(91 days)
No
The document does not mention AI, ML, or any related terms, and the device description and intended use do not suggest the use of such technologies.
Yes
The device is intended to remove plaque (atherectomy) from partially occluded vessels, which is a therapeutic intervention.
No
The Pantheris System is intended to remove plaque (atherectomy) from vessels, indicating a therapeutic purpose rather than a diagnostic one. While it uses OCT for orientation, this is an adjunct to the therapeutic plaque removal, not for diagnosis of a condition.
No
The device description explicitly lists hardware components (Catheter, Sled, Imaging Console, Sterile Drape) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove plaque from blood vessels in the peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter-based system used for a surgical procedure.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a medical device used for a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Product codes
MCW
Device Description
The Pantheris System consists of the Pantheris Catheter, Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console and the Sterile Drape (accessory). The Pantheris Catheter reviewed as part of K152275 has since been modified to help improve manufacturability and usability of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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)
Non-clinical testing demonstrated that the modified Pantheris Catheter meets established specifications for consistent performance. Testing included:
- Design Verification (Working Length, Catheter Flush, OCT Image Generation and Sled Interface, Catheter Field of View, Distal Tip Rotation, Guidewire compatibility, Distal Tip Max OD, Insertion Force, Force to Overcome User Slide Lock, Force to Remove Sled Bag, Force to Remove Sled Bag ring, Full 360° Image, Inflation Cycles, Cut/Pack Cycles, Packed Position Life Cycle, Active position Life Cycle, Balloon Burst)
- Torque Shaft Torque Proof loading
- Drive Shaft Torque Proof loading
- Inflation Luer Tensile Strength
- Flush lumen Tensile Strength
- Distal Catheter Joints Tensile Strength
- Proximal Catheter Joints Tensile Strength
- Simulated Use (Design Validation) (Setup (Ease of Use & Sterility), Functionality (Visualization, Flushing, Device Tracking, Target Sites, Treatment, Markings, Safety), Insertion/Retraction force, Number of Insertions, Post-Retraction (Visualization, Device Tracking, Treatment, Markings, Safety))
- Sterilization Validation
- Packaging Validation
- Product Shelf Life
- Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemolysis extract, Hemolysis direct, Complement Activation, Material Mediated (Rabbit) Pyrogenicity)
- Preclinical Animal Testing (Porcine Study with acute and chronic histopathological assessments and in vivo performance comparison to a predicate device, with 8F Pantheris catheter; Functionality (Radiopacity, OCT marker visibility, Insertion/Retraction, Advance to target location, Ability to orient device to a landmark); Minimum Effective Flow Rate (MEFR) for clear OCT imaging; Thrombogenicity; Safety Assessment)
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
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
Avinger, Inc. Ms. Patty Hevey Vice President, Clinical and Regulatory Affairs 400 Chesapeake Drive Redwood City, CA 94063
Re: K153460
Trade/Device Name: Pantheris System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: January 27, 2016 Received: January 28, 2016
Dear Ms. Hevey:
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 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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
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
510(k) Number (if known) K153460
Device Name Pantheris System
Indications for Use (Describe)
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended 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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3
510(k) Summary
510(k) Notification K_________________________________________________________________________________________________________________________________________________________
GENERAL INFORMATION
Applicant:
Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 U.S.A. Phone: 650-241-7900 Fax: 650-241-7901
Contact Person:
Patty Hevey VP, Clinical and Regulatory Affairs Avinger, Inc. Phone: 650-222-3666 Email: phevey@avinger.com
Date Prepared:
November 30th, 2015
DEVICE INFORMATION
Trade Name:
Pantheris System
Generic/Common Name:
Peripheral Atherectomy Catheter
Classification:
21 CFR§870.4875, Intraluminal Artery Stripper, Class II
Product Codes: MCW
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PREDICATE DEVICES
The modified Pantheris Catheter is substantially equivalent to the original Pantheris Catheter cleared under K152275.
DEVICE DESCRIPTION
The Pantheris System recently received clearance under K152275 to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature using OCTassisted orientation. The Pantheris Catheter reviewed as part of K152275 has since been modified to help improve manufacturability and usability of the catheter. The Pantheris System consists of the Pantheris Catheter, Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console and the Sterile Drape (accessory).
INDICATIONS FOR USE
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
SUBSTANTIAL EQUIVALENCE
The modified Pantheris Catheter is essentially the same device as the original Pantheris Catheter cleared under K152275; both share the same basic design, principles of operations, mechanism of action and indications for use. Any differences between the modified Pantheris Catheter and the original Pantheris Catheter do not alter the intended use of the Pantheris System. The modifications made to the original Pantheris Catheter (K152275) to create the proposed device are provided in Table 1 below. The information included in this submission will establish the substantial equivalency of the modified Pantheris Catheter to the original Pantheris Catheter cleared under K152275.
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| Catheter Section | Design Modifications |
|---|---|
| Distal Assembly | Offering a 7Fr catheter option Modifying the shape of the Apposition Balloon Including additional viewing windows and increasing the length of the Nosecone Housing Replacing the flush channel with vent holes |
| Torque Shaft Assembly | Reducing the working length from 130cm to 110cm Relocating the Occlusion Balloon to the Torque Shaft (thereby obsoleting the optional accessory, Occlusion Sheath) Increasing the Torque Shaft stiffness |
| Handle Assembly | Improving the ergonomics of the handle design Extending the blue color coding across the entire Flush Lumen length |
| Packaged Accessories | Replacing 1mL Syringe with 6mL and 10mL Syringes |
Table 1: Modified Pantheris Catheter Changes
NON-CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
To demonstrate the substantial equivalences of the Pantheris Catheter to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following testing:
- o Design Verification
- Working Length O
- Catheter Flush O
- OCT Image Generation and Sled Interface O
- O Catheter Field of View
- Distal Tip Rotation O
- Guidewire compatibility O
- Distal Tip Max OD O
- Insertion Force O
- Force to Overcome User Slide Lock O
- Force to Remove Sled Bag o
- Force to Remove Sled Bag ring O
- Full 360° Image O
- O Inflation Cycles
- Cut/Pack Cycles O
- Packed Position Life Cycle O
- Active position Life Cycle O
- Balloon Burst O
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- o Torque Shaft Torque Proof loading
- Drive Shaft Torque Proof loading o
- Inflation Luer Tensile Strength O
- Flush lumen Tensile Strength O
- Distal Catheter Joints Tensile Strength O
- Proximal Catheter Joints Tensile Strength O
- Simulated Use (Design Validation) 0
- Setup (Ease of Use & Sterility) O
- Functionality (Visualization, Flushing, Device Tracking, Target Sites, o Treatment, Markings, Safety)
- Insertion/Retraction force o
- Number of Insertions O
- Post-Retraction (Visualization, Device Tracking, Treatment, Markings, o Safety)
- Sterilization Validation ●
- Packaging Validation ●
- Product Shelf Life ●
- Biocompatibility ●
- O Cytotoxicity
- Sensitization O
- Intracutaneous Reactivity O
- o Systemic Toxicity
- Hemolysis extract O
- Hemolysis direct O
- Complement Activation o
- Material Mediated (Rabbit) Pyrogenicity о
- Preclinical Animal Testing ●
- O Porcine Study with acute and chronic histopathological assessments and in vivo performance comparison to a predicate device, with 8F Pantheris catheter
- Functionality o
- Radiopacity
- OCT marker visibility ■
- 트 Insertion/Retraction
- Advance to target location ■
- Ability to orient device to a landmark ■
- Minimum Effective Flow Rate (MEFR) for clear OCT imaging o
- Thrombogenicity O
- Safety Assessment O
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The collective results of the non-clinical testing demonstrate that the modified Pantheris Catheter meets the established specifications necessary for consistent performance for its intended use.
CONCLUSION
The modified Pantheris Catheter has been carefully compared to the original Pantheris Catheter device with respect to intended use and fundamental technological characteristics. Performance testing was conducted to verify and validate the performance of the devices and ensure the modified Pantheris Catheter functions as intended and meet design specifications. The comparison and performance testing results demonstrate that the modified Pantheris Catheter is substantially equivalent to the original Catheter cleared under K152275 for the stated intended use.