(55 days)
Not Found
No
The document describes a mechanical aspiration catheter and tube set, with no mention of AI or ML in its function or description.
Yes.
The device is used for revascularization in patients with acute ischemic stroke, which is a therapeutic intervention.
No
This device, the Millipede 070 Aspiration Catheter, is indicated for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. It is a treatment device, not one used for diagnosis.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the revascularization of patients with acute ischemic stroke by physically removing blood clots from intracranial arteries. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a catheter and tube set designed for insertion into blood vessels and connection to an aspiration pump to physically remove material. This aligns with an interventional medical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose, monitor, or predict disease.
IVD devices are used to perform tests on samples taken from the human body. This device is used to directly treat a condition within the human body.
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 thrombolytic drug therapy or who have not responded to thrombolytic drug 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. The aspiration pump 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
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)
Non-Clinical Testing:
Performance Testing (Bench): The subject and predicate devices have indications for use, operating principle, and design. There are no changes to technological characteristics. Therefore, non-clinical bench testing was not required for the subject Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set.
Biocompatibility: The materials, formulation, and suppliers of the materials used in the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are identical in the subject and predicate devices. The product-contacting packaging materials in the subject and predicate devices are also identical. Therefore, no biocompatibility testing was required for the subject Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set.
Sterilization: The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are sterilized using a validated EO process with a sterility assurance level of 1x10°. There is no change to the sterilization method used for the subject Millipede 070 Aspiration Catheter compared to the predicate device. Therefore, no additional sterilization data was required for the subject Millipede 070 Aspiration Catheter. A different sterilization cycle will be used for the subject Perfuze Aspiration Tube Set compared to the predicate device. A validation was conducted for this cycle using the overkill method according to ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices".
Shelf Life and Packaging: The subject and predicate devices have an identical shelf life and packaging configuration. To ensure that the new sterilization cycle for the Perfuze Aspiration Tube Set does not impact integrity of the sterile barrier, packaging testing was conducted following sterilization with the new process. The device packaging met established specifications.
Animal Study: No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.
Clinical Data: No clinical study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.
Key Results: The subject and predicate devices have the same indications for use, operating principle, and design. The different sterilization cycle used for the Perfuze Aspiration Tube Set does not raise different questions of safety or effectiveness. The successful completion of sterilization and packaging validation demonstrates that the subject device is substantially equivalent to the predicate device.
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
February 26, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Perfuze Ltd. Anne-Marie Gannon Director of Regulatory Affairs Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland
Re: K250012
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: January 30, 2025 Received: January 30, 2025
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.
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) K250012
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 thrombolytic drug therapy or who have not responded to thrombolytic drug 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 - K250012
Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Date Prepared:
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 17th February 2025
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Percutaneous Catheter Catheter, Thrombus Retriever 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. K242504
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. The aspiration pump is
5
connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.
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 thrombolytic drug therapy or who have not responded to thrombolytic drug 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
Millipede 070 Aspiration Catheter;
Perfuze Aspiration Tube Set
(K242504) | Subject Device
Millipede 070 Aspiration Catheter;
Perfuze Aspiration Tube Set
(K250012) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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
thrombolytic drug therapy or who
have not responded to thrombolytic
drug therapy are candidates for
treatment. |
| | The Perfuze Aspiration Tube Set is
indicated to connect the Millipede
070 Aspiration Catheter to a
compatible aspiration pump. | The Perfuze Aspiration Tube Set is
indicated to connect the Millipede
070 Aspiration Catheter to a
compatible aspiration pump. |
| 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 | Same |
| Attribute | Predicate Device
Millipede 070 Aspiration Catheter;
Perfuze Aspiration Tube Set
(K242504) | Subject Device
Millipede 070 Aspiration Catheter;
Perfuze Aspiration Tube Set
(K250012) |
| | 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 for the
proximal end. | |
| 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 | 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 | Ethylene Oxide (EO) | Same |
| Packaging
Configuration | Polyethylene terephthalate Tyvek®
pouch, polyethylene tube,
paperboard packaging card,
cardboard carton. | Same |
| Perfuze
Aspiration Tubing | 100 in length
Tubing ID = 0.110 in
Pinch clamp valve for vacuum
control | Same |
Comparison to the Predicate Device
6
Non-Clinical Testing
Performance Testing (Bench)
The subject and predicate devices have indications for use, operating principle, and design. There are no changes to technological characteristics. Therefore, non-clinical bench testing was not required for the subject Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set.
7
Biocompatibility
The materials, formulation, and suppliers of the materials used in the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are identical in the subject and predicate devices. The product-contacting packaging materials in the subject and predicate devices are also identical. Therefore, no biocompatibility testing was required for the subject Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set.
Sterilization
The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are sterilized using a validated EO process with a sterility assurance level of 1x10 °. There is no change to the sterilization method used for the subject Millipede 070 Aspiration Catheter compared to the predicate device. Therefore, no additional sterilization data was required for the subject Millipede 070 Aspiration Catheter.
A different sterilization cycle will be used for the subject Perfuze Aspiration Tube Set compared to the predicate device. A validation was conducted for this cycle using the overkill method according to ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices".
Shelf Life and Packaging
The subject and predicate devices have an identical shelf life and packaging configuration. To ensure that the new sterilization cycle for the Perfuze Aspiration Tube Set does not impact integrity of the sterile barrier, packaging testing was conducted following sterilization with the new process. The device packaging met established specifications.
Animal Study
No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.
Clinical Data
No clinical study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.
Conclusion
The subject and predicate devices have the same indications for use, operating principle, and design. The different sterilization cycle used for the Perfuze Aspiration Tube Set does not raise different questions of safety or effectiveness. The successful completion of sterilization and packaging validation demonstrates that the subject device is substantially equivalent to the predicate device.