanced to collapse and capture the filter for withdrawal. The device facilitates minimally invasive filter removal, reducing the risks associated with long-term filter implantation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual, dimensional, hemostasis/flushing/compatibility, radiopacity, access capability, and bond tensile strength. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility (hemolysis, PTT, complement activation, platelet/leukocyte count, and thrombogenicity).

Technological Characteristics

Components include PTFE-coated guidewire, 18G needle, 8.2F/10F polymeric sheaths, and snare. Radiopaque features for fluoroscopic visualization. Biocompatibility per ISO and ASTM standards. Mechanical retrieval principle via coaxial sheath/snare assembly. No energy source or software.

Indications for Use

Indicated for the percutaneous retrieval of the Crux Vena Cava Filter via jugular or femoral vein access in patients requiring filter removal.

Regulatory Classification

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.

Predicate Devices

• Günther Tulip Vena Cava Filter Removal Set (K073374)

Reference Devices

• Cook FourSnare Vascular Retrieval Snare (K112185)

Submission Summary (Full Text)

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## K133681

### 510(K) SUMMARY

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JAN 300 2014

| SPONSOR: | Volcano Corporation<br>2870 Kilgore Road<br>Rancho Cordova, CA 95670 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Elisa Hebb<br>Sr. Director Clinical Development<br>Volcano Corporation<br>Tel: [phone] |
| 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 870.5150<br>Class 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"<br>PTFE-coated guidewire, 18 gauge introducer needle, 8.2 F<br>inner sheath with dilator, 10 F outer sheath, Crux Snare,<br>introducer and torque tool. The components are designed<br>to be used percutaneously to retrieve the Crux Vena Cava<br>filter via either the jugular or femoral vein approach. |
| INTENDED USE: | The Crux® Snare Filter Retrieval Set is an endovascular<br>medical device indicated for the retrieval of the Crux® Vena<br>Cava Filter (VCF) percutaneously via the jugular vein or<br>femoral vein approach. |

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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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

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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 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 [phone] or [phone] 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 [phone] or [phone] 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)

OR

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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