(53 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on OCT technology and mechanical components.
No
The device is used to facilitate the placement of guidewires and provide imaging, which are diagnostic and procedural guidance functions, not therapeutic.
Yes
The device description states, "The Tigereye ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology." This explicitly describes a diagnostic function.
No
The device description explicitly lists hardware components: the Tigereye ST CTO-crossing catheter, a Lightbox Sled, and the Lightbox Imaging Console. The performance studies also mention electrical safety, EMC, and mechanical testing, which are associated with hardware.
Based on the provided information, the Tigereye ST System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate the intraluminal placement of guidewires and provide imaging of vessel lumen and wall structures during a percutaneous intervention. This is a procedure performed in vivo (within the living body).
- Device Description: The device is a catheter designed to be inserted into the peripheral vasculature. It uses OCT technology to image the vessel from within.
- Nature of the Technology: OCT is an imaging modality that visualizes structures in situ (in their original place within the body).
IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
The Tigereye ST System is a medical device used in vivo for imaging and facilitating a procedure within the body.
N/A
Intended Use / Indications for Use
The Tigereye ST 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.
Product codes (comma separated list FDA assigned to the subject device)
PDU, NQQ
Device Description
The Tigereye ST System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye ST System consists of the Tigereye ST CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox").
The Tigereye ST 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 ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCTguided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been not been updated since the version that was reviewed and cleared under K212468.
The Tigereye ST 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.
Mentions image processing
Not Found
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 testing conducted establishes that the Tigereye ST CTO-crossing catheter did not raise new questions of the safety and effectiveness from those reviewed and cleared in the Tigereye catheter submission K201330.
Biocompatibility testing: The Tigereye ST catheter was tested and passed the appropriate 10993-1 tests for biocompatibility of materials following eBeam sterilization.
Electrical safety and electromagnetic compatibility (EMC): The subject and predicate devices comply with IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: The software of the Lightbox component of the system has not been changed since the version that was reviewed and cleared in K212468. The software for this device is considered "moderate" in the level of concern.
Mechanical Testing: The mechanical testing of the subject device included:
- Effective length of the device;
- Catheter flush flow rate;
- OCT image generation;
- Catheter field of view;
- Distal tip rotation capability;
- Insertion force of the inner assembly through the hub of the support catheter component;
- Insertion force over a simulated arterial arch;
- OCT image generation and Sled interface capabilities;
- Guidewire compatibility and insertion force through the support catheter component;
- Passive mode life cycle;
- Active mode life cycle;
- Active mode with the tip deflected life cycle;
- Tip deflection cycle;
- OCT image generation and Sled interface;
- Force to cross a simulated occlusion cap;
- Torque shaft torque proof loading;
- Drive shaft torque;
- Drive shaft disengagement;
- Guidewire delivery;
- Tip compression;
- Proximal section torque shaft torque;
- Flush lumen luer tensile strength;
- Distal catheter joints tensile strength; and
- Proximal catheter joints tensile strength.
Animal Testing: The performance bench testing was sufficient to demonstrate substantial equivalence to the predicate device.
Clinical Studies: The performance bench testing was sufficient to demonstrate substantial equivalence to the predicate device.
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
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April 25, 2023
Avinger, Inc. Thomas Lawson VP. Clinical & Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063
Re: K230594
Trade/Device Name: Tigereye ST CTO-Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, NQQ Dated: March 2, 2023 Received: March 3, 2023
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
Ariel G. Ash- Digitally signed by Ariel G. Ash-shakoor -S shakoor -S Date: 2023.04.25 15:02:22 -04'00'
For
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
Indications for Use
510(k) Number (if known) K230594
Device Name
Tigereye ST CTO-crossing Catheter
Indications for Use (Describe)
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the perior 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.
| 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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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 | |
| VP, Clinical & Regulatory Affairs | ||
| Avinger Inc. | ||
| Contact Information | Email: tlawson@avinger.com | |
| Phone: 510-206-1794 | ||
| Date Prepared | 25 April 2023 |
Proposed Device
| Trade Name | Tigereye ST CTO-Crossing Catheter |
|---|---|
| Common Name | Tigereye ST |
| 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 ST System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye ST System consists of the Tigereye ST CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox").
The subject device of this submission is a product improvement of the Tigereye CTOcrossing System reviewed and cleared earlier under K201330.
The Tigereye ST 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 ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCTguided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been not been updated since the version that was reviewed and cleared under K212468.
The Tigereye ST 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) builds on the Tigereye CTO-crossing catheter (K201330) and details additional minor modifications to the design of the Ocelot catheter family to add in functionality of the device.
Indications for Use
The indication for use for the Tigereye ST CTO-crossing catheter is:
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires bevond 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.
Both the subject device and the predicate device have the exact same intended use of the crossing of chronic total occlusions in order to facilitate placement of guidewires in the peripheral vasculature. The subject device and predicate device have a slight difference in
5
materials and use the same packaging.
Comparison of Technological Characteristics with the Predicate Devices
Avinger Inc. has identified the Tigereye CTO-crossing catheter (K201330) as the predicate device for the Tigereye ST CTO-crossing catheter.
The Tigereye ST CTO-crossing catheter is substantially equivalent to the predicate device based upon the following similarities:
Similarities of Tigereye ST and Tigereye catheters:
- · 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.
Comparison of the Tigereye ST CTO-crossing catheter to the predicate device, the Tigereve CTO-crossing catheter.
| Predicate Device | Subject Device | |
|---|---|---|
| Tigereye System | ||
| 5 French | ||
| (Avinger, Inc.) |
K201330 | Tigereye ST System
5 French
(Avinger, Inc.)
(This Submission) |
| Indication for
Use | The Tigereye System is
intended to facilitate the
intraluminal placement of | Same |
| | | |
| | 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. | |
| Intended use | Crossing chronic total
occlusions in peripheral
arteries using real-time
optical coherence
tomography assisted
orientation during catheter
intervention | Same |
| Contraindications | The Tigereye system is
contraindicated for use in the
iliac, coronary, cerebral, renal
or carotid vasculature. | Same |
| Product Code | PDU NQQ | Same |
| Treatment
Method | CTO crossing | Same |
| Technical
Characteristics | | |
| Components of
the System | Catheter
Lightbox Imaging Console
Sled | Same |
| Configuration of
the catheter | 2 components—(1) an
outer cannula that acts as a
support catheter and (2) an
inner assembly that
contains a rotating tip and
the OCT imaging fiber | 2 components—(1) an
outer cannula that acts as a
support catheter and has a
rotating tip, and (2) an
inner assembly that
contains a rotating tip and
the OCT imaging fiber |
| Imaging
Modality | Optical coherence
tomography | Same |
| Imaging Energy
Type | Near-infrared Light | Same |
| Optical Output
Power |