The MDSA is an intraoral device (mandibular repositioning) for the treatment of snoring and sleep apnea. The device is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

Prescription Device
Custom-Made
Mandibular Repositioning Device
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea
Single Patient / Multi-Use
Not for Use in Persons Younger than 18 Years of Age
Home or Sleep Laboratory Environment

Device Description

The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea.

Patient's dental impressions must be used to construct the device. The MDSA is a 2-part device. With an upper containing the hook component in the front that when in the patient's mouth engages a shelf in the lower.

The MDSA is supplied with an Adjuster Key, which is used to move the hook in the upper to advance the lower jaw forward and accordingly advance the mandible and tongue thereby improving patency of the airway, decrease air turbulence and aid improvement of obstructive sleep apnea.

The MDSA can be molded with commonly available materials used by Dental Laboratories either Hard Acrylic and ball clasps or Double Laminate (Hard /Soft) Functional mouthguard materials for the construction of the device.

A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction.

Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs.

The advantage of the MDSA is that its construction can be easily performed by a normally qualified Laboratory Technician using standard Laboratory Equipment. This affords a saving in costs to the end user.

The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.

AI/ML Overview

The provided text is a 510(k) summary for the MDSA (Anti-Snoring / Sleep Apnea Device). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report or a more extensive PMA submission.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical study report would.

Specifically, the document lacks:

A table of acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., reduction in AHI, snore reduction percentages, or specific comfort scores) and no pre-defined acceptance criteria for these metrics.
Sample size used for the test set and data provenance: No test set is mentioned, nor any details about its size, country of origin, or retrospective/prospective nature.
Number of experts and their qualifications for ground truth: No experts are mentioned in the context of establishing ground truth for a test set.
Adjudication method: Not applicable as no ground truth is being established by experts.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a physical intraoral device, not an AI-assisted diagnostic tool for human readers.
Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
Type of ground truth used: Not discussed, as no specific performance outcomes are being evaluated against a ground truth in this document.
Sample size for the training set: Not applicable as this is a physical medical device, not a machine learning model.
How ground truth for the training set was established: Not applicable.

What the document does provide is:

Device Description: An intraoral dental device for the treatment of snoring and sleep apnea, worn during sleep, custom-made, titratable mandibular repositioning device.
Intended Use: To reduce the incidence of snoring and obstructive sleep apnea.
Technological Characteristics Summary: Compares the MDSA to a predicate device (TAP, K962516), highlighting similarities (indications for use, single patient, multi-use, prescription, non-sterile, custom fabricated, adjustable, environment, components, materials, removable) and minor differences (adjuster key vs. winder, hook/shelf mechanism vs. lingual bar).
Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, which means it is as safe and effective as a legally marketed device. This determination is based on the comparison of technological characteristics as outlined.

In conclusion, this 510(k) summary is a regulatory document to establish "substantial equivalence" of a new device to an existing one, not a clinical study report detailing performance against specific acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with a bird on the left, followed by the text "RJ & W". The bird is white and has a simple, cartoon-like design. The text is also white and has a thin, outlined font. The background is black, and there is some texture or pattern visible in the lower right corner of the image.

2 .. . . ills Street, Middle Park, Victoria, Australia. 3206 P: +61 3 9690 9898 F: +61 3 9690 9840 E: rjvkb@bigpond.net.au W: www.rjvkbird.com

OCT 27 2004

A. General Information

K042161

510(k) SUMMARY of SAFETY and EFFECTIVENESS

	1.	Submitter's Name:	R.J. & V.K. Bird PTY Ltd.
	2.	Address:	25 Mills Street,Middle Park, Victoria, Australia, 3206
	3.	Telephone:	011-61-3-9690-9898
	4.	Contact Person:	Jonathon Bird
	5.	Date Prepared:	July 20, 2004
	6.	Registration Number:	3004497268
B. Device
	1.	Name:	MDSA
	2.	Trade Name:	Anti-Snoring / Sleep Apnea Device
	3.	Common Name:	Anti-Snoring / Sleep Apnea Device
	4.	Classification Name:	Device, Anti-Snoring
	5.	Product Code:	LRK
	6.	Class:	II
	7.	Regulation Number:	872.5570

ABN: 63 068 447 932

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K042161
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C. Identification of Legally Marketed Devices

l. Name: TAP
1. K Number: K962516
1. Date Cleared: September 19, 1996

D. Description of the Device

The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea.

A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction.

Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs.

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K042161

3rd of 3

The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.

E. Intended Use Statement

F. Technological Characteristics Summary

Similarities between both devices are the following:

Indications for Use .
Single Patient .
. Multi-Use
. Prescription Device
. Non-Sterile
. Custom Fabricated (Fit)
. Adjustable
. Environment - Home/Sleep Laboratories
. Components
. Two Trays (Upper and Lower)
. Materials - Stainless Steel, Vinyl, Acrylic
. Removable

Differences are the MDSA has a separate Adjuster Key versus a winder. The MDSA has a hook in the upper that engages a shelf in the lower tray rather than a lingual bar, which overcomes impedance of the tongue space when the mandible is advanced forward.

The general differences are minor and do not raise safety concerns.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, represented by flowing lines, suggesting a sense of movement and connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2004

Mr. Jonathon Bird Export Development Manager RJ & VK Bird Pty Limited 25 Mills Street Middle Park, Victoria, AUSTRALIA 3206

Re: K042161

Trade/Device Name: Anti® Snoring/Sleep Apnea Device Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: July 20, 2004 Received: August 10, 2004

Dear Mr. Bird:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Bird

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K042161

Indications for Use

510(k) Number: K042161

Device Name: MDSA®

Indications for Use:

Prescription Device .
. Custom-Made
Mandibular Repositioning Device .
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea ●
Single Patient / Multi-Use .
Not for Use in Persons Younger than 18 Years of Age .
Home or Sleep Laboratory Environment .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stare Quane

(Division Sign-Off (Division Sign-Off)
Division of Anes- «ciniology, General Hospital,
Contral Contral Devices Division Control Jental De 510(k) Number

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Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”