(49 days)
Not Found
Not Found
No
The summary describes a physical kit for taking ear impressions and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is an impression kit used to obtain an accurate imprint of an ear and ear canal, rather than directly treating a condition or disease. Its function is diagnostic/measurement (to gather information), not therapeutic.
No
The device is described as an "Impression Kit" used to "obtain an accurate imprint of an individual ear and ear canal." This process is for creating a physical mold, not for diagnosing a condition or disease.
No
The device description explicitly refers to an "Impression Kit" and mentions predicate devices that are physical impression systems, indicating it is a hardware-based device for taking ear impressions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To obtain an accurate imprint of an individual ear and ear canal." This describes a physical process of creating a mold, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description refers to an "Impression Kit" and compares it to other impression systems. This aligns with a device used for physical molding.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is used to create a physical impression of an anatomical structure.
N/A
Intended Use / Indications for Use
To obtain an accurate imprint of an individual ear and ear canal.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Impression Kits, -- Substantially equivalent to the Silhouette™ Premium Impression System from Siemens Hearing Instruments, Inc. and the Matrics Impression System from Matrics, Inc.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
individual ear and ear canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hearing Health Professionals
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)
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.
Not Found
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
MAY - 2 1997 K970952
SAFETY AND EFFECTIVENESS SUMMARY - PRECISE IMPRESSION KIT
Precise Impression Kit. NAME OF DEVICE: Impression Kits, -- Substantially equivalent to the Silhouette™ TYPE OF DEVICE: Premium Impression System from Siemens Hearing Instruments, Inc. and the Matrics Impression System from Matrics, Inc. To obtain an accurate imprint of an individual ear and ear INTENDED USE: canal. Smooth consistency, ease of insertion, non-allergenic FEATURES: properties, pleasant scent, quick drying time, easy clean up. Kits are assembled for Hearing Health Professionals, who ASSEMBLY: are responsible for any mixing of materials or assembly of components for usage. Material Safety Data Sheets are included for description of TECHNICAL CHARACTERISTICS: technical characteristics.
3/13/97