(308 days)
No
The 510(k) summary describes a physical barrier device (hydrogel) and its delivery system. There is no mention of software, algorithms, data analysis, or any components that would typically incorporate AI/ML. The performance studies focus on the physical and biological properties of the hydrogel and its interaction with nerve tissue.
Yes
The device acts as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma, which is a therapeutic intervention.
No
Explanation: The device is intended as a physical barrier to separate a peripheral nerve end from the surrounding environment to reduce the risk of neuroma development, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a hydrogel, precursor solutions, applicators, and cap forms, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- allay Nerve Cap Function: The allay Nerve Cap is an implantable device used inside the body (in vivo) during surgery. Its purpose is to act as a physical barrier around a peripheral nerve end to prevent neuroma formation. It does not analyze or test any biological specimens.
The description clearly indicates it's a surgical implant used directly on a nerve within the patient's body.
N/A
Intended Use / Indications for Use
The allay Nerve Cap is indicated for use in adults aged 22 years or older as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.
Product codes
SBG
Device Description
The allay Nerve Cap is a sterile, absorbable, in situ formed, hydrogel composed of water and polyethylene glycol (PEG). The hydrogel forms in seconds after delivery of the precursor solutions around a nerve seated in a temporary silicone Cap Form (Figure 1). The hydrogel provides a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve. The Cap Form is removed and discarded after the implantation procedure. The hydrogel nerve cap is absorbed within 8 months.
The allay Nerve Cap system is provided in a plastic tray sealed in a sterile, peelable outer pouch. The product is available in two sizes of a Small Nerve Set, for nerves less than 4 mm in diameter, and a Large Nerves greater than 4 mm in diameter and less than 7 mm in diameter. The allay Nerve Cap system includes a Powder Vial/Vial Adapter. Diluent Solution. Acceleration Solution, Dual Applicator and Adapter, Delivery Tip with Blunt Needle, and the Cap Forms [Small Nerve Set (1, 2, 3, and 4 mm) and Large Nerve Set (5, 6, and 7 mm)].
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve end
Indicated Patient Age Range
adults aged 22 years or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PERFORMANCE TESTING - BENCH
Non-clinical bench testing was performed to demonstrate that the device can function as intended under clinical conditions of use and mitigate the risks to health (e.g., adverse tissue reaction, tissue injury, use error). The non-clinical bench testing performed are presented in Table 2. All tests met pre-defined acceptance criteria.
Table 2: Summary of Non-Clinical Bench Testing for the allay Nerve Cap
- Color Additive Exposure Contact Category: The dissolution of color additive from the allay Nerve Cap within 72 hours was confirmed through in vitro dissolution testing on hydrogel cylinders and in situ formed hydrogel, which leaves behind a colorless, transparent hydrogel. Extracts showed no change in color or turbidity and no visible particulates.
- Determination of pH and Osmolarity Hydrogel Deliverability: Performance benchtop evaluation demonstrated successful delivery of homogenous hydrogel across the full range of Cap Form sizes, even under worst-case conditions (different angles, locations, and maximal bubble introduction). The hydrogel was successfully delivered around the range of nerve sizes per the Instructions for Use, and the Cap Form was successfully removed without breaking or damaging the in situ formed allay Nerve Cap.
- Dimensional Evaluation: Assessed hydrogel physical dimensions and volume, confirming nerve encapsulation within the hydrogel for each nerve size per the Instructions for Use.
- Dimensional Stability: In vitro testing demonstrated hydrogel integrity and persistence for at least four months (16 weeks) under real-time physiologic conditions (37 °C, phosphate buffered saline (PBS) pH 7.4), including maintenance of a protective layer around the nerve, lumen patency, mechanical strength (compressive modulus), and minimal swelling. Dimensional stability was also demonstrated at clinically relevant but worst-case physiologic extremes of osmolarity (240 mOsm/kg to 320 mOsm/kg).
- Dissolution Time: Test demonstrated that the dissolution time is maintained under 5 minutes.
- Gel Time: The test demonstrated that the hydrogel can consistently fill the Cap Form with a gel time of less than 10 seconds.
- Percent Swelling: Characterized maximal percent swelling of the hydrogel, with acceptance criteria between 0% and 45% swelling of the crosslinked hydrogel as measured by weight 24 hours after immersion in PBS @ 37 °C.
- Compression and Rebound Testing: Demonstrated the hydrogel can withstand compressive forces greater than 0.25 N/cm and rebound >95% following force removal.
- Compressive Modulus: Acceptance criteria for this test was the device must have a minimum of 30 KPa compressive modulus of the crosslinked hydrogel after 24 hours in PBS.
- Ease of Preparation: Demonstrated preparation time of less than 10 minutes.
- Pressure Testing: Demonstrated no pressure was exerted on the artificial nerve at any time during hydrogel equilibration, concluding the allay Nerve Cap is non-compressive.
- Device Migration: Ex vivo benchtop testing on ovine nerves confirmed adherence to a clinically relevant range of nerve diameters for up to one week, mitigating against device migration. In vivo animal testing also demonstrated no device migration.
- Wear Resistance Testing: Accelerated wear testing showed no mass loss and no visible particulates released from the hydrogel under compressive, shear, and dynamic mechanical loads after (b)(4) cm passes.
- Mass Loss: Evaluation of hydrogel mass loss over accelerated degradation showed minimal mass loss (2.8%) over the 3-month period post implantation (2.8%, 6 days accelerated) to 6.6% mass loss in the first 8 days (comparable to 4 months in vivo). Substantial degradation (39.8% mass loss) occurred between 8 and 15 days (between 4 months and ~7.5 months), and the remaining 44.2% mass loss occurred rapidly between day 15 and 16.
- Exaggerated Clinical Use Conditions: Ex vivo evaluation demonstrated successful hydrogel formation in the presence of blood or saline, integrating to form an intact allay Nerve Cap with no visible particulates.
- Use Errors: Benchtop testing showed that common use errors (bubble generation, incomplete dissolution, exceeding delivery window, or fluids) did not result in significantly earlier degradation, decreased hydrogel quality, or affected durability.
- Human Factors and Usability: A study with 20 participants (15 surgeons, 5 scrub nurses) demonstrated that the device and Instructions for Use could be followed without any use errors. All surgeons (100%, n=15/15) could perform all critical tasks related to preparing the device and delivering the hydrogel without any failures or use-related errors. Use time was
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR ALLAY NERVE CAP
REGULATORY INFORMATION
FDA identifies this generic type of device as:
In situ polymerizing peripheral nerve cap. An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma.
NEW REGULATION NUMBER: 21 CFR 882.5260
CLASSIFICATION: Class II
PRODUCT CODE: SBG
BACKGROUND
DEVICE NAME: allay Nerve Cap
SUBMISSION NUMBER: DEN230061
DATE DE NOVO RECEIVED: September 19, 2023
Tulavi Therapeutics CONTACT: 160 Knowles Avenue Los Gatos, California 95032
INDICATIONS FOR USE
The allay Nerve Cap is indicated for use in adults aged 22 years or older as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.
LIMITATIONS
The allay Nerve Cap is not designed, sold, or intended for use except as described in the indications for use and is contraindicated for use in:
- . Areas of active surgical site infection.
- Areas of active blood flow. .
- Areas of excessive movement or over a joint. .
1
- . Patients with a known allergy to poly(ethylene glycol) (PEG) or the color additives FD&C Yellow No. 5 Dye (tartrazine) or FD&C Blue No. 1 Dye (brilliant blue FCF).
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS
2
DEVICE DESCRIPTION
The allay Nerve Cap is a sterile, absorbable, in situ formed, hydrogel composed of water and polyethylene glycol (PEG). The hydrogel forms in seconds after delivery of the precursor solutions around a nerve seated in a temporary silicone Cap Form (Figure 1). The hydrogel provides a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve. The Cap Form is removed and discarded after the implantation procedure. The hydrogel nerve cap is absorbed within 8 months.
The allay Nerve Cap system is provided in a plastic tray sealed in a sterile, peelable outer pouch. The product is available in two sizes of a Small Nerve Set, for nerves less than 4 mm in diameter, and a Large Nerves greater than 4 mm in diameter and less than 7 mm in diameter. The allay Nerve Cap system includes a Powder Vial/Vial Adapter. Diluent Solution. Acceleration Solution, Dual Applicator and Adapter, Delivery Tip with Blunt Needle, and the Cap Forms [Small Nerve Set (1, 2, 3, and 4 mm) and Large Nerve Set (5, 6, and 7 mm)].
Image /page/2/Picture/3 description: The image shows a syringe with a needle and several small, white, origami-like objects arranged in a row. The syringe is filled with a blue liquid and has a clear barrel. The needle is attached to the syringe and is pointing towards the left side of the image. The origami-like objects are arranged in a row in front of the syringe. They are all white and have a similar shape. The background is a plain white surface.
Figure 1: Prepared hydrogel precursors ready for delivery system (applicator) with available cap form sizes.
The delivery mechanism of the starting materials to the site of application. the polymerization. mechanism and polymer structure, the intermediate and side produced, and degradation pathway and degradants were described in the device description of the allay Nerve Cap. The characterization of the polymerization reaction to form PEG-based hydrogels was supported by the published scientific literature. 1-23,45,6 Additionally, the material safety data sheets (MSDS), certificates of analysis, and incoming inspection results were provided for the device raw and precursor materials.
SUMMARY OF NONCLINICAL/BENCH STUDIES
Reid, et al. 2015. "PEG Hydrogel Degradation and the Role of the Surrounding Tissue Environment." J Tissue Eng Regen Med, 9(3), 315-318.
2 Fruitier-Polloth (2005). "Safety assessment of polyethylene glycols (PEGs) and their derivatives as used in cosmetic products." Toxicology 214: 1-38.
3 Yamaoka, et al. (1994). "Distribution and tissue uptake of poly (ethylene glycol) with different molecular weights after intravenous administration in mice." J. Pharm. Sc. 83: 601.
4 Sharda, N. et al. (2021) "Pharmacokinetics of 40 kDa polyethylene glycol (PEG) in mice, rats, cynomolgus monkeys and predicted pharmacokinetics in humans." European Journal of Pharmaceutical Sciences. 165, 105928.
3
BIOCOMPATIBILITY/MATERIALS
The allay Nerve Cap is a long-term contact implant (> 30 davs) in contact with tissue/bone. As such, its biocompatibility evaluation was conducted in accordance with ISO 10993-1:2018. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and the FDA guidance, "Use of International Standard ISO-10993. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"." For a long-term contact implant in contact with tissue/bone, the allay Nerve Cap was evaluated for the following: physical and chemical information, cytotoxicity, sensitization, irritation or intracutaneous reactivity, material-mediated pyrogenicity, acute systemic toxicity, subacute/subchronic toxicity, chronic toxicity, implantation, hemocompatibility, genotoxicity, carcinogenicity, and neurotoxicity. As part of this biocompatibility evaluation, the materials of construction (direct, indirect) including the hydrogel and degradation products, the Applicator and the Cap Forms, the packaging materials including the tray, and any additives that might arise from the manufacturing process were assessed (see Table 1).
| Test | Test Method | Results |
|---|---|---|
| allay Nerve Cap | ||
| Cytotoxicity | ISO 10993-5:2009, ISO Elution Method | Non-cytotoxic |
| Sensitization | ISO 10993-10:2010, Maximization Test | |
| in Guinea Pigs | Non-sensitizing | |
| Intracutaneous | ||
| Irritation | ISO 10993-10:2010, Intracutaneous | |
| Reactivity in Rabbits | Non-irritant | |
| Acute Systemic | ||
| Toxicity | ISO 10993-11:2017, Acute Systemic | |
| Toxicity in Mice | Non-toxic | |
| Implantation | ISO 10993-6:2016, Local Subcutaneous | |
| Implantation, 2 Weeks, 13 Weeks, 26 | ||
| Weeks | Non-irritant | |
| In vivo Animal | ||
| Study | ||
| Efficacy - Local | Hydrogel Formed in situ Around | |
| Transected Nerve in Cap Form, 4 Weeks, | ||
| 12 Weeks | Non-irritant | |
| Non-compressive | ||
| No migration or | ||
| adverse tissue | ||
| responses or effects | ||
| observed | ||
| Implantation at | ||
| Clinically Relevant | ||
| Site | Hydrogel Formed in situ Around Sciatic | |
| Nerve, 6 Months, 8 Months | ||
| Neurotoxicity | ISO 10993-1 and ASTM F2901-19, 4 | |
| Weeks, 12 Weeks, 6 Months, 8 Months | Non-irritant | |
| No adverse | ||
| responses were | ||
| observed | ||
| Repeated Exposure | ||
| Systemic Toxicity | Chemical Characterization and | |
| Toxicological Risk Assessment (TRA) | Non-toxic | |
| Test | Test Method | Results |
| (Subacute, | ||
| Subchronic, | ||
| Chronic) | ||
| Hemolysis | ||
| (Indirect Contact) | ISO 10993-4:2017 and ASTM F756 | Non-hemolytic |
| Pyrogenicity | ISO 10993-11:2017 and USP 34 , | |
| USP Rabbit Pyrogen Study, Material | ||
| Mediated | Non-pyrogenic | |
| Genotoxicity | ISO 10993-3:2014, Bacterial Reverse | |
| Mutation Test (Ames Assay), in situ | ||
| Formed | ||
| ISO 10993-3:2014, Bacterial Reverse | ||
| Mutation Test (Ames Assay), in Cap | ||
| Form | ||
| ISO 10993-3:2014, Bacterial Reverse | ||
| Mutation Test (Ames Assay), Fully | ||
| Degraded | ||
| ISO 10993-3:2014, Mouse Lymphoma | ||
| Assay, Dose Finding, in situ Formed | ||
| ISO 10993-3:2014, Mouse Lymphoma | ||
| Assay, Dose Finding, in Cap Form | ||
| ISO 10993-3:2014, Mouse Lymphoma | ||
| Assay, Dose Finding, Fully Degraded | Non-genotoxic | |
| Reproductive | ||
| Toxicity | Chemical Characterization and TRA | Non-toxic |
| Carcinogenicity | Chemical Characterization and TRA | Non-carcinogenic |
| Sterile Cap Forms | ||
| Cytotoxicity | ISO 10993-5:2009, ISO Elution Method | Non-cytotoxic |
| Intracutaneous | ||
| Irritation | ISO 10993-10:2010, Intracutaneous | |
| Reactivity in Rabbits | Non-irritant | |
| Acute Systemic | ||
| Toxicity | ISO 10993-11:2017, Acute Systemic | |
| Toxicity in Mice | Non-toxic | |
| Pyrogenicity | ISO 10993-11:2017 and USP 34 , | |
| USP Rabbit Pyrogen Study, Material | ||
| Mediated | Non-pyrogenic | |
| Sterile Applicator | ||
| Cytotoxicity | ISO-10993-5, ISO Elution Method | Non-cytotoxic |
| Sterile Tray Packaging | ||
| Cytotoxicity | ISO-10993-5, ISO Elution Method | Non-cytotoxic |
| Infrared | ||
| Spectroscopy | Infrared Analysis per ASTM F2475-20 | |
| and ISO 10993-18:2020 | No adverse effects | |
| observed | ||
| Nonvolatile Residue | USP Physiochemical Tests for Plastic | |
| (Aqueous), Non Volatile Residue (USP | Residue ≤ 15 mg | |
| Test | Test Method | Results |
| 43, NF 38, General Chapter ) and | ||
| ASTM F2475-20, Appendix XI | ||
| Particulates | Particulate Analysis, Light Obscuration | |
| Method per USP 43, NF 38, General | ||
| Chapter | No adverse | |
| particulates observed |
Table 1: Biocompatibility Evaluations for the allay Nerve Cap System
5 Webster, et al. (2007). "PEGylated Proteins: Evaluation of their safety in the absence of Definitive Metabolism Studies." Drug Metab Disposition, 35(1), 9-16.
6 Longley, et al. (2013). "Biodistribution and excretion of radiolabeled 40 kDa polyethylene glycol following intravenous administration in mice." J Pharm Sc 10,2(7), p. 2362-2370.
4
5
Chemical Characterization and Toxicological Risk Assessment (TRA):
In order to assess the risks associated with the allay Nerve Cap resulting in an adverse tissue reaction or systemic toxicity effects, chemical characterization and subsequent. TRA of the hvdrogel under worst-case clinical conditions was performed, including identification and quantification of all detected entities extracted from the in situ formed hydrogel, the hydrogel after formation in the Cap Form, as well as the partially and fully degraded hydrogel. The characterization of the entire final finished product ensures that any potential residual chemicals from the manufacturing, packaging, or sterilization processes that could leach from the device during clinical use are not present at levels capable of causing adverse biological responses in patients implanted with the device. The TRA concluded that the extractables from the test article, the allay Nerve Cap, are unlikely to pose a toxicological safety concern. Based on the safety of the allay Nerve Cap as assessed by chemical characterization and TRA, the systemic toxicity (subacute, subchronic, and chronic), reproductive toxicity and carcinogenicity endpoints were evaluated using this testing approach in lieu of the biological testing recommended in ISO 10993-1, annex A.
SHELF LIFE/STERILITY
The allay Nerve Cap and its packaging has been validated for a shelf life of 2 years supported by performance testing using both accelerated aged and real-time aged test samples that were subjected to preconditioning and packaging distribution conditions. The results showed the final product packaging protects the product and maintains sterility under worst-case shipping, handling, and storage conditions.
The allay Nerve Cap is provided sterile using electron beam (E-beam) sterilization and is intended for single use only. The final finished product is sterilized to a sterility assurance level (SAL) of 10-6 using E-beam radiation. E-beam sterilization achieves a minimum internal dose of 25 kGy using the VDmax25 method for the allay Nerve Cap.
Bacterial endotoxin testing using the limulus amebocyte lysate (LAL) kinetic chromogenic test method was evaluated for the allay Nerve Cap to meet the endotoxin limit of
95% ensuring good crosslinking of the polymer. |
| Compressive
Modulus | The compressive properties of the allay Nerve Cap are measured to
ensure the hydrogel has sufficient integrity to prevent nerve
outgrowth in the gel and sufficient cross-linking density to persist at
the site around the nerve for 8 months while remaining soft and
compliant on delivery. The acceptance criteria for this test was the
device must have a minimum of 30 KPa compressive modulus of the
crosslinked hydrogel after 24 hours |
| Test | Test Purpose and Description |
| | in PBS. |
| Ease of
Preparation | Ease of preparation is defined by the time it takes to assemble the
allay Nerve Cap from the initial step of the hydrogel preparation to
the time at which the Applicator is ready for delivery of the hydrogel.
A preparation time longer than 10 minutes indicates PEG melting or
that the PEG powder was stored in inappropriate conditions. The
device must be able to be prepared in less than 10 minutes. |
| Pressure
Testing | Benchtop pressure testing was conducted to demonstrate that there
was no increase in pressure on an artificial nerve using a pressure
transducer as a function of time after formation and equilibration of
the allay Nerve Cap under physiologic conditions. The study
demonstrated that no pressure was exerted on the artificial nerve at
any time during hydrogel equilibration. Therefore, the allay Nerve
Cap is non-compressive. |
| Device
Migration | Ex vivo benchtop testing was conducted on a range of freshly
harvested ovine nerves to confirm that the allay Nerve Cap adheres to
a clinically relevant range of nerve sizes (diameters) for up to one
week under physiologic conditions to mitigate against device
migration both off of the nerve and subsequently from the implant
site. As the in vivo animal testing demonstrated no device migration
on smaller nerves (1 mm rat sciatic nerve, 2 mm rabbit sciatic nerve
for up to 6 months), a range of larger nerves were evaluated, at
minimum establishing the ability to deliver the allay Nerve Cap
around small to medium (1 to 4 mm nerves, 1 to 4 mm Cap Forms,
Small Nerve Set) and up to the maximum 7 mm nerve (7 mm Cap
Form, Large Nerve Set). Testing established that it was not possible
to remove the allay Nerve Cap after firmly pulling on the hydrogel
with forceps in an attempt to remove the hydrogel, consistent with
the in vivo animal testing results demonstrating that the hydrogel
maintains adherence to the transected nerve stump. Therefore, the
hydrogel does not migrate off of the nerve end as established both
through in vitro and in vivo animal testing. |
| Wear
Resistance
Testing | Accelerated wear testing was performed on the allay Nerve Cap to
evaluate the ability of the device to resist wear. The allay Nerve Cap,
delivered around an artificial nerve and placed in a clinically relevant
orientation between two muscle layers (ex vivo chicken muscle),
underwent (b)(4) cm passes to evaluate any wear debris generated
from the hydrogel implants under compressive, shear, and dynamic
mechanical loads. The device passed the acceptance criteria that there
was no mass loss and no visible particulates released from the
hydrogel. |
| Mass Loss | An evaluation of the hydrogel mass loss over the course of
accelerated degradation of the implant was performed in vitro. The
mass of the allay Nerve Cap is characterized by three phases of mass
loss. The study established minimal mass loss occurred over the 3- |
| Test | Test Purpose and Description |
| | month period post implantation (2.8%, 6 days). In the first phase,
spanning 8 days (comparable to 4 months in vivo), only 6.6% mass
loss occurs. In the second phase of mass loss, between 8 and 15 days
(between 4 months and ~7.5 months), substantial degradation is
occurring, over 39.8% of the mass is lost. In the third and final stage
of rapid mass loss, between day 15 and 16, the remaining 44.2% of
mass loss occurs. |
| Exaggerated
Clinical Use
Conditions | In addition to the in vivo assessment of delivery of the in situ
forming hydrogel around the rat and rabbit sciatic nerves after
transection, an ex vivo evaluation of the hydrogel performance after
delivery under exaggerated clinical use conditions was performed.
This represents a worst-case clinical scenario as the proposed
Instructions for Use direct the surgeon not to use the device in a
region of active blood flow. Hydrogel integrity was assessed after
delivery directly into a Wrap Form (identical to a Cap Form but with
an entrance and an exit) containing either a) fresh harvested rat blood
or b) saline (mimicking physiologic fluids and/or irrigation solution).
The hydrogel formed successfully in the presence of blood or saline,
integrating with the blood and saline to form an intact allay Nerve
Cap. No visible particulates were formed. |
| Use Errors | Benchtop testing was performed to evaluate whether use errors
relating to hydrogel preparation and delivery that might result in poor
quality hydrogel formation could impact device performance. The
study was designed to evaluate the impact of each use error on device
performance both immediately after hydrogel preparation and after
the equivalent of 3 months degradation in vivo (6 to 8 days
accelerated degradation). Hydrogels were prepared according to each
worst-case use error and compared with hydrogels formed as
intended per the proposed Instructions for Use. The use errors,
including bubble generation, incomplete dissolution of the powder,
exceeding the delivery window, or fluids did not result in
significantly earlier degradation of the hydrogel, the hydrogel quality,
or affect the durability of the hydrogel as measured through
engineering performance testing. |
| Human Factors
and Usability | A human factors and usability study was conducted to evaluate the
design and usability of the allay Nerve Cap for the intended users,
uses and use environment. The study evaluated the device in the
sterile final finished form, including the final commercial packaging
and tray configuration following the proposed Instructions for Use.
The study design was informed by the FDA guidance, "Applying
Human Factors and Usability Engineering to Medical Devices," ISO
14971:2019, "Application of risk management to medical devices,"
ISO 13485:2015, "Medical Devices - Quality management systems –
Requirements for regulatory purposes," clause 7.3.3a, IEC 62366-1:
2015, "Medical devices - Part 1: Application of usability engineering |
| Test | Test Purpose and Description |
| | to medical devices," and IEC/TR 62366-2:2016, "Medical devices - Part 2: Guidance on the application of usability engineering to medical devices." |
| | A total of 20 participants were included in the human factors and usability study, including fifteen (15) surgeons with relevant surgical experience on nerve repair, including hand surgeons, plastic surgeons, orthopedic surgeons, and podiatrists and five (5) surgical scrub nurses. The surgeons were independently recruited through a market research agency and had no prior knowledge or relationship with the sponsor and were evaluating the product for the first time. The surgeons assembled the allay Nerve Cap and then performed the simulated surgical procedure from removal of the device from the packaging, preparation of the dual-component applicator system, delivery of the hydrogel in situ into the Cap Form around an artificial nerve, and removal of the Cap Form with two different nerve sizes following the Instructions for Use. The scrub nurses were evaluated for their ability to assemble the device in preparation for delivery in the surgical site. The human factors and usability assessment demonstrated that the allay Nerve Cap and proposed Instructions for Use could be followed without any use errors and the use time of 7 Karla M. C. Oliveira et al. "Time course of traumatic neuroma development." PLoS One, Jul 2018, Vol 13(7):e0200548. doi: 10.1371/journal.pone.0200548. PMID: 30011306; PMCID: PMC6047790.
15
repair procedure that can be used to support the effectiveness of the allay Nerve Cap. 8 There is uncertainty regarding whether the allay Nerve Cap will result in functional benefit to human patients since it is difficult to fully assess pain and functional outcomes in animals and whether this data is translatable to human patients. The provided animal studies primarily focused on histological changes rather than behavioral changes in the animal study was able to support the proposed indications for use of the allay Nerve Cap to reduce the risk of development of a symptomatic neuroma because none of the animals implanted with the allay Nerve Cap exhibited neuroma formation within 3 months.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The allay Nerve Cap is indicated for use in adults aged 22 years or older as a physical barrier to separate the peripheral nerve end from the surrounding environment to reduce the risk of the development of a symptomatic neuroma.
The probable benefits outweigh the probable risks for the allay Nerve Cap. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the allay Nerve Cap is granted and the device is classified under the following:
Product Code: SBG Device Type: In situ polymerizing peripheral nerve cap Class: II Regulation: 21 CFR 882.5260
8 Amy M. Moore and Susan E. Mackinnon. "Nerve Repair and Transfers from Hand to Shoulder, Hand Clinics." Clinic Review Articles, May 2016, Vol 32(2), Elsevier, ISBN 9780323445191.