FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K020296

Device Name

ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057

Manufacturer

APOTHECARY PRODUCTS, INC.

Date Cleared

2002-06-25

(148 days)

Product Code

EWD

Regulation Number

N/A

Type

Traditional

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Intended Use

Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.

Device Description

Adult Silicone Ear Plug

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device (Adult Silicone Ear Plugs). It does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to AI/algorithm performance.

Therefore, I cannot fulfill the request using the given input. The document is solely a regulatory approval for marketing the device, confirming its substantial equivalence to a predicate device.

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K Number

K972923

Device Name

SUPER SILIPLUGS EAR PLUGS

Manufacturer

INTERVIEW MEDICAL TECHNOLOGY CORP.

Date Cleared

1997-10-27

(80 days)

Product Code

EWD

Regulation Number

N/A

Type

Traditional

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Intended Use

Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.

Device Description

Super SiliPlugs™ Ear Plugs

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K972923 for "Super SiliPlugs™ Ear Plugs" does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.

The document is a clearance letter from the FDA, stating that the device is "substantially equivalent for the indications for use" to devices marketed prior to May 28, 1976. This indicates that the device's acceptable performance is based on its similarity to existing legally marketed devices, rather than a specific set of new performance metrics and a study to achieve them.

Therefore, I cannot provide the requested table or the detailed study information because it is not present in the given text. The clearance process for this type of device, particularly in 1997, often relied on substantial equivalence demonstration rather than extensive novel performance studies.

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K Number

K971517

Device Name

SILICONE PUTTY EAR PLUGS

Manufacturer

BENTEC MEDICAL, INC.

Date Cleared

1997-06-02

(38 days)

Product Code

EWD

Regulation Number

N/A

Type

Traditional

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Intended Use

Silicone Putty Ear Plugs are used to block water from entering the ear canal.

Device Description

Silicone Putty Ear Plugs

AI/ML Overview

This document is a 510(k) clearance letter for "Silicone Putty Ear Plugs" (K071517). It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory correspondence does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based solely on the provided text. The letter is a regulatory approval document, not a scientific study report.

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K Number

K962292

Device Name

HEARSAVER

Manufacturer

EMTECH LABORATORIES

Date Cleared

1996-10-29

(137 days)

Product Code