(149 days)
The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting, and single-sided deafness.
INDICATIONS:
The Bonebridge bone conduction hearing implant system is intended for the following patients and indications:
- Patients 12 years of age or older.
- Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3kHz) should be better than or equal to 45 dB HL.
- Bilateral fitting of the Bonebridge is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3kHz, or less than 15 dB at individual frequencies.
- Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3kHz).
- The Bonebridge for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.
The MED-EL BONEBRIDGE System augments hearing by providing acoustic input to the inner ear via bone conduction. The MED-EL BONEBRIDGE System consists of two major components: The implant, called Bone Conduction Implant (BCI) and the external audio processor, e.g. the SAMBA 2 BB. The SYMFIT 8.0 software enables the fitting and configuration of the SAMBA 2 BB audio processor and is indicated for professional use only, i.e. used by hearing healthcare professionals during a fitting session of the external audio processor SAMBA 2 BB. Additionally, the SAMBA 2 GO and SAMBA 2 Remote are also subject to this 510(k). Both devices offer a convenient option to adjust simple, pre-defined settings of the compatible SAMBA 2 BB audio processor. Additionally, the SAMBA 2 GO can also be used as an assistive streaming device. The MED-EL BONEBRIDGE System is an active implantable bone conduction hearing system. The MED-EL BONEBRIDGE System is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
The provided text is a 510(k) summary for the MED-EL Elektromedizinische Geraete GmbH's BONEBRIDGE System components (SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving acceptance criteria for a novel device or AI.
Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, is not applicable or not present in this type of regulatory submission.
The document primarily describes comparative bench testing against a predicate device.
Here's the information that can be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics in the format of a table you've requested. Instead, it relies on demonstrating that the new devices perform "as intended" and are "at least as safe and effective" as the predicate devices, based on various bench tests.
| Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance |
|---|---|
| Same basic design concept and technological characteristics as predicate. | SAMBA 2 BB maintains basic design, electronics, housing material, and similar stimulation strategies to predicate. Differences (battery door, dimensions, weight, magnet strength, microphone protection, microphone type, IP rating) do not affect safety or effectiveness. |
| Same energy source as predicate. | SAMBA 2 BB uses the same energy source as predicate. |
| Biocompatible materials in skin contact. | Main materials in skin contact for SAMBA 2 BB evaluated per 10993-1 and shown to be biocompatible and safe. Material identical to predicate. |
| Signal processing maintains basic functionality and overall performance compared to predicate. | SAMBA 2 BB signal processing features same basic functionality as predicate, with new optional noise reduction, compression settings, and improved acoustic classification. Bench testing confirms differences do not affect safety or effectiveness, and overall performance remains identical. |
| Connectivity options maintain functionality compared to predicate. | SAMBA 2 BB offers identical connectivity options as predicate, plus an acoustic interface for MED-EL Wireless Accessories. Bench testing confirms differences do not affect safety or effectiveness. |
| SYMFIT 8.0 software maintains basic working principle, operational environment, moderate level of concern, and purpose as predicate. | SYMFIT 8.0 works to program SAMBA 2 BB, maintains basic working principle and operational environment. Software architecture improved, workflow identical but with adapted UI. Bench and usability testing confirm differences do not affect safety or effectiveness. |
| SYMFIT 8.0 fitting features maintain basic functionality and overall performance compared to predicate. | SYMFIT 8.0 fitting features provide same basic functionality as predicate, with new optional fine-tuning for compression settings. Bench testing confirms differences do not affect safety or effectiveness, and overall performance remains identical. |
| SAMBA 2 GO design concept and SAMBA 2 Remote app-specific design do not impact safety or effectiveness. | SAMBA 2 GO has slightly updated design (neckloop); SAMBA 2 Remote is a mobile app. Bench testing confirms differences do not affect safety or effectiveness. |
| SAMBA 2 GO and SAMBA 2 Remote remote-control features maintain functionality compared to predicate. | SAMBA 2 GO and SAMBA 2 Remote provide identical remote-control features, with SAMBA 2 Remote offering an additional "Sound Balancing" feature for comfort. Bench testing confirms differences do not affect safety or effectiveness. |
| SAMBA 2 GO and SAMBA 2 Remote connectivity maintains functionality compared to predicate. | SAMBA 2 GO uses identical wireless connection, and enables streaming (non-medical purpose). SAMBA 2 Remote uses acoustic interface. Bench testing confirms differences do not affect safety or effectiveness. |
| Device components meet established specifications for safe and consistent performance. | Non-clinical bench tests (electrical, performance, compatibility, reliability, shipping, environmental, electrical safety, EMC, software testing) demonstrated that all components meet established specifications ensuring consistent and safe performance for intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing" and "non-clinical performance testing." This usually implies testing on physical devices or software in a laboratory setting, not patient data. Therefore, concepts like sample size of a patient test set, data provenance (country, retrospective/prospective), etc., are not explicitly provided or relevant in the context of this 510(k) summary, which focuses on device modifications and substantial equivalence via engineering and verification testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth typically refers to clinical data interpreted by experts. This document describes bench testing of hardware and software components.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are for human interpretation of clinical data sets.
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
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a hearing aid system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to software performance, specifically for SYMFIT 8.0, SAMBA 2 GO, and SAMBA 2 Remote. The document states "Software testing according to software's defined Level of Concern" was conducted. This implies standalone testing of the software components. However, specific performance metrics for the software in a "standalone" fashion are not provided, beyond confirming it meets specifications and does not affect safety or effectiveness compared to the predicate.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "bench testing," the "ground truth" would be established engineering specifications, industry standards, and the performance of the predicate device. This is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is not an AI/Machine Learning device that requires a training set in the typical sense.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2020
MED-EL Elektromedizinische Geraete GmbH Carolin Ralser Advanced Regulatory Affairs Specialist Fuerstenweg 77a Innsbruck, Tirol 6020 Austria
Re: K200504
Trade/Device Name: BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote Regulation Number: 21 CFR 874.3340 Regulation Name: Active implantable bone conduction hearing system Regulatory Class: Class II Product Code: PFO Dated: June 29, 2020 Received: July 2, 2020
Dear Carolin Ralser:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date 06/30/2020 See PRA Statement below,
510(k) Number (if known)
Device Name BONEBRIDGE or Bonebridge
Indications for Use (Describe)
INTENDED USE:
The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting, and single-sided deafness.
INDICATIONS:
The Bonebridge bone conduction hearing implant system is intended for the following patients and indications: - Patients 12 years of age or older.
-
Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3kHz) should be better than or equal to 45 dB HL.
-
Bilateral fitting of the Bonebridge is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3kHz, or less than 15 dB at individual frequencies.
-
Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3kHz).
-
The Bonebridge for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
-
Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.
CONTRAINDICATIONS:
-
Chronic or non-revisable vestibular or balance disorders.
-
Abnormally progressive hearing loss.
-
Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
-
Skin or scalp conditions that may preclude attachment of the audio processor or that may interfere with the use of the audio processor.
-
Skull size or abnormality that would preclude appropriate placement of the Bonebridge implant as determined by CT scan.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
Applicant:
MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a 6020 Innsbruck AUSTRIA Phone: +43 577 88 5614 FAX: +43 577 88 5690
Contact Person:
Carolin Ralser Advanced Specialist, External Devices & Software, Regulatory Affairs
MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a 6020 Innsbruck AUSTRIA
Phone: +43 577 88 1268 E-Mail: carolin.ralser@medel.com
Date prepared: July 28, 2020
1. Device Information
Trade Name:
SAMBA 2 BB
SYMFIT 8.0
SAMBA 2 GO
SAMBA 2 Remote
Generic/Common Name:
Active Implantable Bone Conduction Hearing System
Classification
Class II active implantable bone conduction hearing system, per 21 CFR 874. 3340
Classification Panel:
Ear, Nose, and Throat
Product Code:
PFO
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2. Predicate Devices
Samba BB, SYMFIT 7.0 and Remote Control - MED-EL Elektromedizinische Geraete GmbH (K183373)
3. Device Description
The MED-EL BONEBRIDGE System augments hearing by providing acoustic input to the inner ear via bone conduction.
The SAMBA 2 BB is an external audio processor of the existing MED-EL BONEBRIDGE System. The MED-EL BONEBRIDGE System consists of two major components: The implant, called Bone Conduction Implant (BCI) and the external audio processor, e.g. the SAMBA 2 BB. The SYMFIT 8.0 software enables the fitting and configuration of the SAMBA 2 BB audio processor and is indicated for professional use only, i.e. used by hearing healthcare professionals during a fitting session of the external audio processor SAMBA 2 BB.
Additionally, the SAMBA 2 GO and SAMBA 2 Remote are also subject to this 510(k). Both devices offer a convenient option to adjust simple, pre-defined settings of the compatible SAMBA 2 BB audio processor. Additionally, the SAMBA 2 GO can also be used as an assistive streaming device.
The SAMBA 2 BB external audio processor is the successor device of the predicate Samba BB external audio processor (K18373) with the identical intended use, indications and contraindications.
The SYMFIT 8.0 software is the successor device of the predicate SYMFIT 7.0 software (K183373) with the identical intended use, indications and contraindications.
The SAMBA 2 GO and SAMBA 2 Remote are successor devices of the predicate Remote Control (K183373) with the identical intended use, indications and contraindications.
4. Indications for Use
The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications:
- Patients 12 years of age or older. ●
- . Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5,1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
- . Bilateral fitting of the BONEBRIDGE is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than15 dB at individual frequencies.
- Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at0.5, 1, 2, and 3 kHz).
- The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
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. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit air conduction or bone conduction hearing aids.
5. Contraindications
- . Chronic or non-revisable vestibular or balance disorders.
- . Abnormally progressive hearing loss.
- . Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
- . Skin or scalp conditions that may preclude attachment of the audio processor or that may interfere with the use of the audio processor.
- . Skull size or abnormality that would preclude appropriate placement of the Bonebridge implant as determined by CT scan.
6. Technological Characteristics
The MED-EL BONEBRIDGE System is an active implantable bone conduction hearing system. The MED-EL BONEBRIDGE System is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. The updates to the MED-EL BONEBRIDGE System do not affect the device intended use, fundamental operating principles or functional characteristics.
Predicate Comparison and Discussion
The SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO and SAMBA 2 Remote have the same intended use, indications and contraindications as their predicate devices Samba BB, SYMFIT 7.0 and Remote Control.
The SAMBA 2 BB audio processor is a further development with the currently marketed predicate device Samba BB audio processor and compatible with the existing MED-EL BONEBRIDGE System. The primary modifications proposed are to the size and shape of the device as well as the provision of improved optional signal processing and connectivity features. The SYMFIT 8.0 fitting software is a further development of the currently marketed predicate device SYMFIT 7.0 and has been updated to support fitting of the SAMBA 2 BB audio processor. The SAMBA 2 GO and SAMBA 2 Remote are further developments of the currently marketed predicate device Remote Control. The primary modification of the SAMBA 2 GO is the provision of additional streaming functionality whereas the primary modification of the SAMBA 2 Remote is to provide an alternative option to remotely control compatible audio processors via a mobile application.
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MED
| Characteristics /Features | Comparison and Discussion – SAMBA 2 BB with predicate device K183373 |
|---|---|
| Design Concept | The predicate device and the SAMBA 2 BB audio processor share the samebasic design concept and technological characteristics, i.e. all components areintegrated into a single-unit housing using the same electronics and housingmaterial and similar stimulation strategies.The main differences in design characteristics of SAMBA 2 BB compared withthe predicate device are as follows:The SAMBA 2 BB uses a revolving battery door whereas the predicateuses a sliding battery door. The SAMBA 2 BB has slightly different dimensions and is lighter thanthe predicate. The SAMBA 2 BB offers an additional magnet strength option. The microphone protection membrane used for the SAMBA 2 BB ismounted on the exchangeable outer cover whereas for its predicatedevice the same microphone protection membrane is mounted onto thehousing. The SAMBA 2 BB uses two omnidirectional microphones like itspredicate device. SAMBA 2 BB uses a different type of microphones(MEMS). The SAMBA 2 BB has a higher ingress protection (IP) rating The overall design concept of the SAMBA 2 BB compared with its predicatedevice remains unchanged. Bench testing has been conducted to confirm thatthe differences in design characteristics do not affect safety or effectiveness ofthe SAMBA 2 BB. |
| Energy source | The SAMBA 2 BB uses the same energy source as its predicate device. |
| Materials in skincontact | Main materials in skin contact used for SAMBA 2 BB have been evaluatedaccording to 10993-1 and shown to be biocompatible and safe for human use.The main housing material used in SAMBA 2 BB is identical with the mainhousing material used in its predicate device. |
| SignalProcessing | The signal processing of SAMBA 2 BB features the same basic functionality asthe signal processing used with its predicate device; additionally, SAMBA 2 BBallows for new optional noise reduction features, new optional compressionsettings as well as improved acoustic classification.The overall performance of SAMBA 2 BB remains identical when compared withits predicate. Bench testing has been conducted to confirm that the differences |
| Characteristics /Features | Comparison and Discussion – SAMBA 2 BB with predicate device K183373 |
| in signal processing do not affect safety or effectiveness of the SAMBA 2 BB. | |
| Connectivity | The SAMBA 2 BB offers identical connectivity options as its predicate device.Additionally, SAMBA 2 BB supports an acoustic interface to receive commandsfrom compatible MED-EL Wireless Accessories. Bench testing has beenconducted to confirm that the differences in connectivity options do not affectsafety or effectiveness of the SAMBA 2 BB. |
Table 1: Comparison of Technological Characteristics SAMBA 2 BB with predicate K183373
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MED®EL
| Characteristics /Features | Comparison and Discussion -SYMFIT 8.0 with predicate device K183373 |
|---|---|
| Design Concept | SYMFIT 8.0 is needed to program the SAMBA 2 BB audio processor. The basicworking principle as well as the operational environment of SYMFIT 8.0remains identical when compared with its predicate device. SYMFIT 8.0 has thesame moderate level of concern as its predicate device and is used for thesame purpose.The Software architecture of SYMFIT 8.0 has been improved.The workflow of SYMFIT 8.0 is identical with the workflow of its predicatedevice but better graphically represented by a user interface adapted to theexisting BONEBRIDGE fitting process.The overall design concept of SYMFIT 8.0 remains identical when comparedwith its predicate. Bench and usability testing have been conducted to confirmthat the differences in design do not affect safety or effectiveness of theSYMFIT 8.0. |
| Fitting Features | The fitting features of SYMFIT 8.0 provide the same basic functionality as thefitting features used with its predicate device; additionally, SYMFIT 8.0 allowsfor new optional fine-tuning features with regards to compression settings.The overall performance of SYMFIT 8.0 remains identical when compared withits predicate. Bench testing has been conducted to confirm that the differencesin the fitting features do not affect safety or effectiveness of the SYMFIT 8.0. |
Table 2: Comparison of Technological Characteristics SYMFIT 8.0 with predicate K183373
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Table 3: Comparison of Technological Characteristics SAMBA 2 Remote with predicate K183373
| Characteristics /Features | Comparison and Discussion -SAMBA 2 GO and SAMBA 2 Remote withpredicate device K183373 |
|---|---|
| Design Concept | The SAMBA 2 GO is an external hardware device. Its overall design concepthas been slightly updated compared with its predicate device as the SAMBA 2GO comes in form of a neckloop, which also works as an antenna.The SAMBA 2 Remote is a mobile application operated on either an Android oriOS platform. The app-specific design of the SAMBA 2 Remote has no impacton the safety or effectiveness of the medical functionality of the SAMBA 2Remote, i.e. remote-control features.Bench testing has been conducted to confirm that the differences in design donot affect safety or effectiveness of the SAMBA 2 GO and SAMBA 2 Remote. |
| Remote ControlFeatures | SAMBA 2 GO and SAMBA 2 Remote provide identical remote-control featuresas their predicate device. SAMBA 2 Remote provides the additional optionalSound Balancing feature. This feature gives additional comfort to the user incertain environments.Bench testing has been conducted to confirm that the differences in remote-control features do not affect safety or effectiveness of the SAMBA 2 GO andSAMBA 2 Remote. |
| Connectivity | SAMBA 2 GO uses the identical wireless connection as its predicate. TheSAMBA 2 GO enables streaming functionality and can thus be paired withBluetooth-enabled devices or line-in devices. This function has no medicalpurpose and no impact on safety and effectiveness.The SAMBA 2 Remote uses an acoustic interface to connect wirelessly with theSAMBA 2 BB audio processor.Bench testing has been conducted to confirm that the differences inconnectivity do not affect safety or effectiveness of the SAMBA 2 GO andSAMBA 2 Remote. |
7. Performance Data
All necessary bench testing was conducted on SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO and SAMBA 2 Remote to support determination of substantial equivalence to the existing BONEBRIDGE. The nonclinical bench tests included:
- Testing on electrical and performance characteristics ●
- . Compatibility Testing
- Reliability Testing ●
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- . Shipping Test
- . Environmental Testing (solar radiation, substance resistance, resistance against light of certain wavelength)
- . Electrical Safety Testing
- . Electromagnetic compatibility testing
- . Software testing according to software's defined Level of Concern
The results of the non-clinical performance testing demonstrate that SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO and SAMBA 2 Remote meets the established specifications to ensure consistent and safe performance for its intended use.
8. Conclusion
The safety and effectiveness testing performed for the devices show that the SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO and SAMBA 2 Remote perform as intended and confirm that they are at least as safe and effective as the predicate devices.
The SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO and SAMBA 2 Remote are substantially equivalent to the predicate devices.
§ 874.3340 Active implantable bone conduction hearing system.
(a)
Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Performance data must validate force output in a clinically relevant model.
(ii) Impact testing in a clinically relevant anatomic model must be performed.
(iii) Mechanical integrity testing must be performed.
(iv) Reliability testing consistent with expected device life must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Labeling must include:
(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;
(ii) Instructions for use;
(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;
(iv) A shelf life, for device components provided sterile;
(v) A patient identification card; and
(vi) A patient user manual.