The Tiara Medical Systems Advantage II Nasal Mask is intended to be used with continuous positive airway pressure devices (CPAP); operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

Device Description

The Tiara Medical Systems Advantage II™ Nasal Mask is an externally placed mask covering the nose such that positive pressure from a positive pressure source is directed of the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.

The mask consists of a molded polycarbonate shell with a soft, resilient silicone skin-contacting rille mask conforms to the patient's facial features. A silicone forehead cushion is available for added comfort.

The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source the mask with a polyethylene split "c" ring. The built in vent slots (2) are located attacres to the from of the make with a perfect's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use.

Canadation access is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.

AI/ML Overview

The provided submission document K031935 for the Tiara Medical Systems Advantage II™ Nasal Mask is a 510(k) premarket notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details about specific acceptance criteria and detailed study results.

The document does not contain the requested information regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative measures like pressure accuracy, leak rates, or specific comfort metrics. The document broadly states "Design verification tests were performed on the TMS Advantage II Nasal Mask as a result of risk analysis and product opportunities and were verified to meet acceptance criteria." This implies that internal acceptance criteria were met, but these criteria are not detailed.
Reported Device Performance: Not quantitatively reported. The document states that the modifications "have no impact on the safety and efficacy of the device" compared to the predicate, and that it is "substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not mentioned.
Data Provenance: Not mentioned. It's safe to assume this was an internal validation based on the nature of the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Experts and Qualifications: Not mentioned. Given that this is a nasal mask, "ground truth" might refer to performance metrics against engineering specifications, not clinical diagnoses by experts.

4. Adjudication Method:

Adjudication Method: Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: No, this is highly unlikely for a nasal mask. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and AI might assist in that interpretation. This document is for a physical medical device (nasal mask).

6. If a Standalone (Algorithm Only) Performance Study Was Done:

Standalone Study: No, this is not applicable. The device is a physical nasal mask, not an algorithm.

7. The Type of Ground Truth Used:

Ground Truth: Not explicitly stated. For a physical device like a nasal mask, "ground truth" would likely refer to engineering specifications, performance standards (e.g., airflow resistance, pressure integrity, material biocompatibility), and user comfort/fit assessments against pre-defined criteria. The document mentions "Design verification tests" and "risk analysis and product opportunities," implying a focus on meeting safety and performance standards for the device itself.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not mentioned. This concept is typically relevant for machine learning algorithms, which are not involved here.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there's no machine learning algorithm involved requiring a "training set."

Summary of Key Information Provided:

Device Trade Name: Advantage II Nasal Mask
Intended Use: With continuous positive airway pressure devices (CPAP) operating at or above 3 cmH2O for the treatment of obstructive sleep apnea in adult patients (>30kg). Intended for single-patient use at home or in hospital/institutional environments.
Predicate Devices: TMS Advantage Series (K012207) and Sullivan AutoSet Nasal CPAP System (K980721).
Basis for Substantial Equivalence: Same intended use, operating principle, technology, materials in contact with skin, and manufacturing process as the predicate devices.
Verification: "Design verification tests were performed... and were verified to meet acceptance criteria." "Modifications ... have no impact on the safety and efficacy of the device."

In conclusion, the provided 510(k) submission, as expected for this type of device and regulatory pathway, focuses on demonstrating substantial equivalence through design verification against internal criteria and comparison to predicate devices, rather than detailed clinical study data with specific acceptance criteria as might be seen for novel diagnostic or therapeutic devices.

Summary

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Additional Requested Information, K031935 Section 510(k) Notification, Amended Submission TMS Advantage IITM ATTACH 040302-1

Tiara Medical Systems, Inc. 14414 Detroit Ave., Ste. 205 Lakewood, OH 44107

MAR - 3 2004

Attachment 1 – 510(k) Summary of Safety and Effectiveness [As required by 21 CFR 807.92(c)]

Submitter Name:	Tiara Medical Systems, Inc.
Submitter Address :	14414 Detroit Ave. Ste. 205 Lakewood, OH 44107
Contact Person:	Geoffrey Sleeper
Phone Number:	(216) 521-1220
Fax Number:	(216) 521-1399
Date Prepared:	June 2003
Device Trade Name:	Advantage II
Device Common Name:	Nasal Mask
Classification Name:	Ventilator, Noncontinuous (Respirator), 73BZD
Predicate devices:	TMS Advantage Series, K012207,Sullivan AutoSet Nasal CPAP System (includes ResMed Protoge)K980721
Reason for submission:	Modification to design, labeling

Device Description:

Device Dooription.
The Tiara Medical Systems Advantage II™ Nasal Mask is an externally placed mask covering the nose The nation of oyetems heal such that positive pressure from a positive pressure source is directed of the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.

The mask connects to a conventional air delivery hose between the mask and the positive airway The mask connecto to a conventional an polycarbonate vented elbow/swivel . The elbow/swivel pressure source the mask with a polyethylene split "c" ring. The built in vent slots (2) are located attacres to the from of the make with a perfect's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use.

Canadation access is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.

Intended Use:

The Tiara Medical Systems Advantage II Nasal Mask is intended to be used with continuous positive rine fiara modifical Gyotonio have a cabove 3 cmH20 for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

Substantial Equivalence/ Device Technological Characteristics and Comparison to Predicate Device(s):

The modified device has the following similarities to the previously cleared predicate devices:

same intended use -
same operating principle -
same technology, same materials in contact with patient's skin -
same manufacturing process -

Design verification tests were performed on the TMS Advantage II Nasal Mask as a result of risk Design vehilouten tools word portunities were verified to meet acceptance criteria. Tiara Medical andison and product opeditions have no impact on the safety and efficacy of the device. Oystems had actornined in this submission is substantially equivalent to the predicate device, and complies with the applicable standards referenced in the "FDA Reviewer Guidance for Premarket Notifications," November 1993."

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Image /page/1/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" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

Mr. Geoffrey Sleeper Vice President Tiara Medical Systems, Incorporated 14414 Detroit Avenue, Suite 205 Lakewood, Ohio 44107

Re: K031935

Trade Name: Advantage II Nasal Mask, Models TMS-2520 and TMS-2530 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 15, 2004 Received: January 16, 2004

Dear Mr. Sleeper:

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 cither 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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Page 2 - Mr. Geoffrey Sleeper

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setmon CFR Part 807); labeling (21 CFR Part 001); good manation (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Actived in your Section product radiation control provisions (Sections 551 312 ce as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to Jega This letter will allow you to ocgin marketing of substantial equivalence of your device to a legally premarket notification. The PDA Iniding of substantial of 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 If you desire specific advice for your ac not one of the regulation entitled.
contact the Office of Compliance at (301) 594-4646. Also, please note the move abtain contact the Office of Comphance at (301) 55 (21CFR Patt 807.97). You may obtain "Misbranding by relefence to premarks. Iouities. In the Act from the Division of Small
other general information on your responsibilities under the Act from when (800) 638, 2 other general information on your responsion.com in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-idemansin html Manufacturers, International and Consumer Pleases agov/odrh/dsma/dsmamain.html.

Sincerely yours,

Ove
Chin Lin, Ph.D.

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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INDICATIONS FOR USE

[510(k)] Number: K031935

Device Name: Tiara Medical Systems Advantage II™ Nasal Mask

Indications For Use:

The Tiara Medical Systems Advantage II Nasal Mask is intended bo be used with ontinuous The Tiala Medical Oystems Auvantage II Nacariting at or above 3 cmH20 for the treatment of positive alway pressure devices (OF Ar ); operating at on early of the mast on be used in the obstructive sleep apriled. The mask is likendou for Single patter on adult patients nome of in a noophalities spositive airway pressure has been prescribed.

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

Over-the-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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n Sign-Off) on of Anesthesiology, General Hospital. Infection Control. Den

510(k) Number: K031935

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).