(71 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as identical to a predicate from 1993, which predates widespread AI/ML in medical devices.
Yes
The device is a hearing aid, which is a common therapeutic device used to treat hearing loss by amplifying sound.
No
Explanation: The device is described as a hearing aid, which amplifies and transmits sound to the ear. Its "Intended Use" is not for diagnosis, but rather for assisting hearing.
No
The device description explicitly states it is a "Beltone Composer 2000 BTE HP Air Conduction Hearing Aid," which is a hardware device (Behind-the-Ear hearing aid). It also references a predicate device that is also a hardware hearing aid.
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 diagnostic purposes.
- Device Description: The description confirms it's a hearing aid, which is a therapeutic device, not a diagnostic one.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic testing, or any other activities typically associated with IVD devices.
Therefore, the Beltone Composer 2000 BTE HP Air Conduction Hearing Aid is a hearing aid, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
No
This clearance letter does not contain any language or specific authorization for a Predetermined Change Control Plan (PCCP). PCCP authorization is explicitly stated within the clearance letter when granted, outlining the specific changes allowed to be made without requiring a new 510(k). This document primarily describes the predicate device and the minor labeling change, not a framework for future modifications.
Intended Use / Indications for Use
To amplify and transmit sound to the ear
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Beltone TYPE OF DEVICE: Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 874.3300 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
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Beltone Composer 2000 BTE HP NAME OF DEVICE:
Composer 2000 BTE HP Air The Beltone TYPE OF DEVICE: Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.
To amplify and transmit sound to the ear INTENDED USE:
FEATURES : Dispenser programmable User remote control
ASSEMBLY : Assembled from standard components that are widely used by other hearing aid manufacturers
-- TECHNICAL CHARACTERISTICS: Technical specifications comply with S3.22-1987 ANSI Standards
FIT: Audiological characteristics dictated by individual audiogram
CONTROLS : Volume control, switches, and optional dispenser operated trimmer controls similar to those of other devices
POWER : Standard hearing aid battery
A USER'S MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH HEARING AID.