(29 days)
Millipede 088 Access Catheter: The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
Millipede 070 Aspiration Catheter: The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) 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.
Perfuze Aspiration Tube Set: The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
Millipede 088 Access Catheter: The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set: The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a RHV. The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter. The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
This document describes the K242504 submission for the Perfuze Ltd. Millipede 088 Access Catheter, Millipede 070 Aspiration Catheter, and Perfuze Aspiration Tube Set. This is a 510(k) premarket notification for devices that are substantially equivalent to previously cleared predicate devices. The devices are catheters used in neurovascular procedures.
This submission focuses on a change in color additives used in the proximal shaft of the catheters and does not involve any AI/ML components. Therefore, many of the requested categories related to AI/ML performance, such as human reader improvement with AI assistance, standalone algorithm performance, training/test set sizes, expert qualifications, and ground truth establishment for AI/ML, are not applicable in this context.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test/Attribute | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO MEM Elution) | Non-cytotoxic |
| Sensitization (ISO Guinea Pig Maximization) | No sensitization response | |
| Irritation (ISO Intracutaneous Reactivity) | Met requirements | |
| Acute Systemic Toxicity (ISO Acute Systemic Injection) | Met requirements | |
| Material-Mediated Pyrogenicity | Non-pyrogenic | |
| Hemocompatibility – Complement Activation (SC5b-9) | Not a potential activator of the complement system | |
| Hemocompatibility – Partial Thromboplastin Time | Not an activator of the intrinsic coagulation pathway | |
| Hemocompatibility – ASTM Direct and Indirect (extract-based) Hemolysis | Non-hemolytic in both direct and indirect tests | |
| Hemocompatibility – Platelet and Leukocyte Count | No effect on platelet and leukocyte concentrations | |
| Performance Testing | Visual Inspection | Met established specifications (conformance to specifications) |
| Tensile Strength | Met established specifications (bonds between sections) | |
| Air Leakage | Device integrity suitable for intended use (pressurized to 300kPa) | |
| Sterilization | Sterility Assurance Level (SAL) | Validated EO process with SAL of 1x10-6 |
| Shelf Life & Packaging | Shelf Life & Packaging Configuration | Identical to predicate devices (no new testing required) |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML test set. The testing performed was for device biocompatibility and mechanical performance, not for an AI/ML algorithm. The specific number of devices tested for each biocompatibility and performance test is not detailed in this summary. The data provenance would be from laboratory testing conducted according to ISO and ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on the safety and effectiveness of a physical medical device (catheter) with a material change, not an AI/ML algorithm requiring expert-established ground truth. Expert involvement would be in the design, execution, and interpretation of the physical and chemical tests, typically by qualified laboratory personnel and engineers, rather than clinical experts establishing "ground truth" for a diagnostic reading.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human interpretation or AI/ML output requiring consensus, not for the direct physical and biological testing of a catheter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This was not an AI/ML device. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. For this submission, the "ground truth" for the device's properties are established by rigorous testing against pre-defined engineering specifications and biocompatibility standards (e.g., ISO 10993-1). For example, the "ground truth" for tensile strength is whether test samples break below a specified force, and for cytotoxicity, it's whether cell viability meets a threshold.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device.
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September 20, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Perfuze Ltd. Anne-Marie Gannon Director of Regulatory Affairs Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland
Re: K242504
Trade/Device Name: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, NRY Dated: August 22, 2024 Received: August 22, 2024
Dear Anne-Marie Gannon:
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 (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/cdrb/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.
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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
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Indications for Use
510(k) Number (if known) K242504
Device Name Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Indications for Use (Describe)
Millipede 088 Access Catheter
The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
Millipede 070 Aspiration Catheter
The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) 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.
Perfuze Aspiration Tube Set
The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
| 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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510(k) Summary - K242504
Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Date Prepared:
Subject Device
Proprietary Name: Common/Usual Name: Classification Name: Requlatory Class: Regulation: Product Code:
Predicate Device
Proprietarv Name: Common/Usual Name: Classification Name: Regulatory Class: Regulation: Product Code: Manufacturer: 510(k) Number:
Subject Device
Proprietary Name:
Common/Usual Name: Classification Name: Regulatory Class: Regulation: Product Code:
Predicate Device
Proprietary Name:
Common/Usual Name: Classification Name: Regulatory Class: Regulation: Product Code: Manufacturer: 510(k) Number:
Perfuze Ltd. Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland
Anne-Marie Gannon +353 91 428083 19th September, 2024
Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature ll 21 CFR 870.1250 QJP
Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature ============================================================================================================================================================================== 21 CFR 870.1250 QJP Perfuze Ltd. K233648
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Percutaneous Catheter Catheter, Thrombus Retriever ll 21 CFR 870.1250 NRY
Millipede 070 Aspiration Catheter: Perfuze Aspiration Tube Set Percutaneous Catheter Catheter, Thrombus Retriever ll 21 CFR 870.1250 NRY Perfuze Ltd. K232524
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Device Description
Millipede 088 Access Catheter
The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter. RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).
The Millipede 088 Access Catheter is a single lumen. reinforced, variable stiffness catheter. The distal seqment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a RHV. The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.
The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.
For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
Indications for Use
Millipede 088 Access Catheter
The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
Millipede 070 Aspiration Catheter: Perfuze Aspiration Tube Set
Millipede 070 Aspiration Catheter
The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 seqments, basilar, and vertebral arteries) 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.
Perfuze Aspiration Tube Set
The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
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Comparison to the Predicate Devices
The intended use of the subject devices is identical to their respective predicate devices. The subject and predicate devices have similar technological characteristics as shown in the following tables.
Millipede 088 Access Catheter
| Attribute | Predicate DeviceMillipede 088 Access Catheter (K233648) | Subject DeviceMillipede 088 Access Catheter(K242504) |
|---|---|---|
| RegulationNumber | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | QJP | Same |
| Indications forUse | The Millipede 088 Access Catheter isindicated for use in facilitating the insertionand guidance of microcatheters into aselected blood vessel in theneurovasculature. | Same |
| Prescription/Over-the-Counter Use | Prescription | Same |
| DeviceDescription | Single-use, variable stiffness, wire-reinforced catheter with a single lumen.The catheter is comprised of a hollowcylindrical tube bonded at the proximal endto a standard luer fitting. The wall of thetube is constructed using metals andpolymers. A radiopaque marker providesvisual confirmation of the distal tip locationunder fluoroscopy. | Same |
| Principle ofOperation | May be used with support catheters toassist in accessing the targetneurovasculature. | Same |
| Techniques forUse | Standard percutaneous, interventionaltechniques, including access sitepreparation, introduction of the catheterinto the access vessel, advancing thecatheter under fluoroscopy, withdrawingthe catheter, and closing the access site. | Same |
| Materials | Polymers and metals commonly used inthe manufacture of medical devices. | Proximal end of catheter: Samepolymers and metalreinforcement with changes tothe color additives used.Distal end of catheter: SameAccessories and packaging:Same |
| Distal Tip | Soft, flexible. | Same |
| Catheter WallConstruction | Coil and braid reinforced, with ribbedsurface at distal section. | Same |
| Coating | Hydrophilic coating | Same |
| Catheter Profile | 8 Fr | Same |
| Inner Diameter | Distal: 0.088"Proximal: 0.088" | Same |
| Outer Diameter | Distal: 0.104"Proximal: 0.108" | Same |
| Working Length | 120 cm | Same |
| Attribute | Predicate DeviceMillipede 088 Access Catheter (K233648) | Subject DeviceMillipede 088 Access Catheter (K242504) |
| PackagedAccessories | RHV and Valve Crossing Tool | Same |
| Condition Supplied | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide (EO), Sterility AssuranceLevel 10-6 | Same |
| PackagingConfiguration | The catheters are placed in a protectivepolyethylene tube, mounted withaccessory RHV and valve crossing toolonto a cardboard packaging card, placedinto a pouch, sealed, and labeled. Thesealed pouch and Instructions for Use areplaced in a labeled shelf carton box. | Same |
| Labelled Shelf Life | 12 months | Same |
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Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
| Attribute | Predicate DeviceMillipede 070 Aspiration Catheter,Perfuze Aspiration Tube Set (K232524) | Subject DeviceMillipede 070 AspirationCatheter, Perfuze AspirationTube Set (K242504) |
|---|---|---|
| RegulationNumber | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Indications for Use | The Millipede 070 Aspiration Catheter,with the Perfuze Aspiration Tube Set anda compatible aspiration pump, is indicatedfor use in the revascularization of patientswith acute ischemic stroke secondary tointracranial large vessel occlusive disease(within the internal carotid, middlecerebral - M1 and M2 segments, basilar,and vertebral arteries) within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) or who failIV t-PA therapy are candidates fortreatment.The Perfuze Aspiration Tube Set isindicated to connect the Millipede 070Aspiration Catheter to acompatible aspiration pump. | Same |
| Prescription/Over-the-Counter Use | Prescription | Same |
| Attribute | Predicate DeviceMillipede 070 Aspiration Catheter,Perfuze Aspiration Tube Set (K232524) | Subject DeviceMillipede 070 AspirationCatheter, Perfuze AspirationTube Set (K242504) |
| DeviceDescription | Single lumen catheter designed to beintroduced over a steerable guidewire toaccess the neurovasculature. The semi-rigid proximal section transitions to aflexible distal tip to facilitate advancementthrough vessels. A single radiopaquemarker at the distal end facilitatesfluoroscopic visualization. The outersurface of the catheter is coated with ahydrophilic coating to reduce frictionduring navigation in the vasculature. Aluer fitting on the catheter hub is used forthe attachment of accessories. A strainrelief at the hub provides kink resistance atthe proximal end. | Same |
| Principle ofOperation | Designed to remove thrombus from theneurovasculature using direct aspiration. | Same |
| Techniques forUse | Standard percutaneous, intravasculartechniques. | Same |
| Materials | Polymers and metals commonly used inthe manufacture of medical devices. | Proximal end of catheter:Same polymers and metalreinforcement with changes tothe color additives used.Distal end of catheter: SameAccessories and packaging:Same |
| Distal Tip | Tapered, soft, flexible | Same |
| Catheter WallConstruction | Braid and coil reinforcement, with ribbedinternal surface at distal end. | Same |
| Coating | Hydrophilic Coating | Same |
| Catheter Profile | 6 Fr | Same |
| Inner Diameter | Distal: 0.070 inProximal: 0.069 in | Same |
| Outer Diameter | Distal: 0.0835 inProximal: 0.0865 in | Same |
| Working Length /Effective length | 136 cm | Same |
| PackagedAccessories | Rotating Hemostasis Valve | Same |
| ConditionSupplied | Sterile and Single Use | Same |
| SterilizationMethod | EO | Same |
| PackagingConfiguration | Polyethylene terephthalate Tyvek®pouch, polyethylene tube, paperboardpackaging card, cardboard carton. | Same |
| AspirationTubing | 100 in lengthTubing ID = 0.110 inch | Same |
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Biocompatibility
The subject Millipede 070 Aspiration Catheter and Millipede 088 Access Catheter include a change to the color additives used in the proximal shaft compared to the predicate devices. To ensure these new color additives were assessed, relevant biocompatibility endpoints were addressed through biocompatibility testing in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process". The table below summarizes the biocompatibility testing completed.
Biocompatibility testing of the Millipede 070 Aspiration Catheter (listed below), which utilizes the same color additives, was used to also support the biocompatibility of the Millipede 088 Access Catheter.
| Test | Results |
|---|---|
| Cytotoxicity - ISO MEM Elution | The test article is non-cytotoxic. |
| Sensitization – ISO Guinea PigMaximization Sensitization Test | The test article did not elicit a sensitization response. |
| Irritation - ISO IntracutaneousReactivity | Requirements of the ISO intracutaneous reactivity testwere met for the test article. |
| Acute Systemic Toxicity - ISO AcuteSystemic Injection | Requirements of the ISO acute systemic injection testwere met for the test article. |
| Material-Mediated Pyrogenicity | The test article is non-pyrogenic. |
| Hemocompatibility – ComplementActivation (SC5b-9) | The test article is not considered to be a potentialactivator of the complement system. |
| Hemocompatibility – PartialThromboplastin Time | The test article is not considered to be an activator ofthe intrinsic coagulation pathway. |
| Hemocompatibility – ASTM Direct andIndirect (extract-based) Hemolysis | The test article is considered non-hemolytic in both directand indirect hemolysis tests. |
| Hemocompatibility – Platelet andLeukocyte Count | The test article is not considered to have an effect onplatelet and leukocyte concentrations. |
Performance Testing
Non-clinical bench testing was performed to confirm that the change to the color additives used in the proximal shaft does not impact the visual characteristics or mechanical integrity of the devices.
The non-clinical bench testing of the Millipede 070 Aspiration Catheter (listed below) was used to also support the visual characteristics and mechanical integrity of the Millipede 088 Access Catheter.
| Test | Test Method | Conclusions |
|---|---|---|
| Visual Inspection | Device surface characteristics were assessed toconfirm conformance to the specifications. | The device metestablishedspecifications. |
| Tensile Strength | The tensile strength was evaluated for the bondsbetween sections of the catheter. | The device metestablishedspecifications. |
| Air Leakage | Resistance to air leak was assessed bypressurizing the catheter to 300kPa andmonitoring for air leaks. | The device integrity issuitable for its intendeduse. |
Shelf Life and Packaging
The subject devices' shelf life and packaging configuration remain identical to that of the predicate devices. Therefore, no shelf-life testing or packaging validation was required to demonstrate substantial equivalence between the subject and predicate devices.
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Sterilization
The Millipede 088 Access Catheter, Millipede 070 Aspiration Catheter, and Perfuze Aspiration Tube Set are sterilized using a validated EO process with a sterility assurance level of 1x10-6. The sterilization method is identical for the subject and predicate devices.
Animal Study
No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.
Clinical Data
The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the subject and predicate devices. Therefore, no clinical study was conducted.
Conclusion
The indications for use of the Millipede 088 Access Catheter, Millipede 070 Aspiration Catheter, and Perfuze Aspiration Tube Set are identical to the predicate devices. The subject and the predicate devices use the same operating principles and have similar designs. The differences in color additives discussed in this submission do not raise different or new questions of safety or effectiveness. The successful completion of biocompatibility testing and performance testing demonstrates that the subject Millipede 088 Access Catheter and Millipede 070 Aspiration Catheter are substantially equivalent to the respective predicate devices.
§ 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).