(78 days)
Not Found
No
The summary describes a mechanical thrombectomy device and its physical properties and performance in mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The input imaging modality is fluoroscopy, which is used for visualization, not for processing or analysis that would typically involve AI/ML in this context.
Yes
The device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke, which is a therapeutic intervention.
No
The device is a retriever designed to remove thrombus and restore blood flow, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly details a physical medical device (flexible, tapered core, shaped section, radiopaque coil, platinum wires, hydrophilic coating, torque device, insertion tool) intended for mechanical thrombus removal, not a software-only application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Modified Trevo Retriever is a medical device designed to be inserted into the neurovasculature to physically remove a thrombus (blood clot). It is a therapeutic device used within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "restor[ing] blood flow in the neurovasculature by removing thrombus." This is a direct intervention, not a diagnostic test.
- Device Description: The description details its physical components and how it's used to interact with the thrombus within the vessel.
- Performance Studies: The performance studies focus on the device's mechanical properties and ability to function in a simulated environment, not on the accuracy of a diagnostic measurement.
The device is a therapeutic medical device, specifically a mechanical thrombectomy device.
N/A
Intended Use / Indications for Use
The Modified 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
Like the predicate device, the Modified Trevo 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 and new radiopaque platinum wires in the shaped section allow fluoroscopic visualization. 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
Not Found
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 Testing: the device's ability to be used in a neurovascular model per procedural instructions outlined in the Instructions for Use was successfully evaluated.
Tensile Testing: the device's mechanical integrity under tensile loads was successfully evaluated.
Radial Force Testing: the resulting radial force when the device is constrained radially was successfully evaluated.
Tip Deflection Force Testing: the force to deflect the distal tip of the device was successfully evaluated.
Torque/Tensile Durability: the ability of the device to withstand torque and tensile load cycles . without fracture was successfully evaluated.
Kink Resistance: the ability of the device shaft to resist kinking was successfully evaluated.
Platinum Wire and Joint Durability: the platinum wire and joint integrity following loading . cycles was successfully evaluated.
Platinum Wire Attachment: the platinum wire attachment strength was successfully evaluated.
Radiopacity: the visibility of the platinum shaped section under fluoroscopy during use was successfully evaluated.
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
2012
510(k) Summary
| Trade Name: | Modified Trevo Retriever |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Catheter, Thrombus Retriever, 21CFR 870.1250 Class II |
| Submitter: | Concentric Medical, Inc. |
| 301 E. Evelyn Avenue | |
| Mountain View, CA 94041 | |
| Tel 650-938-2100 | |
| Fax 650-237-5230 | |
| Facility Registration #2954917 | |
| Contact: | Kirsten Valley |
| Vice President, Technology and Regulatory Affairs | |
| Date Prepared: | October 24, 2012 |
| Predicate Device: | Trevo Retriever (K120961) |
Device Description
Like the predicate device, the Modified Trevo 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 and new radiopaque platinum wires in the shaped section allow fluoroscopic visualization. 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 Indications for Use are identical to that of the predicate devices and are as follows:
The Modified 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.
The intended therapeutic use of the device is not impacted and no new issues of safety and effectiveness are raised by the modification.
1
Technological Characteristics
The Modified Trevo Retriever has the same technological characteristics as the predicate device. The basic design, materials used, and function have not been changed. Radiopaque platinum wires have been added to the shaped section to allow fluoroscopic visualization.
Testing Summary
The results of verification and validation testing conducted on the Modified Trevo 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:
- . Simulated Use Testing: the device's ability to be used in a neurovascular model per procedural instructions outlined in the Instructions for Use was successfully evaluated.
- . Tensile Testing: the device's mechanical integrity under tensile loads was successfully evaluated.
- . Radial Force Testing: the resulting radial force when the device is constrained radially was successfully evaluated.
- . Tip Deflection Force Testing: the force to deflect the distal tip of the device was successfully evaluated.
- Torque/Tensile Durability: the ability of the device to withstand torque and tensile load cycles . without fracture was successfully evaluated.
- . Kink Resistance: the ability of the device shaft to resist kinking was successfully evaluated.
Verification and Validation of modified components includes:
- Platinum Wire and Joint Durability: the platinum wire and joint integrity following loading . cycles was successfully evaluated.
- . Platinum Wire Attachment: the platinum wire attachment strength was successfully evaluated.
- . Radiopacity: the visibility of the platinum shaped section under fluoroscopy during use was successfully evaluated.
Summary of Substantial Equivalence
The Modified Trevo Retriever is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The conclusions drawn from the verification and validation testing conducted using the Modified Trevo Retriever demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Concentric Medical, Inc. c/o Ms. Kirsten Valley Vice President, Technology and Regulatory Affairs 301 E. Evelyn Avenue Mountain View, CA 94041
OCT 31 2012
Re: K122478
Trade/Device Name: Modified Trevo Retriever Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Dated: August 13, 2012 Received: August 14, 2012
Dear Ms. Valley:
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 101 abouted in the encreated of the enactment date of the Medical Device Amendments, or to econmised pror to May 20, 2011 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 general controls provincitire, 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 If your device is exassified (500 aros). 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.
3
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 or any i vith 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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ruh. Reann, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Statement of Indications for Use
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | Modified Trevo Retriever |
| Indications for Use: | The Modified 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. |
INDICATIONS FOR USE
Prescription Use X (Per 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 CDRH, Office of Device Evaluation (ODE)
Samuel K. Shimp III
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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510(k) Number K122478