Wallaby Avenir Coil System

K173711 · Wallaby Medical, Inc. · HCG · May 4, 2018 · Neurology

Device Facts

• Record ID: K173711
• Device Name: Wallaby Avenir Coil System
• Applicant: Wallaby Medical, Inc.
• Product Code: HCG · Neurology
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.

Device Story

The Wallaby Avenir Coil System consists of platinum/tungsten embolization coils attached to a delivery pusher. Used in neurovascular and peripheral procedures; coils are inserted via microcatheter under angiographic visualization. The physician positions the coil within an aneurysm or vascular anomaly to induce blood stasis and thrombosis. Once positioned, the coil is mechanically detached from the pusher. The system is available in various shapes, lengths, and sizes to accommodate different anatomical requirements. The device is intended for use by physicians in clinical settings. It benefits patients by providing a minimally invasive method to occlude aneurysms and vascular malformations, reducing the risk of rupture or abnormal blood flow.

Clinical Evidence

Evidence includes bench testing (dimensional analysis, delivery/retrieval forces, resheathability, detachment characterization, tensile testing, coil stiffness, corrosion resistance, particulate testing, MR compatibility, packaging/shelf-life, sterilization, endotoxin, and extensive ISO 10993 biocompatibility testing) and a GLP chronic canine survival study. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Implant: Pt/W alloy (92/8%) with polyolefin stretch-resistant member. Delivery pusher: SS 304, PTFE, PET shrink tubing, Pt/Ir alloys, and Loctite 4311 epoxy. Sheath: HDPE. Mechanical detachment via manual delivery wire manipulation. Sterilization: EO (ISO 11135). MR conditional. Complies with ASTM F2129, F3044, F2119, F2213, F2052, F2128, ISO 10993, ISO 10555-1, ISO 11070, and USP 788.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and arterial/venous embolization in peripheral vasculature.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Predicate Devices

• Axium Detachable Coil System (K162704)

Reference Devices

• Microplex Coil System (K102365)

Submission Summary (Full Text)

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Mav 4, 2018

Wallaby Medical, Inc. Rebecca K. Pine Official Correspondent 23181 Verdugo Drive. Suite 104A Laguna Hills, California 92653

Re: K173711

Trade/Device Name: Wallaby Avenir Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: April 4, 2018 Received: April 5, 2018

Dear Rebecca K. Pine:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173711

Device Name Wallaby Avenir Coil System

#### Indications for Use (Describe)

The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.

| 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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### 510(k) Summary- K173711

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Wallaby Medical, Inc. |
|---------------------------|-------------------------------------------------------------------------------------------------|
| DATE PREPARED: | May 2, 2018 |
| CONTACT PERSON: | Rebecca K Pine<br>23181 Verdugo Dr.<br>Suite 104A<br>Laguna Hills, CA 92653<br>[phone] |
| TRADE NAME: | Wallaby Avenir Coil System |
| COMMON NAME: | Neurovascular embolization device |
| CLASSIFICATION<br>NAME: | Neurovascular embolization device |
| DEVICE<br>CLASSIFICATION: | Class 2, per 21 CFR 882.5950 |
| PRODUCT CODE | HCG, KRD |
| PREDICATE DEVICES: | Primary<br>Axium Detachable Coil System, K162704<br>Reference<br>Microplex Coil System, K102365 |

## Reason for submission:

Commercialization of new embolization coil system.

### Description of the Device Subject to Premarket Notification:

The Wallaby Avenir Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are mechanically detached from the delivery pusher in serial manner until the aneurysm is occluded.

### Indication for Use:

The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.

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# Technical Characteristics:

The Wallaby Avenir Coil System has similar physical and technical characteristics to the predicate devices, as shown in the table below.

| | Wallaby Avenir Coil System | Primary Predicate<br>Axium Detachable Coil<br>System (K162704) | Similarities/<br>Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Endovascular embolization of<br>blood flow in the human neuro<br>and peripheral vasculature. | Endovascular embolization of<br>blood flow in the human neuro<br>and peripheral vasculature. | SAME |
| Anatomical Site | Neurovasculature<br>Peripheral vasculature<br>(arterial/venous) | Neurovasculature<br>Peripheral vasculature<br>(arterial/venous) | SAME |
| Delivery to Site | Via delivery wire through<br>microcatheter | Via delivery wire through<br>microcatheter | SAME |
| Coil selection | Physician determined | Physician determined | SAME |
| Visualization | Visible under radiographic<br>imaging | Visible under radiographic<br>imaging | SAME |
| | Implant characteristics | | |
| Coil Types | Frame, fill, finish | Frame, Fill, finish | SAME |
| Secondary<br>Shapes | Complex/Helical | Complex/Helical | SAME |
| Flexibility | Coil-like, highly flexible | Coil-like, highly flexible | SAME |
| Main coil<br>material | Pt/W alloy (92/8%) | Pt/W alloy (92/8%) | SAME |
| Stretch<br>Resistant<br>Member | Polyolefin | Polyolefin | SAME |
| Coil Delivery<br>Mechanism | Stainless Steel Hypotube | Stainless Steel Hypotube | SAME |
| Coil<br>detachment | Mechanical | Mechanical | SAME |
| Primary Coil<br>Diameter | 0.011" - 0.0145" | 0.0108" - 0.0145" | SAME |
| Coil Secondary<br>Diameter | 1mm - 25mm | 1mm - 25mm | SAME |
| Coil Wire<br>Diameter | 0.0013" - 0.003" | 0.0013" - 0.003" | SAME |
| Coil Length | 1cm - 60cm | 1cm - 50cm | The available Coil<br>Length is slightly<br>(10cm) greater than the<br>Axium predicate<br>however this length<br>range is represented in<br>the reference predicate<br>device (K102365) |
| | Delivery wire/pusher characteristics | | |
| Working length | 180cm | 180cm | SAME |
| OD | 0.014" | 0.014" | SAME |
| Materials<br>of<br>Construction | SS 304<br>PTFE<br>PET shrink Tubing | SS 304<br>PTFE<br>PET shrink tubing | Although<br>adhesive/epoxy is<br>utilized to facilitate the |
| | Wallaby Avenir Coil System | Primary Predicate<br>Axium Detachable Coil<br>System (K162704) | Similarities/<br>Differences |
| | Platinum/Ir alloy (80/20%)<br>Platinum/iridium alloy<br>(90/10%)<br>Loctite 4311<br>Epoxy | Platinum/Tungsten alloy<br>(92/8%) | joining of components,<br>this does not pose a<br>fundamental difference;<br>the materials of<br>construction is the<br>SAME |
| | Sheath Characteristics | | |
| Working length | 120cm | 119cm | Although the working<br>length dimension is not<br>identical, the difference<br>is minor (1cm);<br>therefore, the<br>fundamental<br>construction is the<br>SAME |
| OD | 0.028" | 0.030" | Although the outside<br>diameter dimension is<br>not identical, the<br>difference is minor<br>(.002"); therefore, the<br>fundamental<br>construction is the<br>SAME |
| ID | 0.017" | 0.019" | Although the inside<br>diameter dimension is<br>not identical, the<br>difference is minor<br>(.002"); therefore, the<br>fundamental<br>construction is the<br>SAME |
| Materials<br>of<br>Construction | HDPE | HDPE<br>Polypropylene | Although the polymers<br>vary, all are common<br>endovascular materials;<br>therefore, the<br>fundamental materials of<br>construction are the<br>SAME |
| Detachment<br>equipment<br>components | None required | Instant Detacher | Mechanical detachment<br>fulfilled through manual<br>means-substantially<br>equivalent |
| User interface | Delivery wire | Handpiece + delivery wire<br>(primary method)<br>Delivery wire only (secondary<br>method) | SAME - The Wallaby<br>mechanical detachment<br>method is the same as<br>the Axium detachment<br>coil method using only<br>the delivery wire. |
| Power Source | Mechanical | Mechanical | SAME |
| Connection | Direct attachment to delivery<br>wire | Direct attachment to delivery<br>wire | SAME |
| | Wallaby Avenir Coil System | Primary Predicate<br>Axium Detachable Coil<br>System (K162704) | Similarities/<br>Differences |
| | How Provided | | |
| Sterilization | EO | EO | SAME |
| Use | Sterile, single use | Sterile, single use | SAME |
| Packaged<br>configuration | Stored within dispenser coil,<br>Tyvek pouch, & shipping<br>carton | Stored within dispenser coil,<br>Tyvek pouch, & shipping<br>carton | SAME |

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Each of the technical attributes of the Wallaby Avenir Coil System are present in the predicate device.

# Performance Data:

All necessary testing has been performed for the Wallaby Avenir Coil System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

| Test | Test Method Summary | Results |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Dimensional Analysis | Verified established device specification through dimensional measurement | All device met the established criteria |
| Delivery and retrieval Forces | Characterization of the maximum force required to deliver and retrieve the coil through the microcatheter | All devices performed as intended |
| Resheathability | Testing performed in simulated use condition to demonstrate that the device meets product multiple resheathing requirement within worst case tortuosity vessel conditions | All devices performed as intended |
| Detachment Characterization | Verified through anatomical model testing for detachment force, and detachment reliability. Verified activation of detachment system. | All devices performed as intended |
| Tensile Testing | Verified stretch resistant member tensile strength, full system tensile strength, and detachment wire joint tensile strength by mechanical test equipment | All devices performed as intended |
| Coil Stiffness | Using wire diameter and coil diameter measurements to perform verification by analysis on coil stiffness, to show equivalence of the device characteristics to the predicate | All devices performed as intended |
| Physician Simulated Use Validation | Verified through anatomical model in simulated use environment that the physician users evaluated device clinical equivalence to predicate device | All devices performed as intended |
| GLP Survival Animal Study | Animal testing to evaluate the in vivo performance of the device in a chronic canine model. Histopathology performance metrics were compared to the predicate device | All devices performed as intended |
| Pitting Corrosion Resistance (implant) | Corrosion resistance testing per ASTM F2129 | All devices performed as intended |
| Galvanic Corrosion | Galvanic corrosion resistance testing per | All devices performed as intended |
| Resistance (implant) | ASTM F3044 | |
| Corrosion Resistance (pusher) | Corrosion resistance testing per ISO 10555-1 and ISO 11070 | All devices performed as intended |
| Particulate Testing | Particulate testing per USP 788 for ≥10µm and ≥25µm particles. | All devices performed as intended |
| MR Compatibility | MR testing performed per ASTM F2119, ASTM F2213, ASTM F2052, ASTM F2128 and additional MRA characterization testing. | Testing demonstrated the device is MR conditional |
| Packaging and Shelf Life Validation | Sterile barrier integrity and seal strength testing performed per ISO 11607-1/-2, ASTM F88, ASTM F1980, ASTM F2096, ASTM D4169, ISTA 2A. Sterile barrier integrity and seal strength also tested post accelerated aging conditions. | Packaging and device demonstrates the ability to perform as intended through the labeled shelf life of the device. |
| Sterilization Validation | Per ISO 11135, Annex B Overkill Method | Sterilization process achieves sterility assurance level of 10-6 |
| Endotoxin Testing | Bacterial endotoxin assay validation per USP 85 and USP 161 | There are no interfering factors associated with the device. The endotoxin levels for the device are below 2.15 EU/device. |
| Biocompatibility Testing - Cytotoxicity (implant, pusher, sheath) | Cytotoxicity - MEM Elution (GLP) - 72 hour extract per ISO 10993-5 | Non-cytotoxic |
| Biocompatibility Testing - Cytotoxicity (implant, pusher, sheath) | MTT Cytotoxicity Assay Using L-929 Mouse Fibroblast Cells per ISO 10993-5 | Non-cytotoxic |
| Biocompatibility-Sensitization (implant, pusher, sheath) | Sensitization - ISO Guinea Pig Maximization Sensitization Test (polar/nonpolar extracts) ISO 10993-10 | Did not elicit sensitization response |
| Biocompatibility - Irritation (implant, pusher, sheath) | Irritation or Intracutaneous irritation reactivity - ISO Intracutaneous Irritation Test (polar/nonpolar extracts) ISO 10993-10 | Non-irritant |
| Biocompatibility - Acute Toxicity (implant, pusher, sheath) | Acute systemic toxicity - ISO Acute Systemic Injection Test (polar/non polar extracts) per ISO 10993-11 | No signs of toxicity |
| Biocompatibility-Pyrogenicity (implant, pusher, sheath) | Pyrogenicity- ISO Material Mediated Rabbit pyrogen per ISO 10993-11 | Non-pyrogenic |
| Biocompatibility-Hemocompatibility (implant, pusher, sheath [extract only]) | Hemocompatibility - ASTM Hemolysis Assay - Direct Contact and Extract Method per ISO 10993-4 | Non-hemolytic |
| Biocompatibility-Hemocompatibility (implant, pusher) | Complement Activation SC5b-9 Assay per ISO 10993-4 | The test article results are satisfactory under the test conditions employed |
| Biocompatibility-Hemocompatibility (implant, pusher) | Partial Thromboplastin Time (PTT) per ISO 10993-4 | The test article does not pose a greater biocompatibility risk than the existing commercial devices |
| Biocompatibility-Hemocompatibility (implant, pusher) | Platelet and Leukocyte Counts per ISO 10993-4 | The test article does not pose a greater biocompatibility risk than existing commercial devices. |
| Biocompatibility-Hemocompatibility (implant, pusher) | Thromboresistance Evaluation- 4hr dog per ISO 10993-4 | Non-thrombolytic |
| Biocompatibility-<br>Genotoxicity (implant) | ISO In Vitro Mouse Lymphoma with<br>Extended Treatment per ISO 10993-3 | Non-mutagenic and non-clastogenic |
| Biocompatibility-<br>Genotoxicity (implant) | ISO Bacterial Mutagenicity Test - Ames<br>Assay ( 5 Salmonella Strains<br>and 1 E. Coli Strain - 2 Extracts) per ISO<br>10993-3 | Non-mutagenic |
| Biocompatibility-<br>Implantation (implant) | ISO Intramuscular Implantation Test- 2<br>weeks, 6 weeks, 13 weeks per ISO 10993-6 | Non-irritant |
| Biocompatibility -<br>extractables (implant, pusher) | Exhaustive chemical extraction per ISO<br>10993-17/-18 | Device is biologically safe for its<br>intended use |

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The Wallaby Avenir Coil System met all specified criteria and did not raise new safety or performance questions.

# Basis for Determination of Substantial Equivalence:

# Conclusion

Wallaby Avenir Coil System has the same intended use, technological characteristics and performance and is substantially equivalent to the predicate device.