(61 days)
Not Found
No
The provided text describes a mechanical aspiration catheter and tube set. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device (Millipede 070 Aspiration Catheter) is indicated for the revascularization of patients with acute ischemic stroke, which is a direct treatment for a disease condition.
No
The device is an aspiration catheter designed for revascularization in stroke patients by removing intracranial large vessel occlusive disease, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components like a catheter, RHV, and tube set, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Millipede 070 Aspiration Catheter and the Perfuze Aspiration Tube Set are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set is for the revascularization of patients with acute ischemic stroke by directly interacting with the patient's vasculature to remove blood clots. This is an in vivo procedure, not an in vitro examination of a specimen.
- The device description details a catheter and tube set for aspiration within the body. The components described are designed for insertion into blood vessels and connection to an aspiration pump, not for analyzing samples outside the body.
- The performance studies involve animal studies and no clinical study. While animal studies are common for medical devices, IVD devices typically require clinical studies involving human specimens to demonstrate performance metrics like sensitivity, specificity, etc.
- The predicate device is an aspiration catheter. This further reinforces that the device is intended for a similar in vivo procedure.
Therefore, the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are considered medical devices used for therapeutic intervention within the body, not IVD devices used for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
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)
NRY
Device Description
The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (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
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
- Millipede 070 Aspiration Catheter: Evaluated in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process". Classified as an externally communicating device that contacts circulating blood for a limited (
§ 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
October 18, 2023
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 and 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: K232524
Trade/Device Name: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 18, 2023 Received: August 18, 2023
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232524
Device Name Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Indications for Use (Describe)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K232524
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
- Proprietary Name: Common/Usual Name: Classification Name: Requlatory Class: Requlation: Product Code: Manufacturer: 510(k) Number:
Perfuze Ltd. Unit 6. Galway Business Park, Dangan. Galway, H91 W7CP, Ireland Anne-Marie Gannon +353 91 428083 12th October 2023
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Percutaneous Catheter Catheter, Thrombus Retriever . 21 CFR 870.1250 NRY
SOFIA Plus Aspiration Catheter Percutaneous Catheter Catheter, Thrombus Retriever . 21 CFR 870.1250 NRY MicroVention, Inc. K173200
Device Description
The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (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.
4
Indications for Use
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.
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Device | SOFIA Plus Aspiration Catheter | |
| (K173200) | Millipede 070 Aspiration Catheter; | |
| Perfuze Aspiration Tube Set (K232524) | ||
| Regulation | ||
| Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Indications for | ||
| Use | The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVention Tubing Kit is intended 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 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. | ||
| Prescription/over- | ||
| the-counter use | Prescription | Same |
| Attribute | Predicate Device | Subject Device |
| SOFIA Plus Aspiration Catheter | ||
| (K173200) | Millipede 070 Aspiration Catheter; | |
| Perfuze Aspiration Tube Set (K232524) | ||
| 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. | Same |
| Distal Tip | Straight - steam shapeable by user. | Tapered, soft, flexible. |
| Catheter Wall Construction | Braid and coil reinforcement. | Braid and coil reinforcement, with ribbed internal surface at distal end. |
| Coating | Hydrophilic coating | Same |
| Catheter Profile | 6 Fr | Same |
| Inner Diameter | 0.070 in | Distal: 0.070 in |
| Proximal: 0.069 in | ||
| Outer Diameter | Distal: 0.082 in | |
| Proximal: 0.083 in | Distal: 0.0835 in | |
| Proximal: 0.0865 in | ||
| Effective Length / | ||
| Working Length | 125 - 131 cm | 136 cm |
| Packaged Accessories | Introducer sheath and shaping mandrel | Rotating Hemostasis Valve |
| Condition Supplied | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide (EO) | Same |
| Packaging Configuration | Polyester/polyethylene/Tyvek® pouch, polyethylene tube, polyethylene card, paperboard carton. | Polyethylene terephthalate Tyvek® pouch, polyethylene tube, paperboard packaging card, cardboard carton. |
| Aspiration Tubing | 112 in length | |
| Tubing ID = 0.110 in | ||
| Integrated valve for vacuum control | 100 in length | |
| Tubing ID = 0.110 in | ||
| Pinch clamp valve for vacuum control |
Comparison to the Predicate Device
5
6
Biocompatibility Testing
Millipede 070 Aspiration Catheter
The Millipede 070 Aspiration Catheter is constructed using materials that are commonly used in the medical device industry. All patient-contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process". The Millipede 070 Aspiration Catheter is classified per ISO 10993-1 as an externally communicating device that contacts circulating blood for a limited (