(59 days)
No
The description focuses on mechanical components and their function for retrieving a vena cava filter, with no mention of AI or ML capabilities.
No
The device is solely indicated for the retrieval of a Vena Cava Filter, which is a mechanical procedure to remove a foreign object, not to treat a disease or condition or restore function.
No
The device is indicated for the retrieval of a vena cava filter, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists multiple physical components (guidewire, needle, sheaths, snare, tools) and describes bench testing for physical properties (dimensional, hemostasis, radiopacity, bond tensile), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "retrieval of the Crux® Vena Cava Filter (VCF) percutaneously via the jugular vein or femoral vein approach." This describes a surgical or interventional procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The components listed (guidewire, needle, sheaths, snare, etc.) are all tools used for a physical retrieval procedure within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for a therapeutic/interventional purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MMX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiopaque features on the sheaths and snare provide the physician with visibility during angiography.
Anatomical Site
jugular vein or femoral vein
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)
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)
- Material Mediated Pyrogenicity o
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.
Günther Tulip Vena Cava Filter Removal Set (K073374)
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.
Cook FourSnare Vascular Retrieval Snare (K112185)
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
K133681
510(K) SUMMARY
・
JAN 300 2014
| SPONSOR: | Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Elisa Hebb
Sr. Director Clinical Development
Volcano Corporation
Tel: 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 870.5150
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"
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. |
| 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. |
.
.
:
:
్లా శిశు
:
. .
Interactive Review
1
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
2
Material Mediated Pyrogenicity o
.
・
Conclusion
ﻬﺮ ﺗﻮﺳﻂ ﺍﻟﻤ
Completion of these tests concluded that the proposed Crux Snare Filter Retrieval Set is substantially equivalent to the predicate device and reference device.
.
:
,
3
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.
4
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
5
1 - 12 - 10 - 10 - 2014
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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