Otoport Pro

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. March 15, 2024 Otodynamics Ltd % Chandler Thames Director of Quality Rook Quality Systems 1155 Mount Vernon Hwy #800 Dunwoody, Georgia 30338 Re: K240430 Trade/Device Name: Otoport Pro Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: February 12, 2024 Received: February 14, 2024 ### Dear Chandler Thames: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240430 Device Name Otoport Pro #### Indications for Use (Describe) The Otoport Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function. | Type of Use ( <i>Select one or both, as applicable</i> ) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span> <span style="padding-right:5px;"> <b> ☒ Prescription Use </b> </span> (Part 21 CFR 801 Subpart D) </span> <span style="padding-left:20px;"> <span style="padding-right:5px;"> ☐ </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ ### SUBMITTER Otodynamics Ltd 30-38 Beaconsfield Rd Hatfield, Hertfordshire ALI0 8BB, United Kingdom Phone: +44 1707 267540 Email: daniel.budd@otodynamics.com Contact Person: Daniel Budd, QA Manager Date Prepared: 15.03.2024 ## DEVICE | Trade Name: | Otoport Pro | |----------------------|-----------------------------------------------------------------------| | Common Name: | Otoport Pro | | Classification Name: | Audiometer/ Evoked response auditory stimulator (874.1050 & 882.1900) | | Regulatory Class: | Class II | | Product Codes: | EWO &GWJ | ## PREDICATE DEVICE The legally marketed device to which equivalence is being claimed [807.92(a)(3)] is the Otoport/Otocheck OAE+ABR™, K143395. This predicate has not been the subject of any design-related recalls. ## DEVICE DESCRIPTION The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening. Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery. The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required. Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device. The previous version of the Otoport product (Otoport OAE+ABR) required an adaptor 'shell' to be fitted over the base unit if AABR functionality was required (Figure 1 below) In the Otoport Pro design (Figure 2 below) all test modalities are included inside the base unit. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a handheld Otodynamics device being held by two hands. The device has a screen at the top, followed by a series of buttons and a keypad. The keypad has numbers 1-9 and 0, along with other symbols. The device is white and has the brand name "Otodynamics" printed on it. Image /page/4/Figure/1 description: The image shows a handheld device with a screen displaying a graph labeled "DPZ TEST". The graph shows a red line fluctuating between -10 and 20 dBSPL across a frequency range of 2 to 8 kHz. Below the screen, there are several buttons, including a numeric keypad from 1 to 9, a 0 button, and other function buttons labeled "CANCEL", "MANUAL", and "END". Figure 2 ## INDICATIONS FOR USE Figure 1 The Otoport Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear 'Pass' or 'Refer' result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be trained. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The same Otoacoustic Emissions (OAEs) & Auditory Brainstem Response (ABR) techniques and principles of response analysis are utilized in both the subject and predicate devices. {5}------------------------------------------------ TABLE 1. COMPARISON BETWEEN THE SUBJECT DEVICE AND THE PREDICATE OTOPORT/OTOCHECK 0AE+ABR (K143395) | | TABLE 1. COMPARISON BETWEEN THE SUBJECT DEVICE AND THE PREDICATE OTOPORT/OTOCHECK 0AE+ABR (K143395) | | | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device<br>Otoport Pro (K240430) | Predicate Device<br>Otoport/Otocheck OAE+ABR<br>(K143395) | Overview of similarities<br>and differences | | Common Name | Audiometer<br>Evoked response auditory stimulator | Audiometer<br>Evoked response auditory stimulator | Same | | Class | II | II | Same | | Product Code | EWO&GWJ | EWO&GWJ | Same | | Classification<br>Regulation | 874.1050<br>882.1900 | 874.1050<br>882.1900 | Same | | Intended Use | For the detection of peripheral<br>hearing loss and for use in the<br>characterization of and diagnosis of<br>auditory and hearing-related<br>disorders. | For the detection of peripheral<br>hearing loss and for use in the<br>characterization of and diagnosis of<br>auditory and hearing-related<br>disorders. | Same | | Indications for Use | The Otoport Pro device is indicated for<br>use when there is a requirement to<br>screen for hearing disorders by<br>objective and non-invasive means.<br>ABR, TEOAE and DPOAE screening test<br>results are automatically interpreted<br>and a clear 'Pass' or 'Refer' result is<br>presented to the user. | The Otoport/Otocheck OAE+ABR<br>device is indicated for use when there<br>is a requirement to screen for hearing<br>disorders by objective and non-<br>invasive means. Test results are<br>automatically interpreted and a clear<br>'Pass' or 'Refer' result is presented to<br>the user. | Same | | | Use of the device is indicated when<br>the patient is unable to give reliable<br>voluntary responses to sound,<br>especially with infants. | Use of the device is indicated when<br>the patient is unable to give reliable<br>voluntary responses to sound,<br>especially with infants. | | | | Use of the device facilitates the early<br>detection of hearing loss and its<br>characterization. | Use of the device facilitates the early<br>detection of hearing loss and its<br>characterization. | | | | Where the individual to be screened is<br>healthy with no medical conditions<br>related to the ear, as in the case of<br>well-baby hearing screening, the user<br>can be a trained screener. In all other<br>cases the user should be an<br>audiologist or medical professional. | Where the individual to be screened is<br>healthy with no medical conditions<br>related to the ear, as in the case of<br>well-baby hearing screening, the user<br>can be a trained screener. In all other<br>cases the user should be an<br>audiologist or medical professional. | | | | The TEOAE and DPOAE analytical<br>functions of the device are indicated<br>when objective non-invasive clinical<br>investigations require the<br>characterization and monitoring of the<br>functional status of the peripheral<br>auditory function. For this purpose,<br>the device is intended to be used by<br>audiologists or other professionals<br>skilled in audiology. These TEOAE<br>and DPOAE tests are applicable to<br>populations of any age to obtain<br>objective evidence of peripheral<br>auditory function | The TEOAE and DPOAE analytical<br>functions of the device are indicated<br>when objective non-invasive clinical<br>investigations require the<br>characterization and monitoring of the<br>functional status of the peripheral<br>auditory function. For this purpose,<br>the device is intended to be used by<br>audiologists or other professionals<br>skilled in audiology. These TEOAE<br>and DPOAE tests are applicable to<br>populations of any age to obtain<br>objective evidence of peripheral<br>auditory function | | | Overall Device Design | Handheld device (L195mm x W70mm x D2.8mm; 214g)<br>(7 3/4" x 2 3/4"x 11/8" 0.47pounds)<br>Stimulates the ear with quiet sounds.<br>Non-invasive, records physiological<br>responses to these sounds.<br>Automatically evaluates the evidence<br>for a response.<br>Reports a concise result output about<br>the presence or absence of normal<br>responses.<br>Saves a detailed record of the test.<br>Device alerts to the possibility of<br>hearing loss and documents the status<br>of the ear. | Handheld device (L280mm x W83mm x D45mm; 446g)<br>(11" x 3 1/4" x 13/4" 1 pound)<br>Stimulates the ear with quiet sounds.<br>Non-invasive, records physiological<br>responses to these sounds.<br>Automatically evaluates the evidence<br>for a response.<br>Reports a concise result output about<br>the presence or absence of normal<br>responses.<br>Saves a detailed record of the test.<br>Device alerts to the possibility of<br>hearing loss and documents the status<br>of the ear. | Otoport Pro is smaller and<br>lighter.<br>The predicate Otoport<br>OAE+ABR was heavier and<br>larger because it incorporated<br>an adaptor 'shell', fitted over the<br>basic Otoport OAE product, to<br>provide AABR functionality. In<br>the Otoport Pro subject device,<br>the AABR functionality has been<br>built into the basic handheld<br>device as the attachment of an<br>ABR adaptor shell is not<br>required. | | Device<br>Components/<br>Features | Stimulates the ear with either<br>transient or tonal sounds via an<br>inserted earpiece | Stimulates the ear with either<br>transient or tonal sounds via an<br>inserted earpiece | Same | | | Registers interfering acoustic noise<br>and advises users when this is too<br>large for testing to take place. | Registers interfering acoustic noise and<br>advises users when this is too large for<br>testing to take place. | Same | | | Implements otoacoustic emission<br>technology to record TEOAE and<br>DPOAEs responses to sound applied<br>via an inserted earpiece (probe) | Implements otoacoustic emission<br>technology to record TEOAE and<br>DPOAEs responses to sound applied<br>via an inserted earpiece (probe) | Same | | | Provides an intensity and frequency<br>analysis of the OAE response,<br>numerically and graphically | Provides an intensity and frequency<br>analysis of the OAE response,<br>numerically and graphically | Same | | | Automatically determines and displays<br>the presence or absence of a normal<br>TEOAE or DPOAE response | Automatically determines and displays<br>the presence or absence of a normal<br>TEOAE or DPOAE response | Same | | | Implements auditory brainstem<br>response (ABR) technology to record<br>electro physiological responses via<br>surface electrodes | Implements auditory brainstem<br>response (ABR) technology to record<br>electro physiological responses via<br>surface electrodes | Same | | | Stimulates the ear for ABR screening<br>at 30,35,40, or 45dBnHL (60dBHL for<br>training) | Stimulates the ear for ABR screening<br>at 30,35,40, or 45dBnHL (60dBHL for<br>training) | Same | | | Registers interfering electrical noise<br>and advises users when this is too<br>large for testing to take place. | Registers interfering electrical noise<br>and advises users when this is too<br>large for testing to take place. | Same | | | Registers the electrical impedance of<br>electrode connections to the patient<br>and advises users when this is too<br>large for testing to take place | Registers the electrical impedance of<br>electrode connections to the patient<br>and advises users when this is too<br>large for testing to take place | Same | | | Performs statistical analysis on the<br>ABR response to decide if it is present<br>and normal | Performs statistical analysis on the<br>ABR response to decide if it is present<br>and normal | Same | | | Automatically determines and displays<br>the presence or absence of a normal<br>ABR response | Automatically determines and displays<br>the presence or absence of a normal<br>ABR response | Same | | | Serves as a hearing based on the<br>presence or<br>absence of a normal OAE or ABR<br>response | Serves as a hearing based on the<br>presence or<br>absence of a normal OAE or ABR<br>response | Same | | Population | Infant and adult (Infant only for<br>AABR) | Infant and adult (Infant only for AABR) | Same | | Intended user | Trained operators for screening, and<br>professionals for screening and clinical<br>use | Trained operators for screening, and<br>professionals for screening and clinical<br>use | Same | | Safety<br>characteristics | Electrically isolated from any device<br>connected to its UCB-C charging and<br>data connector.<br>Acoustic stimulation levels physically<br>constrained and monitored with active<br>protection against single faults. | Electrically isolated from any device<br>connector to its Hirose charging and<br>data connector.<br>Acoustic stimulation levels physically<br>constrained and monitored with active<br>protection against single faults. | Same | | Enclosure material | The device enclosure materials are<br>Polylac PA-765 Flame retardant ABS.<br>Injection moulding. | The device enclosure materials are<br>Polylac PA-765 Flame retardant ABS.<br>Injection moulding. | Same materials. Comply with<br>the current biocompatibility<br>standards. | | Materials of<br>Construction | Probe: plastic encapsulated insert<br>earphone containing microphone and<br>receiver, fitted with disposable single<br>use plastic tip | Probe: plastic encapsulated insert<br>earphone containing microphone and<br>receiver, fitted with disposable single<br>use plastic tip | Same | | | For ABR screening - Surface, self-<br>adhesive skin electrodes.<br>Electrode cables: PVC (Biocompatible) | For ABR screening - Surface, self-<br>adhesive skin electrodes<br>Electrode cables: PVC; Nylon<br>(Biocompatible) | Same materials. Comply with<br>the biocompatibility standards. | | | Electronic circuitry providing<br>stimulation drive to the probe,<br>amplification for the signals, received<br>from the probe microphone and<br>electrodes, signal processing for<br>response enhancement and noise<br>rejection, microprocessor for signal<br>and statistical analysis, all<br>encapsulated in a plastic housing,<br>including graphic display unit and data<br>input facilities plus rechargeable<br>battery. | Electronic circuitry providing stimulation<br>drive to the probe, amplification for the<br>signals, received from the probe<br>microphone and electrodes, signal<br>processing for response enhancement<br>and noise rejection, microprocessor for<br>signal and statistical analysis, all<br>encapsulated in a plastic housing,<br>including graphic display unit and data<br>input facilities plus rechargeable<br>battery. | Similar. Individual circuit<br>components have been changed<br>to avoid obsolescence with<br>equivalent or superior<br>performance items. | | Sterile | No | No | Same | | Duration of<br>placement | Less than 5 minutes per ear | Less than 5 minutes per ear | Same | | Usage of patient<br>contact items | Acoustic probe tip and electrodes are<br>single patient use only | Acoustic probe tip and electrodes are<br>single patient use only | Same | | Anatomical<br>placement | Scalp, forehead, nape, shoulder | Scalp, forehead, nape, shoulder | Same | | Number of<br>Electrodes | 3 | 3 | Same…