(29 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the catheters and tube set, with no mention of AI or ML capabilities.
Yes
The Millipede 070 Aspiration Catheter, used with the Perfuze Aspiration Tube Set and an aspiration pump, is indicated for revascularization in patients with acute ischemic stroke, which constitutes a therapeutic intervention.
No.
The devices (catheter and tube set) are described as tools for facilitating insertion, guidance, and revascularization (removing occlusions), not for identifying or diagnosing a medical condition.
No
The device description clearly details physical hardware components including catheters, valves, and tubing, and the performance studies focus on mechanical and visual properties, not software performance.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of these devices is to facilitate the insertion and guidance of other catheters into blood vessels (Millipede 088 Access Catheter) and for the revascularization of patients with acute ischemic stroke by removing blood clots (Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set). These are therapeutic and interventional procedures, not diagnostic tests performed on samples taken from the body.
- Device Description: The descriptions detail the physical components and function of catheters and tubing used for accessing and manipulating within the vascular system. There is no mention of reagents, assays, or analysis of biological samples.
- Performance Studies: The performance studies described are non-clinical bench tests evaluating mechanical integrity and visual characteristics, not diagnostic accuracy metrics like sensitivity, specificity, or AUC.
- Input Imaging Modality: Fluoroscopy is used for visualization during the procedure, which is common for interventional devices, not for analyzing biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The devices described here are tools used within the body to perform a therapeutic intervention.
N/A
Intended Use / 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
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.
Product codes (comma separated list FDA assigned to the subject device)
QJP, NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature; intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
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 Testing
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 testing determined the test article is non-cytotoxic, did not elicit a sensitization response, met requirements for intracutaneous reactivity and acute systemic injection, is non-pyrogenic, is not considered a potential activator of the complement system, is not considered an activator of the intrinsic coagulation pathway, is considered non-hemolytic in both direct and indirect hemolysis tests, and is not considered to have an effect on platelet 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.
- Visual Inspection: Device surface characteristics were assessed to confirm conformance to the specifications. Conclusion: The device met established specifications.
- Tensile Strength: The tensile strength was evaluated for the bonds between sections of the catheter. Conclusion: The device met established specifications.
- Air Leakage: Resistance to air leak was assessed by pressurizing the catheter to 300kPa and monitoring for air leaks. Conclusion: The device integrity is suitable for its intended use.
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.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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.
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) 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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4
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
5
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.
6
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 Device
Millipede 088 Access Catheter (K233648) | Subject Device
Millipede 088 Access Catheter
(K242504) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | QJP | Same |
| Indications for
Use | 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. | Same |
| Prescription/Over-
the-Counter Use | Prescription | Same |
| Device
Description | Single-use, variable stiffness, wire-
reinforced catheter with a single lumen.
The catheter is comprised of a hollow
cylindrical tube bonded at the proximal end
to a standard luer fitting. The wall of the
tube is constructed using metals and
polymers. A radiopaque marker provides
visual confirmation of the distal tip location
under fluoroscopy. | Same |
| Principle of
Operation | May be used with support catheters to
assist in accessing the target
neurovasculature. | Same |
| Techniques for
Use | Standard percutaneous, interventional
techniques, including access site
preparation, introduction of the catheter
into the access vessel, advancing the
catheter under fluoroscopy, withdrawing
the catheter, and closing the access site. | Same |
| Materials | Polymers and metals commonly used in
the manufacture of medical devices. | Proximal end of catheter: Same
polymers and metal
reinforcement with changes to
the color additives used.
Distal end of catheter: Same
Accessories and packaging:
Same |
| Distal Tip | Soft, flexible. | Same |
| Catheter Wall
Construction | Coil and braid reinforced, with ribbed
surface 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 Device
Millipede 088 Access Catheter (K233648) | Subject Device
Millipede 088 Access Catheter (K242504) |
| Packaged
Accessories | RHV and Valve Crossing Tool | Same |
| Condition Supplied | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide (EO), Sterility Assurance
Level 10-6 | Same |
| Packaging
Configuration | The catheters are placed in a protective
polyethylene tube, mounted with
accessory RHV and valve crossing tool
onto a cardboard packaging card, placed
into a pouch, sealed, and labeled. The
sealed pouch and Instructions for Use are
placed in a labeled shelf carton box. | Same |
| Labelled Shelf Life | 12 months | Same |
7
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
| Attribute | Predicate Device
Millipede 070 Aspiration Catheter,
Perfuze Aspiration Tube Set (K232524) | Subject Device
Millipede 070 Aspiration
Catheter, Perfuze Aspiration
Tube Set (K242504) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 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 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.
The Perfuze Aspiration Tube Set is
indicated to connect the Millipede 070
Aspiration Catheter to a
compatible aspiration pump. | Same |
| Prescription/Over
-the-Counter Use | Prescription | Same |
| Attribute | Predicate Device
Millipede 070 Aspiration Catheter,
Perfuze Aspiration Tube Set (K232524) | Subject Device
Millipede 070 Aspiration
Catheter, Perfuze Aspiration
Tube Set (K242504) |
| Device
Description | Single lumen catheter designed to be
introduced over a steerable guidewire to
access the neurovasculature. The semi-
rigid proximal section transitions to a
flexible distal tip to facilitate advancement
through vessels. A single radiopaque
marker at the distal end facilitates
fluoroscopic visualization. The outer
surface of the catheter is coated with a
hydrophilic coating to reduce friction
during navigation in the vasculature. A
luer fitting on the catheter hub is used for
the attachment of accessories. A strain
relief at the hub provides kink resistance at
the proximal end. | Same |
| Principle of
Operation | Designed to remove thrombus from the
neurovasculature using direct aspiration. | Same |
| Techniques for
Use | Standard percutaneous, intravascular
techniques. | Same |
| Materials | Polymers and metals commonly used in
the manufacture of medical devices. | Proximal end of catheter:
Same polymers and metal
reinforcement with changes to
the color additives used.
Distal end of catheter: Same
Accessories and packaging:
Same |
| Distal Tip | Tapered, soft, flexible | Same |
| Catheter Wall
Construction | Braid and coil reinforcement, with ribbed
internal surface at distal end. | Same |
| Coating | Hydrophilic Coating | Same |
| Catheter Profile | 6 Fr | Same |
| Inner Diameter | Distal: 0.070 in
Proximal: 0.069 in | Same |
| Outer Diameter | Distal: 0.0835 in
Proximal: 0.0865 in | Same |
| Working Length /
Effective length | 136 cm | Same |
| Packaged
Accessories | Rotating Hemostasis Valve | Same |
| Condition
Supplied | Sterile and Single Use | Same |
| Sterilization
Method | EO | Same |
| Packaging
Configuration | Polyethylene terephthalate Tyvek®
pouch, polyethylene tube, paperboard
packaging card, cardboard carton. | Same |
| Aspiration
Tubing | 100 in length
Tubing ID = 0.110 inch | Same |
8
9
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 Pig | |
| Maximization Sensitization Test | The test article did not elicit a sensitization response. |
| Irritation - ISO Intracutaneous | |
| Reactivity | Requirements of the ISO intracutaneous reactivity test |
| were met for the test article. | |
| Acute Systemic Toxicity - ISO Acute | |
| Systemic Injection | Requirements of the ISO acute systemic injection test |
| were met for the test article. | |
| Material-Mediated Pyrogenicity | The test article is non-pyrogenic. |
| Hemocompatibility – Complement | |
| Activation (SC5b-9) | The test article is not considered to be a potential |
| activator of the complement system. | |
| Hemocompatibility – Partial | |
| Thromboplastin Time | The test article is not considered to be an activator of |
| the intrinsic coagulation pathway. | |
| Hemocompatibility – ASTM Direct and | |
| Indirect (extract-based) Hemolysis | The test article is considered non-hemolytic in both direct |
| and indirect hemolysis tests. | |
| Hemocompatibility – Platelet and | |
| Leukocyte Count | The test article is not considered to have an effect on |
| platelet 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 to | |
| confirm conformance to the specifications. | The device met | |
| established | ||
| specifications. | ||
| Tensile Strength | The tensile strength was evaluated for the bonds | |
| between sections of the catheter. | The device met | |
| established | ||
| specifications. | ||
| Air Leakage | Resistance to air leak was assessed by | |
| pressurizing the catheter to 300kPa and | ||
| monitoring for air leaks. | The device integrity is | |
| suitable for its intended | ||
| use. |
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.
10
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.