(151 days)
No
The description focuses on the physical characteristics and mechanical function of the coils and delivery system. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an embolization coil system intended for the treatment of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic purpose.
No
The device is an embolization coil system used for treating neurovascular abnormalities and other vascular conditions by creating blood stasis and thrombosing aneurysms. It is a therapeutic device, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description clearly outlines physical components (coils, delivery pusher) made of materials like platinum/tungsten, and the performance studies include testing on these physical components (e.g., tensile testing, corrosion resistance, biocompatibility, MR compatibility). This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Wallaby Avenir Coil System is a physical implantable device (coils) used to embolize blood vessels. It is inserted directly into the patient's vasculature.
- Intended Use: The intended use is to physically block blood flow in aneurysms and other vascular abnormalities. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The device is a therapeutic medical device used for embolization, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
HCG, KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization
Visible under radiographic imaging
Anatomical Site
Neurovasculature
Peripheral vasculature (arterial/venous)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician users
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)
Test: Dimensional Analysis
Test Method Summary: Verified established device specification through dimensional measurement
Results: All device met the established criteria
Test: Delivery and retrieval Forces
Test Method Summary: Characterization of the maximum force required to deliver and retrieve the coil through the microcatheter
Results: All devices performed as intended
Test: Resheathability
Test Method Summary: Testing performed in simulated use condition to demonstrate that the device meets product multiple resheathing requirement within worst case tortuosity vessel conditions
Results: All devices performed as intended
Test: Detachment Characterization
Test Method Summary: Verified through anatomical model testing for detachment force, and detachment reliability. Verified activation of detachment system.
Results: All devices performed as intended
Test: Tensile Testing
Test Method Summary: Verified stretch resistant member tensile strength, full system tensile strength, and detachment wire joint tensile strength by mechanical test equipment
Results: All devices performed as intended
Test: Coil Stiffness
Test Method Summary: 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
Results: All devices performed as intended
Test: Physician Simulated Use Validation
Test Method Summary: Verified through anatomical model in simulated use environment that the physician users evaluated device clinical equivalence to predicate device
Results: All devices performed as intended
Test: GLP Survival Animal Study
Test Method Summary: 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
Results: All devices performed as intended
Test: Pitting Corrosion Resistance (implant)
Test Method Summary: Corrosion resistance testing per ASTM F2129
Results: All devices performed as intended
Test: Galvanic Corrosion Resistance (implant)
Test Method Summary: Galvanic corrosion resistance testing per ASTM F3044
Results: All devices performed as intended
Test: Corrosion Resistance (pusher)
Test Method Summary: Corrosion resistance testing per ISO 10555-1 and ISO 11070
Results: All devices performed as intended
Test: Particulate Testing
Test Method Summary: Particulate testing per USP 788 for >=10µm and >=25µm particles.
Results: All devices performed as intended
Test: MR Compatibility
Test Method Summary: MR testing performed per ASTM F2119, ASTM F2213, ASTM F2052, ASTM F2128 and additional MRA characterization testing.
Results: Testing demonstrated the device is MR conditional
Test: Packaging and Shelf Life Validation
Test Method Summary: 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.
Results: Packaging and device demonstrates the ability to perform as intended through the labeled shelf life of the device.
Test: Sterilization Validation
Test Method Summary: Per ISO 11135, Annex B Overkill Method
Results: Sterilization process achieves sterility assurance level of 10-6
Test: Endotoxin Testing
Test Method Summary: Bacterial endotoxin assay validation per USP 85 and USP 161
Results: There are no interfering factors associated with the device. The endotoxin levels for the device are below 2.15 EU/device.
Test: Biocompatibility Testing - Cytotoxicity (implant, pusher, sheath)
Test Method Summary: Cytotoxicity - MEM Elution (GLP) - 72 hour extract per ISO 10993-5
Results: Non-cytotoxic
Test: Biocompatibility Testing - Cytotoxicity (implant, pusher, sheath)
Test Method Summary: MTT Cytotoxicity Assay Using L-929 Mouse Fibroblast Cells per ISO 10993-5
Results: Non-cytotoxic
Test: Biocompatibility-Sensitization (implant, pusher, sheath)
Test Method Summary: Sensitization - ISO Guinea Pig Maximization Sensitization Test (polar/nonpolar extracts) ISO 10993-10
Results: Did not elicit sensitization response
Test: Biocompatibility - Irritation (implant, pusher, sheath)
Test Method Summary: Irritation or Intracutaneous irritation reactivity - ISO Intracutaneous Irritation Test (polar/nonpolar extracts) ISO 10993-10
Results: Non-irritant
Test: Biocompatibility - Acute Toxicity (implant, pusher, sheath)
Test Method Summary: Acute systemic toxicity - ISO Acute Systemic Injection Test (polar/non polar extracts) per ISO 10993-11
Results: No signs of toxicity
Test: Biocompatibility-Pyrogenicity (implant, pusher, sheath)
Test Method Summary: Pyrogenicity- ISO Material Mediated Rabbit pyrogen per ISO 10993-11
Results: Non-pyrogenic
Test: Biocompatibility-Hemocompatibility (implant, pusher, sheath [extract only])
Test Method Summary: Hemocompatibility - ASTM Hemolysis Assay - Direct Contact and Extract Method per ISO 10993-4
Results: Non-hemolytic
Test: Biocompatibility-Hemocompatibility (implant, pusher)
Test Method Summary: Complement Activation SC5b-9 Assay per ISO 10993-4
Results: The test article results are satisfactory under the test conditions employed
Test: Biocompatibility-Hemocompatibility (implant, pusher)
Test Method Summary: Partial Thromboplastin Time (PTT) per ISO 10993-4
Results: The test article does not pose a greater biocompatibility risk than the existing commercial devices
Test: Biocompatibility-Hemocompatibility (implant, pusher)
Test Method Summary: Platelet and Leukocyte Counts per ISO 10993-4
Results: The test article does not pose a greater biocompatibility risk than existing commercial devices.
Test: Biocompatibility-Hemocompatibility (implant, pusher)
Test Method Summary: Thromboresistance Evaluation- 4hr dog per ISO 10993-4
Results: Non-thrombolytic
Test: Biocompatibility-Genotoxicity (implant)
Test Method Summary: ISO In Vitro Mouse Lymphoma with Extended Treatment per ISO 10993-3
Results: Non-mutagenic and non-clastogenic
Test: Biocompatibility-Genotoxicity (implant)
Test Method Summary: ISO Bacterial Mutagenicity Test - Ames Assay ( 5 Salmonella Strains and 1 E. Coli Strain - 2 Extracts) per ISO 10993-3
Results: Non-mutagenic
Test: Biocompatibility-Implantation (implant)
Test Method Summary: ISO Intramuscular Implantation Test- 2 weeks, 6 weeks, 13 weeks per ISO 10993-6
Results: Non-irritant
Test: Biocompatibility-extractables (implant, pusher)
Test Method Summary: Exhaustive chemical extraction per ISO 10993-17/-18
Results: Device is biologically safe for its intended use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
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.(b)
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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 |
| 23181 Verdugo Dr. | |
| Suite 104A | |
| Laguna Hills, CA 92653 | |
| (760) 809-5178 | |
| TRADE NAME: | Wallaby Avenir Coil System |
| COMMON NAME: | Neurovascular embolization device |
| CLASSIFICATION | |
| NAME: | Neurovascular embolization device |
| DEVICE | |
| CLASSIFICATION: | Class 2, per 21 CFR 882.5950 |
| PRODUCT CODE | HCG, KRD |
| PREDICATE DEVICES: | Primary |
| Axium Detachable Coil System, K162704 | |
| Reference | |
| 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.
4
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
Axium Detachable Coil
System (K162704) | Similarities/
Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Endovascular embolization of
blood flow in the human neuro
and peripheral vasculature. | Endovascular embolization of
blood flow in the human neuro
and peripheral vasculature. | SAME |
| Anatomical Site | Neurovasculature
Peripheral vasculature
(arterial/venous) | Neurovasculature
Peripheral vasculature
(arterial/venous) | SAME |
| Delivery to Site | Via delivery wire through
microcatheter | Via delivery wire through
microcatheter | SAME |
| Coil selection | Physician determined | Physician determined | SAME |
| Visualization | Visible under radiographic
imaging | Visible under radiographic
imaging | SAME |
| | Implant characteristics | | |
| Coil Types | Frame, fill, finish | Frame, Fill, finish | SAME |
| Secondary
Shapes | Complex/Helical | Complex/Helical | SAME |
| Flexibility | Coil-like, highly flexible | Coil-like, highly flexible | SAME |
| Main coil
material | Pt/W alloy (92/8%) | Pt/W alloy (92/8%) | SAME |
| Stretch
Resistant
Member | Polyolefin | Polyolefin | SAME |
| Coil Delivery
Mechanism | Stainless Steel Hypotube | Stainless Steel Hypotube | SAME |
| Coil
detachment | Mechanical | Mechanical | SAME |
| Primary Coil
Diameter | 0.011" - 0.0145" | 0.0108" - 0.0145" | SAME |
| Coil Secondary
Diameter | 1mm - 25mm | 1mm - 25mm | SAME |
| Coil Wire
Diameter | 0.0013" - 0.003" | 0.0013" - 0.003" | SAME |
| Coil Length | 1cm - 60cm | 1cm - 50cm | The available Coil
Length is slightly
(10cm) greater than the
Axium predicate
however this length
range is represented in
the reference predicate
device (K102365) |
| | Delivery wire/pusher characteristics | | |
| Working length | 180cm | 180cm | SAME |
| OD | 0.014" | 0.014" | SAME |
| Materials
of
Construction | SS 304
PTFE
PET shrink Tubing | SS 304
PTFE
PET shrink tubing | Although
adhesive/epoxy is
utilized to facilitate the |
| | Wallaby Avenir Coil System | Primary Predicate
Axium Detachable Coil
System (K162704) | Similarities/
Differences |
| | Platinum/Ir alloy (80/20%)
Platinum/iridium alloy
(90/10%)
Loctite 4311
Epoxy | Platinum/Tungsten alloy
(92/8%) | joining of components,
this does not pose a
fundamental difference;
the materials of
construction is the
SAME |
| | Sheath Characteristics | | |
| Working length | 120cm | 119cm | Although the working
length dimension is not
identical, the difference
is minor (1cm);
therefore, the
fundamental
construction is the
SAME |
| OD | 0.028" | 0.030" | Although the outside
diameter dimension is
not identical, the
difference is minor
(.002"); therefore, the
fundamental
construction is the
SAME |
| ID | 0.017" | 0.019" | Although the inside
diameter dimension is
not identical, the
difference is minor
(.002"); therefore, the
fundamental
construction is the
SAME |
| Materials
of
Construction | HDPE | HDPE
Polypropylene | Although the polymers
vary, all are common
endovascular materials;
therefore, the
fundamental materials of
construction are the
SAME |
| Detachment
equipment
components | None required | Instant Detacher | Mechanical detachment
fulfilled through manual
means-substantially
equivalent |
| User interface | Delivery wire | Handpiece + delivery wire
(primary method)
Delivery wire only (secondary
method) | SAME - The Wallaby
mechanical detachment
method is the same as
the Axium detachment
coil method using only
the delivery wire. |
| Power Source | Mechanical | Mechanical | SAME |
| Connection | Direct attachment to delivery
wire | Direct attachment to delivery
wire | SAME |
| | Wallaby Avenir Coil System | Primary Predicate
Axium Detachable Coil
System (K162704) | Similarities/
Differences |
| | How Provided | | |
| Sterilization | EO | EO | SAME |
| Use | Sterile, single use | Sterile, single use | SAME |
| Packaged
configuration | Stored within dispenser coil,
Tyvek pouch, & shipping
carton | Stored within dispenser coil,
Tyvek pouch, & shipping
carton | SAME |
5
6
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- | ||
| Genotoxicity (implant) | ISO In Vitro Mouse Lymphoma with | |
| Extended Treatment per ISO 10993-3 | Non-mutagenic and non-clastogenic | |
| Biocompatibility- | ||
| Genotoxicity (implant) | ISO Bacterial Mutagenicity Test - Ames | |
| Assay ( 5 Salmonella Strains | ||
| and 1 E. Coli Strain - 2 Extracts) per ISO | ||
| 10993-3 | Non-mutagenic | |
| Biocompatibility- | ||
| Implantation (implant) | ISO Intramuscular Implantation Test- 2 | |
| weeks, 6 weeks, 13 weeks per ISO 10993-6 | Non-irritant | |
| Biocompatibility - | ||
| extractables (implant, pusher) | Exhaustive chemical extraction per ISO | |
| 10993-17/-18 | Device is biologically safe for its | |
| intended use |
7
8
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.