(350 days)
No
The summary describes a mechanical thrombectomy device and does not mention any AI or ML components. The clinical study data focuses on comparing the device's performance to predicate devices based on standard clinical outcomes.
Yes
The device is described as a 'mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke,' directly indicating its role in treating a medical condition.
No
Explanation: The ERIC Retrieval Device is a mechanical thrombectomy device designed to treat ischemic stroke by removing thrombus and restoring blood flow. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "mechanical thrombectomy device" consisting of "retrieval spheres secured on a pusher wire," which are physical hardware components designed to capture and remove blood clots.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ERIC Retrieval Device Function: The ERIC Retrieval Device is a mechanical device designed to be inserted into the body (specifically the neurovasculature) to physically remove blood clots. It does not analyze or test specimens taken from the body.
The information provided clearly describes a medical device used for a therapeutic procedure (removing a clot) rather than a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The ERIC Retrieval Device is indicated 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 ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from 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
Age 18 and older (i.e., candidates must have had their 18th birthday)
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)
Verification Test Summary:
- Test Description: Dimensional Testing (Expanded Diameter & Device Overall Length)
- Test Method: Device attributes (overall device length and expanded outer diameter (OD) of the shaped section) were measured.
- Result: Pass
- Conclusions: The longer overall length and smaller OD of the subject device offerings does not affect the performance of the device.
- Test Description: Fluoroscopic Guidance Marker Testing
- Test Method: The radiopacity of device markers were assessed under fluoroscopy during non-clinical testing.
- Result: Pass
- Conclusions: Both subject and predicate devices are sufficiently visible under fluoroscopy.
- Test Description: Advance/Retraction Force Testing
- Test Method: The advance and retract forces of the subject device in a tortuous model were compared with the forces measured for one or more predicate devices.
- Result: Pass
- Conclusions: The advance and retract forces of the subject device were comparable with the forces measured for the predicate device.
- Test Description: Re-Sheathing Testing
- Test Method: The ability to re-sheath the device was evaluated compared with the predicate device.
- Result: Pass
- Conclusions: The ability to re-sheath the subject device is comparable to that of the predicate device tested.
- Test Description: Radial Force Testing
- Test Method: The radial force of the subject device was measured by radially compressing the device and was compared with the radial forces measured for predicate device.
- Result: Pass
- Conclusions: The radial force of the subject device is comparable to that of the predicate device tested.
- Test Description: Tensile Strength Testing
- Test Method: The peak tensile strength to failure in different sections of the subject device was evaluated and compared with that measured for the predicate device.
- Result: Pass
- Conclusions: The system tensile strength of the subject device is comparable to that of the predicate device tested.
- Test Description: Kink Resistance Testing
- Test Method: Kink resistance of the subject device was evaluated when wrapped around a series of mandrels of decreasing radii until permanent deformation was observed or until the smallest radius was used.
- Result: Pass
- Conclusions: Kink resistance of the subject device is equivalent to that of the predicate device tested.
- Test Description: Austenite Finish (Af) Testing
- Test Method: Af temperature testing of the subject device determined at what temperature the shape recovery transformation is complete upon heating and is a property of the pseudoelastic material used.
- Result: Pass
- Conclusions: The Af temperature of the subject device is less than the product use temperature (body temperature) and, thus, satisfies requirements for clinical applications.
- Test Description: Simulated Use/Performance Testing
- Test Method: The ability to reliably deploy and use the subject device in a tortuous benchtop model was evaluated and compared with one or more predicate devices.
- Result: Pass
- Conclusions: Simulated use testing was comparable with that of the predicate device.
- Test Description: Corrosion Resistance Testing
- Test Method: Metallic components intended for fluid path contact were evaluated for signs of corrosion.
- Result: Pass
- Conclusions: Corrosion resistance testing of the subject device showed no signs of corrosion.
- Test Description: Particulate Evaluation Testing
- Test Method: Particulate evaluation testing of the subject device was evaluated in a tortuous benchtop model and was compared with that of the predicate device.
- Result: Pass
- Conclusions: Particulate evaluation was comparable with that of the predicate device.
- Test Description: Torque Response Testing
- Test Method: The torque ability of the subject device in a tortuous benchtop model was evaluated and compared with the predicate device.
- Result: Pass
- Conclusions: Torque response testing indicated that the core wire of the subject device rotates freely with the proximal sphere and, thus, has equivalent torqueability compared to the predicate device.
Biocompatibility Evaluation:
- Test: Cytotoxicity: L929 MEM Elusion Test
- Test Summary: There was no biological reactivity (Grade 0) of the cells exposed to the test article extract.
- Conclusions: Non-cytotoxic
- Test: Sensitization: Kligman Maximization Test in Guinea Pigs
- Test Summary: The test article extracts elicited no reaction at the challenge (0% sensitization) following an induction phase.
- Conclusions: Non-sensitizer
- Test: Intracutaneous Reactivity in White Rabbits
- Test Summary: No evidence of irritation (score 0.0).
- Conclusions: Non-irritating
- Test: Systemic Injection Test in Mice
- Test Summary: No biologically significant weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice was observed.
- Conclusions: Systemically non-toxic
- Test: Rabbit Pyrogen Test (Material Mediated)
- Test Summary: No rabbit showed an individual rise in temperature of 0.5 °C. The temperature increases for the test animals were 0.0 °C.
- Conclusions: Non-pyrogenic
- Test: ASTM Blood Compatibility - Direct and Indirect Contact Hemolysis
- Test Summary: The test article demonstrated 0.12% hemolysis in direct contact and 0.00% hemolysis in indirect contact.
- Conclusions: Non-hemolytic
- Test: Unactivated Partial Thromboplastin Time Test
- Test Summary: An average coagulation time of the test article showed no significant difference from the control.
- Conclusions: No effect on coagulation of human plasma
- Test: Complement Activation Test (Direct Contact)
- Test Summary: The plasma exposed to the test article for 90 minutes was found to exhibit no statistically significant increase in C3 and SC5b-9.
- Conclusions: Non-activating
- Test: Platelet and Leukocyte Count Assay (Direct Contact)
- Test Summary: The concentration of White Blood Cells (WBC) and Platelets (Plt) in human blood exposed to the test article was not statistically significantly decreased.
- Conclusions: No effect on hematological parameters
- Test: Thrombogenicity
- Test Summary: The test article had a thrombus formation score of "2" and was considered thromboresistant.
- Conclusions: Non-thrombogenic
Animal Testing Summary:
- Study Type: Acute and chronic in vivo testing in a porcine model.
- Sample Size: Not specified, but involved multiple animals.
- Key Results: Histological evaluation demonstrated that the tissue response to both test and control devices were similar. There was no evidence of perforation or dissection in vessels treated with either the test or control devices. There was no evidence of downstream thromboembolic or ischemic injury. Chronic study animals remained healthy, gained weight, and survived to scheduled termination. Study endpoints were met, and ERIC Retrieval Devices were shown to be safe and equivalent to the predicate device.
Clinical Study Data (ETIS Observational Cohort Study, NCT03776877):
- Study Type: Prospective, multi-center, observational, Good Clinical Practice (GCP) compliant study.
- Sample Size: N=206 patients treated with ERIC™ device; N=1058 patients treated with Trevo or Solitaire.
- Primary Effectiveness Outcome: Achievement of an mTICI score of 2b or greater in the target vessel.
- ERIC Device Cohort: 166/202 (82.2% (76.9-87.5%))
- Trevo/Solitaire Cohort: 842/1044 (80.7% (78.2-83.1%))
- Key Results: The primary effectiveness outcome success rate for the ERIC device cohort is statistically non-inferior to the mTICI rate for the Trevo/Solitaire cohort.
- Primary Effectiveness Endpoint (mTICI 2b-3) - Use of Rescue Mechanical Thrombectomy Device Considered Treatment Failure:
- ERIC (N=206): 130/206 (63.1%)
- Trevo/Solitaire (N=1058): 639/1058 (60.4%)
- Primary Safety Outcome: Occurrence of symptomatic intracerebral hemorrhage (sICH) within 24 hours post-procedure.
- ERIC Device Cohort: 7/169 (4.1% (1.1-7.2%))
- Trevo/Solitaire Cohort: 81/965 (8.4% (6.6-10.2%))
- Key Results: The rate of occurrence of the primary safety outcome for the ERIC device cohort is statistically non-inferior to the sICH rate for the Trevo/Solitaire cohort. Note: The number of missing patients without follow-up CT/MRI in the ERIC-treated group is proportionally higher than the number of missing patients without follow-up CT/MRI in the Trevo/Solitaire-treated group. Therefore, the occurrence of sICH within 24-48 hours with the ERIC-treated patients could be higher than the confidence intervals presented in this table.
- Secondary Outcome: Good clinical outcome (90-day mRS 0-2).
- ERIC (N=206): 67/136 (49.3% (40-57.7%))
- Trevo/Solitaire (N=1058): 413/919 (44.9% (41.7-48.2%))
- Key Results: The results of this analysis demonstrate that the 90-day mRS of the ERIC arm and the control arm are substantially equivalent based on available follow-up data.
Overall Conclusion: The angiographic and clinical outcomes demonstrate that the ERIC™ device performs similarly to the Trevo and Solitaire in terms of successful reperfusion rate and good clinical outcome (mRS 0-2) at 90 days based on available follow-up data in the two analysis groups. The ERIC™ device also exhibits a comparable safety profile, including similar rates of procedural complications, sICH, and 90-day all-cause mortality based on available follow-up data in the two analysis groups. The information presented demonstrates the substantial equivalence between the predicate and the ERIC™ Retrieval Device regarding the design, construction materials, operating principle, bench testing, animal testing and clinical performance for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Primary Effectiveness Outcome: Successful reperfusion at end of procedure (mTICI 2b-3)
- ERIC Device Cohort: 82.2% (76.9-87.5%)
- Trevo/Solitaire Cohort: 80.7% (78.2-83.1%)
- Primary Safety Outcome: Occurrence of sICH within 24h-48h
- ERIC Device Cohort: 4.1% (1.1-7.2%)
- Trevo/Solitaire Cohort: 8.4% (6.6-10.2%)
- Primary Effectiveness Endpoint (mTICI 2b-3) – ERIC Device vs Trevo/Solitaire: Use of Rescue Mechanical Thrombectomy Device Considered Treatment Failure
- ERIC: 63.1%
- Trevo/Solitaire: 60.4%
- Secondary Outcome Good Clinical Outcome (90-day mRS 0-2)
- ERIC: 49.3% (40-57.7%)
- Trevo/Solitaire: 44.9% (41.7-48.2%)
Predicate Device(s)
Reference Device(s)
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
March 31, 2022
Image /page/0/Picture/11 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MicroVention, Inc. Sapna Singh Director, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656
Re: K211120
Trade/Device Name: ERIC Retrieval Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 25, 2022 Received: March 28, 2022
Dear Sapna Singh:
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,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211120
Device Name ERIC Retrieval Device
Indications for Use (Describe)
The ERIC Retrieval Device is indicated 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.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K211120 510(k) Summary
| Trade Name: | ERIC™ Retrieval Device |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | II, 21 CFR 870.1250, NRY |
| Submitted By: | MicroVention, Inc. |
| 35 Enterprise | |
| Aliso Viejo, California, USA | |
| Contact: | Sapna Singh |
| Director, Regulatory Affairs | |
| MicroVention, Inc. | |
| Sapna.Singh@MicroVention.com | |
| Tel: (714) 247-8000 x 8162 | |
| Date: | March 29, 2022 |
| Predicate Device: | Trevo XP ProVue Retriever (6x25 mm), K143077 |
| Trevo XP ProVue Retriever (4x30mm), K150616 | |
| Modified Trevo ProVue Retriever (3x20 mm and 4x20 mm), K132641 | |
| Reference Device: | Solitaire™ FR Revascularization Device (K113455) |
| Device Description: | The ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a |
| mechanical thrombectomy device designed to restore blood flow by removing | |
| clots from vasculature in patients suffering from acute ischemic stroke. The | |
| device consists of retrieval spheres secured on a pusher wire that are designed to | |
| capture and remove blood clots from the neurovasculature. The device is inserted | |
| into a microcatheter to navigate to the target location and retrieve the thrombus | |
| while the device is withdrawn from the vessel. | |
| Indications for Use: | The ERIC™ Retrieval Device is indicated to restore blood flow in the |
| neurovasculature by removing thrombus in patients experiencing ischemic |
4
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.
Comparison of Technological Characteristics with the Predicate Device:
The subject device, ERIC™ Retrieval Device, is substantially equivalent to the predicate device in terms of intended use, scientific technology, and fundamental design. A tabular comparison of the technological characteristics between the predicate device and subject device is provided below.
Table 1: Technological Characteristics Comparison
| Device
| Characteristics | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Trevo XP ProVue (6x25 mm, K143077 and 4x30 mm, K150616) | |||
| Modified Trevo ProVue | |||
| Retriever (3x20 mm and 4x20 mm K132641) | ERIC™ Retrieval Device | ||
| Manufacturer | Stryker | MicroVention | N/A |
| Classification | 21 CFR 870.1250, Class II | 21 CFR 870.1250, Class II | Same |
| Device | |||
| Classification | |||
| Name | Catheter, Thrombus | ||
| Retriever | Catheter, Thrombus Retriever | Same | |
| Product Code | NRY | NRY | Same |
| Indications for Use | The Trevo XP 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. | The ERIC Retrieval Device is | ||
| indicated 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 | ||
| Target Population | Patients with symptoms of an ischemic stroke | Patients with symptoms of an ischemic stroke | Same |
| Anatomical Sites | Neurovasculature | Neurovasculature | Same |
| Device | |||
| Characteristics | Predicate Device | Subject Device | Comparison |
| Trevo XP ProVue (6x25 mm, K143077 and 4x30 mm, K150616) | |||
| Modified Trevo ProVue | |||
| Retriever (3x20 mm and | |||
| 4x20 mm K132641) | ERIC™ Retrieval Device | ||
| Principal Device Dimensions & Materials | |||
| Size | |||
| (Retriever | |||
| Diameter × Length) | |||
| (mm) | 3×20 | ||
| 4×20 | |||
| 4×30 | |||
| 6×25 | 3×15 | ||
| 3×20 | |||
| 3×25 | |||
| 4×18 | |||
| 4×24 | |||
| 4×30 | |||
| 4×36 | |||
| 4×42 | |||
| 6×26 | |||
| 6×35 | |||
| 6×44 | Bench and animal testing | ||
| have demonstrated that the | |||
| different overall lengths of | |||
| the subject device | |||
| offerings do not raise new | |||
| questions regarding safety | |||
| and efficacy. | |||
| Stent & Core Wire | |||
| (Shaft) | Nitinol | Nitinol | Same |
| Stent Radiopaque | |||
| Wire | Platinum/Tungsten | None | Minor difference does not |
| raise new questions | |||
| regarding safety and | |||
| efficacy. Both | |||
| devices have radiopaque | |||
| characteristics. | |||
| Distal Marker/Coil | Platinum/Tungsten | Tantalum | Similar. Both are |
| commonly used medical | |||
| grade materials. Material | |||
| difference does not raise | |||
| new questions of safety and | |||
| efficacy. | |||
| Proximal | |||
| Marker/Coil | 304 Stainless Steel | Tantalum | Similar. Both are |
| commonly used medical | |||
| grade materials. Material | |||
| difference does not raise | |||
| new questions of safety and | |||
| efficacy. | |||
| Solder | Gold/Tin | N/A | Minor difference does not |
| raise new questions | |||
| regarding safety and | |||
| efficacy. | |||
| Hydrophilic | |||
| Coating | Sodium Hyaluronate Mixture | None | Difference does not raise |
| new questions of safety and | |||
| efficacy. Hydrophilic | |||
| coatings are commonly | |||
| used to | |||
| Device | |||
| Characteristics | Predicate Device | Subject Device | Comparison |
| Trevo XP ProVue (6x25 mm, K143077 and 4x30 mm, K150616) | |||
| Modified Trevo ProVue Retriever (3x20 mm and 4x20 mm K132641) | ERIC™ Retrieval Device | ||
| lubricate some vascular devices. | |||
| Pusher Shrink | |||
| Tubing | None | Polyethylene | Polyethylene is a |
| commonly used medical grade plastic. Difference does not raise new questions of safety and efficacy. | |||
| Additional Characteristics | |||
| Packaging | |||
| Materials and | |||
| Configuration | Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film Pouch, HDPE Tubing Clips, Chipboard carton | Polyethylene Hoop, polycarbonate mounting card, Tyvek/Film Pouch, HDPE Tubing Clips, Bleached Sulfate carton | Minor difference does not raise new questions regarding safety and efficacy. |
| Supplied As | Sterile/Single Use | Sterile/Single Use | Same |
| Sterilization | |||
| Method | Ethylene Oxide | Electron Beam | Minor difference in method does not raise new questions regarding safety and efficacy. Both devices demonstrate a SAL of 10-6 |
5
6
Verification Test Summary:
The results of verification and validation testing conducted on the subject device demonstrate that it performs
as intended and are summarized as follows:
Table 2: Verification and Validation Testing
| Test Description | Test Method | Result | Conclusions |
|---|---|---|---|
| Dimensional Testing | |||
| (Expanded Diameter & | |||
| Device Overall Length) | Device attributes (overall device | ||
| length and expanded outer | |||
| diameter (OD) of the shaped | |||
| section) were measured. | Pass | The longer overall length and | |
| smaller OD of the subject | |||
| device offerings does not | |||
| affect the performance of the | |||
| device. | |||
| Test Description | Test Method | Result | Conclusions |
| Fluoroscopic Guidance | |||
| Marker Testing | The radiopacity of device | ||
| markers were assessed under | |||
| fluoroscopy during non-clinical | |||
| testing. | Pass | Both subject and predicate | |
| devices are sufficiently visible | |||
| under fluoroscopy. | |||
| Advance/Retraction Force | |||
| Testing | The advance and retract forces | ||
| of the subject device in a | |||
| tortuous model were compared | |||
| with the forces measured for one | |||
| or more predicate devices. | Pass | The advance and retract | |
| forces of the subject device | |||
| were comparable with the | |||
| forces measured for the | |||
| predicate device. | |||
| Re-Sheathing Testing | The ability to re-sheath the | ||
| device was evaluated compared | |||
| with the predicate device. | Pass | The ability to re-sheath the | |
| subject device is comparable | |||
| to that of the predicate device | |||
| tested. | |||
| Radial Force Testing | The radial force of the subject | ||
| device was measured by radially | |||
| compressing the device and was | |||
| compared with the radial forces | |||
| measured for predicate device. | Pass | The radial force of the subject | |
| device is comparable to that | |||
| of the predicate device tested. | |||
| Tensile Strength Testing | The peak tensile strength to | ||
| failure in different sections of | |||
| the subject device was evaluated | |||
| and compared with that | |||
| measured for the predicate | |||
| device. | Pass | The system tensile strength of | |
| the subject device is | |||
| comparable to that of the | |||
| predicate device tested. | |||
| Kink Resistance Testing | Kink resistance of the subject | ||
| device was evaluated when | |||
| wrapped around a series of | |||
| mandrels of decreasing radii | |||
| until permanent deformation was | |||
| observed or until the smallest | |||
| radius was used. | Pass | Kink resistance of the subject | |
| device is equivalent to that of | |||
| the predicate device tested. | |||
| Austenite Finish (Af) | |||
| Testing | Af temperature testing of the | ||
| subject device determined at | |||
| what temperature the shape | |||
| recovery transformation is | |||
| complete upon heating and is a | |||
| property of the pseudoelastic | |||
| material used. | Pass | The Af temperature of the | |
| subject device is less than the | |||
| product use temperature | |||
| (body temperature) and, thus, | |||
| satisfies requirements for | |||
| clinical applications. | |||
| Simulated Use/ | |||
| Performance Testing | The ability to reliably deploy | ||
| and use the subject device in a | |||
| tortuous benchtop model was | |||
| evaluated and compared with | |||
| one or more predicate devices. | Pass | Simulated use testing was | |
| comparable with that of the | |||
| predicate device. | |||
| Test Description | Test Method | Result | Conclusions |
| Corrosion Resistance | |||
| Testing | Metallic components intended | ||
| for fluid path contact were | |||
| evaluated for signs of corrosion. | Pass | Corrosion resistance testing of | |
| the subject device showed no | |||
| signs of corrosion. | |||
| Particulate Evaluation | |||
| Testing | Particulate evaluation testing of | ||
| the subject device was evaluated | |||
| in a tortuous benchtop model | |||
| and was compared with that of | |||
| the predicate device. | Pass | Particulate evaluation was | |
| comparable with that of the | |||
| predicate device. | |||
| Torque Response Testing | The torque ability of the subject | ||
| device in a tortuous benchtop | |||
| model was evaluated and | |||
| compared with the predicate | |||
| device. | Pass | Torque response testing | |
| indicated that the core wire of | |||
| the subject device rotates | |||
| freely with the proximal | |||
| sphere and, thus, has | |||
| equivalent torqueability | |||
| compared to the predicate | |||
| device. |
7
8
Biocompatibility Evaluation:
The in vitro and in vivo biocompatibility safety studies performed on the terminally sterilized ERIC™ Retrieval Device have demonstrated the biocompatibility of the proposed device and support compliance with ISO 10993-1, 'Biological Evaluation of Medical Devices,' and the FDA Biocompatibility Guidance.
Per ISO 10993-1, the ERIC™ Retrieval device is categorized as an external communicating device with limited exposure. The device was determined to be non-cytotoxic, non-irritating, non-irritating, non-toxic, nonpyrogenic, non-hemolytic, non-activating, and has no effect on coagulation of human plasma and hematological parameters. The biocompatibility evaluation are summarized as follows:
| Table 3: Biocompatibility Testing | ||
|---|---|---|
| -- | ----------------------------------- | -- |
| Test | Test Summary | Conclusions |
|---|---|---|
| Cytotoxicity: L929 MEM | ||
| Elusion Test | There was no biological reactivity (Grade 0) of | |
| the cells exposed to the test article extract. | Non-cytotoxic | |
| Sensitization: Kligman | ||
| Maximization Test in | ||
| Guinea Pigs | The test article extracts elicited no reaction at the | |
| challenge (0% sensitization) following an | ||
| induction phase. | Non-sensitizer | |
| Intracutaneous Reactivity in | ||
| White Rabbits | No evidence of irritation (score 0.0). | Non-irritating |
9
| Test | Test Summary | Conclusions |
|---|---|---|
| Systemic Injection Test in | ||
| Mice | No biologically significant weight loss, | |
| mortality, or evidence of systemic toxicity from | ||
| the extract exposure to the mice was observed. | Systemically non-toxic | |
| Rabbit Pyrogen Test | ||
| (Material Mediated) | No rabbit showed an individual rise in | |
| temperature of 0.5 °C. The temperature increases | ||
| for the test animals were 0.0 °C. | Non-pyrogenic | |
| ASTM Blood Compatibility |
- Direct and Indirect Contact
Hemolysis | The test article demonstrated 0.12% hemolysis
in direct contact and 0.00% hemolysis in indirect
contact. | Non-hemolytic |
| Unactivated Partial
Thromboplastin Time Test | An average coagulation time of the test article
showed no significant difference from the
control. | No effect on coagulation
of human plasma |
| Complement Activation
Test (Direct Contact) | The plasma exposed to the test article for 90
minutes was found to exhibit no statistically
significant increase in C3 and SC5b-9. | Non-activating |
| Platelet and Leukocyte
Count Assay (Direct
Contact) | The concentration of White Blood Cells (WBC)
and Platelets (Plt) in human blood exposed to the
test article was not statistically significantly
decreased. | No effect on
hematological
parameters |
| Thrombogenicity | The test article had a thrombus formation score
of "2" and was considered thromboresistant. | Non-thrombogenic |
Sterilization, Shelf-Life, and Packaging Integrity:
The ERIC™ Retrieval Device is labeled as a single-use, sterile device. The sterilization process for the ERIC™ Retrieval Device has been successfully validated and process monitoring controls are in place to assure that the device is electron beam sterilized to achieve a minimum SAL of 10-9 with bacterial endotoxin