(140 days)
No
The device description focuses on the mechanical aspects of the retriever and its materials, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to treat ischemic stroke by removing thrombus and restoring blood flow, which are therapeutic actions.
No
The device is described as a "Retriever" intended to "restore blood flow in the neurovasculature by removing thrombus." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical medical device (retriever) with specific dimensions, materials (platinum wires), coatings, and accompanying tools (torque device, insertion tool). This is not a software-only device.
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 retriever designed to be inserted into blood vessels to remove clots.
- Mechanism of Action: The device physically interacts with the thrombus within the blood vessel.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.
The device described is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
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
NRY
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. Radiopaque platinum wires in the shaped section and new radiopaque markers on the new truncated distal end 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. The Modified Trevo ProVue Retriever is offered in two sizes.
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
The results of verification and validation 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:
- Dimensional Verification: Verified dimensions using specified measurement tool.Dimensional verification meets acceptance criteria.
- Retriever Proximal Joint Tensile Strength: Identified joint and cut sample for test. Recorded peak tensile force results. Retriever Proximal Joint Tensile Strength meets acceptance criteria.
- Retriever Mid Joint Tensile Strength: Identified joint and cut sample for test. Recorded peak tensile force results. Retriever Mid Joint Tensile Strength meets acceptance criteria.
- Retriever Tip Tensile Strength: Loaded sample. Recorded peak tensile force results. Retriever Tip Tensile Strength meets acceptance criteria.
- Retriever Shaped Section Radial Force: Constrained shaped section of retriever to specified diameter. Recorded radial force results. Retriever Shaped Section Radial Force meets acceptance criteria.
- Retriever/Vessel Interaction (Tip Flexibility): Loaded sample so that the distal tip was flexed. Recorded peak compression/flex force results. Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria.
- Retriever Torque Tensile Durability: Gripped device and applied rotations to torque device. Pulled tensile cycles to a max load then last cycle to failure. Recorded results. Retriever Torque Tensile Durability meets acceptance criteria.
- Retriever Platinum Wire Joint Strength: Identified joint and cut sample for test. Recorded peak tensile force on each individual platinum wire results. Retriever Platinum Wire Joint Strength meets acceptance criteria.
- Retriever Platinum Wire and Joint Durability: Wrapped and unwrapped the entire length of the shaped section of the retriever (sheathed in insertion tool) around a pin and repeat. Performed visual inspection and recorded results. Performed deploy/reload cycles into insertion tool. Performed visual inspection and recorded results. Retriever Platinum Wire and Joint Durability meets acceptance criteria.
- Radiopacity: Radiopacity was assessed based on visual assessment of the device being used under fluoroscopy. Radiopacity meets acceptance criteria.
- Retriever/Microcatheter Deliverability: Measured the force to push the device through a tortuous model. Retriever/Microcatheter Deliverability meets acceptance criteria.
- Proximal Curl Resistance: Applied rotations to distal end of core wire with device constrained. Recorded the number of rotations until a loop results or stop rotations at specified number if no loop results. Proximal Curl Resistance meets acceptance criteria.
- Simulated Use: 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. Simulated Use meets acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
5. 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: | February 25, 2014 |
| Predicate Device: | Concentric Trevo ProVue Retriever (K122478) |
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. Radiopaque platinum wires in the shaped section and new radiopaque markers on the new truncated distal end 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. The Modified Trevo ProVue Retriever is offered in two sizes.
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 is substantially equivalent to the predicate device in terms of basic design, materials used, and function. A comparison of the subject device with predicate device is summarized in the below table.
| Feature | Results |
|---|---|
| Indications for Use | Same |
| Device Description | Same except new truncated distal end with new distal |
| radiopaque markers. | |
| Target Population | Same |
| Accessory Devices Provided | Same |
| Materials | Same |
| Overall Length | Same except 3x20 size is longer. |
| Total Shaped Section Length | Shorter than predicate device. |
| Active Shaped Section | |
| Length | Same |
| Distal Tip and Distal Taper | |
| Length | Not applicable to subject device, modified device distal |
| end has been truncated. | |
| Proximal Core Wire Diameter | Same except 3x20 size has a smaller diameter |
| Shaped Section Diameter | Same except 3x20 size has a smaller diameter |
| Packaging Materials and | |
| Configuration | Same |
| Sterilization Method | Same |
| How Supplied | Same |
Product Feature Comparison of Subject Device with Predicate Device
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.
Results of verification and validation 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
2
The results of verification and validation 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 | Conclusions | |
|---|---|---|---|
| 1. | Dimensional Verification | Verified dimensions using specified | |
| measurement tool. | Dimensional verification meets | ||
| acceptance criteria. | |||
| 2. | Retriever Proximal Joint | ||
| Tensile Strength | Identified joint and cut sample for | ||
| test. Recorded peak tensile force | |||
| results. | Retriever Proximal Joint Tensile | ||
| Strength meets acceptance criteria. | |||
| 3. | Retriever Mid Joint | ||
| Tensile Strength | Identified joint and cut sample for | ||
| test. Recorded peak tensile force | |||
| results. | Retriever Mid Joint Tensile Strength | ||
| meets acceptance criteria. | |||
| 4. | Retriever Tip Tensile | ||
| Strength | Loaded sample. Recorded peak | ||
| tensile force results. | Retriever Tip Tensile Strength | ||
| meets acceptance criteria. | |||
| 5. | Retriever Shaped | ||
| Section Radial Force | Constrained shaped section of | ||
| retriever to specified diameter. | |||
| Recorded radial force results. | Retriever Shaped Section Radial | ||
| Force meets acceptance criteria. | |||
| 6. | Retriever/Vessel | ||
| Interaction (Tip | |||
| Flexibility) | Loaded sample so that the distal tip | ||
| was flexed. Recorded peak | |||
| compression/flex force results. | Retriever/Vessel Interaction (Tip | ||
| Flexibility) meets acceptance | |||
| criteria. | |||
| 7. | Retriever Torque | ||
| Tensile Durability | Gripped device and applied rotations | ||
| to torque device. Pulled tensile | |||
| cycles to a max load then last cycle | |||
| to failure. Recorded results. | Retriever Torque Tensile Durability | ||
| meets acceptance criteria. | |||
| 8. | Retriever Platinum Wire | ||
| Joint Strength | Identified joint and cut sample for | ||
| test. Recorded peak tensile force on | |||
| each individual platinum wire results. | Retriever Platinum Wire Joint | ||
| Strength meets acceptance criteria. | |||
| 9. | Retriever Platinum Wire | ||
| and Joint Durability | Wrapped and unwrapped the entire | ||
| length of the shaped section of the | |||
| retriever (sheathed in insertion tool) | |||
| around a pin and repeat. Performed | |||
| visual inspection and recorded | |||
| results. Performed deploy/reload | |||
| cycles into insertion tool. Performed | |||
| visual inspection and recorded | |||
| results. | Retriever Platinum Wire and Joint | ||
| Durability meets acceptance criteria. | |||
| 10. | Radiopacity | Radiopacity was assessed based on | |
| visual assessment of the device | |||
| being used under fluoroscopy. | Radiopacity meets acceptance | ||
| criteria. | |||
| 11. | Retriever/Microcatheter | ||
| Deliverability | Measured the force to push the | ||
| device through a tortuous model. | Retriever/Microcatheter | ||
| Deliverability meets acceptance | |||
| criteria. | |||
| 12. | Proximal Curl | ||
| Resistance | Applied rotations to distal end of core | ||
| wire with device constrained. | |||
| Recorded the number of rotations | |||
| until a loop results or stop rotations | |||
| at specified number if no loop | |||
| results. | Proximal Curl Resistance meets | ||
| acceptance criteria. | |||
| 13. | Simulated Use | Simulated use testing used a silicone | |
| neurovascular model cast from | |||
| actual human neurovascular arteries. | |||
| This bench testing model replicates | |||
| the tortuosity, diameter and location | Simulated Use meets acceptance | ||
| criteria. | |||
| Test | Test Method Summary | Conclusions | |
| 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. |
3
Biocompatibility
The modified Trevo ProVue Retriever was assessed for impact to biocompatibility. Materials used in the modified Trevo ProVue Retriever are all the same materials used in the cleared Trevo ProVue Retriever (K122478). Furthermore, screening testing was performed successfully, providing further assurance that any design or process changes did not adversely affect the biocompatibility of the modified Trevo ProVue Retriever. Screening testing included cytotoxicity, hemolysis, and physicochemical testing, summarized below. Both the modified Trevo ProVue Retriever and the cleared Trevo ProVue Retriever meet biological safety requirements per ISO 10993-1 for externally communicating medical devices with circulating blood contact for less than 24 hours.
| Test
| Description | Result | Conclusion | |||
|---|---|---|---|---|---|
| Cytotoxicity | |||||
| Using the | |||||
| ISO Elution | |||||
| Method | Dilution | Result Grade | Pass/Fail | Non-cytotoxic. | |
| Undiluted | 3 – Moderate | ||||
| reactivity | * | The score of “3” is not attributed to the | |||
| changes made to the modified Trevo | |||||
| ProVue Retriever since this result is | |||||
| consistent with historical cytotoxicity data | |||||
| collected on Retriever devices (such as | |||||
| K122478) with hydrophilic coating. | |||||
| 50% | 0 – No reactivity | Pass | |||
| 25% | 0 – No reactivity | Pass | |||
| 12.5% | 0 – No reactivity | Pass | |||
| 6.25% | 0 – No reactivity | Pass | |||
| 3.13% | 0 – No reactivity | Pass | |||
| ASTM | |||||
| Hemolysis | |||||
| (combined | |||||
| direct | |||||
| contact and | |||||
| extract) | Pass. | ||||
| Hemolytic index: 0.0% (direct contact) and 0.4% | |||||
| (extract) | Non-Hemolytic | ||||
| Physicoche- | |||||
| mical Tests | |||||
| Plastics | Pass. | ||||
| Non-volatile residue: 2 mg | |||||
| Residue on ignition: ≤ 2 mg | |||||
| Heavy metal: |