Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and functional characteristics of a catheter, with no mention of AI or ML capabilities.

Therapeutic

No.
The device facilitates the insertion and guidance of microcatheters into blood vessels, but it does not directly treat a disease or condition. Its purpose is to assist in a medical procedure, not to provide therapy itself.

Diagnostic

No
The device is an access catheter used to facilitate the insertion and guidance of microcatheters. Its intended use does not involve diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components (catheter, RHV, valve crossing tool) and performance testing related to these physical attributes (dimensional inspection, kink resistance, flow rate, etc.), indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Millipede 088 Access Catheter is not an In Vitro Diagnostic (IVD) 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 procedural device used in vivo (within the body) during a medical procedure.
Device Description: The description details a physical catheter designed for navigation within blood vessels.
Lack of In Vitro Testing: The performance studies focus on bench testing, biocompatibility, shelf life, and sterilization. There is no mention of testing involving biological samples (like blood, tissue, etc.) outside of the body for diagnostic purposes.
Input Imaging Modality: Fluoroscopy is an imaging technique used in vivo to visualize the device within the body.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The Millipede 088 Access Catheter does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

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, 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)

Bench Performance Testing:

Test: Dimensional Inspection
- Test Method: The device dimensions were measured to confirm conformance to the specifications.
- Conclusions: The device met established specifications.
Test: Visual Inspection
- Test Method: Device surface characteristics were assessed to confirm freedom from defects that could affect clinical use.
- Conclusions: The device surface characteristics are suitable for its intended use.
Test: Simulated Use Testing
- Test Method: Deliverability and compatibility with accessory devices were evaluated in a neurovascular model.
- Conclusions: The device performs as intended under simulated use conditions.
Test: Hydrophilic Coating Integrity
- Test Method: The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles.
- Conclusions: The hydrophilic coating integrity is suitable for its intended use.
Test: Particulate Recovery
- Test Method: The purpose of this test was to quantify the particulate sizes and counts generated during simulated use of the test article.
- Conclusions: The particulate generation was similar to control devices.
Test: Kink Resistance
- Test Method: Test specimen segments were formed into a defined bend diameter to evaluate kink resistance.
- Conclusions: The device met established specifications.
Test: Tip Stiffness
- Test Method: The bending stiffness of the catheter tip was measured to confirm conformance to the specification derived from comparator devices.
- Conclusions: The device met established specifications.
Test: Air Leakage
- Test Method: Tested per ISO 10555-1:2013 Annex D.
- Conclusions: The device integrity is suitable for its intended use.
Test: Liquid Leakage
- Test Method: Tested as per ISO 10555-1:2013 Annex C.
- Conclusions: The device integrity is suitable for its intended use.
Test: Static Burst
- Test Method: Tested as per ISO 10555-1 Annex F.
- Conclusions: The device integrity is suitable for its intended use.
Test: Catheter Joint Tensile Testing
- Test Method: The tensile strength was evaluated for the bonds between sections of the catheter.
- Conclusions: The device met established specifications.
Test: Torque Strength
- Test Method: The test specimens were rotated with the distal end constrained from movement to evaluate integrity after rotation.
- Conclusions: The device met established specifications.
Test: Flow Rate Characterization
- Test Method: The flow rate of saline and a contrast-saline solution was characterized when injected through the catheter.
- Conclusions: The flow rate was characterized.

Biocompatibility Testing (in accordance with ISO 10993-1:2018):

Test: Cytotoxicity - ISO MEM Elution
- Results: The test article is non-cytotoxic.
Test: Sensitization – ISO Guinea Pig Maximization Sensitization Test
- Results: The test article did not elicit a sensitization response.
Test: Irritation - ISO Intracutaneous Reactivity
- Results: Requirements of the ISO intracutaneous reactivity test were met for the test article.
Test: Acute Systemic Toxicity – ISO Acute Systemic Injection
- Results: Requirements of the ISO acute systemic injection test were met for the test article.
Test: Material-Mediated Pyrogenicity
- Results: The test article is non-pyrogenic.
Test: Hemocompatibility – Complement Activation (SC5b-9)
- Results: The test article is not considered to be a potential activator of the complement system.
Test: Hemocompatibility – Partial Thromboplastin Time
- Results: The test article is not considered to be an activator of the intrinsic coagulation pathway.
Test: Hemocompatibility – ASTM Hemolysis
- Results: The test article is considered non-hemolytic.
Test: Hemocompatibility – Thromboresistance
- Results: The test article had similar thromboresistance characteristics as the control device.

Shelf Life and Packaging:

Device performance verified by functional and performance testing after 12-month accelerated aging according to ASTM F1980. Original packaging testing for the predicate device supports the subject device's 12-month shelf life.

Sterilization:

Confirmatory EO residual testing confirmed EO residuals were within the limits specified in ISO 10993-7.

Animal Study:

Conclusions: No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.

Clinical Data:

Conclusions: 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)

K231802

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

December 14, 2023

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 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: K233648

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: November 14, 2023 Received: November 14, 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

Enclosure

2

Indications for Use

510(k) Number (if known) K233648

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.

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary K233648

Submitter Information

Submitter's Name: Address:

Contact Person: Telephone: Date Prepared:

Subject Device

Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Requlation: Product Code:

Predicate Device

Proprietary Name: Common/Usual Name: Classification Name: Regulatory 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 December12th, 2023

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. K231802

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, 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 subject Millipede 088 Access Catheter is identical to the predicate device.

4

Comparison to the Predicate Device

The intended use of the subject device is identical to the predicate device. The subject and predicate devices have similar technological characteristics as shown in the following table.

| Attribute | Predicate Device
Millipede 088 Access Catheter (K231802) | Subject Device
Millipede 088 Access Catheter
(K233648) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
patient-contacting materials.

Distal end of catheter: Same
metal reinforcement with
additional polymer materials in
distal tip.

5

Performance Testing (Bench)

The successful completion of the performance testing listed in the table below demonstrates that the subject Millipede 088 Access Catheter meets the defined design specifications and is suitable for its intended use.

Test	Test Method	Conclusions
Dimensional
Inspection	The device dimensions were measured to
confirm conformance to the specifications.	The device met established
specifications.
Visual Inspection	Device surface characteristics were
assessed to confirm freedom from defects
that could affect clinical use.	The device surface
characteristics are suitable for
its intended use.
Simulated Use
Testing	Deliverability and compatibility with
accessory devices were evaluated in a
neurovascular model.	The device performs as
intended under simulated use
conditions.
Hydrophilic
Coating Integrity	The integrity of the hydrophilic coating was
evaluated after multiple insertion and
withdrawal cycles.	The hydrophilic coating integrity
is suitable for its intended use.
Particulate
Recovery	The purpose of this test was to quantify the
particulate sizes and counts generated
during simulated use of the test article.	The particulate generation
was similar to control devices.
Kink Resistance	Test specimen segments were formed into a
defined bend diameter to evaluate kink
resistance.	The device met established
specifications.
Tip Stiffness	The bending stiffness of the catheter tip
was measured to confirm conformance to
the specification derived from comparator
devices.	The device met established
specifications.
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	The device integrity is suitable
for its intended use.
Liquid Leakage	Tested as per ISO 10555-1:2013 Annex C.	The device integrity is suitable
for its intended use.
Static Burst	Tested as per ISO 10555-1 Annex F.	The device integrity is suitable
for its intended use.
Catheter Joint
Tensile Testing	The tensile strength was evaluated for the
bonds between sections of the catheter.	The device met established
specifications.
Torque Strength	The test specimens were rotated with the
distal end constrained from movement to
evaluate integrity after rotation.	The device met established
specifications.

6

Test	Test Method	Conclusions
Flow Rate
Characterization	The flow rate of saline and a contrast-
saline solution was characterized when
injected through the catheter.	The flow rate was characterized

Biocompatibility

The subject device includes some material differences compared to the predicate device. To ensure that all new materials were assessed, relevant biocompatibility endpoints were addressed through biocompatibility testing of the subject Millipede 088 Access Catheter. The testing was completed in accordance with ISO 10993-1:2018. The table below summarizes the biocompatibility testing completed.

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 Hemolysis	The test article is considered non-hemolytic.
Hemocompatibility – Thromboresistance	The test article had similar thromboresistance
characteristics as the control device.

Shelf Life and Packaging

The subject device has a labeled shelf life of 12 months, compared to 8 months for the predicate device. Device performance was verified by functional and performance testing after 12-month accelerated aging according to ASTM F1980.

Packaging validation for the predicate device included testing on units subjected to accelerated aging to simulate a 12-month shelf life as per ASTM F1980. This was used to support the labelled 8-month shelf life for the predicate device. The packaging is identical for the subject and predicate devices. Therefore, the original packaging testing for the predicate device remains valid and supports the subject device's 12-month shelf life. No further packaging testing is required for the subject device.

Sterilization

The sterilization method is identical for the subject and predicate devices. Confirmatory EO residual testing was repeated on the subject Millipede 088 Access Catheter to confirm that the design differences did not impact residual EO levels of the testing confirmed that EO residuals were within the limits specified in ISO 10993-7.

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.

7

Conclusion

The indications for use of the Millipede 088 Access Catheter are identical to the predicate device. The subject Millipede 088 Access Catheter and the predicate device use the same operating principles and have a similar design. The differences identified in this submission do not raise different or new questions of safety or effectiveness. The successful completion of performance and biocompatibility testing demonstrates that the subject Millipede 088 Access Catheter is substantially equivalent to the predicate device.