(44 days)
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No
The description focuses on basic amplification and transmission of sound using standard components, with no mention of AI or ML.
Yes
The device is intended to amplify and transmit sound to the ear, which is a therapeutic function for individuals with hearing impairment.
No
The device is described as an amplifier to transmit sound to the ear, indicating it is a hearing aid, which is a therapeutic or assistive device, not a diagnostic one.
No
The device description explicitly states it is a "body aid" and describes physical components like a "3 position switch" and "audio input," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To amplify and transmit sound to the ear." This describes a device that interacts with the body to improve hearing, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a body aid that amplifies sound and is worn externally. This aligns with the function of a hearing aid, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information based on specimen analysis
Therefore, this device falls under the category of a hearing aid, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Both the 48 and the 49PP are small slim-lined body aids. Their unique shape fits snugly and inconspicuously into any pocket or other places,e.g. brasiere etc. The 48 and the 49PP both have audio input that allows the connection to external sources. Also both have 3 position switch for off-telecoil-microphone.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ear
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
0
MAR 2 8 1997
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | Rexton's Model 48 and 49PP | |
|---|---|---|
| Type of Device: | Body Aid - Substantially equivalent to other body aids. | |
| Intended Use: | To amplify and transmit sound to the ear. | MAR 28 1997 |
| Features: | Both the 48 and the 49PP are small slim-lined body aids. Their unique shape fits | |
| snugly and inconspicuously into any pocket or other places,e.g. brasiere etc. The | ||
| 48 and the 49PP both have audio input that allows the connection to external | ||
| sources. Also both have 3 position switch for off-telecoil-microphone. | ||
| Assembly: | Assembled from standard components which are widely utilized by other | |
| hearing aid manufacturers. | ||
| Technical | ||
| Characteristics: | Technical specifications comply with S3.22-1987 ANSI Specifications. | |
| Preliminary data sheets for the 48 and 49PP are enclosed. | ||
| Fit: | The frequency response of this product is dictated by the individual | |
| audiogram from each client. | ||
| Power: | Standard battery size AA. |
: ····
A user's manual and other information is supplied with each hearing aid (enclosed).
. .