K Number
DEN190055
Device Name
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
Manufacturer
Date Cleared
2021-10-01

(653 days)

Product Code
Regulation Number
874.4450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.
Device Description
The iotaSOFT™ Insertion System is designed to assist the surgeon during cochlear implantation by controlling electrode array insertion speed. The system consists of a single-use, sterile drive unit (iotaSOFT™ DRIVE Unit) connected to a reusable, non-sterile touch screen control console and footpedal (iotaSOFT Controller and Accessories) (Figure 1).
More Information

Not Found

Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight, MED-EL Flex 24 & 28

No
The description focuses on controlling insertion speed and provides performance data based on mechanical properties and clinical outcomes, with no mention of AI/ML algorithms or data processing for decision-making.

Yes.
The device is intended to aid in the placement of cochlear implant electrode arrays, an intervention aimed at treating hearing loss.

No
The device aids in the physical placement of a cochlear implant electrode array by controlling insertion speed, rather than detecting, diagnosing, or monitoring a disease or condition. Its function is procedural assistance, not diagnostic.

No

The device description explicitly states the system consists of a single-use, sterile drive unit and a reusable, non-sterile touch screen control console and footpedal, indicating the presence of hardware components beyond just software.

Based on the provided information, the iotaSOFT™ Insertion System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the device is intended to "aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion." This is a surgical assistance device used during a medical procedure on a living patient.
  • Device Description: The description confirms it's a system designed to "assist the surgeon during cochlear implantation by controlling electrode array insertion speed." This reinforces its role in the surgical process.
  • Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The iotaSOFT system does not perform any such analysis on biological specimens. It is a tool used directly on the patient's anatomy during surgery.

Therefore, the iotaSOFT™ Insertion System falls under the category of a surgical instrument or device used in a medical procedure, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

The iotaSOFT™ Insertion System is indicated for use only (a) with the Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight, and MED-EL Flex 24 & 28 cochlear implant electrode arrays; and (b) after giving due consideration to all relevant facts and circumstances, including the surgeon's clinical judgment and the array's instructions for use, contraindications, limitations for use, and any accompanying surgical guides.

Product codes

QQH

Device Description

The iotaSOFT™ Insertion System is designed to assist the surgeon during cochlear implantation by controlling electrode array insertion speed. The system consists of a single-use, sterile drive unit (iotaSOFT™ DRIVE Unit) connected to a reusable, non-sterile touch screen control console and footpedal (iotaSOFT Controller and Accessories).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cochlea (radiographically normal)

Indicated Patient Age Range

12 years and older

Intended User / Care Setting

Surgeon / Hospital Environment

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

Nonclinical/Bench Studies:

  • Biocompatibility: The iotaSOFT™ Drive Unit components in direct patient contact (right and left drive housings, stage base, arm heat shrink, bone screws, and silicone in contact with tissue/bone/CSF) passed all biocompatibility requirements for an external communicating device in limited contact with tissue/bone/dentin (, USP ) on sterilized iotaSOFT Drive Unit met acceptance criteria (80mN at both 1mm/s and 0.1mm/s.
    • Maximum drive wheel pinch force 80mN.
  • Maximum Drive Wheel Pinch Force (Bench):

§ 874.4450 Powered insertion system for a cochlear implant electrode array.

(a)
Identification. A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
(i) Verification of cochlear implant attachment force, release force, and insertion speed;
(ii) Testing to demonstrate the device does not damage or degrade the cochlear implant (including the lead and array portions of the cochlear implant); and
(iii) Comparison testing with manual insertion to evaluate:
(A) Differences in cochlear implant array insertion force associated with use of the device; and
(B) Intracochlear placement of the cochlear implant array (intended scala placement and array insertion depth, together with minimal array tip foldover and cochlear scala translocation).
(3) Usability testing in a simulated hospital environment with an anatomically relevant model (
e.g., cadaver testing) that evaluates the following:(i) Successful use to aid in placement of the electrode array into the cochlea; and
(ii) Harms caused by use errors observed.
(4) Changes in cochlear implant compatibility are determined to significantly affect the safety or effectiveness of the device and must be validated through performance testing or a rationale for omission of any testing.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(7) The patient-contacting components of the device must be demonstrated to be sterile and non-pyrogenic.
(8) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(9) Software verification, validation, and hazard analysis must be performed for any software components of the device.
(10) Labeling must include:
(i) The recommended training for the safe use of the device;
(ii) Summary of the relevant clinical and non-clinical testing pertinent to use of the device with compatible electrode arrays; and
(iii) A shelf life.

0

DE NOVO CLASSIFICATION REQUEST FOR IOTASOFTTM INSERTION SYSTEM - DRIVE UNIT, CONTROLLER AND ACCESSORIES

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Powered insertion system for a cochlear implant electrode array. A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.

NEW REGULATION NUMBER: 21 CFR 874.4450

CLASSIFICATION: Class II

PRODUCT CODE: QQH

BACKGROUND

DEVICE NAME: iotaSOFT Insertion System - Drive Unit, Controller and Accessories

SUBMISSION NUMBER: DEN190055

DATE DE NOVO RECEIVED: December 18, 2019

SPONSOR INFORMATION:

IotaMotion, Inc. 14 ½ S. Clinton St. Iowa City, Iowa 52240

INDICATIONS FOR USE

The iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

LIMITATIONS

The iotaSOFT™ Insertion System is not indicated for use in patients with craniofacial abnormalities, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g. fibrosis, fracture, or ossification), or cochlear malformations.

The iotaSOFT™ Insertion System is only intended for use on individuals 12 years of age or older.

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The iotaSOFT™ Insertion System is indicated for use only (a) with the Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight, and MED-EL Flex 24 & 28 cochlear implant electrode arrays; and (b) after giving due consideration to all relevant facts and circumstances, including the surgeon's clinical judgment and the array's instructions for use, contraindications, limitations for use, and any accompanying surgical guides.

The sale, distribution, and use of the iotaSOFT Insertion System are restricted to prescription use in accordance with 21 CFR 801.109.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The iotaSOFT™ Insertion System is designed to assist the surgeon during cochlear implantation by controlling electrode array insertion speed. The system consists of a single-use, sterile drive unit (iotaSOFT™ DRIVE Unit) connected to a reusable, non-sterile touch screen control console and footpedal (iotaSOFT Controller and Accessories) (Figure 1).

Image /page/1/Figure/5 description: The image shows a medical device system with several components. The components include a control console with a screen displaying "Press Right Footpedal to Insert Electrode" and an insertion rate of 0.5 mm/s, a sterile disposable drive unit, and a foot pedal. The text indicates that the control console and foot pedal are non-sterile and reusable, while the drive unit is sterile and disposable.

Figure 1: iotaSOFTTM Insertion System Overview: The iotaSOFTTM Insertion System is made up of the three main components shown: User Control Console, Drive Unit (screwdriver not shown), and surgeon footpedal controller. Components within Blue dashed region represent components used within the sterile surgical field. Green dash region represents components used outside the sterile surgical field.

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System Components

iotaSOFT Drive Unit (sterile, disposable)Drive (Motor) Unit
Drive Head
Unit Base
Self-Drilling Screws x2
Screw Driver
iotaSOFT Controller and Accessories (non-sterile, reusable)Touch Screen
Graphical User Interface
Rolling Stand Assembly
Foot pedal
Accessory Control Console Power Supply
Accessory USB extender cables x2

SYSTEM COMPONENT DESCRIPTION: iotaSOFT™ DRIVE Unit

Image /page/2/Figure/3 description: This image shows a medical device with several labeled parts. The device includes a drive unit, a cable, a drive head, and an arm. It also has a locking tab, a unit base, self-drilling bone screws, a hinge, and wheels. Additionally, there is a loading notch visible in the image.

Figure 2: iotaSOFTTM | DRIVE Unit Sub-Components

Drive (Motor) Unit: The Drive Unit is supplied sterile in a tray with Tyvek lid with the screwdriver packaged within. The Drive unit (Figure 2) couples to the electrode lead via the drive head (A) which is linked to a drive cable housed within the semi-rigid, "stay-put" gooseneck arm (B) of the main drive unit (C). The drive unit is held within the unit base (D) that is secured to the patient via self-drilling bone screws (G). The power/ communications cable (E) is passed off the sterile field and connected to the main control console. The drive unit is designed to be adjustable by sliding forward or backwards within the base or removable for electrode loading then replacing and securing into the base with the side locking tabs (F). Based on patient anatomy, the drive head trajectory and angle may also be adjusted by bending the flexible, semi-rigid arm and/or rotating drive head (Figure 3).

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Image /page/3/Picture/0 description: The image shows six different diagrams of a medical device. The diagrams show the device in different positions and with different functions. The first diagram shows the device in a closed, neutral position. The second diagram shows the device with a bendable neck. The third diagram shows the device with a rotatable head. The fourth diagram shows the device with a clasping action. The fifth diagram shows the device with a drive unit slide. The sixth diagram shows the device with a toggle lock.

Figure 3: iotaSOFTTM | DRIVE Unit adjustability features to manually manipulate drive head position and electrode array insertion trajectory.

Drive Head: The drive head consists of two halves which clamp to the CI electrode lead via spring loaded hinge. The drive wheels are houses within the drive head with the wheel geometries designed to cup around the electrode lead and facilitate loading. The electrode engagement mechanism is compatible with the electrode arrays listed above having multiple and varying lead nominal diameters ranging 0.8 to 1.2mm. The drive head tips are additionally designed with grooved, keyhole inner geometry or track to accommodates for "winged" electrodes to maintain the proper electrode array contact orientation toward the modiolus during insertion (Figure 4) The drive head is design with a spring clamp and engagement gap, (~0.38 mm) to prevent over-compressing the electrode lead. A forceps loading notch is incorporated which increases ease of electrode coupling to the drive head. The loading notch allows both closure of the drive head halves around the electrode while being held with forceps and enables subsequent release of the forceps without re-opening the drive head tip is tapered for improved operative views and made of a semi-transparent polycarbonate plastic which allows visualization of the electrode within the drive tips and operative light transmission.

Image /page/3/Picture/3 description: The image shows a close-up of a mechanical device. The device appears to be made of a light-colored material, possibly plastic or metal, and has several components, including wheels and fasteners. The image also includes text labels pointing to specific parts of the device, such as the "Drive Wheel" and "Idler Wheel."

Figure 4: iotaSOFT | Drive Head representation of drive wheels (right) and clasping hinge coupling mechanism to electrode lead (left).

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Unit Base: The unit base provides an adjustable yet stable and secure platform for the drive unit to sit within. The base holds the main drive unit and enables smooth, sliding adjustments with dual locking side toggle tabs. The base inner well "cupped" design allows the drive unit to securely slide within the base yet enables one-handed installation or removal of the unit. Similarly, the dual locking side tabs add additional stabilization once the desired unit positioning has been achieved. Additionally, the base "foot" region holds the pre-loaded, semi-captive screws. The geometry of the base and contact angle of the "foot region" is designed to match curvature of the skull and sit over skin flap between base and skull bone (Figure 5).

Image /page/4/Figure/1 description: This image shows a diagram of a medical device with measurements. The device is 77mm in length. The diagram also shows a screw with measurements of 1mm, 3mm, 7mm, and 3mm, as well as a vertical measurement of 30mm.

Figure 5: iotaSOFTTM | DRIVE Unit Dimensions: Approximate dimensions in mm.

Screwdriver & Self-Drilling Screws: Screwdriver is provided sterile to screw the self-drilling screws x2 into the skull to secure and stabilize the unit base. The bone screws are self-drilling titanium bone screws with nominal outer diameter of 1.5mm and nominal length of 7mm (Figure 5). The bone screws are preloaded and semi-captive in unit base by a retaining silicone plug. When used as intended in combination within the unit base the screw functional length into skull is limited to maximum depth of 3mm.

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SYSTEM COMPONENT DESCRIPTION: iotaSOFT™ Controller & Accessories

Touch screen control console with Graphical User Interface (GUI): The Control console (Figure 6) provides power and communication across iotaSOFT™ system components including the Drive unit and surgeon foot pedal. The console consists of an all-in-one computer with high definition Projected Capacitive (PCAP) touchscreen screen and USB connections for the foot pedal and drive unit cables. The iotaSOFT™ software is directly loaded at startup to operate the DRIVE Unit.

Control Footpedal: The surgeon has handsfree control of the Drive unit and insertion rate setting (0.1mm/sec to 1.0mm/sec) via the non-sterile foot pedal (Figure 6). The surgeon controls the CI advancement and retraction using the foot pedal. With left, yellow pedal reversing electrode and right, blue pedal advancing per standard convention. The center, black button can be pressed to access insertion rate control menu and/or select to confirm and close menus.

Accessories: Control console power supply and 2 USB extender cables: The Control Console power supply plugs into the mains power outlet. Two USB 10ft extension cables are secured and connected to the console with excess length coiled on the rolling stand basket (Figure 6). The system is designed such that the foot pedal and drive unit cable ends can be connected to either console USB cable pigtails for normal operation.

Image /page/5/Picture/4 description: The image shows a medical device on a rolling stand. The device has a screen that displays the word "iotamotion" and a button that says "Start". There is a basket attached to the stand, and a foot pedal is on the floor. The device is likely used for physical therapy or rehabilitation.

Figure 6: iotaSOFT | Control console, footpedal, rolling stand assembly with power supply and USB cable extenders.

Rolling Stand Assembly - The rolling stand (Figure 6) allows the surgeons to position the Control Console at a convenient location within 3 feet of surgical table for visibility and accessibility during the procedure. The rolling stand assembly includes a basket and a separate control console power supply mounting bracket. (NOTE: console, rolling stand, cable connections, and foot pedal are intended for operation outside of the sterile field).

SUMMARY OF NONCLINICAL/BENCH STUDIES

The non-clinical/bench studies conducted on the iotaSOFT System to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized in the sections below.

BIOCOMPATIBILITY

The iotaSOFT™ Drive Unit components and type of contact are described below. The patient-contacting components of the iotaSOFTTM Drive Unit passed all biocompatibility requirements for an external communicating device in limited contact with tissue/bone/dentin with an exposure duration of limited ( and USP ) with the sterilized iotaSOFT Drive Unit. All samples met the acceptance criteria (80mN was met at both the 1mm/s and 0.1mm/s о insertion rates

  • maximum drive wheel pinch force of 1 For one subject, NRT measurements were not obtained due to un-identified temporal bone fracture through the internal auditory canal.

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LABELING

A surgical instructions for use is a necessary part of the labeling. This surgical instructions for use includes a list of compatible validated cochlear implants and a summary of supporting nonclinical and clinical performance data.

The contraindications identified in the iotaSOFT labeling contribute to the defined indications for use for the iotaSOFT. In accordance with 21 CFR 807.81(a)(3), FDA has determined that removal or modification of any of the contraindications will require submission of a premarket notification [510(k)], which includes non-clinical performance testing to demonstrate that intended users can use the device as intended with compatible cochlear implants, or rationale for omission of any testing (e.g., applicable data from a comparable model of cochlear implant).

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of a powered insertion system for a cochlear implant electrode array and the measures necessary to mitigate these risks.

Identified Risks to HealthMitigation Measures
Risks to health relating to device interface with patient anatomy, including:
Damage to skull tissue Damage to dura mater Bone damage Cerebrospinal fluid leak Damage to cochlea; hearing loss, tinnitus, vertigoClinical performance testing
Usability testing
Non-clinical performance testing
Labeling
Cochlear implant insertion failure leading to:
Trauma to cochlear structures resulting in residual hearing loss or nerve degeneration Suboptimal array placement (including array rotation) leading to poor hearing performance Failure to disengage from cochlear implant at end of procedure, leading to manual correction and insertionClinical performance testing
Non-clinical performance testing
Usability testing
Cochlear implant compatibility validation
Software verification, validation, and hazard analysis
Labeling
Damage to cochlear implant during insertion leading to poor cochlear implant performance and/or compromised implant reliabilityNon-clinical performance testing
Usability testing
Cochlear implant compatibility validation
Shelf life testing
Software verification, validation, and hazard analysis
Labeling

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| Adverse tissue reaction, including irritation /

inflammation of surgical siteBiocompatibility evaluation
Electromagnetic interference, thermal injury,
or electric shockElectrical safety testing
Electromagnetic compatibility (EMC) testing
Labeling
InfectionSterilization validation
Shelf life testing
Labeling
Excessive operation time leading to increased
exposure to anesthesiaClinical performance testing
Usability testing
Labeling

SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the powered insertion system for a cochlear implant electrode array is subject to the following special controls:

  • Clinical performance testing must demonstrate that the device performs as intended (1) under anticipated conditions of use, including evaluation of all adverse events.
  • Non-clinical performance testing must demonstrate that the device performs as (2) intended under anticipated conditions of use. Testing must include:
    • Verification of cochlear implant attachment force, release force and insertion (i) speed;
    • (ii) Testing to demonstrate the device does not damage or degrade the cochlear implant (including the lead and array portions of the cochlear implant);
    • (iii) Comparison testing with manual insertion to evaluate:
      • Differences in cochlear implant array insertion force associated with use of (A) the device; and
      • Intracochlear placement of the cochlear implant array (intended scala (B) placement and array insertion depth, together with minimal array tip foldover and cochlear scala translocation).
  • Usability testing in a simulated hospital environment with an anatomically relevant (3) model (e.g., cadaver testing) that evaluates the following:
    • Successful use to aid in placement of the electrode array into the cochlea; and (i)
    • Harms caused by use errors observed. (ii)
  • (4) Changes in cochlear implant compatibility are determined to significantly affect the safety or effectiveness of the device and must be validated through performance testing or a rationale for omission of any testing.
  • The patient-contacting components of the device must be demonstrated to be (ર) biocompatible.
  • (6) Performance testing must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
  • (7) The patient-contacting components of the device must be demonstrated to be sterile and non-pyrogenic.

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  • (8) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
  • Software verification, validation, and hazard analysis must be performed for any (9) software components of the device.
  • (10) Labeling must include:
    • The recommended training for the safe use of the device; (i)
    • (ii) Summary of the relevant clinical and non-clinical testing pertinent to use of the device with compatible electrode arrays; and
    • A shelf life. (iii)

BENEFIT-RISK DETERMINATION

CI manufacturer surgical guides recommendations vary. They may include discussion of speed of insertion and insertion forces and recommentation. Insertion utilizing a powered insertion device incorporates a hybrid approach. Utilization of the iotaSOFT device should be performed in consideration of the CI surgical instructions. Stabilized, steady, and slow insertions are recognized in the cochlear implant industry recommended surgical practices and academic literature recognizes these insertions as surgical approaches which decrease the risk of additional hearing loss or vestibular symptoms from inherently uncontrolled, variable, and excessively forceful insertions. 1 ,2,3,4,5.6,7

The iotaSOFT Insertion System stabilizes the electrode and permits slower constant motion (down to 0.1mm/sec insertion speed) and provides a more controlled insertion than is possible with manual, human capabilities. A study by Kesler et al. found that the lower limit of a manual, constant forward insertion motion by a CI surgeon to be a speed of 0.87 mm/sec. Y Lower maximum insertion force and lower insertion force variation were demonstrated for iotaSOFT versus manual insertion in synthetic cochlear model testing. Additionally, iotaSOFT holds and stabilizes the electrode during insertion to free up the surgeon's hand to guide a cochlear implant electrode array with manual tools. This design aspect of iotaSOFT attempts to reduce the risk of unwanted movement of the electrode array such as tremor or inadvertent manual surgeon movements. However, iotaSOFT versus manual insertions were similar per comparative cadaveric assessment in terms of array placement in the cochlea (including cochlear translocations), tip foldover, and insertion angle. Therefore, the benefits that were observed preclinically for iotaSOFT were restricted to more controlled insertion and lower insertion forces (and insertion force variation) than manual insertion.

Considering the clinical performance testing of 21 iotaSOFT implantations by 3 physicians, as of 1-month post activation, electrode impedances and neural telemetry measures were considered normal. Adverse events following the proposed surgical were generally as expected for cochlear implant surgeries2 and as expected when considered relative to manual cochlear implantation, e.g., there were no vestibular related adverse events outside of the mild and

2 CSF leak occurred in one case when otologic drill was used for pilot hole (drill use is not according to iotaSOFT's instructions for use).

17

temporary symptoms as reported in cochlear implantations, in general. The following limitations are associated with the clinical study:

  • . Direct comparison data to manual insertions was not included in the scope of the study.
  • Preservation of residual hearing was not within the scope of this clinical confirmatory . study and 1-month postoperative hearing threshold data were not reported.
  • Clinical study endpoint interval was at 1-month, postoperative; therefore, there was no ● long-term data provided.

Direct clinical benefit was not observed in the clinical and cadaveric studies of powered insertion as compared to manual insertion, and therefore, uncertainty exists in terms of the actual clinical benefit of powered insertion. However, the clinical confirmatory study measures of safety and effectiveness did indicate patient clinical performance using iotaSOFT for electrode arrav insertion was as expected and consistent with that seen at 1-month followup with manual insertions.

Risks associated with the use of iotaSOFT can be considered mitigated with surgeon training and labeling for indicated patients (12 years and older) for the 4 tested and validated cochlear implant arrays: Cochlear Slim Straight, MED-EL Flex 28, MED-EL Flex 24, Advanced Bionics HiFocus SlimJ. When used as intended, the risks due to use of iotaSOFT appeared to be no greater in severity or prevalence than risks associated with manual insertion.

In conclusion, the benefit/risk profile for the iotaSOFT Insertion System is considered favorable for the following reasons:

  • . Regarding clinical risk, adverse events/unmitigated risks related to the IotaSOFT insertion device use were not observed in the clinical and usability studies.
  • As evidenced by benchtop performance characterizations, the iotaSOFT permits ● slower, more controlled insertions with a reduction in both maximum insertion force and insertion force variation of cochlear implant arrays versus manual insertion.
  • The benefit of the device design related to slow, controlled insertion and the potential for reduced intracochlear trauma is supported by cochlear implant industry recommended surgical practices and academic literature.

References:

  • Lehnhardt E. Intracochlear placement of cochlear implant electrodes in soft surgery 1. technique. HNO. 1993;41:356-359.
  • Rajan GP, Kontorinis G. Kuthubutheen J. The Effects of Insertion Speed on Inner Ear 2. Function during Cochlear Implantation: A Comparison Study. Audiol Neurotol. 2013;18(1):17-22.
    1. Mirsalehi M, Rau TS, Harbach L, et al. Insertion forces and intracochlear trauma in temporal bone specimens implanted with a straight atraumatic electrode array. Eur Arch Oto-Rhino-Larvngology, 2017:274(5):2131-2140.

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    1. De Seta D, Torres R, Russo FY, et al. Damage to inner ear structure during cochlear implantation: Correlation between insertion force and radio-histological findings in temporal bone specimens. Hear Res. 2017;344:90-97. doi:https://doi.org/10.1016/j.heares.2016.11.002
  • న. Eshraghi AA, Van De Water TR. Cochlear implantation trauma and noise-induced hearing loss: Apoptosis and therapeutic strategies. Anat Rec Part A Discov Mol Cell Evol Biol. 2006;288A(4):473-481. doi:10.1002/ar.a.20305
  • Kontorinis G, Lenarz T, Stöver T, Paasche G. Impact of the Insertion Speed of Cochlear 6. Implant Electrodes on the Insertion Forces. Otol Neurotol. 2011;32(4).
    1. Roland PS, Wright CG. Surgical Aspects of Cochlear Implantation: Mechanisms of Insertional Trauma. In: Advances in Oto-Rhino-Laryngology. Vol 64. ; 2006:11-30. doi:10.1159/000094642
  • Kesler K, Dillon NP, Fichera L, Labadie RF. Human Kinematics of Cochlear Implant 8. Surgery: An Investigation of Insertion Micro-Motions and Speed Limitations. Otolaryngol Neck Surg. 2017:157(3):493-498. doi:10.1177/0194599817704391

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 iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

The probable benefits outweigh the probable risks for the iotaSOFT Insertion System. 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 iotaSOFT Insertion System is granted and the device is classified as follows:

Product Code: OOH Device Type: Powered insertion system for a cochlear implant electrode array Regulation Number: 21 CFR 874.4450 Class: II