(267 days)
No
The 510(k) summary describes a mechanical catheter and its accessories. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on physical and mechanical properties, not algorithmic performance.
No.
This device is an access catheter designed to facilitate the insertion and guidance of other microcatheters. It does not directly treat a disease or condition itself, but rather aids in the delivery of other therapeutic interventions.
No
Explanation: The device is an access catheter used to facilitate the insertion and guidance of microcatheters. It does not perform any diagnostic function such as detecting, identifying, or characterizing disease.
No
The device description clearly outlines physical components (catheter, RHV, valve crossing tool) and performance studies related to physical properties and animal testing, indicating it is a hardware device.
Based on the provided information, the Millipede 088 Access Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to facilitate the insertion and guidance of microcatheters into blood vessels in the neurovasculature. This is a procedure performed in vivo (within the body), not in vitro (outside the body, typically on biological samples).
- Device Description: The description details a catheter designed for navigating blood vessels, a hemostasis valve, and a valve crossing tool. These are all components used in a surgical or interventional procedure within the body.
- Anatomical Site: The specified anatomical site is the neurovasculature, which is within the body.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body during a procedure.
- Performance Studies: The performance studies described (simulated use, animal testing, etc.) are relevant to a device used in vivo.
IVD devices are typically used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. The Millipede 088 Access Catheter does not perform this function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QJP
Device Description
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, coil-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Neurovasculature
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:
- 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 Hemolysis: The test article is considered non-hemolytic.
- Hemocompatibility - Thromboresistance: The test articles have similar thromboresistance characteristics as the control devices.
-
Performance Testing:
- Dimensional Inspection: The device met established specifications.
- Tip Stiffness: The device met established specifications.
- Visual Inspection: The device surface characteristics are suitable for its intended use.
- Simulated Use Testing: The device performs as intended under simulated use conditions.
- Hydrophilic Coating Integrity: The hydrophilic coating integrity is suitable for its intended use.
- Particulate Recovery: The particulate size and count were similar to control devices.
- Tensile Strength: The device met established specifications.
- Air Leakage: The device integrity is suitable for its intended use.
- Liquid Leakage: The device integrity is suitable for its intended use.
- Static Burst: The device integrity is suitable for its intended use.
- Luer Integrity: The luers on the device are suitable for their intended use.
- Kink Resistance: The device met established specifications.
- Torque Strength: The device met established specifications.
- Flow Rate Characterization: The flow rate was characterized.
- Radiopacity: The radiopacity of the Millipede 088 Access Catheter was similar to a control device.
-
Animal Testing:
- Study Type: In vivo performance and safety assessment in two studies in a porcine model.
- Time points: 3-day and 30-day.
- Assessment: Usability, radiopacity, thromboresistance, and vessel injury.
- Key results: The results for the subject device were comparable to a control device, demonstrating acceptable results.
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.
K190010, K161152, K152541, K193034, K203840, K182097, K183464, K133177, K090752
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, 2022
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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Perfuze Ltd. Anne-Marie Gannon Director of Regulatory Affairs Unit 6, Galway Business Park, Dangan Galway, H91 W7CP Ireland
Re: K214048
Trade/Device Name: Millipede 088 Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: August 18, 2022 Received: August 22, 2022
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, 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
2
Indications for Use
510(k) Number (if known) K214048
Device Name Millipede 088 Access Catheter
Indications for Use (Describe)
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.
| 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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3
K214048 - 510(k) Summary
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 September 20, 2022
Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature = 21 CFR 870.1250 QJP
TracStar™ Large Distal Platform Zoom™ 88 Large Distal Platform Zoom™ 88-T Large Distal Platform Guide Catheter Catheter, Percutaneous, Neurovasculature . 21 CFR 870.1250 QJP DQY Imperative Care K203764
Reference Devices
The following table lists the reference devices that were used to support the substantial equivalence determination in this submission.
| 510(k)
Number | Product
Code | Name of Device | Device Manufacturer |
|------------------|-----------------|------------------------------------------------|----------------------------------------------------|
| K190010 | NRY | Penumbra System Reperfusion
Catheter JET 7 | Penumbra Inc. |
| K161152 | DQY | Navien Intracranial Support
Catheter | Micro Therapeutics Inc. d/b/a
ev3 Neurovascular |
| K152541 | NRY | Penumbra System ACE 64
Reperfusion Catheter | Penumbra Inc. |
| K193034 | DQY | AXS Infinity LS Plus Long
Sheath | Stryker Neurovascular |
| K203840 | QJP, DQY | BOSS 8F Balloon Guide
Catheter | Marblehead Medical LLC |
| K182097 | DQY | React 71 Catheter | Micro Therapeutics Inc. d/b/a
ev3 Neurovascular |
4
| 510(k)
Number | Product
Code | Name of Device | Device Manufacturer |
|------------------|-----------------|------------------------------------------|-------------------------|
| K183464 | NRY | AXS Catalyst 7 Distal Access
Catheter | Stryker Neurovascular |
| K133177 | DQY, DQO | Modified HD Guide Catheter | Concentric Medical Inc. |
| K090752 | NRY | Penumbra Reperfusion
Catheter 054 | Penumbra Inc. |
Device Description
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, coil-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.
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.
The Indications for Use statement for the Millipede 088 Access Catheter is not identical to the predicate device. However, both the Millipede 088 Access Catheter and the predicate device can be used to facilitate insertion and guidance of microcatheters into the neurovasculature. The differences in the Indications for Use statement do not raise new questions of safety and effectiveness for the Millipede 088 Access Catheter relative to the predicate device.
Comparison to the Predicate Device
The subject and predicate devices have similar technological characteristics as shown in the following table.
| Attribute | Predicate Device
TracStar™ Large Distal Platform
Zoom™ 88 Large Distal Platform
Zoom™ 88-T Large Distal Platform
(K203764) | Subject Device
Millipede 088 Access Catheter |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | QJP, DQY | QJP |
| Attribute | Predicate Device | Subject Device |
| | TracStar™ Large Distal Platform
Zoom™ 88 Large Distal Platform
Zoom™ 88-T Large Distal Platform
(K203764) | Millipede 088 Access Catheter |
| Indications for use | The TracStar Large Distal Platform is indicated for the introduction of
interventional devices into the
peripheral, coronary, and neuro
vasculature.
The ZOOM 88 and ZOOM 88-T
Large Distal Platform are indicated
for the introduction of interventional
devices into the peripheral, coronary,
and neuro vasculature. | 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. |
| Prescription/over-
the-counter use | Prescription | Same |
| Device Description | Single-use, variable stiffness, wire-
reinforced catheters with a single
lumen. The catheters are 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
vasculature. | 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. | Same |
| Distal Tip | Beveled edge, soft, flexible, and
atraumatic | Square edge, soft, flexible, and
atraumatic |
| Catheter Wall
Construction | Coil-reinforced | Coil-reinforced with ribbed surface
at distal section |
| Coating | Hydrophilic Coating | Same |
| Catheter Profile | 8 Fr | Same |
| Inner Diameter | Distal: 0.088"
Proximal: 0.088" | Distal: 0.088"
Proximal: 0.087" |
| Outer Diameter | Distal: 0.106"
Proximal: 0.108" | Distal: 0.104"
Proximal: 0.108" |
| Effective Length | 80cm -110cm | 115cm |
| Packaged
Accessories | RHV | RHV and Valve Crossing Tool |
| Condition | Sterile and Single Use | Same |
| Attribute | Predicate Device
TracStarTM Large Distal Platform
ZoomTM 88 Large Distal Platform
ZoomTM 88-T Large Distal Platform
(K203764) | Subject Device
Millipede 088 Access Catheter |
| 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 onto a
polyethylene packaging card, placed
into a pouch, sealed, and labeled.
The sealed pouch and IFU are
placed in a labeled shelf carton box. | 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 IFU are
placed in a labeled shelf carton
box. |
5
6
Biocompatibility Testing
The Millipede 088 Access 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 088 Access Catheter is classified per ISO 10993-1 as an externally communicating device that contacts circulating blood for a limited (