(144 days)
Not Found
No
The summary describes a mechanical thrombectomy device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are limited to bench testing of the physical device.
Yes
The document explicitly states the device is used for "treatment of acute ischemic stroke" and is a "Thrombectomy Device" designed to "restore blood flow." These are therapeutic applications.
No
This device is a thrombectomy device designed to remove thrombus and restore blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "Thrombectomy Device" designed for mechanical removal of thrombus, indicating it is a physical medical device, not software. The performance studies also describe bench testing related to physical properties like kink resistance, radial force, and tensile strength.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The pRESET LITE Thrombectomy Device is a mechanical device designed to physically remove thrombus (blood clots) from blood vessels in the brain. It is used within the body to restore blood flow.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within the living body) to treat acute ischemic stroke by removing a physical obstruction.
The device is a therapeutic device used in an interventional procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
-
The pRESET LITE Thrombectomy Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
-
The pRESET LITE Thrombectomy Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experienciscone within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
Product codes (comma separated list FDA assigned to the subject device)
POL, NRY
Device Description
The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovasculature (internal carotid artery (ICA) and the middle cerebral artery (MCA))
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)
Bench Testing:
- Simulated Use: Possible to safely and reliably prepare, deploy and retract the device in a nominal and worst-case 3D model as described in the instructions for use without damage to the device. (Pass)
- Simulated Clot Retrieval: Possible to retrieve synthetic clots from a 3D neurovascular model as described in the instructions for use. (Pass)
- Kink Resistance: Possible to deploy the device to the intended location without kinking of the device. (Pass)
- Dimensional Verification: Expanded outer diameter (OD), Retriever device length, Working length of retrieval device, Effective length of retrieval device, Diameter of heat shrink, Uncovered length, Marker position, System length measurements met acceptance criteria. (Pass)
- Radial Force: The relative Chronic Outward Force (RCOF) in the labeled vessel diameters met acceptance criteria. (Pass)
- Austenitic Finish (Af) Transition Temperature: The Af transition temperature was appropriate for clinical use. (Pass)
- Radiopacity: Proximal and distal ends of the retrieval device were radiopaque. (Pass)
- System Surface Finish: The external surface of the effective length of the device appeared free from extraneous matter, process and surface defects. (Pass)
- Device Deployment: Possible to safely and reliably deploy the device as described in the instructions for use without damage to the device. (Pass)
- Retraction into the Microcatheter: Possible to advance a representative microcatheter over the deployed device, at the site of deployment, until it is fully contained within the inner lumen of the microcatheter without damage to the device. (Pass)
- Delivery and Re-sheathing Forces: The maximum delivery and re-sheathing forces measured during simulated use clinical conditions met acceptance criteria. (Pass)
- Re-Sheathing: Possible to re-sheath the device, as described in the instructions for use, after it has been prepared, deployed and retracted as described in the instructions for use. (Pass)
- System Tensile Strength: The minimum tensile strength of the thrombectomy system was evaluated to the acceptance criteria. (Pass)
- Torque Strength: The system did not break after 3 full rotations of the insertion wire. (Pass)
- Ancillary Device Compatibility: The device was compatible with ancillary devices as listed in the Directions for Use (DFU). (Pass)
Biocompatibility Testing:
- Cytotoxicity (ISO MEM elution - L929 fibroblast cultures method): Non-cytotoxic
- Hemocompatibility (Hemolysis - ASTM Method direct contact): No hemolysis indicated
- Hemocompatibility (Hemolysis - ASTM Method indirect extract): No hemolysis indicated
Sterilization: Validated to ensure a sterility assurance level (SAL) of 10^-6.
Shelf Life: Packaging remains functional and maintains sterility for up to 3 years.
Animal Testing: No animal testing was required.
Clinical Data: No clinical testing was required.
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
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.
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October 21, 2023
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
phenox Limited Rachel McDaid Senior Regulatory Affairs Specialist Kamrick Court, Ballybrit Business Park, Galway H91 XY38, Ireland
Re: K231539
Trade/Device Name: pRESET LITE Thrombectomy Device Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: September 22, 2023 Received: September 22, 2023
Dear Rachel McDaid:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
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
2
Indications for Use
510(k) Number (if known) K231539
Device Name pRESET LITE Thrombectomy Device
Indications for Use (Describe)
-
The pRESET LITE Thrombectomy Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
-
The pRESET LITE Thrombectomy Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experienciscone within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "phenox" in a simple, sans-serif font. The letters are a dark blue color, and the word is presented in all lowercase. The font is clean and modern, with consistent line thickness throughout each letter.
510(k) Summary (21 CFR 807.92)
K231539
I. SUBMITTER
| phenox Limited, |
|---|
| Kamrick Court |
| Ballybrit Business Park, |
| Galway, Ireland, |
| H91 XY38. |
| Primary Correspondent Name: | Rachel McDaid |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Phone: | +353 91 740 100 |
| Email: | rachel.mcdaid@wallabyphenox.com |
| Secondary Correspondent Name: | Emily Dobosz |
| Title: | Senior Manager of Regulatory Affairs |
| Phone: | +353 91 740 100 |
Date Prepared: 20th October 2023
II. DEVICE
Email:
Device Trade Name: pRESET® LITE Thrombectomy Device Common or Usual Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment; Catheter, Thrombus Retriever Classification: Class II device according to 21 CFR 882.5600; 21 CFR 870.1250 Product Code: POL, NRY Review Panel: Neurology
emily.dobosz@wallabyphenox.com
III. PREDICATE DEVICE Device Name: pRESET® Thrombectomy Device Manufacturer: phenox Limited 510(k) Number: K222848
IV. DEVICE DESCRIPTION
The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.
4
Materials of Use: See table below for details of the materials used in the construction of the pRESET® LITE Thrombectomy Device.
| Component | Material |
|---|---|
| Retrieval Structure | Nitinol |
| Push-Wire | Nitinol |
| Connector Shell | Nitinol |
| Marker coils | Platinum/Iridium |
| Shrink Tubing | PTFE |
| Introducer Sheath | HDPE |
Table 1: Materials used in the construction of the pRESET® LITE Thrombectomy Device
V. INDICATIONS FOR USE
Comparison of Indications for Use for the pRESET ® LITE Thrombectomy Device and predicate device pRESET® Thrombectomy Device.
| Parameter | Predicate Device (K222848) | Subject Device (K231539) |
|---|---|---|
| pRESET® Thrombectomy Device | pRESET® LITE Thrombectomy Device | |
| Indications for Use | 1. The pRESET Thrombectomy Device is | |
| indicated for use to restore blood flow in the | ||
| neurovasculature by removing thrombus for | ||
| the treatment of acute ischemic stroke to | ||
| reduce disability in patients with a persistent, | ||
| proximal anterior circulation, large vessel | ||
| occlusion, and smaller core infarcts who have | ||
| first received thrombolytic therapy. | ||
| Endovascular therapy with the device should | ||
| be started within 6 hours of symptom onset. |
-
The pRESET Thrombectomy Device is
indicated to restore blood flow by removing
thrombus from a large intracranial vessel in
patients experiencing ischemic stroke within
8 hours of symptom onset. Patients who are
ineligible for thrombolytic therapy or who fail
thrombolytic therapy are candidates for
treatment. | 1. The pRESET LITE Thrombectomy Device is
indicated for use to restore blood flow in the
neurovasculature by removing thrombus for
the treatment of acute ischemic stroke to
reduce disability in patients with a persistent,
proximal anterior circulation, large vesselocclusion, and smaller core infarcts who have
first received thrombolytic therapy.
Endovascular therapy with the device should
be started within 6 hours of symptom onset. -
The pRESET LITE Thrombectomy Device is
indicated to restore blood flow by removing
thrombus from a large intracranial vessel in
patients experiencing ischemic stroke within 8
hours of symptom onset. Patients who are
ineligible for thrombolytic therapy or who fail
thrombolytic therapy are candidates for
treatment. |
Table 2: Indications for Use for the pRESET® LITE Thrombectomy Device and pRESET® Thrombectomy Device
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Table 3. Comparison of technological characteristics of the pRESET® LITE Thrombectomy Device and pRESET® Thrombectomy Device
| Parameter | Predicate Device | Subject Device |
|---|---|---|
| Trade Name | pRESET® Thrombectomy Device | pRESET® LITE Thrombectomy Device |
| 510(k) Number | K222848 | K231539 |
| Product Classification | II | II |
| Classification | ||
| Regulation | 21 CFR 882.5600, | |
| 21 CFR 870.1250 | 21 CFR 882.5600, | |
| 21 CFR 870.1250 | ||
| Product Code | POL, NRY | POL, NRY |
| Principle of Operation | The device is used in the neurovasculature to restore blood flow for treatment of acute ischemic stroke. | The device is used in the neurovasculature to restore blood flow for treatment of acute ischemic stroke. |
| Device Sizes | 4x20mm | |
| 5x40mm | ||
| 6x30mm | 4x20mm | |
| 3x20mm | ||
| Materials | Retrieval Structure- Nitinol | |
| Markers- Platinum/Iridium | ||
| Push Wire- Stainless Steel | ||
| Shrink Tubing- PTFE | Retrieval Structure- Nitinol | |
| Markers- Platinum/Iridium | ||
| Push Wire- Nitinol | ||
| Shrink Tubing- PTFE | ||
| Use | Sterile, Single Use | Sterile, Single Use |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Packaging | Stored within dispenser coil, | |
| Tyvek pouch, and shipping carton. | Stored within dispenser coil, | |
| Tyvek pouch, and shipping carton. |
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Image /page/6/Picture/0 description: The image shows the word "phenox" in a stylized, sans-serif font. The color of the text is a dark blue. The letters are evenly spaced and appear to be part of a logo or brand name. The background is plain white.
VII. PERFORMANCE DATA
BIOCOMPATIBILITY
Biocompatibility testing was conducted based on International Organization for Standardization (ISO) 10993-1:2018: "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and the US FDA guidance document "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" (2020). Results confirmed the pRESET® LITE Thrombectomy Device is biocompatible.
The biocompatibility evaluation of the pRESET® LITE Thrombectomy Device included relevant data sources related to component material history of safe biological use and testing, and where applicable, safe previous use in previously cleared product and testing. In addition, Table 4 below summarizes testing performed on the pRESET® LITE Thrombectomy Device.
| Biological Effect | Test Name | Conclusions |
|---|---|---|
| Cytotoxicity | ISO MEM elution - L929 fibroblast | |
| cultures method | Non-cytotoxic | |
| Hemocompatibility | Hemolysis (ASTM Method) direct | |
| contact | No hemolysis indicated | |
| Hemocompatibility | Hemolysis (ASTM Method) indirect | |
| extract | No hemolysis indicated |
Table 4. Biocompatibility Test Results for the pRESET® LITE Thrombectomy Device
STERILIZATION
The pRESET® LITE Thrombectomy Device is sterilized by Ethylene Oxide gas. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10° in accordance with the EN ISO 11135:2014 & A1:2019 and AAMI TIR28:2016.
SHELF LIFE
Aging studies have established the pRESET® LITE Thrombectomy Device packaging remains functional and maintains sterility for up to 3 years. Aging studies for packaging integrity, seal strength and device functionality were performed and met acceptance criteria.
NON-CLINICAL PERFORMANCE DATA
Non-clinical testing was completed to support the substantial equivalence determination to the predicate. The tests are summarized below.
Performance Testing - Bench
The following bench testing was performed to support substantial equivalence.
Table 5. Performance Test Results for the pRESET® LITE Thrombectomy Device
| Test Name | Description | Conclusions |
|---|---|---|
| Simulated Use | It shall be possible to safely and reliably prepare, deploy and | |
| retract the device in a nominal and worst-case 3D model as | ||
| described in the instructions for use without damage to the | ||
| device. | Pass | |
| Simulated Clot | ||
| Retrieval | It shall be possible to retrieve synthetic clots from a 3D | |
| neurovascular model as described in the instructions for use. | Pass | |
| Kink Resistance | It shall be possible to deploy the device to the intended | |
| location without kinking of the device. | Pass | |
| Dimensional | ||
| Verification | Expanded outer diameter (OD) | |
| Retriever device length | ||
| Working length of retrieval device | ||
| Effective length of retrieval device | ||
| Diameter of heat shrink | ||
| Uncovered length | ||
| Marker position | ||
| System length | Pass | |
| Radial Force | The relative Chronic Outward Force (RCOF) in the labeled | |
| vessel diameters must meet acceptance criteria. | Pass | |
| Austenitic Finish (Af) | ||
| Transition | ||
| Temperature | The Af transition temperature shall be appropriate for clinical use. | Pass |
| Radiopacity | Proximal and distal ends of the retrieval device must be | |
| radiopaque. | Pass | |
| System Surface Finish | The external surface of the effective length of the device shall | |
| appear free from extraneous matter, process and surface | ||
| defects. | Pass | |
| Device Deployment | It shall be possible to safely and reliably deploy the device as | |
| described in the instructions for use without damage to the | ||
| device. | Pass | |
| Retraction into the | ||
| Microcatheter | It shall be possible to advance a representative microcatheter | |
| over the deployed device, at the site of deployment, until it is | ||
| fully contained within the inner lumen of the microcatheter | ||
| without damage to the device. | Pass | |
| Delivery and Re- | ||
| sheathing Forces | The maximum delivery and re-sheathing forces measured | |
| during simulated use clinical conditions. | Pass | |
| Re-Sheathing | It shall be possible to re-sheath the device, as described in the | |
| instructions for use, after it has been prepared, deployed and | ||
| retracted as described in the instructions for use. | Pass | |
| System Tensile | ||
| Strength | The minimum tensile strength of the thrombectomy system is | |
| evaluated to the acceptance criteria. | Pass | |
| Torque Strength | The system must not break after 3 full rotations of the insertion | |
| wire. | Pass | |
| Ancillary Device | ||
| Compatibility | The device shall be compatible with ancillary devices as listed | |
| in the Directions for Use (DFU). | Pass |
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Performance Testing - Animal
No animal testing was required to support substantial equivalence.
Clinical Data
No clinical testing was required to support substantial equivalence.
VIII. CONCLUSIONS
phenox Limited has demonstrated that the pRESET® LITE Thrombectomy Device is substantially equivalent to the pRESET® Thrombectomy Device (K222848) based on the same intended use, similar technological characteristics, similar materials, and the same operating principle. The differences in technological characteristics do not raise new questions of safety or effectiveness. Substantial equivalence is also supported by bench testing.