(203 days)
Tip-Shape Echelon Micro Catheter (K042187)
No
The device description and performance studies focus on the physical properties and functionality of a microcatheter for delivering therapeutic devices. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device description states that the Wallaby 017 Micro Catheter is "intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils." This indicates it is a delivery system for therapeutic devices or materials, not a therapeutic device itself.
No
Explanation: The device is described as a microcatheter intended to access vasculature for the infusion of therapeutic devices and materials, such as embolization materials and contrast media, and for the delivery of embolic coils. Its function is to deliver or infuse, not to diagnose.
No
The device description clearly outlines a physical catheter and associated hardware components (introducer sheath, shaping mandrel, etc.). It is a tangible medical device, not software.
Based on the provided information, the Wallaby 017 Micro Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for accessing vasculature for the controlled selective infusion of therapeutic devices and materials. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an in vivo medical device, not a device used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), detect analytes, or provide diagnostic information based on in vitro testing.
In Vitro Diagnostic devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Wallaby 017 Micro Catheter's function is to deliver therapeutic agents or devices directly into the body.
N/A
Intended Use / Indications for Use
The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials and of diagnostic materials such as contrast media as well as delivery of embolic coils.
Product codes
KRA, QJP, DQY
Device Description
The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature.
The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Design Verification Testing - Bench
Performance testing was conducted to support the premarket submission. The results of the design verification and validation testing performed confirm that the Wallaby 017 Micro Catheter conforms to the pre-defined acceptance criteria. Testing included:
- Visual Inspection: The device was visually inspected. The device met all pre-defined acceptance criteria.
- Dimensional Inspection: The device was evaluated to verify the dimensional requirements were met. The device met all pre-defined acceptance criteria.
- Simulated Use: The device was evaluated in a simulated anatomy model for the preparation and ease of assembly, introducer sheath compatibility and peel away, ancillary device compatibility with guidewire and guide catheter, trackability, compatibility with embolic coil, lubricity and durability of hydrophilic coating, and kink resistance. The device performs as intended and met all pre-defined acceptance criteria under simulated use conditions.
- Physician Validation (Usability): The device was evaluated in a simulated anatomy model by physicians in comparison with the predicate. The device performs as intended and demonstrates equivalency to the comparator device under simulated use conditions.
- Delivery and Retrieval: The device was subjected to delivery and retrieval testing, including delivery and retrieval of a guidewire and embolic coil, in a vascular model and met all pre-defined acceptance criteria.
- Tip Stiffness: The device tip was deflected on a universal testing machine and met the acceptance criteria.
- Tip Shaping: The device tip was shaped with the shaping mandrel and steam and met the pre-defined acceptance criteria.
- System Tensile (hub, shaft, tip): The device was evaluated to verify the tensile strength of the full system meets the minimum tensile strength requirement. The device met the predefined acceptance criteria.
- Elongation to Failure: The device elongation was evaluated during the shaft tensile testing. The device met all pre-defined acceptance criteria.
- Torque To Failure: The device was evaluated for catheter integrity during hub rotations with distal end held stationary. The device met all pre-defined acceptance criteria.
- Coating Integrity: The device coating integrity was inspected pre- and post-insertion and retrieval using a vascular model and met all pre-defined acceptance criteria.
- Coating Lubricity: The device was evaluated for frictional forces on a universal testing machine and met all pre-defined acceptance criteria.
- Catheter Dynamic and Static Burst (Pressure) Leak (Liquid) Leak (Air): The device was evaluated to verify the device does not leak, burst, and is compatible with accessories per ISO 10555-1 and ISO 594-1.
- Kink Resistance: The device was evaluated for resistance to kinking around bends with clinically relevant radii and met acceptance criteria.
- Particulate: The device was evaluated within a simulated anatomy model for particulate generation. The device met all pre-defined acceptance criteria and was comparable to the reference device.
- Corrosion Resistance: The catheter is corrosion resistant per ISO 10555-1.
- Radiopacity: The device was evaluated for marker band visibility under fluoroscopy and met the pre-defined acceptance criteria.
- DMSO and Liquid Embolic Compatibility: The device was evaluated for DMSO and liquid embolic compatibility and met the pre-defined acceptance criteria.
Design Verification Testing – Animal
No animal testing was deemed necessary to support the substantial equivalence of the Wallaby 017 Micro Catheter.
Sterilization and Shelf Life
The Wallaby 017 Micro Catheter is sterilized using an Ethylene Oxide (EO) sterilization cycle. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Aging studies for the Wallaby 017 Micro Catheter have established that the device and packaging remain functional for the 12-month shelf-life. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.
Biocompatibility
Biocompatibility testing for the Wallaby 017 Micro Catheter and accessories was performed in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Evaluation and testing within a risk management process.
- MTT - L-929 Cytotoxicity Study: 1XMEM test extract showed no cytotoxic potential to L-929 mouse fibroblast cells undiluted or at any dilution. (Conclusion: Non-cytotoxic)
- ISO Intracutaneous Irritation: The difference between the average scores of the test article extract and the vehicle control are 0.0; 0.1. (Conclusion: Non-irritant)
- ISO Guinea Pig Maximization Sensitization: Test and control animals' responses are not greater than "0". (Conclusion: Non-sensitizing)
- ISO Acute Systemic Toxicity: No abnormal clinical signs indicative of toxicity were observed for 72 hours. All animals were alive at the end of 72 hours and body weight changes were within acceptable parameters. (Conclusion: Non-toxic)
- Materials Mediated Rabbit Pyrogen: No rabbit temperature rise ≥ 0.5°C. (Conclusion: Non-pyrogenic)
- Complement Activation - SC5b-9 Assay: Results within acceptable range and not statistically different than activated NHS control or negative control. (Conclusion: Not a potential activator of complement system)
- ASTM Hemolysis — Direct Contact and Extract Method: Blank corrected hemolytic index: 0.4; 0.0. (Conclusion: Non-hemolytic)
- Thromboresistance Evaluation: No adverse effects or clinical signs during test period and no thrombus score > 3 for either test or control device. (Conclusion: Thromboresistance of test device similar to control device)
- Chemical Characterization- Physiochemical Tests for Plastics (ISO 10993-18): Extractable and leachable chemical characterization and the toxicological risk assessment (buffering capacity, non-volatile residue (NVR) and heavy metals) of the Wallaby 017 Micro Catheter demonstrated that the extractables and leachables of the subject device were similar to that of the reference device. (Conclusion: Pass)
- Steam Shaping Mandrel: The shaping mandrel was excluded from any direct biocompatibility testing and instead was included during testing of the Wallaby 017 Micro Catheter as part of sample preparation by inserting the shaping mandrel into the tip for a timed minimum of 5 minutes, when applicable.
- Mandrel Card: The mandrel card was excluded since it has no patient contact and only contacts the shaping mandrel which was included during sample preparation.
- Introducer Sheath Subassembly: The introducer sheath subassembly was not tested for biocompatibility because the introducer sheath was previously cleared with the Wallaby Avenir Coil System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROWLER SELECT LP ES Microcatheter (K214025)
Reference Device(s)
Tip-Shape Echelon Micro Catheter (K042187)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
April 25, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Wallaby Medical Joseph Tang Quality Engineer 22901 Mill Creek Drive Laguna Hills, California 92653
Re: K223139
Trade/Device Name: Wallaby 017 Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, QJP, DQY Dated: March 23, 2023 Received: March 23, 2023
Dear Joseph Tang:
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 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-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).
Sincerelv.
Naira Muradyan -S
Naira Muradvan, 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) K223139
Device Name Wallaby 017 Micro Catheter
Indications for Use (Describe)
The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K223139 510(k) Summary
As required by 21 CFR 807.92
| Applicant: | Wallaby Medical |
|---|---|
| 22901 Mill Creek Drive | |
| Laguna Hills, CA 92653 | |
| Contact: | Joseph Tang |
| Phone number: | 714 904 6097 |
| Date Prepared: | April 24, 2023 |
| Device Trade Name: | Wallaby 017 Micro Catheter |
| Device Common Name: | Catheter, Continuous Flush, KRA, QJP, DQY |
| Classification Name: | Class II, KRA (21 CFR 870.1210), QJP and DQY (21 CFR 870.1250) |
| Predicate Device: | PROWLER SELECT LP ES Microcatheter (K214025) |
| Reference Device: | Tip-Shape Echelon Micro Catheter (K042187) |
Device Description a.
The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature.
The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.
b. Indications for Use
The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials and of diagnostic materials such as contrast media as well as delivery of embolic coils.
Device Compatibility C.
The Wallaby 017 Micro Catheter is designed to introduce embolic coils up to an outer diameter (OD) of 0.0145" (0.3683 mm) and guide wires up to an OD of 0.014″ (0.36 mm) and to infuse diagnostic agents or therapeutic devices such as embolization materials into the peripheral and neuro vasculature.
Non-clinical bench testing has been conducted to evaluate compatibility of the Wallaby 017 Micro Catheter with DMSO (dimethyl sulfoxide) and DMSO-based liquid embolic agents.
4
Predicate Device Comparison d.
The predicate device for the Wallaby 017 Micro Catheter is the PROWLER SELECT LP ES Microcatheter (K214025). The reference device for the Wallaby 017 Micro Catheter is the Tip-Shape Echelon Micro Catheter (K042187). The tables below describe the technological differences between the Wallaby 017 Micro Catheter, PROWLER SELECT LP ES Microcatheter and the Tip-Shape Echelon Micro Catheter, respectively:
| Device Name | Predicate Device:
PROWLER SELECT LP
ES Microcatheter | Reference Device:
Tip-Shape Echelon Micro
Catheter | Subject Device:
Wallaby 017 Micro
Catheter | Rationale for Difference
(if applicable) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Number | K214025 | K042187 | K223139 | |
| Classification | Class II, KRA, DQY,
QJP | Class II, KRA | Class II, KRA, DQY, QJP | SAME as predicate |
| Indications for
Use | The PROWLER
SELECT LP ES
Microcatheter is
intended for the
introduction of
embolic devices and
infusion of
diagnostic agents
into the peripheral
and neuro
vasculature. | The Tip-Shape Echelon
Micro Catheter is
intended to access
peripheral and neuro
vasculature for the
controlled selective
infusion of physician-
specified therapeutic
agents such as
embolization materials
and of diagnostic
materials such as
contrast media. | The Wallaby 017 Micro
Catheter is intended to
access peripheral and
neuro vasculature for
the controlled selective
infusion of physician-
specified therapeutic
devices such as
embolization materials
and of diagnostic
materials such as
contrast media as well
as delivery of embolic
coils. | SAME |
| | Materials | | | |
| Shaft | | | | |
| Extrusions | Outer layer: Nylon
and Pellethane
Inner layer:
PTFE | Outer layer:
Pebax (polyether block
amide), Polyamide
Inner layer:
PTFE | Outer layer:
Pebax (polyether block
amide), Barium Sulfate
Infused Pebax, Aesno
Med (Polyamide)
Inner layer:
PTFE | Device materials are
biocompatible and the
subject device passed all
testing. |
| Wire
Reinforcement | Stainless-steel Braid | Nitinol Braid | Nitinol Braid | |
| Components | | | | |
| Hub | Grilamid | Polyamide | Polyamide (Trogamid) | Device materials are
biocompatible and the
subject device passed all
testing. |
| Coating | Hydrophilic Coating | Hydrophilic Coating | Hydrophilic Coating | biocompatible and the
subject device passed all
testing. |
| Strain Relief | Not provided | Pebax, Polyolefin | Pebax | |
| Colorant | Blue or Purple | Clear/Natural or Purple | Natural or Green or
Blue | The subject device
colorants are
biocompatible. |
| Marker Band | Pt-W Coil | Pt/Ir Band | Pt/Ir Band | SAME |
| Tip Configuration | Straight, 45°, 90° | Straight, 45°, 90°, steam
shapeable by user | Straight, 45°, 90°,
steam shapeable by
user | SAME |
| Accessories | | | | |
| Device Name | Predicate Device:
PROWLER SELECT LP
ES Microcatheter | Reference Device:
Tip-Shape Echelon Micro
Catheter | Subject Device:
Wallaby 017 Micro
Catheter | Rationale for Difference
(if applicable) |
| Shaping Mandrel | Stainless Steel | Stainless Steel | Stainless Steel | SAME |
| Introducer Sheath | N/A | Polyamide | HDPE | The device materials are
biocompatible and the
subject device passed all
testing. |
| | Dimensions | | | |
| Shaft | | | | |
| Proximal OD | 0.03 in | 0.0275 in | 0.028 in | SIMILAR |
| Distal OD | 0.02 in | 0.024 in | 0.025 in | |
| ID | 0.0165 in | 0.017 in | 0.017 in | SAME |
| Effective Length | 150 cm | 150 cm | 150 cm | SAME |
| Coating Length | 30 cm | 100 cm | 100 cm | SAME as the reference. |
| | Accessories | | | |
| Introducer Sheath
ID | N/A | 0.041 in | 0.044 in | The introducer sheath
of the subject device |
| Introducer Sheath
OD | N/A | 0.054 in | 0.055 in | was evaluated to allow
introduction of the |
| Introducer Sheath
Length | N/A | 4.5 in | 5.1 in | microcatheter into
compatible guide
catheters. |
| Shaping Mandrel
OD | Not provided | 0.014 in | 0.014 in | SAME as the reference. |
| | Packaging Materials | | | |
| Pouch | Tyvek and PET/PE
film | Tyvek and nylon | Tyvek and nylon | Packaging materials are
similar and typical for |
| Packaging | HDPE Hoop | Polyethylene tube | PET Tray | medical devices. The
packaging maintains |
| Mandrel Card | Not provided | HDPE | HDPE | sterility of the device
throughout shelf life. |
| Display Carton | SBS Paperboard | SBS Paperboard | SBS Paperboard | SAME |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | SAME |
| How Supplied | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use | SAME |
| Shelf Life | 27 months | 36 months | 12 months | A 12-month shelf life
was validated for the
subject device. |
Table 1. Technological Comparison to PROWLER SELECT LP ES Microcatheter and Tip-Shape Echelon Micro Catheter
5
Performance Testing e.
To establish substantial equivalence of the Wallaby 017 Micro Catheter to the PROWLER SELECT LP ES Microcatheter and the Tip-Shape Echelon Micro Catheter and to meet the requirements of the risk analysis, non-clinical bench and biological compatibility testing were conducted. The testing performed and results are summarized below.
Design Verification Testing - Bench
6
Performance testing was conducted to support the premarket submission. The results of the design verification and validation testing performed confirm that the Wallaby 017 Micro Catheter conforms to the pre-defined acceptance criteria. Testing included:
| Test | Methods and Results |
|---|---|
| Visual Inspection | The device was visually inspected. The device met all pre-defined acceptance criteria. |
| Dimensional Inspection | The device was evaluated to verify the dimensional requirements were met. The device met all pre-defined acceptance criteria. |
| Simulated Use | The device was evaluated in a simulated anatomy model for the preparation and ease of assembly, introducer sheath compatibility and peel away, ancillary device compatibility with guidewire and guide catheter, trackability, compatibility with embolic coil, lubricity and durability of hydrophilic coating, and kink resistance. The device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. |
| Physician Validation | |
| (Usability) | The device was evaluated in a simulated anatomy model by physicians in comparison with the predicate. The device performs as intended and demonstrates equivalency to the comparator device under simulated use conditions. |
| Delivery and Retrieval | The device was subjected to delivery and retrieval testing, including delivery and retrieval of a guidewire and embolic coil, in a vascular model and met all pre-defined acceptance criteria. |
| Tip Stiffness | The device tip was deflected on a universal testing machine and met the acceptance criteria. |
| Tip Shaping | The device tip was shaped with the shaping mandrel and steam and met the pre-defined acceptance criteria. |
| System Tensile (hub, shaft, tip) | The device was evaluated to verify the tensile strength of the full system meets the minimum tensile strength requirement. The device met the predefined acceptance criteria. |
| Elongation to Failure | The device elongation was evaluated during the shaft tensile testing. The device met all pre-defined acceptance criteria. |
| Torque To Failure | The device was evaluated for catheter integrity during hub rotations with distal end held stationary. The device met all pre-defined acceptance criteria. |
| Coating Integrity | The device coating integrity was inspected pre- and post-insertion and retrieval using a vascular model and met all pre-defined acceptance criteria. |
| Coating Lubricity | The device was evaluated for frictional forces on a universal testing machine and met all pre-defined acceptance criteria. |
| Catheter Dynamic and Static | |
| Burst (Pressure) | |
| Leak (Liquid) | |
| Leak (Air) | The device was evaluated to verify the device does not leak, burst, and is compatible with accessories per ISO 10555-1 and ISO 594-1. |
| Kink Resistance | The device was evaluated for resistance to kinking around bends with clinically relevant radii and met acceptance criteria. |
| Particulate | The device was evaluated within a simulated anatomy model for particulate generation. The device met all pre-defined acceptance criteria and was comparable to the reference device. |
| Corrosion Resistance | The catheter is corrosion resistant per ISO 10555-1. |
| Radiopacity | The device was evaluated for marker band visibility under fluoroscopy and met the pre-defined acceptance criteria. |
| DMSO and Liquid Embolic | |
| Compatibility | The device was evaluated for DMSO and liquid embolic compatibility and met the pre-defined acceptance criteria. |
Table 2. Wallaby 017 Micro Catheter Bench Testing Summary
7
Design Verification Testing – Animal
No animal testing was deemed necessary to support the substantial equivalence of the Wallaby 017 Micro Catheter.
Sterilization and Shelf Life
The Wallaby 017 Micro Catheter is sterilized using an Ethylene Oxide (EO) sterilization cycle. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10 ° in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Aging studies for the Wallaby 017 Micro Catheter have established that the device and packaging remain functional for the 12-month shelf-life. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.
Biocompatibility
Biocompatibility testing for the Wallaby 017 Micro Catheter and accessories was performed in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Evaluation and testing within a risk management process. Biocompatibility testing completed for the device included:
| Test | Standard | Results | Conclusion |
|---|---|---|---|
| Catheter | |||
| MTT - L-929 | |||
| Cytotoxicity Study | ISO 10993-5 | 1XMEM test extract showed no cytotoxic | |
| potential to L-929 mouse fibroblast cells | |||
| undiluted or at any dilution. | Non-cytotoxic | ||
| ISO Intracutaneous | |||
| Irritation | ISO 10993-10 | The difference between the average | |
| scores of the test article extract and the | |||
| vehicle control are 0.0; 0.1. | Non-irritant | ||
| ISO Guinea Pig | |||
| Maximization | |||
| Sensitization | ISO 10993-10 | Test and control animals' responses are | |
| not greater than "0". | Non-sensitizing | ||
| ISO Acute Systemic | |||
| Toxicity | ISO 10993-11 | No abnormal clinical signs indicative of | |
| toxicity were observed for 72 hours. All | |||
| animals were alive at the end of 72 hours | |||
| and body weight changes were within | |||
| acceptable parameters. | Non-toxic | ||
| Materials Mediated | |||
| Rabbit Pyrogen | USP | No rabbit temperature rise ≥ 0.5°C. | Non-pyrogenic |
| Complement | |||
| Activation - SC5b-9 | |||
| Assay | Results within acceptable range and not | ||
| statistically different than activated NHS | |||
| control or negative control. | Not a potential | ||
| activator of | |||
| complement system | |||
| ASTM Hemolysis — | |||
| Direct Contact and | |||
| Extract Method | ISO 10993-4 | Blank corrected hemolytic index: 0.4; | |
| 0.0. | Non-hemolytic | ||
| Thromboresistance | |||
| Evaluation | No adverse effects or clinical signs during | ||
| test period and no thrombus score > 3 | |||
| for either test or control device. | Thromboresistance of | ||
| test device similar to | |||
| control device |
Table 3. Biocompatibility Testing
8
| Chemical
Characterization-
Physiochemical Tests
for Plastics | ISO 10993-18 | Extractable and leachable chemical
characterization and the toxicological
risk assessment (buffering capacity, non-
volatile residue (NVR) and heavy metals)
of the Wallaby 017 Micro Catheter
demonstrated that the extractables and
leachables of the subject device were
similar to that of the reference device. | Pass |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Steam Shaping
Mandrel | The shaping mandrel was excluded from any direct biocompatibility testing and instead
was included during testing of the Wallaby 017 Micro Catheter as part of sample
preparation by inserting the shaping mandrel into the tip for a timed minimum of 5
minutes, when applicable. | | |
| Mandrel Card | The mandrel card was excluded since it has no patient contact and only contacts the
shaping mandrel which was included during sample preparation. | | |
| Introducer Sheath
Subassembly | The introducer sheath subassembly was not tested for biocompatibility because the
introducer sheath was previously cleared with the Wallaby Avenir Coil System. | | |
Clinical
No clinical testing was deemed necessary to support the substantial equivalence of the Wallaby 017 Micro Catheter.
Conclusion
The Wallaby 017 Micro Catheter is substantially equivalent to the predicate PROWLER SELECT LP ES Microcatheter based on the non-clinical testing results, as well as similar principles of operation, materials of construction, packaging, usability, and the indications for use. Any differences between the subject device and the predicate device do not raise new questions of safety and effectiveness.