(28 days)
No
The summary does not mention AI, ML, or any related terms, and the description of the device and performance studies focuses on mechanical and optical functions.
No
The device is intended to facilitate the placement of guidewires, not to directly treat a condition. It provides assistance for a medical procedure (percutaneous intervention), but is not the therapeutic agent itself.
Yes
The device uses Optical Coherence Tomography (OCT) to provide "OCT-assisted orientation as an adjunct to fluoroscopy" to facilitate guidewire placement beyond stenotic lesions. This use of OCT to image and guide the procedure suggests a diagnostic function, as it provides information about the internal anatomy to direct the intervention.
No
The device description explicitly states that the Ocelot System consists of a catheter, a console, and an umbilical, which are all hardware components.
Based on the provided information, the Ocelot System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Ocelot System is used to facilitate the placement of guidewires within the peripheral vasculature of a patient. This is an in vivo (within a living organism) procedure.
- Device Description: The device components (catheter, console, umbilical) and their function (OCT-assisted orientation during a percutaneous intervention) are consistent with a medical device used directly on a patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The Ocelot System does not perform this function.
Therefore, the Ocelot System is a medical device used for an in vivo procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ocelot System 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 using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Product codes
DQY, PDU
Device Description
The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
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 previously conducted with the Ocelot Catheter to support a determination of substantial equivalence to the predicate Tip penetration testing was performed to ensure the catheter did not device. advance when the tip is engaged in tissue.
• Visual and Dimensional Verification
• Tensile Testing
• Torque Testing
• Guidewire advancement
• Device Advancement
• Tip Deflection Testing
• Device leak testing
• Luer Leak Testing
• Spiral Blade Functional Testing
• Coating Friction Testing
• Tip Penetration Testing
• In Vitro Simulated Use Testing
• Shelf Life Testing
• Tip-Stall Testing
• Tip Penetration Testing
• Flexibility/Trackability
The above testing confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications and external standard requirements. Results of non-clinical testing demonstrated that the Ocelot Catheter is substantially equivalent to the predicate device for the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
510(k) Summary
DEC 7 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.
- Name and Address of Applicant A. Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 Contact Person B. Albert Boniske Sr. Manager, Regulatory and Quality Affairs (650) 241-7004
C. Date Prepared
November 8, 2012
D. Device Name
| Trade Name: | Ocelot Catheter |
|---|---|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter |
Device Classification E.
| Classification: | 21 CFR §870.1250 |
|---|---|
| Product Code: | DQY |
| Device Class: | Class II |
F. Predicate Device
The Ocelot Catheter is substantially equivalent to the original Ocelot Catheter (K122380).
G. Device Description
The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
1
Image /page/1/Picture/1 description: The image shows a close-up of handwritten text. The text appears to be a combination of letters and numbers, with "K12346" on the top line and "2/3" on the bottom line. The handwriting is bold and clear, making the characters easily distinguishable.
Intended Use H.
The Ocelot System 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 using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Substantial Equivalence I.
The Ocelot Catheter is substantially equivalent to the originally cleared Ocelot Catheter (K122380). The subject and predicate devices have the same mechanism of action (manual advancement) and perform the same function (placement of guidewires beyond stenotic lesions in the peripheral vasculature). The design changes implemented to create Ocelot NEXT include a slightly larger torque coil and modified torque shaft, a longer hypotube in the handle assembly, a strain relief just distal to the rotator knob, the addition of a coil around the shaped distal segment and a modified spiral flute design in the distal tip. The modified distal tip represents a hybrid between the original Ocelot Catheter spiral flute configuration and the Wildcat Catheter's bilateral wedges (K111338). The changes to the Ocelot Catheter cleared under K122338 results in no significant changes to technological characteristics and do not raise any new issues of safety or effectiveness.
Non-Clinical Performance Data ).
The following non-clinical testing was previously conducted with the Ocelot Catheter to support a determination of substantial equivalence to the predicate Tip penetration testing was performed to ensure the catheter did not device. advance when the tip is engaged in tissue.
| • Visual and Dimensional Verification | • Spiral Blade Functional Testing |
|---|---|
| • Tensile Testing | • Coating Friction Testing |
| • Torque Testing | • Tip Penetration Testing |
| • Guidewire advancement | • In Vitro Simulated Use Testing |
| • Device Advancement | • Shelf Life Testing |
| • Tip Deflection Testing | • Tip-Stall Testing |
| • Device leak testing | • Tip Penetration Testing |
| • Luer Leak Testing | • Flexibility/Trackability |
The above testing confirmed that the Ocelot Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications
2
Avinger, Inc.
and external standard requirements. Results of non-clinical testing demonstrated that the Ocelot Catheter is substantially equivalent to the predicate device for the stated intended use.
K. Conclusions
The Ocelot Catheter has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Non-clinical testing was conducted to validate the performance of the devices and ensure the Ocelot Catheter functions as intended and meet design specifications. The comparison and nonclinical results demonstrate that the devices are substantially equivalent to the predicate device for the stated intended use.
3
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 in flight, represented by three curved lines. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Avinger, Inc. Mr. Albert Boniske Sr. Manager, Regulatory and Quality Affairs 400 Chesapeake Drive Redwood City, CA 94063
SFP 1 8 2013
Re: K123462
Trade/Device Name: Ocelot Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: November 8, 2012 Received: November 9, 2012
Dear Mr. Boniske:
This letter corrects our substantially equivalent letter of December 7, 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 (OS) 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,
Zin.Z.
Bra
Dir
Div
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Avinger, Inc.
Indications for Use Statement
510(k) Number (if known): K_ | 2346 Z
Device Name: Ocelot Catheter
Indications for Use:
The Ocelot System is intended to facilitate the intraluminal placement of conventional The Occlose System is meetidons (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted performeral valuature processory. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
| Prescription Use | X | 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 Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K123462 |
|---|---|
| --------------- | --------- |