(149 days)
K18373
No
The document describes a bone conduction hearing system that uses an implant and external audio processor to amplify sound. There is no mention of AI or ML in the intended use, device description, or performance studies. The software described is for fitting and configuration, not for intelligent signal processing.
Yes
The Bonebridge is designed to improve hearing for patients with various types of hearing loss by providing amplified acoustic input to the inner ear via bone conduction, which directly addresses a medical condition to alleviate its symptoms.
No
The device is a hearing implant system designed to improve hearing for patients with specific types of hearing loss. It functions by providing acoustic input to the inner ear via bone conduction, rather than by diagnosing conditions.
No
The device description explicitly states the system consists of two major components: an implant (Bone Conduction Implant) and an external audio processor. It also mentions the system is an active implantable bone conduction hearing system with an implanted transducer and electronics components. While software is part of the system (SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote), the core medical device functionality relies on hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Bonebridge is a hearing implant system that works by directly stimulating the skull bone to transmit sound to the inner ear. It is a physical device implanted in the body and an external audio processor.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The device's function is to improve hearing through mechanical vibration, not through diagnostic testing of bodily fluids or tissues.
Therefore, the Bonebridge falls under the category of a medical device, specifically an active implantable bone conduction hearing system, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
PFO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
12 years of age or older.
Intended User / Care Setting
SYMFIT 8.0 software 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.
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)
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
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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
5
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.
6
. 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.
7
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 same |
| basic design concept and technological characteristics, i.e. all components are | |
| integrated into a single-unit housing using the same electronics and housing | |
| material and similar stimulation strategies. | |
| The main differences in design characteristics of SAMBA 2 BB compared with | |
| the predicate device are as follows: | |
| The SAMBA 2 BB uses a revolving battery door whereas the predicate | |
| uses a sliding battery door. The SAMBA 2 BB has slightly different dimensions and is lighter than | |
| the predicate. The SAMBA 2 BB offers an additional magnet strength option. The microphone protection membrane used for the SAMBA 2 BB is | |
| mounted on the exchangeable outer cover whereas for its predicate | |
| device the same microphone protection membrane is mounted onto the | |
| housing. The SAMBA 2 BB uses two omnidirectional microphones like its | |
| predicate 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 predicate | |
| device remains unchanged. Bench testing has been conducted to confirm that | |
| the differences in design characteristics do not affect safety or effectiveness of | |
| the SAMBA 2 BB. | |
| Energy source | The SAMBA 2 BB uses the same energy source as its predicate device. |
| Materials in skin | |
| contact | Main materials in skin contact used for SAMBA 2 BB have been evaluated |
| according 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 main | |
| housing material used in its predicate device. | |
| Signal | |
| Processing | The signal processing of SAMBA 2 BB features the same basic functionality as |
| the signal processing used with its predicate device; additionally, SAMBA 2 BB | |
| allows for new optional noise reduction features, new optional compression | |
| settings as well as improved acoustic classification. | |
| The overall performance of SAMBA 2 BB remains identical when compared with | |
| its 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 commands | |
| from compatible MED-EL Wireless Accessories. Bench testing has been | |
| conducted to confirm that the differences in connectivity options do not affect | |
| safety or effectiveness of the SAMBA 2 BB. |
Table 1: Comparison of Technological Characteristics SAMBA 2 BB with predicate K183373
8
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 basic |
| working principle as well as the operational environment of SYMFIT 8.0 | |
| remains identical when compared with its predicate device. SYMFIT 8.0 has the | |
| same moderate level of concern as its predicate device and is used for the | |
| same purpose. |
The Software architecture of SYMFIT 8.0 has been improved.
The workflow of SYMFIT 8.0 is identical with the workflow of its predicate
device but better graphically represented by a user interface adapted to the
existing BONEBRIDGE fitting process.
The overall design concept of SYMFIT 8.0 remains identical when compared
with its predicate. Bench and usability testing have been conducted to confirm
that the differences in design do not affect safety or effectiveness of the
SYMFIT 8.0. |
| Fitting Features | The fitting features of SYMFIT 8.0 provide the same basic functionality as the
fitting features used with its predicate device; additionally, SYMFIT 8.0 allows
for new optional fine-tuning features with regards to compression settings.
The overall performance of SYMFIT 8.0 remains identical when compared with
its predicate. Bench testing has been conducted to confirm that the differences
in 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
9
Table 3: Comparison of Technological Characteristics SAMBA 2 Remote with predicate K183373
| Characteristics /
Features | Comparison and Discussion -SAMBA 2 GO and SAMBA 2 Remote with
predicate device K183373 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design Concept | The SAMBA 2 GO is an external hardware device. Its overall design concept
has been slightly updated compared with its predicate device as the SAMBA 2
GO 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 or
iOS platform. The app-specific design of the SAMBA 2 Remote has no impact
on the safety or effectiveness of the medical functionality of the SAMBA 2
Remote, i.e. remote-control features.
Bench testing has been conducted to confirm that the differences in design do
not affect safety or effectiveness of the SAMBA 2 GO and SAMBA 2 Remote. |
| Remote Control
Features | SAMBA 2 GO and SAMBA 2 Remote provide identical remote-control features
as their predicate device. SAMBA 2 Remote provides the additional optional
Sound Balancing feature. This feature gives additional comfort to the user in
certain 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 and
SAMBA 2 Remote. |
| Connectivity | SAMBA 2 GO uses the identical wireless connection as its predicate. The
SAMBA 2 GO enables streaming functionality and can thus be paired with
Bluetooth-enabled devices or line-in devices. This function has no medical
purpose and no impact on safety and effectiveness.
The SAMBA 2 Remote uses an acoustic interface to connect wirelessly with the
SAMBA 2 BB audio processor.
Bench testing has been conducted to confirm that the differences in
connectivity do not affect safety or effectiveness of the SAMBA 2 GO and
SAMBA 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 ●
10
- . 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.