(151 days)
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.
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.
The provided text describes a medical device, the Wallaby Avenir Coil System, and its substantial equivalence to a predicate device. It includes a table of technical characteristics and a summary of performance data from various tests. However, it does not include the specific information requested about acceptance criteria for device performance, particularly related to AI/algorithm performance. It is a submission for a neurovascular embolization device, which is a physical medical device, not an AI/algorithm-driven one.
Therefore, most of the requested information regarding AI/algorithm performance, such as:
- Acceptance criteria related to AI/algorithm performance.
- Study proving device meets acceptance criteria specifically for AI/algorithm performance.
- Sample size and data provenance for AI test set.
- Number of experts and qualifications for AI ground truth.
- Adjudication method for AI test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth for AI.
- Sample size for AI training set.
- How AI training set ground truth was established.
...is not available in the provided document, as it pertains to a physical medical device.
The document states that "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." The "Performance Data" table lists various tests conducted, and for each, it states "All devices performed as intended" or similar positive outcomes. These are the "reported device performance" and the "study that proves the device meets the acceptance criteria" in a general sense for a physical device.
Here's the relevant information that can be extracted, largely focusing on the physical device performance rather than AI:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria for each test in a clear table format, except by implying that the device successfully met the "established criteria" or "performed as intended." The "acceptance criteria" are generally derived from relevant standards (e.g., ASTM, ISO, USP) and the intended function of the device to be substantially equivalent to the predicate. The reported performance is consistently positive.
| Test | Implicit Acceptance Criteria (based on "as intended" or "established criteria") | Reported Device Performance |
|---|---|---|
| Dimensional Analysis | Device dimensions meet established specifications. | All devices met the established criteria. |
| Delivery and retrieval Forces | Forces for delivery and retrieval remain within acceptable, characterized limits for safe operation through microcatheter. | All devices performed as intended. |
| Resheathability | Device can be resheathed multiple times under worst-case tortuosity vessel conditions. | All devices performed as intended. |
| Detachment Characterization | Detachment force and reliability are within specified limits; detachment system activates reliably. | All devices performed as intended. |
| Tensile Testing | Stretch resistant member, full system, and detachment wire joint tensile strengths meet specifications. | All devices performed as intended. |
| Coil Stiffness | Coil stiffness characteristics are equivalent to the predicate device. | All devices performed as intended. |
| Physician Simulated Use Validation | Physician users evaluate the device as clinically equivalent to the predicate device in simulated use. | All devices performed as intended. |
| GLP Survival Animal Study | In vivo performance and histopathology metrics are comparable to the predicate device in a chronic canine model. | All devices performed as intended. |
| Pitting Corrosion Resistance (implant) | Meets ASTM F2129 corrosion resistance standards. | All devices performed as intended. |
| Galvanic Corrosion Resistance (implant) | Meets ASTM F3044 galvanic corrosion resistance standards. | All devices performed as intended. |
| Corrosion Resistance (pusher) | Meets ISO 10555-1 and ISO 11070 corrosion resistance standards. | All devices performed as intended. |
| Particulate Testing | Particulate levels (≥10µm and ≥25µm) meet USP 788 criteria. | All devices performed as intended. |
| MR Compatibility | Meets ASTM F2119, ASTM F2213, ASTM F2052, ASTM F2128, and MRA characterization testing requirements for MR conditional status. | Testing demonstrated the device is MR conditional. |
| Packaging and Shelf Life Validation | Sterile barrier integrity and seal strength maintained through labeled shelf life according to ISO 11607-1/-2, ASTM F88, ASTM F1980, ASTM D4169, ISTA 2A, including post-accelerated aging. | Packaging and device demonstrates the ability to perform as intended through the labeled shelf life of the device. |
| Sterilization Validation | Achieves a Sterility Assurance Level (SAL) of 10^-6 per ISO 11135, Annex B Overkill Method. | Sterilization process achieves sterility assurance level of 10^-6. |
| Endotoxin Testing | No interfering factors; endotoxin levels are below 2.15 EU/device 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, Sensitization, Irritation, etc.) | Various ISO 10993 standards (e.g., ISO 10993-5, -10, -11, -4, -3, -6, -17/-18) met for non-cytotoxicity, non-sensitization, non-irritation, no acute systemic toxicity, non-pyrogenicity, non-hemolysis, satisfactory complement activation, etc. | Non-cytotoxic, Did not elicit sensitization response, Non-irritant, No signs of toxicity, Non-pyrogenic, Non-hemolytic, Satisfactory results, Not greater biocompatibility risk, Non-thrombolytic, Non-mutagenic, Non-clastogenic, Biologically safe. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for most tests (e.g., "All devices performed as intended"). For the GLP Survival Animal Study, it refers to a "chronic canine model" but doesn't specify the number of animals. For particulate testing, it's implied that a statistically relevant sample was tested per USP 788.
- Data Provenance: The animal study was a "GLP Survival Animal Study," implying a controlled laboratory setting. Other tests were "performed on test units representative of finished devices" in a laboratory environment, likely at the manufacturer's facility or a certified contract lab. Country of origin not specified, but the applicant is Wallaby Medical, Inc. in California, USA. The studies are prospective in the sense that they are specifically designed to test the device before market submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device, not an AI/algorithm.
- For the "Physician Simulated Use Validation," it mentions "physician users" but does not specify the number or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for a physical medical device. The tests are typically objective measurements or observations against established standards.
5. 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:
- No, this is not an AI-assisted device. Therefore, no MRMC study as described was performed. The "Physician Simulated Use Validation" might be seen as a form of human interaction but not in the context of improving human reading with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical performance characteristics, the "ground truth" is defined by engineering specifications, material science standards (ASTM, ISO), biological safety standards (ISO 10993), and regulatory requirements for medical devices. For the animal study, histopathology results likely served as a form of ground truth regarding biological response.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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 (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
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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 Pine23181 Verdugo Dr.Suite 104ALaguna Hills, CA 92653(760) 809-5178 |
| TRADE NAME: | Wallaby Avenir Coil System |
| COMMON NAME: | Neurovascular embolization device |
| CLASSIFICATIONNAME: | Neurovascular embolization device |
| DEVICECLASSIFICATION: | Class 2, per 21 CFR 882.5950 |
| PRODUCT CODE | HCG, KRD |
| PREDICATE DEVICES: | PrimaryAxium Detachable Coil System, K162704ReferenceMicroplex 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 PredicateAxium Detachable CoilSystem (K162704) | Similarities/Differences | |
|---|---|---|---|
| Intended Use | Endovascular embolization ofblood flow in the human neuroand peripheral vasculature. | Endovascular embolization ofblood flow in the human neuroand peripheral vasculature. | SAME |
| Anatomical Site | NeurovasculaturePeripheral vasculature(arterial/venous) | NeurovasculaturePeripheral vasculature(arterial/venous) | SAME |
| Delivery to Site | Via delivery wire throughmicrocatheter | Via delivery wire throughmicrocatheter | SAME |
| Coil selection | Physician determined | Physician determined | SAME |
| Visualization | Visible under radiographicimaging | Visible under radiographicimaging | SAME |
| Implant characteristics | |||
| Coil Types | Frame, fill, finish | Frame, Fill, finish | SAME |
| SecondaryShapes | Complex/Helical | Complex/Helical | SAME |
| Flexibility | Coil-like, highly flexible | Coil-like, highly flexible | SAME |
| Main coilmaterial | Pt/W alloy (92/8%) | Pt/W alloy (92/8%) | SAME |
| StretchResistantMember | Polyolefin | Polyolefin | SAME |
| Coil DeliveryMechanism | Stainless Steel Hypotube | Stainless Steel Hypotube | SAME |
| Coildetachment | Mechanical | Mechanical | SAME |
| Primary CoilDiameter | 0.011" - 0.0145" | 0.0108" - 0.0145" | SAME |
| Coil SecondaryDiameter | 1mm - 25mm | 1mm - 25mm | SAME |
| Coil WireDiameter | 0.0013" - 0.003" | 0.0013" - 0.003" | SAME |
| Coil Length | 1cm - 60cm | 1cm - 50cm | The available CoilLength is slightly(10cm) greater than theAxium predicatehowever this lengthrange is represented inthe reference predicatedevice (K102365) |
| Delivery wire/pusher characteristics | |||
| Working length | 180cm | 180cm | SAME |
| OD | 0.014" | 0.014" | SAME |
| MaterialsofConstruction | SS 304PTFEPET shrink Tubing | SS 304PTFEPET shrink tubing | Althoughadhesive/epoxy isutilized to facilitate the |
| Wallaby Avenir Coil System | Primary PredicateAxium Detachable CoilSystem (K162704) | Similarities/Differences | |
| Platinum/Ir alloy (80/20%)Platinum/iridium alloy(90/10%)Loctite 4311Epoxy | Platinum/Tungsten alloy(92/8%) | joining of components,this does not pose afundamental difference;the materials ofconstruction is theSAME | |
| Sheath Characteristics | |||
| Working length | 120cm | 119cm | Although the workinglength dimension is notidentical, the differenceis minor (1cm);therefore, thefundamentalconstruction is theSAME |
| OD | 0.028" | 0.030" | Although the outsidediameter dimension isnot identical, thedifference is minor(.002"); therefore, thefundamentalconstruction is theSAME |
| ID | 0.017" | 0.019" | Although the insidediameter dimension isnot identical, thedifference is minor(.002"); therefore, thefundamentalconstruction is theSAME |
| MaterialsofConstruction | HDPE | HDPEPolypropylene | Although the polymersvary, all are commonendovascular materials;therefore, thefundamental materials ofconstruction are theSAME |
| Detachmentequipmentcomponents | None required | Instant Detacher | Mechanical detachmentfulfilled through manualmeans-substantiallyequivalent |
| User interface | Delivery wire | Handpiece + delivery wire(primary method)Delivery wire only (secondarymethod) | SAME - The Wallabymechanical detachmentmethod is the same asthe Axium detachmentcoil method using onlythe delivery wire. |
| Power Source | Mechanical | Mechanical | SAME |
| Connection | Direct attachment to deliverywire | Direct attachment to deliverywire | SAME |
| Wallaby Avenir Coil System | Primary PredicateAxium Detachable CoilSystem (K162704) | Similarities/Differences | |
| How Provided | |||
| Sterilization | EO | EO | SAME |
| Use | Sterile, single use | Sterile, single use | SAME |
| Packagedconfiguration | Stored within dispenser coil,Tyvek pouch, & shippingcarton | Stored within dispenser coil,Tyvek pouch, & shippingcarton | 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-Genotoxicity (implant) | ISO In Vitro Mouse Lymphoma withExtended Treatment per ISO 10993-3 | Non-mutagenic and non-clastogenic |
| Biocompatibility-Genotoxicity (implant) | ISO Bacterial Mutagenicity Test - AmesAssay ( 5 Salmonella Strainsand 1 E. Coli Strain - 2 Extracts) per ISO10993-3 | Non-mutagenic |
| Biocompatibility-Implantation (implant) | ISO Intramuscular Implantation Test- 2weeks, 6 weeks, 13 weeks per ISO 10993-6 | Non-irritant |
| Biocompatibility -extractables (implant, pusher) | Exhaustive chemical extraction per ISO10993-17/-18 | Device is biologically safe for itsintended 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.
§ 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).