(103 days)
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No
The description focuses on physical materials and tools for creating ear impressions, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to create an accurate imprint of the ear and ear canal, which is a diagnostic or preparatory step, not a therapeutic function itself.
No
This device is used to take an imprint of an ear and ear canal for non-diagnostic purposes, such as fitting hearing aids. It does not identify a disease, condition, or state of health.
No
The device description explicitly states it is an "impression kit" containing "materials" and "components" for obtaining an ear imprint, indicating it is a physical device, not software.
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 is a physical process for creating a mold, not a diagnostic test performed in vitro (outside the body) on biological specimens to provide information about a patient's health status.
- Device Description: The description details a kit with materials for creating an impression. It involves mixing materials and physical application to the ear. This aligns with a physical impression process, not an in vitro diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a disease or condition.
IVD devices are typically used to examine specimens like blood, urine, tissue, etc., to diagnose, monitor, or screen for diseases or conditions. This device's function is purely to create a physical mold of the ear.
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)
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Device Description
The above mentioned impression kits are designed to provide the tools necessary for a Hearing Health Professional to obtain an accurate imprint of an individual ear and ear The Hearing Health Professional receives materials in the form of a kit, and is canal. responsible for any mixing of materials, or assembly of components for usage.
Impression material is handled in bulk form, prior to being packaged in kits. This . material, whether in bulk or kit form, is identical. The material in the impression kits are substantially equivalent to Audalin Liquid and Impression Polymer. (There is no 510(k) for the Audalin impression material as it is exempt because it was in commercial distribution prior to 5/28/96.)
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 and ear canal
Indicated Patient Age Range
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Intended User / Care Setting
Hearing Health Professional
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
SUMMARY-- PRECISE, TYMPANETTE, AND XACTO IMPRESSION KIT SUBSTANTIAL EQUIVALENCE
The above mentioned impression kits are designed to provide the tools necessary for a Hearing Health Professional to obtain an accurate imprint of an individual ear and ear The Hearing Health Professional receives materials in the form of a kit, and is canal. responsible for any mixing of materials, or assembly of components for usage.
FEB - 4 1997
Impression material is handled in bulk form, prior to being packaged in kits. This . material, whether in bulk or kit form, is identical. The material in the impression kits are substantially equivalent to Audalin Liquid and Impression Polymer. (There is no 510(k) for the Audalin impression material as it is exempt because it was in commercial distribution prior to 5/28/96.) 1416 ?
Impression Kits
- . Smooth Consistency
- Ease of Insertion .
- Non-Allergenic Properties ●
- Pleasant Scent ●
- Quick Drving Time ●
- Ease in Clean Up
Audalin Liquid/Impression Polymer
- Smooth Consistency .
- Ease of Insertion .
- Non-Alletgenic Properties .
- Pleasant Scent ●
- Quick Drying Time ●
- Ease in Clean Up .
10/18/96
1
SAFETY AND EFFECTIVENESS SUMMARY - PRECISE, TYMPANETTE, AND XACTO IMPRESSION KITS
| NAME OF DEVICE: | Precise, Tympanette and Xacto Impression Kits. |
|---|---|
| TYPE OF DEVICE: | Impression Kits, -- Substantially equivalent to Audalin Liquid and Audalin Impression Polymer. |
| INTENDED USE: | To obtain an accurate imprint of an individual ear and ear canal. |
| FEATURES: | Smooth consistency, ease of insertion, non-allergenic properties, pleasant scent, quick drying time, easy clean up. |
| ASSEMBLY: | Kits are assembled for Hearing Health Professionals, who are responsible for any mixing of materials or assembly of components for usage. |
| TECHNICAL CHARACTERISTICS: | Material Safety Data Sheets are included for description of technical characteristics. |
10/18/96
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