(153 days)
No
The summary describes image processing and interpretation for display, but there is no mention of AI, ML, or any learning algorithms being used for analysis, diagnosis, or guidance beyond basic image processing.
No.
The device is intended to facilitate guidewire placement and provide imaging, which are diagnostic and procedural guidance functions, not direct therapeutic treatment.
Yes
The device provides "real-time diagnosis of vessel condition and morphology" and "provides a qualitative view of the vessel's structure inside traversed vessels," which are diagnostic functions.
No
The device is a system that includes hardware components (catheter, Sled, Lightbox 3 console with PC and OCT engine) in addition to software. While the submission focuses on software updates, the overall device is not software-only.
Based on the provided text, the Tigereye System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Tigereye System's Function: The Tigereye System is an intraluminal device. It is inserted directly into the peripheral vasculature to facilitate guidewire placement and provide real-time imaging of the vessel lumen and wall structures in situ. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for facilitating guidewire placement and providing OCT-assisted orientation and imaging within the peripheral vasculature.
Therefore, the Tigereye System is an in vivo diagnostic and interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tigereye 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 and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Tigereye System is contraindicated for use in the iliac, coronary, cerebral, renal, or carotid vasculature.
Product codes (comma separated list FDA assigned to the subject device)
PDU, NQQ
Device Description
The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox 3 Imaging Console (referred to as "Lightbox 3" or "L300").
The subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.
The Tigereye CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox 3 imaging console.
The Lightbox 3 console is comprised of a PC and an OCT engine, all contained within a casing. The operator monitor has a touchscreen that allows the user to interact with the console software for controlling the console, monitoring the procedure, and facilitating data input before, during, and after the procedure. The Lightbox 3 console is an optical transceiver, transmitting light to the intraluminal environment through an optical fiber in the catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The resulting OCT image is displayed on the monitor and provides a qualitative view of the vessel's structure inside traversed vessels as an adjunct to standard imaging techniques (e.g., fluoroscopy) during percutaneous peripheral vascular procedures.
The software of the Lightbox 3 console has been updated to version 1.0.300, which builds on version 4.6.0 that was reviewed and cleared under K201330.
The Tigereye catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
This Traditional 510(k) is focused solely on the updates to the software and design of the Lightbox 3 imaging console component of the Tigereye System. The Tigereye CTOcrossing catheter and the Sled in this submission are exactly the same as the catheter and Sled that were cleared in K201330.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical coherence tomography
Anatomical Site
Peripheral Vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility, such as a cardiac catheter lab or a hospital.
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 performance tests conducted, including design validation and user testing, establishes that the Tigereye CTO-crossing catheter does not raise new questions of the safety and effectiveness from that of the Tigereye System cleared under K201330.
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.
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.
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
§ 870.1250 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 6, 2022
Avinger, Inc. Thomas Lawson VP, Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063
Re: K212468
Trade/Device Name: Tigereye CTO-Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, NQQ Dated: December 2, 2021 Received: December 3, 2021
Dear Thomas Lawson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212468
Device Name
Tigereye CTO-crossing Catheter
Indications for Use (Describe)
The Tigereye 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 and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Tigereye System is contraindicated for use in the iliac, coronary, cerebral, renal, or carotid vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
510(k) SUMMARY
General Information
| Submitter | Avinger, Inc. |
|---|---|
| Address | 400 Chesapeake Drive |
| Redwood City, CA 94063 | |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD |
| Director, Clinical & Regulatory Affairs | |
| Avinger Inc. | |
| Contact Information | Email: tlawson@avinger.com |
| Phone: 510-206-1794 | |
| Date Prepared | 4 January 2022 |
Proposed Device
| Trade Name | Tigereye CTO-Crossing Catheter |
|---|---|
| Common Name | Tigereye |
| Regulation Number and | |
| Classification Name | 21 CFR§870.1250, Catheter for Crossing Total |
| Occlusions | |
| 21 CFR§892.1560, Imaging System Optical Coherence | |
| Tomography (OCT) | |
| Product Code | PDU, NQQ |
| Regulatory Class | II |
Predicate Device
| Trade Name | Tigereye CTO-Crossing Catheter |
|---|---|
| Common Name | Tigereye |
| Premarket Notification | K201330 |
| Regulation Number and | |
| Classification Name | 21 CFR§870.1250, Catheter for Crossing Total |
| Occlusions | |
| 21 CFR§892.1560, Imaging System Optical Coherence | |
| Tomography (OCT) | |
| Product Code | PDU, NQQ |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. |
4
Device Description and Proposed Modifications
The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox 3 Imaging Console (referred to as "Lightbox 3" or "L300").
The subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.
The Tigereye CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox 3 imaging console.
The Lightbox 3 console is comprised of a PC and an OCT engine, all contained within a casing. The operator monitor has a touchscreen that allows the user to interact with the console software for controlling the console, monitoring the procedure, and facilitating data input before, during, and after the procedure. The Lightbox 3 console is an optical transceiver, transmitting light to the intraluminal environment through an optical fiber in the catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The resulting OCT image is displayed on the monitor and provides a qualitative view of the vessel's structure inside traversed vessels as an adjunct to standard imaging techniques (e.g., fluoroscopy) during percutaneous peripheral vascular procedures.
The software of the Lightbox 3 console has been updated to version 1.0.300, which builds on version 4.6.0 that was reviewed and cleared under K201330.
The Tigereye catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
This Traditional 510(k) is focused solely on the updates to the software and design of the Lightbox 3 imaging console component of the Tigereye System. The Tigereye CTOcrossing catheter and the Sled in this submission are exactly the same as the catheter and Sled that were cleared in K201330.
5
Indications for Use
The indication for use for the Tigereye System is:
The Tigereye 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 and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
The Tigereve system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Both the subject device and the Tigereye predicate device components of the system have the same intended use of the crossing of chronic total occlusions in order to facilitate placement of guidewires in the peripheral vasculature.
Comparison of Technological Characteristics with the Predicate Device
The Tigereye CTO-crossing catheter is substantially equivalent to the predicate device based upon the following similarities:
Similarities of the Tigereye System (this submission) and the Tigereye System (K201330):
- · Both devices are intended to be used to cross chronic total occlusions (CTOs) in peripheral vessels;
- · Both devices are used in cardiac catheter labs in either a hospital or an officebased lab;
- Both devices are advanced to the target occlusion through an indwelling vascular sheath:
- Advancement of the both devices is monitored by external fluoroscopy and intravascular OCT imaging;
- · Both devices consist of a rotating tip that actively engages the occlusive tissue causing dissection of the tissue on multiple planes, a cannula that creates and sustains a channel through the tissue by compressing the tissue, and a power source to cause the device tip to move the occluding tissue aside;
- · Both devices create a channel through the occlusion to facilitate advancement of guidewires and other tools as needed for treatment of the patient; and
- · Both devices have equivalent sizes in terms of outer diameter and working length of the cannula.
- · Both devices use the OCT imaging software contained in the Lightbox 3 console to measure the lumen of vessels in which they are indwelling;
6
- · Both devices are connected to the Lightbox via an accessory, termed the Sled, that is covered by a sterile drape in order to separate sterile and non-sterile surfaces; and
- Both catheters are packaged in a lidded tray made from identical materials that then is placed within a pouch and then sealed.
Comparison of the Tigereye System (this submission) to the predicate device, the Tigereye System (K201330).
| Subject Device | Predicate Device | |
|---|---|---|
| Tigereye System | ||
| (Avinger, Inc.) | Tigereye System | |
| (Avinger, Inc.) | ||
| (This Submission) | K201330 | |
| Indication for Use | The Tigereye 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 and | ||
| imaging. The system is | ||
| an adjunct to fluoroscopy | ||
| by providing images of | ||
| vessel lumen and wall | ||
| structures. |
The Tigereye system is
contraindicated for use in
the iliac, coronary,
cerebral, renal or carotid
vasculature | Same |
| Intended use | Crossing chronic total
occlusions in peripheral
arteries using real-time
optical coherence
tomography assisted | Same |
| | orientation during
catheter intervention | |
| Product Code | PDU NQQ | Same |
| Treatment Method | CTO crossing | Same |
| Technical
Characteristics | | |
| Components of
the System | Catheter
Lightbox 3 Console
Sled | Catheter
Lightbox 250 Console
Sled |
| Lightbox Imaging
Console | Lightbox 3
Software version 1.0.300 | Lightbox 250
Software version 4.6.0 |
| Lightbox Imaging
Console Use | OCT imaging in
peripheral vascular
procedures in
conjunction with a
compatible Avinger
product | Same |
| Compatible
Avinger Products | Pantheris atherectomy
catheter (K172236)
Pantheris SV
atherectomy catheter
(K182341)
Tigereye CTO-crossing
catheter (K201330) | Same |
| Imaging Console
dimensions | Height: 27 cm
Width: 44 cm
Depth: 13 cm | Height: 175 cm
Width: 69 cm
Depth: 71 cm |
| Lightbox Imaging
Console Weight | 100 dB | > 50 dB |
| Pulse duration | $≤$ 10 µs | 30 µs |
| Axial resolution | $≤$ 20 µm | Same |
| Lateral resolution | $