(75 days)
No
The description focuses on the mechanical design and function of the catheter and an optional accessory for manual or assisted rotation. There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes.
The device is used to facilitate the intraluminal placement of guidewires beyond stenotic lesions, which is a therapeutic intervention in the peripheral vasculature.
No
The device is designed to facilitate the placement of guidewires and cross stenotic lesions, which are interventional rather than diagnostic functions.
No
The device description clearly details physical components like a catheter shaft, distal tip, proximal handle, and an optional accessory (Juicebox) with a handle, toggle switch, and release button. These are hardware components, not software.
Based on the provided information, the Wildcat Catheter and the Juicebox accessory are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Wildcat Catheter and Juicebox are used directly within the patient's peripheral vasculature to facilitate guidewire placement and cross lesions.
- The intended use clearly describes a procedure performed in vivo (within the living body). It's about navigating and treating blockages within blood vessels, not analyzing samples taken from the body.
- The device description details a physical catheter and an accessory for manipulating it within the body. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- The input imaging modality is Fluoroscopy, which is an in vivo imaging technique.
Therefore, the Wildcat Catheter and Juicebox are medical devices used for interventional procedures, not IVD devices.
N/A
Intended Use / Indications for Use
The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the illiac, coronary, cerebral or carotid vasculature.
The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger Wildcat catheter.
Product codes
DQY, PDU
Device Description
The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature.
The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement. Subsequent to conventional quidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit.
Juicebox is an optional accessory used to provide assisted distal tip rotation when using a compatible Avinger catheter. It consists of a handle with a rotation toggle switch and a release button. Juicebox is designed to be placed over the catheter handle. This accessory is provided separately, irradiated for sterility, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 non-clinical testing was conducted to support a determination of substantial equivalence to the predicate devices. The collective results of the above testing confirmed that the Wildcat Catheter performs according to the stated intended use and raises no new issues of safety or effectiveness when used with the Juicebox. Results of non-clinical testing demonstrated that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate devices for its intended use.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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510(k) Summary
MAR 1 2 2012
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name and Address of Applicant
Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 Phone: (650) 241-7900 Fax: (650) 241-7901
Contact Person B.
Sevrina Ciucci, RAC Regulatory Affairs Consultant Phone: (408) 316-4837
C. Date Prepared
December 27, 2011
- D. Device Name
| Trade Name: | Wildcat Catheter used with Juicebox |
|---|---|
| Common Name: | Guidewire Support Catheter and Accessory |
| Classification Name: | Percutaneous Catheter |
Device Classification E.
| Classification: | 21 CFR §870.1250 |
|---|---|
| Product Code: | DQY |
| Device Class: | Class II |
F. Predicate Device
The Avinger Wildcat Catheter used with the Juicebox is substantially equivalent to the Avinger Wildcat Catheter (K111338) and the Avinger Wildcat Guidewire Support Catheter 6F used with the Juicebox (K111704).
G. Device Description
The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature.
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The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement.
Subsequent to conventional quidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit.
Juicebox is an optional accessory used to provide assisted distal tip rotation when using a compatible Avinger catheter. It consists of a handle with a rotation toggle switch and a release button. Juicebox is designed to be placed over the catheter handle. This accessory is provided separately, irradiated for sterility, and intended for single use only.
H. Intended Use
The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous The Wildcat Catheter is contraindicated for use in the illiac, intervention. coronary, cerebral or carotid vasculature.
The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter.
Substantial Equivalence l.
The Avinger Wildcat Catheter is substantially equivalent to the Avinger Wildcat Catheter (K111338) and the Avinger Wildcat Guidewire Support Catheter 6F used with the Juicebox (K111704). The Wildcat Catheter used with the Juicebox substantially equivalent to the stated predicates in technological is characteristics, device design and packaging, procedural steps, performance testing, safety characteristics, and product labeling. The subject and predicate devices have the same mechanism of action (manual advancement of the Catheter) and perform the same function (access discrete regions of the peripheral vasculature). The Wildcat Catheter is the exact same device as the Wildcat Guidewire Support Catheter 6F and is identical in design, manufacturing, operation, and material composition as its FDA-cleared predicates, and as such, has the same technological characteristics. The changes to the Wildcat Catheter
2
labeling cleared under K111338 result in no significant changes to technological characteristics and do not raise any new issues of safety or effectiveness.
J. Non-Clinical Performance Data
The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate devices.
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No. on antiquestion
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The collective results of the above testing confirmed that the Wildcat Catheter performs according to the stated intended use and raises no new issues of safety or effectiveness when used with the Juicebox. Results of non-clinical testing demonstrated that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate devices for its intended use.
K. Conclusions
The Avinger Wildcat Catheter used with the Juicebox has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Wildcat Catheter used with the Juicebox functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate device for its intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Avinger, Inc. c/o Ms. Sevrina Ciucci Regulatory Affairs Consultant 400 Chesapeake Drive Redwood, CA 94063
SEP 18 2013
Re: K113838 Trade/Device Name: Wildcat Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter
Regulatory Class: Class II Product Code: PDU Dated: December 27, 2011 Received: December 28, 2011
Dear Ms. Ciucci:
This letter corrects our substantially equivalent letter of March 12, 2012.
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
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Zm.Z.
for
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
510(k) Number (if known): K
Wildcat Catheter Device Name:
×
Indications for Use:
The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the garipheral vasculature prior to further percutaneous intervention. The Wildcat Catheter pontraindicated for use in the illiac, coronary, cerebral or carotid vasculature.
The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger Wildcat catheter.
Prescription Use
Or
Over-The-Counter Use
(per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sigh-Off) Division of C 510(k) Number