(175 days)
Not Found
No
The summary describes a mechanical thrombectomy device and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is indicated for use to restore blood flow by removing thrombus in patients experiencing ischemic stroke, which directly treats a medical condition.
No
The device is a thrombectomy device, which is used to physically remove blood clots to restore blood flow. Its indications for use and device description clearly state its therapeutic purpose of removing thrombus, rather than diagnosing a condition.
No
The device description explicitly states it is a "Thrombectomy Device" designed for mechanical removal of thrombus, and the performance studies include bench testing on physical attributes like force, dimensions, and clot retrieval, indicating it is a physical medical device, not software only.
Based on the provided information, 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 Description and Intended Use: The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are described as mechanical devices used to physically remove thrombus (blood clots) from blood vessels in the brain. Their intended use is to restore blood flow in patients experiencing ischemic stroke.
- Mechanism of Action: The device works by physically interacting with and removing the clot within the blood vessel. It does not analyze biological samples or provide diagnostic information based on the analysis of those samples.
The device is a therapeutic medical device used for intervention and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
-
The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the 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 Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are 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.
Product codes (comma separated list FDA assigned to the subject device)
POL, NRY
Device Description
The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are 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 designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and 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, large vessels of the neurovasculature such as the internal carotid artery (ICA) and 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)
BIOCOMPATIBILITY
Biocompatibility testing was conducted based on ISO 10993-1: "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 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"." Results confirmed the pRESET Delta devices are biocompatible.
Testing included Cytotoxicity (MTT Cytotoxicity) which concluded Non-cytotoxic, and Hemocompatibility (ASTM Hemolysis Direct Contact and ASTM Hemolysis Extract Method) which concluded No hemolysis indicated for both.
STERILIZATION
The pRESET® Delta Thrombectomy Device Product Family 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. The sterilization cycle has been validated via the half cycle method.
SHELF LIFE
Aging studies were conducted to establish the pRESET® DeltaThrombectomy Device Product Family 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 (Bench Testing)
The following bench testing was carried out on pRESET® Delta Thrombectomy Device Product Family to support substantial equivalence. The results of this testing demonstrated compliance to all the design attributes and that the device performs as intended and the acceptance criteria have been satisfied.
- Packaging Inspection: Pass (Corrugated shipper provides adequate protection to the carton, pouch, and device. Shelf carton provides adequate protection to the pouch and device. Sterile pouch provides adequate protection and sterile barrier to the device.)
- Relative Chronic Outward Force (RCOF): Pass (The relative chronic outward force (RCOF) in the labeled vessel diameters must meet acceptance criteria.)
- Dimensional: Pass (The expanded outer diameter (OD) of the retriever device. The diameter of the body markers. The length of the body markers.)
- Simulated Use: Pass (It shall be possible to safely and reliably prepare, deploy, and retract the device as described in the instructions for use without damage to the device.)
- Simulated Clot Retrieval: Pass (It shall be possible to retrieve synthetic clots from a 3D neurovascular model as described in the instructions for use.)
- Kink Resistance: Pass (The device system must have the ability to be delivered to the intended site without any kinking of the insertion wire.)
- Deployment: Pass (It shall be possible to safely and reliably deploy the device as described in the instructions for use without damage to the device.)
- Retraction into the Microcatheter: Pass (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.)
- Re-Sheathing: Pass (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.)
- Ancillary Device Compatibility: Pass (The device shall be compatible with ancillary devices as listed in the Directions for Use (DFU).)
- Particulate Analysis: Pass (Number and size of particulates generated by device during simulated use shall be comparable to predicate device.)
- Radiopacity: Pass (Proximal end, distal end, and the body markers of the retrieval device must be radiopaque.)
Performance Testing - Animal
No animal testing was required to support substantial equivalence.
Clinical Testing
No clinical testing was required to support substantial equivalence.
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.
0
February 28, 2025
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym 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: K242676
Trade/Device Name: pRESET Delta Thrombectomy Device and pRESET Delta 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: January 30, 2025 Received: January 30, 2025
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
2
assistance/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
Enclosure
3
Indications for Use
510(k) Number (if known) K242676
Device Name
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
Indications for Use (Describe)
-
The pRESET Delta Thrombectorny Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the 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 Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are 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.
| 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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4
Image /page/4/Picture/0 description: The image shows the word "phenox" in a blue, sans-serif font. The letters are all lowercase and connected. The word is the main focus of the image and is centered. The font is simple and modern.
RESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
510(k) Summary (21 CFR 807.92 (c))
K242676
I. SUBMITTER
| phenox Limited, |
|---|
| Kamrick Court, |
| Ballybrit Business Park, |
| Galway, Ireland |
| H91 XY38 |
| Primary Correspondent Name: | Rachel McDaid |
|---|---|
| Title: | Senior Regulatory Affairs Specialist |
| Phone: | +353 (0)91 740100 |
| Email: | rachel.mcdaid@wallabyphenox.com |
| Secondary Correspondent Name: | Emily Dobosz |
| Title: | Senior Manager of Regulatory Affairs |
| Phone: | +353 (0)91 740100 |
| Email: | emily.dobosz@wallabyphenox.com |
Date Prepared: 26th February 2025
II. DEVICE
Device Trade Name: pRESET® Delta Thrombectomy Device and pRESET® Delta 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
III. PREDICATE DEVICES
Device Name: pRESET® Thrombectomy Device and pRESET® LITE Thrombectomy Device Manufacturer: phenox Limited 510(k) Number: K222848 and K231539
IV. DEVICE DESCRIPTION
Device Description:
The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are 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 designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA).
5
Image /page/5/Picture/0 description: The image shows the word "phenox" in a simple, sans-serif font. The letters are a dark blue color. The word is presented in a clean and straightforward manner, with no additional design elements or embellishments.
10(k) pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
The device is supplied sterile and intended for single use only.
Materials of Use:
See table 1 below for details of the materials used in the construction of the pRESET Delta Thrombectomy Device Product Family (which consist of the pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device).
Table 1: Materials used in the construction of the pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
| Component | pRESET® Delta Thrombectomy Device | pRESET® Delta LITE Thrombectomy Device |
|---|---|---|
| Retrieval Structure | Nitinol | Nitinol |
| Push-Wire | Stainless Steel Wire | Nitinol |
| Connector Shell | Nitinol | Nitinol |
| Marker Coils | Platinum/Iridium | Platinum/Iridium |
| Body Markers | Platinum/Iridium | Platinum/Iridium |
| Shrink Tubing | PTFE | PTFE |
| Introducer Sheath | HDPE | HDPE |
V. INDICATIONS FOR USE
Please see Table 2 below for comparison of indications for use between subject devices and predicate devices.
Table 2: Indications for Use of pRESET® Delta Thrombectomy Device Product Family and predicate devices
| Parameter | Predicate Devices (K222848, K231539) | Subject Devices |
|---|---|---|
| pRESET Thrombectomy Device and pRESET LITE | pRESET Delta Thrombectomy Device and pRESET | |
| Thrombectomy Device | Delta LITE Thrombectomy Device | |
| Indications | ||
| for Use | 1. The pRESET® Thrombectomy Device and pRESET® | |
| LITE Thrombectomy Device are 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 and pRESET®
LITE Thrombectomy Device are 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® Delta Thrombectomy Device and pRESET®
Delta LITE Thrombectomy Device are 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® Delta Thrombectomy Device and pRESET®
Delta LITE Thrombectomy Device are 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. |
| Parameter | Predicate Devices | Subject Devices |
| Trade Name | pRESET® Thrombectomy Device
pRESET® LITE Thrombectomy Device | pRESET® Delta Thrombectomy Device
pRESET® Delta LITE Thrombectomy
Device |
| 510(k) Number | K222848
K231539 | K242676 |
| Product
Classification | Class II | Class 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 LITE
3x20mm LITE | 4x20mm
5x40mm
6x30mm
4x20mm LITE
3x20mm LITE |
| Materials | Retrieval Structure- Nitinol
Markers- Platinum/Iridium
Push Wire- Stainless Steel/Nitinol
Shrink Tubing- PTFE | Retrieval Structure- Nitinol
Markers (including Body Markers)-
Platinum/Iridium
Push Wire- Stainless Steel/Nitinol
Shrink Tubing- PTFE |
| Use | Sterile, Single Use | Sterile, Single Use |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 3 years | 3 years |
| Packaging
Configuration/
Components | Stored within dispenser coil, Tyvek
pouch, and shipping carton. | Stored within dispenser coil, Tyvek pouch,
and shipping carton. |
6
Special 510(k) pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison of technological characteristics between the subject devices and predicate devices is summarized in Table 3 below:
Table 3: Comparison of technological characteristics of the pRESET® Delta and predicate devices
7
k) pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
VII. PERFORMANCE DATA
BIOCOMPATIBILITY
Biocompatibility testing was conducted based on ISO 10993-1: "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 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
Results confirmed the pRESET Delta devices are biocompatible.
The biocompatibility evaluation of the pRESET® Delta 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 (K222848, K231539). In addition, Table 4 below summarizes additional testing performed on the pRESET® Delta devices.
| Test | Test Description | Conclusion |
|---|---|---|
| Cytotoxicity | ||
| ISO 10993-5 | MTT Cytotoxicity | Non-cytotoxic |
| Hemocompatibility | ||
| ISO 10993-4 | ASTM Hemolysis Direct Contact | No hemolysis indicated |
| ASTM Hemolysis Extract Method | No hemolysis indicated |
Table 4: Summary of biocompatibility testing results for the pRESET® Delta
STERILIZATION
The pRESET® Delta Thrombectomy Device Product Family 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.
The sterilization cycle has been validated via the half cycle method.
SHELF LIFE
Aging studies were conducted to establish the pRESET® DeltaThrombectomy Device Product Family 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
The following non-clinical performance tests were performed to support the substantial equivalence determination.
Performance Testing - Bench
The following bench testing was carried out on pRESET® Delta Thrombectomy Device Product Family to support substantial equivalence. The results of this testing demonstrated compliance to all the design attributes and that the device performs as intended and the acceptance criteria have been satisfied.
The tests are summarized in Table 5 below.
8
Special 510(k) pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
| Test Title | Specification | Conclusions |
|---|---|---|
| Packaging Inspection | Corrugated shipper provides adequate protection to the carton, pouch, and device. | |
| Shelf carton provides adequate protection to the pouch and device. | ||
| Sterile pouch provides adequate protection and sterile barrier to the device. | Pass | |
| Relative Chronic | ||
| Outward Force | ||
| (RCOF) | The relative chronic outward force (RCOF) in the labeled vessel diameters must meet acceptance criteria. | Pass |
| Dimensional | The expanded outer diameter (OD) of the retriever device. | |
| The diameter of the body markers. | ||
| The length of the body markers. | Pass | |
| Simulated Use | It shall be possible to safely and reliably prepare, deploy, and retract the device 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 | The device system must have the ability to be delivered to the intended site without any kinking of the insertion wire. | Pass |
| 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 |
| 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 |
| Ancillary Device | ||
| Compatibility | The device shall be compatible with ancillary devices as listed in the Directions for Use (DFU). | Pass |
| Particulate | ||
| Analysis | Number and size of particulates generated by device during simulated use shall be comparable to predicate device. | Pass |
| Radiopacity | Proximal end, distal end, and the body markers of the retrieval device must be radiopaque. | Pass |
Table 5: Summary of bench testing performed to support substantial equivalence
9
10(k) pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device
Standards utilized in bench testing:
ASTM F640-23 "Standard Test Methods for Determining Radiopacity for Medical Use"
FDA guidance documents utilized in bench testing:
"Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions" (2019)
"Applying Human Factors and Usability Engineering to Medical Devices" (2016)
Performance Testing - Animal
No animal testing was required to support substantial equivalence.
Clinical Testing
No clinical testing was required to support substantial equivalence.
VIII. CONCLUSIONS
phenox Limited has demonstrated that the pRESET® Delta Thrombectomy Device and the pRESET® Delta LITE Thrombectomy Device are substantially equivalent to the respective predicate devices, the pRESET® Thrombectomy Device (K222848) and the pRESET® LITE Thrombectomy Device (K231539).
The pRESET® Delta Thrombectomy Device and pRESET® Delta LITE Thrombectomy Device have the same intended use, similar technological characteristics, same materials, and the same operating principle as the pRESET Thrombectomy Device and pRESET LITE Thrombectomy Device. Substantial equivalence is supported by bench performance, biocompatibility, and shelflife testing.