(66 days)
Not Found
No
The description focuses on the mechanical design and function of a medical device for thrombus removal, with no mention of AI or ML capabilities.
Yes
The device is intended to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which is a direct therapeutic intervention to treat a medical condition.
No
The device is described as a "Trevo Retriever" which is intended to restore blood flow by removing thrombus, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly details a physical medical device (a retriever with a core, shaped section, radiopaque coil, coating, torque device, and insertion tool) intended for mechanical thrombus removal. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical tool (a retriever) designed to be inserted into blood vessels to physically remove a clot.
- Mechanism of Action: The device works by physically interacting with the thrombus within the blood vessel.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples (like blood, tissue, etc.) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
The Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. A platinum coil allows fluoroscopic visualization. In addition, the shaped section is also radiopaque. The Retriever has a hydrophilic coating to reduce friction. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque device and insertion tool are provided with the Retriever.
The Modified Trevo ProVue Retriever consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. The shaped section is also radiopaque. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
Neurovasculature
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)
Simulated Use -- Deliverability, Deployment, and Reloadability: Simulated use testing used a silicone neurovascular model cast from actual human neurovascular arteries. This bench testing model replicates the tortuosity, diameter and location of the arteries in the neurovasculature including the internal carotid artery (ICA) siphon. The model ends at the mid carotid arteries and proximal support is provided by a guide catheter. The model incorporates a re-circulating water bath at 37°C pressurized between 2 - 2.5 psi (100 - 126 mm Hg) to simulate the human arterial circulation. All testing follows the procedural instructions outlined in the Instructions for Use. Simulated thrombus is used to assess the devices ability to retrieve clot.
Results: All samples passed the acceptance criteria. Device continues to meet same design requirements as predicate device K122478.
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.
Not Found
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
JAN 17 2014
510(k) Summary
| Trade Name: | Modified Trevo ProVue Retriever | |
|---|---|---|
| Common Name: | Catheter, Thrombus Retriever | |
| Classification Name: | Thrombus Retriever, 21CFR 870.1250 Class II | |
| Product Code: | NRY | |
| Submitter: | Concentric Medical, Inc. | |
| 301 E. Evelyn Avenue | ||
| Mountain View, CA 94041 | ||
| Tel 510-413-2681 | ||
| Fax 510-413-2558 | ||
| Facility Registration #2954917 | ||
| Contact: | Sarah Meyer | |
| Senior Regulatory Affairs Specialist | ||
| Date Prepared: | December 13, 2013 | |
| Predicate Device: | Concentric Trevo ProVue Retriever (K122478) | |
| Feature | Cleared Trevo ProVue Retriever | |
| (K122478) | Modified Trevo | |
| ProVue Retriever | ||
| Indications for Use | The Trevo ProVue Retriever is intended to restore | |
| blood flow in the neurovasculature by removing | ||
| thrombus in patients experiencing ischemic stroke | ||
| within 8 hours of symptom onset. Patients who are | ||
| ineligible for intravenous tissue plasminogen | ||
| activator (IV t-PA) or who fail IV t-PA therapy are | ||
| candidates for treatment. | Same as cleared | |
| device | ||
| Device Description | The Retriever consists of a flexible, tapered core | |
| wire with a shaped section at the distal end. A | ||
| platinum coil allows fluoroscopic visualization. In | ||
| addition, the shaped section is also radiopaque. The | ||
| Retriever has a hydrophilic coating to reduce friction. | ||
| The Retriever has a shaft marker to indicate | ||
| proximity of Retriever tip relative to Microcatheter tip. | ||
| A torque device and insertion tool are provided with | ||
| the Retriever. | Same as cleared | |
| device | ||
| Target Population | Patients with symptoms of an ischemic stroke | Same as cleared |
| device | ||
| Anatomical Sites | Neurovasculature | Same as cleared |
| device | ||
| Accessory Devices | ||
| Provided | ||
| (not in direct contact | ||
| with patient) | Insertion tool and torque device provided in product | |
| package | Same as cleared | |
| device | ||
| Regulation Number | 21CFR 870.1250 | Same as cleared |
| device | ||
| Regulation Name | Catheter, Thrombus Retriever | Same as cleared |
| device | ||
| Regulatory Class | II | Same as cleared |
| device | ||
| Product Code | NRY | Same as cleared |
| device | ||
| Core Wire Material | Nitinol (nickel titanium alloy) | Same as cleared |
| device | ||
| Distal Shaped | ||
| Section Material | Nitinol | Same as cleared |
| device | ||
| Feature | Cleared Trevo ProVue Retriever | |
| (K122478) | Modified Trevo | |
| ProVue Retriever | ||
| Coil Material Distal | ||
| to Distal Shaped | ||
| Section | Platinum/Tungsten | Same as cleared |
| device | ||
| Shaped Section | ||
| Radiopaque Wire | Platinum/Tungsten | Same as cleared |
| device | ||
| Coil Material | ||
| Proximal to | ||
| Shaped Section | 304 Stainless Steel | Same as cleared |
| device | ||
| Solder | Gold/Tin | Same as cleared |
| device | ||
| Hydrophilic Coating | Sodium hyaluronate mixture | Same as cleared |
| device | ||
| Nominal Design Attributes | ||
| Overall Length | 180 cm | Same as cleared |
| device | ||
| Total Shaped | ||
| Section Length | ||
| (nominal) | 37 mm | Same as cleared |
| device | ||
| Active Shaped | ||
| Section | ||
| Length (nominal) | 20 mm | Same as cleared |
| device | ||
| Distal Tip Length | ||
| (nominal) | 4 mm | Same as cleared |
| device | ||
| Proximal Core Wire | ||
| Diameter | 0.0180" | Same as cleared |
| device | ||
| Shaped Section | ||
| Diameter (nominal) | 4 mm | Same as cleared |
| device | ||
| Distal Taper | ||
| Length (nominal) | 10 mm | Same as cleared |
| device | ||
| Packaging | ||
| Materials and | ||
| Configuration | Polyethylene Hoop, polycarbonate mounting card, | |
| Tyvek/Film Pouch, HDPE Tubing Clips, Chipboard | ||
| carton | Same as cleared | |
| device | ||
| Sterilization | ||
| Method | 100% EtO | Same as cleared |
| device | ||
| How Supplied | Sterile/Single Use | Same as cleared |
| device |
Device Description
The Modified Trevo ProVue Retriever consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. The shaped section is also radiopaque. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Indications for Use
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
1
Technological Characteristics and Product Feature Comparison
The Modified Trevo ProVue Retriever with a modified platinum wire weave is substantially equivalent to the predicate device in terms of design, materials used, and function. A comparison of the subject device with predicate device is summarized in the below table.
Comparison of Cleared Trevo ProVue Retriever to the Modified Trevo ProVue Retriever
2
Risk Assessment
Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined the modifications to the predicate device raise no new questions of safety or effectiveness.
3
Results of testing have demonstrated the Modified Trevo ProVue Retriever is substantially equivalent to the predicate device. Furthermore, the modifications did not result in any new failure modes nor were there any changes to existing failure modes.
Testing Summary
The results of testing conducted on the Modified Trevo ProVue Retriever demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following tests were performed on the proposed device:
| Test | Test Method Summary | Results |
|---|---|---|
| Simulated | ||
| Use -- | ||
| Deliverability, | ||
| Deployment, | ||
| and | ||
| Reloadability | Simulated use testing used a | |
| silicone neurovascular model | ||
| cast from actual human | ||
| neurovascular arteries. This | ||
| bench testing model replicates | ||
| the tortuosity, diameter and | ||
| location of the arteries in the | ||
| neurovasculature including the | ||
| internal carotid artery (ICA) | ||
| siphon. The model ends at the | ||
| mid carotid arteries and proximal | ||
| support is provided by a guide | ||
| catheter. The model | ||
| incorporates a re-circulating | ||
| water bath at 37°C pressurized | ||
| between 2 - 2.5 psi (100 - 126 | ||
| mm Hg) to simulate the human | ||
| arterial circulation. All testing | ||
| follows the procedural | ||
| instructions outlined in the | ||
| Instructions for Use. Simulated | ||
| thrombus is used to assess the | ||
| devices ability to retrieve clot | All samples passed the | |
| acceptance criteria. |
Device continues to meet
same design requirements
as predicate device
K122478. |
In summary, the results of simulated testing for deliverability, deployment, and reloadability that were conducted on the Modified Trevo ProVue Retriever demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
4
Summary of Substantial Equivalence
The Modified Trevo ProVue Retriever is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The conclusions drawn from risk assessments and the testing conducted using the Modified Trevo ProVue Retriever demonstrate that the device performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
Concentric Medical % Ms. Sarah Meyer Senior Regulatory Affairs Specialist 301 East Evelyn Ave. Mountain View, CA 94041
Re: K133464
Trade/Device Name: Trevo ProVue Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: December 18, 2013 Received: December 19, 2013
Dear Ms. Meyer:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Ms. Sarah Meyer
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" (21CFR 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,
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K133464
Device Name: Trevo ProVue Retriever
Indications For Use:
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of 1