The Otomag™ Alpha Scund Processor is intended for use with the Otomag™ Headband or Otomag™ Softband (no age limitations), or with the Otomag™ Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

Patients with conductive or mixed hearing losses, who can still benefit from amplification of . sound. The pure tose average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed . hearing loss. The difference between the left and right sides BC thresholds should be less than 100B on average measured at 0.5, 1, 2, and 4 kHz. or less than 15 dB at individual frequencies.
Patients who have a profound sensorineural hearing loss in one ear and normal bearing in the ● opposite ear, who for some reason will not or cannot use an AC CROS. The pure tome average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1. 2 and 3 kHz).

Device Description

The subject of this Traditional 510(k) is to obtain clearance for a modification in the method of sterifization and packaging for the Alpha (M) Magnetic Implant, cleared under 510(k) K102199, and the Surgical and Implant Templates, via a Letter to File under 510(k) K102199, and to supply these components of the system as sterile. The predicate device components are provided nonsterile and must be sterifized prior to implantation by gravity steam (autoclaving). The proposed method of sterilization for these components is by Ethylene Oxide (EO).

The Otomag™ Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.

The Otomag™ System is configured in either of two configurations. The first configuration is the Alpha (S), where the Otomag™ Sound Processor is attached magnetically to a Headband or Softband. The second configuration is the Alpha (M), where the Otomag™ Sound Processor is attached magnetically to an implanted magnet. The Headband, Softband, or Magnetic Implant holds the sound processor against the head, and vibration is transduced through direct contact with the patient's skin and the bone below.

The Otomag™ System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing toss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments avoilable to the audiologist in the software allow for programming the Ottomage System for individual patient hearing loss.

AI/ML Overview

The document provided describes a 510(k) submission for a modification to the Otomag Bone Conduction Hearing System, specifically regarding the method of sterilization and packaging for the Alpha (M) Magnetic Implant and associated surgical templates. This is a regulatory submission for a device change and does not include a study proving device performance against acceptance criteria in the typical sense of a clinical trial or comparative effectiveness study for a diagnostic or therapeutic output.

Instead, the submission focuses on validating the changes made to the manufacturing process (sterilization and packaging) to ensure the device remains safe and effective and substantially equivalent to the previously cleared predicate device (K102199). The "acceptance criteria" here relate to the successful completion of specific non-clinical tests demonstrating that the manufacturing changes do not compromise the device's safety or performance.

Therefore, many of the requested points regarding sample sizes, ground truth, expert adjudication, MRMC studies, and standalone performance for a diagnostic/therapeutic algorithm are not applicable to this type of submission.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria (Demonstrated by Compliance to Standards)	Reported Device Performance (as stated in the submission)
Risk Management	Compliance with ISO 14971 (Application of risk management to medical devices)	"The changes have been appropriately validated and raise no new questions of safety and effectiveness."
Sterilization Efficacy	- Sterility Assurance Level (SAL) of 10^-6 for Ethylene Oxide (EO) sterilization (DIN EN ISO 11135-1)- Compliance with EN 556-1 (Requirements for medical devices to be designated "STERILE")- Compliance with DIN EN ISO 11138-1 (Biological Indicators)- Compliance with EN 1422 (Ethylene Oxide Sterilisers- Requirements and Test Procedures)	"Sterilization Validation: to assure a sterility assurance level (SAL) of 10^-6 using one half cycle"
Sterilant Residuals	Compliance with ISO 10993-7 (Ethylene Oxide-Sterilization Residuals)	"Sterilant Residuals: to assure that the residuals that remain on the device are considered acceptable per ISO 10993-7:2009."
Packaging Integrity	- Seal integrity (ASTM F1929-98, ASTM F88F88M-09)- Requirements for materials, sterile barrier systems, and packaging systems (ISO 11607-1, ISO 11607-2, DIN EN 868-5)- Resistance to environmental conditions (ISTA 2A)	"Packaging Process Validation: to assure that the sealing of the Tyvek® pouches maintains package integrity.""Packaging Validation: to assure seal integrity of the pouches that they would withstand the rigors of the intended sterilization and distribution environments."
Biocompatibility	Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) for patient contact materials.	"The materials that compose the Magnetic Implant Template and Surgical Template meet the requirements of ISO 10993-1 for biocompatibility."
Shelf Life	Validation of product and packaging requirements after defined shelf life (ASTM F1980-07)	"Shelf Life Validation: to validate that product and packaging meet requirements after defined shelf life."
Overall Safety & Effectiveness	Maintain substantial equivalence to predicate device (K102199)	"The testing information presented in this submission demonstrates the device is as safe and effective and substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests conducted (e.g., sterilization validation, packaging validation) typically involve a statistically relevant number of units for the specific test, but the exact sample sizes for each validation are not detailed in this summary. These are non-clinical engineering and manufacturing validation tests, not human subject trials, so "country of origin of the data" or "retrospective/prospective" does not apply in the usual sense. The data would originate from the testing laboratories.

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)

This is not applicable as the "ground truth" for these tests relates to validated manufacturing processes and material properties, not diagnostic or clinical outcomes requiring expert interpretation. The "experts" would be the engineers, scientists, and quality personnel conducting and reviewing the validation studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no human interpretation or adjudication of outputs in these types of manufacturing process validation tests. The results are typically objective measurements against defined specifications.

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

An MRMC comparative effectiveness study was not done. This submission is for a modification to a medical device's manufacturing process (sterilization and packaging), not for a diagnostic or therapeutic algorithm where human reader performance would be a relevant metric.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation of an "algorithm" was not done. This device is a hearing system, and the submission addresses changes to its sterilization and packaging, not the performance of an independent algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for these validation studies is typically based on:

Established scientific principles and engineering standards: For example, a sterility assurance level (SAL) of 10^-6 is a well-defined standard for sterile medical devices.
Material specifications and biocompatibility standards: For the patient contact materials.
Test methods from recognized standards organizations: Such as ISO, ASTM, DIN, AAMI for packaging, sterility, and residuals testing.
Predicate device's established safety and effectiveness: The modifications are being compared to the existing cleared device to ensure substantial equivalence.

8. The sample size for the training set

This is not applicable. This submission is for a physical medical device and manufacturing process changes, not for an AI/ML algorithm that would involve training data.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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KI32189

Image /page/0/Picture/2 description: The image shows the logo for Sophono. The logo consists of a stylized ear shape on the left, followed by the word "Sophono" in a bold, sans-serif font. Below the word "Sophono" is a tagline in a smaller font, but the text is not legible. The logo is black and white.

5744 Central Avenue #100, Boulder, CO 80301 Telephone: +1 720-407-5160 • Fax: +1 720-407-5168 • www.sophomo.com.

510(k) Summary: Otomag Bone Conduction Hearing System

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and title of the Code of Federal Requiations Part 807 (21 CFR §807), and in particular §807.92, this summary of substantial equivatence information is being submitted.

Submitted By: Sophono, Inc. 5744 Central Avenue #100 Boulder, Colorado 80301

Establishment Registration Number: 3008514292

Contact Person:

Krista B. Travnor, M.A., RAC Director of Regulatory Affairs Ph: 720 407-5160 Fax: 720 407-5168 Email: krista.traynor@sophono.com

Date Prepared: July 12, 2013

Trade or Proprietary Name: Otomag Bone Conduction Hearing System

Regulation Number: 21 CFR §874.3300

Regulation Name: Hearing Aid, Bone Conduction

Regulatory Class: Class II

Product Code: LXB

Panel: Ear Nose and Throat Specialty Panel

Predicate Device: Otomag Bone Conduction Hearing System - K102199

Device Description:

The Otomag™ Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.

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Intended Use:

The Otoman Alpha Sound Processor is intended for use with the Otomag Headbard or Otomag Softband (no age limitations), or with the Otomon Magnetic Implant (patients 5 years of age and up). This is the same intended use, and for the same patient population as the current legally marketed device.

Technological Characteristics:

Technological characteristics of the modified device that are equivalent to throse of the predicate device are:

Overall device performance and operating principle ●
. Fundamental technology of the device

Technological characteristics that are different between the modified device and the predicate are:

Packaging and expiration dating: The Magnetic Implant, Surgical Template and Implant . Template are supplied on a high-density polyethylene (HDPE) card in double Tyvelt pouches.
Method of Sterilization: The method is by Ethylene Oxide (EO) .
Patient Contact Materials: The Surgical Template is now composed of high-density . polyethyiene (HDPE) plastic instead of anodized aluminum.

Performance Standards:

The changes reported in this submission for the Alpha (M) Magnetic Implant and accessories conform to applicable requirements of the following National and International Standards.

ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices

ISO 15223-1 Second Edition 2012-07-01, Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements

DIN EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

EN 556-1:2006 Sterifisation of Medical Devices - Requirements for medical devices to be designated "STERILE" Part 1: Requirements for medical devices that have been sterlised in their final packaging

DIN EN ISO 11138-1:2008 Sterilisation of Health Care Products Biological Indicators- Part 1: General

EN 1422:2009 Ethylene Oxide Sterilisers- Requirements and Test Procedures

AAMI ANSI ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

DIN EN ISO 10993-7:2009 Birological Evaluation of Medical Devices - Part 7: Ethylene Oxide-Sterilisation Residuals

AAMI ANSI ST72:2011 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

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DIN 58948-7 2010 Sterilisation- Low Temperature Sterilisers - Part 7: Installation Requirements and Service Supply Requirements for Ethylene Oxide Sterilisers

ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2 First edition 2006-04-15 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

DIN EN 868-5-2009 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

ISTA 2A 2011 Preshipment Test Procedures

ASTM F1980-07 (Reapproved 2011). Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F1929-98 (Reapproved 2004), Standard Test Method for Detecting Seal Leaks in Porqus Medical Packaging by Dye Penetration

ASTM F88F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials

Non-Clinical Performance Testing:

Testing included the following:

Packaging Process Validation: to assure that the sealing of the Tyvels pouches maintains . package integrity
. Shipping Validation: to assure product and package meet requirements after exposure to environmental conditions
. Sterilization Validation: to assure a stertlity assurance level (SAL) of 10 " using one half cycle
. Sterilant Residuals: to assure that the residuals that remain on the device are considered acceptable per ISO 10993-7:2009. Bictogical Evaluation of Medical Devices - Part 7: Ethylene Oxide-Sterilization Residuals.
. Packaging Validation: to assure seal integrity of the pouches that they would withstand the rigors of the intended sterilization and distribution environments
Shelf Life Validation: to validate that product and packaging meet requirements after . defined shelf life

The modified device has been subjected to extensive safety and vertication testing. The testing information presented in this submission demonstrates the device is as safe and effective and substantially equivalent to the predicate device.

Conclusion:

The EO sterilization method, change in patient contact materials, and modified packaging and labeling does not alter the intended use, indications for use or fundamental scientific technological characteristics of the device and all processes have been validated. The materials that compose the Maanetic Implant Template and Surgical Template meet the requirements of ISO 10993-1 for biocompatibility. Based on non-clinical testing, the changes have been appropriately validated and raise no new questions of safety and effectiveness. The Otomag Bone Conduction Hearing System performs the same and is as safe and effective and considered to be substantially equivalent to the previously 510(k) cleared predicate device (K102199).

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2013

Sophono, Inc. c/o Krista Traynor, M.A., RAC Director of Regulatory Affairs 5744 Central Avenue #100 Boulder, CO 80301

Re: K132189

Trade/Device Name: Otomag Bone Conduction Hearing System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Class II Product Code: LXB Dated: August 26, 2013 Received: August 27, 2013

Dear Ms. Traynor:

We have reviewed your Section 510(k) premarket notification of intent to market the device ' referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting 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.

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Page 2 - Krista Traynor, M.A., RAC

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K132189

Device Name: Otomag Bone Conduction Hearing System

Indications for Use:

Patients with conductive or mixed hearing losses, who can still benefit from amplification of . sound. The pure tose average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed . hearing loss. The difference between the left and right sides BC thresholds should be less than 100B on average measured at 0.5, 1, 2, and 4 kHz. or less than 15 dB at individual frequencies.
Patients who have a profound sensorineural hearing loss in one ear and normal bearing in the ● opposite ear, who for some reason will not or cannot use an AC CROS. The pure tome average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1. 2 and 3 kHz).

Prescription Uze AND/OR Over-The-Counter Use 1 (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PACE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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Page 1 of 1

Regulation Number and Section

§ 874.3302 Bone-conduction hearing aid.

(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.