(203 days)
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.
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.
Here's a summary of the acceptance criteria and the study details for the Wallaby 017 Micro Catheter, based on the provided document.
It's important to note that the document describes a medical device rather than an AI/ML powered device. Therefore, many of the typical questions for AI studies (like sample size for test/training sets, ground truth methodology with experts, adjudication, or MRMC studies) are not applicable here. The "performance" being evaluated is the physical and functional performance of the catheter itself, not the performance of an algorithm.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are based on passing various bench tests and biocompatibility evaluations. The full "acceptance criteria" are implied by "met all pre-defined acceptance criteria" for each test. Specific numerical thresholds for each criterion are not provided in this summary but would have been defined in detailed test protocols.
Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Design Verification | Visual Inspection | Met pre-defined acceptance criteria | Met all pre-defined acceptance criteria. |
| Dimensional Inspection | Met pre-defined acceptance criteria | Met all pre-defined acceptance criteria. | |
| Simulated Use | Performs as intended, met all criteria | Performs as intended and met all pre-defined acceptance criteria under simulated use conditions. | |
| Physician Validation (Usability) | Performs as intended, equivalent to comparator | Performs as intended and demonstrates equivalency to the comparator device under simulated use conditions. | |
| Delivery and Retrieval | Met pre-defined acceptance criteria | Met all pre-defined acceptance criteria. | |
| Tip Stiffness | Met acceptance criteria | Met the acceptance criteria. | |
| Tip Shaping | Met pre-defined acceptance criteria | Met the pre-defined acceptance criteria. | |
| System Tensile (hub, shaft, tip) | Met minimum tensile strength requirement | Met the predefined acceptance criteria. | |
| Elongation to Failure | Met all pre-defined acceptance criteria | Met all pre-defined acceptance criteria. | |
| Torque To Failure | Met pre-defined acceptance criteria | Met all pre-defined acceptance criteria. | |
| Coating Integrity | Met pre-defined acceptance criteria | Met all pre-defined acceptance criteria. | |
| Coating Lubricity | Met all pre-defined acceptance criteria | Met all pre-defined acceptance criteria. | |
| Catheter Dynamic and Static Burst/Leak | Does not leak/burst, compatible with accessories | Evaluated to verify the device does not leak, burst, and is compatible with accessories per ISO 10555-1 and ISO 594-1. | |
| Kink Resistance | Met acceptance criteria | Met acceptance criteria. | |
| Particulate | Met pre-defined acceptance criteria, comparable to reference device | Met all pre-defined acceptance criteria and was comparable to the reference device. | |
| Corrosion Resistance | Corrosion resistant per ISO 10555-1 | Corrosion resistant per ISO 10555-1. | |
| Radiopacity | Marker band visibility under fluoroscopy, met criteria | Met the pre-defined acceptance criteria. | |
| DMSO and Liquid Embolic Compatibility | Met pre-defined acceptance criteria | Met the pre-defined acceptance criteria. | |
| Biocompatibility | Cytotoxicity (MTT - L-929) | Non-cytotoxic | Non-cytotoxic. |
| Intracutaneous Irritation | Non-irritant | Non-irritant. | |
| Sensitization (Guinea Pig Maximization) | Non-sensitizing | Non-sensitizing. | |
| Acute Systemic Toxicity | Non-toxic (no abnormal clinical signs) | Non-toxic. | |
| Rabbit Pyrogen | Non-pyrogenic | Non-pyrogenic. | |
| Complement Activation - SC5b-9 Assay | Not a potential activator of complement system | Not a potential activator of complement system. | |
| Hemolysis — Direct Contact and Extract Method | Non-hemolytic | Non-hemolytic. | |
| Thromboresistance Evaluation | No adverse effects, thrombus score ≤ 3 | Thromboresistance of test device similar to control device. | |
| Chemical Characterization (Physiochemical) | Extractables/leachables similar to reference, pass | Pass. | |
| Sterilization/Shelf Life | Sterility Assurance Level | SAL of 10^-6^ (ISO 11135:2014) | Verified to ensure a sterility assurance level (SAL) of 10^-6^. |
| Shelf Life (12 months) | Device and packaging remain functional | Established that the device and packaging remain functional for the 12-month shelf-life. |
Study Details (Applicable for a medical device cleared via 510(k))
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify exact sample sizes (N-values) for each bench test. For example, "The device was evaluated..." doesn't indicate if this was one unit or multiple units.
- The data provenance is from non-clinical bench testing performed by Wallaby Medical for regulatory submission in the United States (as indicated by the FDA 510(k) process). It is prospective in the sense that the testing was conducted specifically to support this regulatory submission.
- No human-collected test sets (like medical images) are involved, so country of origin of data in that sense is not applicable.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is a physical medical device, not an AI/ML algorithm. "Ground truth" for physical device performance is established through standardized engineering and biological tests against predefined specifications and industry standards (e.g., ISO standards).
- For the "Physician Validation (Usability)" test, it states "The device was evaluated in a simulated anatomy model by physicians." The number and qualifications of these physicians are not detailed in this summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to expert review for AI/ML algorithm performance. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a non-AI medical device without human "readers" in the context of an AI study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is standalone in the sense that it is a physical product, but the concept of "standalone algorithm performance" does not apply.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ISO 10555-1, ISO 594-1, ISO 11135:2014, ISO 10993 series, USP <151>), and comparison to legally marketed predicate devices. The results of the bench tests and biocompatibility evaluations, when conforming to these standards and specifications, are the "ground truth" for proving the device's safety and effectiveness.
-
The sample size for the training set:
- Not applicable. There is no AI/ML model for which to define a training set.
-
How the ground truth for the training set was established:
- Not applicable. There is no AI/ML model or training set.
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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
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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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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.
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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 LPES Microcatheter | Reference Device:Tip-Shape Echelon MicroCatheter | Subject Device:Wallaby 017 MicroCatheter | 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 forUse | The PROWLERSELECT LP ESMicrocatheter isintended for theintroduction ofembolic devices andinfusion ofdiagnostic agentsinto the peripheraland neurovasculature. | The Tip-Shape EchelonMicro Catheter isintended to accessperipheral and neurovasculature for thecontrolled selectiveinfusion of physician-specified therapeuticagents such asembolization materialsand of diagnosticmaterials such ascontrast media. | The Wallaby 017 MicroCatheter is intended toaccess peripheral andneuro vasculature forthe controlled selectiveinfusion of physician-specified therapeuticdevices such asembolization materialsand of diagnosticmaterials such ascontrast media as wellas delivery of emboliccoils. | SAME |
| Materials | ||||
| Shaft | ||||
| Extrusions | Outer layer: Nylonand PellethaneInner layer:PTFE | Outer layer:Pebax (polyether blockamide), PolyamideInner layer:PTFE | Outer layer:Pebax (polyether blockamide), Barium SulfateInfused Pebax, AesnoMed (Polyamide)Inner layer:PTFE | Device materials arebiocompatible and thesubject device passed alltesting. |
| WireReinforcement | Stainless-steel Braid | Nitinol Braid | Nitinol Braid | |
| Components | ||||
| Hub | Grilamid | Polyamide | Polyamide (Trogamid) | Device materials arebiocompatible and thesubject device passed alltesting. |
| Coating | Hydrophilic Coating | Hydrophilic Coating | Hydrophilic Coating | biocompatible and thesubject device passed alltesting. |
| Strain Relief | Not provided | Pebax, Polyolefin | Pebax | |
| Colorant | Blue or Purple | Clear/Natural or Purple | Natural or Green orBlue | The subject devicecolorants arebiocompatible. |
| Marker Band | Pt-W Coil | Pt/Ir Band | Pt/Ir Band | SAME |
| Tip Configuration | Straight, 45°, 90° | Straight, 45°, 90°, steamshapeable by user | Straight, 45°, 90°,steam shapeable byuser | SAME |
| Accessories | ||||
| Device Name | Predicate Device:PROWLER SELECT LPES Microcatheter | Reference Device:Tip-Shape Echelon MicroCatheter | Subject Device:Wallaby 017 MicroCatheter | Rationale for Difference(if applicable) |
| Shaping Mandrel | Stainless Steel | Stainless Steel | Stainless Steel | SAME |
| Introducer Sheath | N/A | Polyamide | HDPE | The device materials arebiocompatible and thesubject device passed alltesting. |
| 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 SheathID | N/A | 0.041 in | 0.044 in | The introducer sheathof the subject device |
| Introducer SheathOD | N/A | 0.054 in | 0.055 in | was evaluated to allowintroduction of the |
| Introducer SheathLength | N/A | 4.5 in | 5.1 in | microcatheter intocompatible guidecatheters. |
| Shaping MandrelOD | Not provided | 0.014 in | 0.014 in | SAME as the reference. |
| Packaging Materials | ||||
| Pouch | Tyvek and PET/PEfilm | Tyvek and nylon | Tyvek and nylon | Packaging materials aresimilar and typical for |
| Packaging | HDPE Hoop | Polyethylene tube | PET Tray | medical devices. Thepackaging maintains |
| Mandrel Card | Not provided | HDPE | HDPE | sterility of the devicethroughout shelf life. |
| Display Carton | SBS Paperboard | SBS Paperboard | SBS Paperboard | SAME |
| SterilizationMethod | 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 lifewas validated for thesubject device. |
Table 1. Technological Comparison to PROWLER SELECT LP ES Microcatheter and Tip-Shape Echelon Micro Catheter
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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
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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 StaticBurst (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 EmbolicCompatibility | 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
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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-929Cytotoxicity Study | ISO 10993-5 | 1XMEM test extract showed no cytotoxicpotential to L-929 mouse fibroblast cellsundiluted or at any dilution. | Non-cytotoxic |
| ISO IntracutaneousIrritation | ISO 10993-10 | The difference between the averagescores of the test article extract and thevehicle control are 0.0; 0.1. | Non-irritant |
| ISO Guinea PigMaximizationSensitization | ISO 10993-10 | Test and control animals' responses arenot greater than "0". | Non-sensitizing |
| ISO Acute SystemicToxicity | ISO 10993-11 | No abnormal clinical signs indicative oftoxicity were observed for 72 hours. Allanimals were alive at the end of 72 hoursand body weight changes were withinacceptable parameters. | Non-toxic |
| Materials MediatedRabbit Pyrogen | USP <151> | No rabbit temperature rise ≥ 0.5°C. | Non-pyrogenic |
| ComplementActivation - SC5b-9Assay | Results within acceptable range and notstatistically different than activated NHScontrol or negative control. | Not a potentialactivator ofcomplement system | |
| ASTM Hemolysis —Direct Contact andExtract Method | ISO 10993-4 | Blank corrected hemolytic index: 0.4;0.0. | Non-hemolytic |
| ThromboresistanceEvaluation | No adverse effects or clinical signs duringtest period and no thrombus score > 3for either test or control device. | Thromboresistance oftest device similar tocontrol device |
Table 3. Biocompatibility Testing
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| ChemicalCharacterization-Physiochemical Testsfor Plastics | ISO 10993-18 | Extractable and leachable chemicalcharacterization and the toxicologicalrisk assessment (buffering capacity, non-volatile residue (NVR) and heavy metals)of the Wallaby 017 Micro Catheterdemonstrated that the extractables andleachables of the subject device weresimilar to that of the reference device. | Pass |
|---|---|---|---|
| Steam ShapingMandrel | The shaping mandrel was excluded from any direct biocompatibility testing and insteadwas included during testing of the Wallaby 017 Micro Catheter as part of samplepreparation by inserting the shaping mandrel into the tip for a timed minimum of 5minutes, when applicable. | ||
| Mandrel Card | The mandrel card was excluded since it has no patient contact and only contacts theshaping mandrel which was included during sample preparation. | ||
| Introducer SheathSubassembly | The introducer sheath subassembly was not tested for biocompatibility because theintroducer 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.
§ 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).