The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.

Device Description

The TAP PAP Nasal Pillow Mask consists of a boil & bite type dental appliance. A small bracket that extends beyond the lips to attach the mask frame (Mask - Upper Mouth Piece Adjustment Joint). Two soft silicone nasal pillows are located on the mask frame to seal against the nostrils. The nasal pillows come in three sizes and can be individually rotated to align with the user's nares. A corrugated flexible tube extends upwards from the mask frame to a 22 mm connector which connects to a breathing tube of a CPAP or bi-level device. The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: TAP PAP Nasal Pillow Mask

1. Table of Acceptance Criteria and Reported Device Performance

Test/Attribute	Acceptance Criteria	Reported Device Performance
Pressure Drop	No pass/fail criteria, reportable values only. (Implied: must be low enough for CPAP machines to supply required flow, and patient exhalation through mouth should have no resistance).	50 lpm: 0.2 cm H₂O 100 lpm: 0.6 cm H₂O
Bias (vent) Flow / Exhaust Flow	No pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher leak rate indicates greater CO2 washout and is not clinically significant).	6 cm H₂O: 23 lpm 10 cm H₂O: 30 lpm 20 cm H₂O: 42 lpm
Dead Space	No pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher reported value is acceptable if CO2 washout demonstrates effectiveness).	95 ml
CO2 Washout (per ISO 17510-2)	Changes in CO2 at various pressures to be < 20% and < 60% from baseline.	4 cm H₂O: 4% increase 5 cm H₂O: 4% increase 10 cm H₂O: 2% increase Occluded: 7% increase
Mask Weight	No pass/fail criteria, reportable values only. Should be comparable to the predicate.	59 gm
Cleaning Durability	Visual and performance testing compared pre- and post-cleaning, found to be similar. (Implied: Device maintains performance specifications after repeated cleaning).	Met performance specifications.
Environmental (Hot/Cold Exposure & Drop Test)	Device meets performance specifications after exposure to 50℃ for 72 hours and 20℃ for 24 hours.	Met performance specifications after conditioning and cleaning.
Biocompatibility (ISO 10993-1)	Pass/fail criteria per each respective ISO 10993 test for cytotoxicity, sensitization, irritation, genotoxicity, and implantation, based on patient contact type and duration for various parts (mask shell, assembly, pillow seals, mouth tray, tubing, headgear, chin strap, nut, bolt).	All materials passed the applicable ISO 10993-1 test requirements.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of devices or individuals) used for each non-clinical test. It mentions "samples" for environmental testing but doesn't quantify them. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective) for these non-clinical tests, as they appear to be laboratory-based performance evaluations rather than human subject studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are non-clinical (laboratory/mechanical) performance tests, not clinical studies requiring expert-established ground truth. The "ground truth" for these tests is based on established engineering and safety standards (e.g., ISO 17510-2, ISO 10993).

4. Adjudication method for the test set

Not applicable. As these are non-clinical, objective tests, an adjudication method for a test set is not needed. The results are measured directly against predefined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a CPAP patient interface, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on established international standards and engineering specifications, such as:

ISO 17510-2 for CO2 washout.
ISO 10993 series for biocompatibility.
Standard methods for measuring physical attributes like pressure drop, bias flow, dead space, and weight.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI that would require a ground truth for training. The product's design is validated through engineering principles and non-clinical testing.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as point 8.

Summary

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K122350 510(k) Summary Page 1 of 6

Date Prepared	31-Oct-12
Airway Management, Inc.	3418 Midcourt Rd.
	Suite 114
	Carrollton, TX 75006
	Tel - 214-369-0978
	Fax - 214-691-3151
Official Contact:	Dale Siebenmorgen - Manager of Quality and Regulatory
Proprietary or Trade Name:	TAP PAP Nasal Pillow Mask
Common/Usual Name:	CPAP Patient interface
Classification Code/Name:	BZD - non-continuous ventilator (IPPB)
	21 CFR 868.5905
	Class 2
Predicate Devices:	K992384 - Stevenson CPAP/Pro

Device Description:

The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.

Indications for Use:

The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>661b/30kg) use in the home, hospital or other clinical setting,

Patient Population: Adults (>66 lbs / 30 kg)

Environment of Use: Home, hospital or other clinical settings

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510(k) Summary Page 2 of 6 31-Oct-12

Predicate Device Comparison:

The TAP PAP Nasal Pillow Mask has been compared to the predicate and is viewed as substantially equivalent because:

Indications -

The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been ● diagnosed by a physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>661b/30kg) use in the home, hospital or other clinical setting.
The predicate CPAP/Pro (K992384) is intended to treat adult OSA, but it is a patient . interface which must connect to CPAP and bi-level devices, therefore the indications for use are considered substantially equivalent.
. Substantially equivalent to Stevenson CPAP/Pro (K992384).

Discussion - The indications for use are equivalent to the predicate.

Patient Population -

The TAP PAP Nasal Pillow Mask and the predicate CPAP/Pro are both intended for . adults (>66 lbs. / 30 kg.).
Discussion - The intended patient population is identical to the predicate.

Technology -

Technology is the use of an upper dental tray with boils & bite impression material . which has a bracket to hold nasal pillows and tubing. The nasal pillows are offered in multiple sizes and fit in the nares of the patient. They each on a means for relieving excess flow, vent holes, and connect to the positive pressure equipment with a standard 22 mm corrugated tubing.
Discussion - The technology of tubing, nasal pillow2s and a manifold is identical to the predicate. The difference in placing the manifold closer to the patient in the proposed device is a matter of comfort for the user vs. the manifold remote from the patient and bracket holding 2 separate tubes with the nasal pillows as the predicate has. The difference in this design configuration increases the dead space, but the performance of the proposed device in Pressure vs. Flow and CO2 washout testing demonstrates that it is equivalent and the differences are not clinically significant and safety and effectiveness is not affected.

Materials -

The materials are standard medical grade materials and have been tested per ISO 10993. . Discussion - The materials have been tested per ISO 10993-1 and passed the requirements of each test.

Environment of Use -

The masks are intended for use in the home, hospital, or sleep laboratories. . Discussion - The environments of sue are identical to the predicate.

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510(k) Summary Page 3 of 6 31-Oct-12

Differences –

There are no differences between the predicate and the proposed device which would raise any new safety or risks and thus can be found to be substantially equivalent.

Attributes	TAP PAP Nasal Pillow Mask	StevensonCPAP/Pro K992384
Intended Use	Non-invasive ventilator interface for CPAP or bi-level treatment	Non-invasive ventilator interface for CPAP or bi-level treatment
Indications for Use	The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.	Intended to treat adult OSA
Patient Population	Adults (>66 lbs. / 30 kg.)	Adults (>66 lbs. / 30 kg.)
Environment of Use	HomeHospitalOther clinical settings	Not specified
Duration of Use	Single patient, multi-use	Single patient, multi-use
Prescriptive	Yes	Yes
Method of fixation	Boil & bite dental tray with bracket attachment	Boil & bite dental tray with bracket attachment
Sealing method	Soft nasal pillows	Soft nasal pillows
Positive pressure source	CPAP or bi-level equipment	CPAP or bi-level equipment
Means to relieve excess flow	Vent holes	Diffuser near pillows
Tray configurations	Boil & Bite with heat sensitive impression material	Boil & Bite with heat sensitive impression material
Bracket for adjusting tubing and nasal pillows	Yes	Yes
Tubing from pillows to connector to gas source	Yes	Yes
Different Pillow sizes	3	3
Technical Specifications / Performance Testing
Operating Pressure range	4 – 20 cm H₂O	4 – 18 cm H₂O
Dead Space	95 ml	45 ml
Pressure Drop	Flow50 lpm100 lpm	Drop0.2 cm H₂O0.6 cm H₂O	Not available or reported
Exhaust flow / Pressure	Pressure (cm H₂O)61020	Flow (lpm)233042	Pressure (cm H₂O)61020	Flow (lpm)152133
Weight	59 gm	55 gm
Gross Dimensions (no head gear)	280 mm (H) x 67 mm (W) x 220 mm (D)	260 mm (H) x 100 mm (W) x 100 mm (D)

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. 510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------31-Oct-12

Non-clinical Testing Summary -

We have performed a number of tests typical of CPAP patient interfaces. These tests include:

Pressure Drop

Standard test method of using a standard flow and measuring pressure drop .
No pass / fail criteria, reportable values only .
Discussion The proposed device has a low pressure drop at 50 and 100 lpm and is only a . reported value. CPAP machines are able to supply the required flow at these low resistance values. As the patient exhaled through their mouth there is no resistance to breathing.

Bias (vent) Flow (Pressure / Exhaust Flow

Standard test method using CPAP unit at various flow rates and measuring the leak at the . patient interface
. No pass / fail criteria, reportable values only. It should be comparable to the predicate.
Discussion The proposed device has a slightly higher "Leak or Flow" rate at all pressure . vs. the predicate which means greater CO2 washout. The differences do not have any clinical significance.

Dead space

Standard test method of measuring the volume of the parts near the patient.
. No pass / fail criteria, reportable values only. It should be comparable to the predicate.
Discussion The proposed device has a "manifold" near the patient with a single hose . coming from the CPAP unit and the nasal pillows attached to the manifold. The predicate has the manifold remote from the patient and then 2 separate tubes with individual nasal pillows coming from the manifold to the patient. The higher reported dead space is based upon measuring the proposed device with the manifold, tubing, and nasal pillows vs. the predicate was the tubing and nasal pillows only but not the remote manifold. While the reported value for the proposed is higher 95 ml vs. 45 ml, the Pressure vs. Flow and the CO2 washout data demonstrated that the proposed device effectively flushed the patient interface as it had higher leak rates than the predicate at the same pressures and the proposed device passed the CO2 washout per ISO 17510-2 criteria. Therefore the higher dead space is not clinically significant nor does it affect safety and effectiveness.

CO2 washout per ISO 17510-2

Tested per ISO 17510-2 .
Pass / fail criteria per ISO 17510-2 allow for changes in CO2 at various pressures to be < . 20% and < 60% from baseline).

Pressure	Mask ETCO₂	% Increase
4 cm H₂O	5.4 %	4%
5 cm H₂O	5.4 %	4%
10 cm H₂O	5.3 %	2%
Occluded	5.6 %	7%

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510(k) Summary Page 5 of 6 31-Oct-12

. Discussion - The proposed mask demonstrated that it meet the requirements of CO2 washout per ISO 17510-2.

Mask Weight

Simply weighed the devices ●
. No pass / fail criteria, reportable values only. It should be comparable to the predicate.
. Discussion - The proposed device vs. the predicate were equivalent.

Cleaning durability

Repeated cleaning was performed per the recommended cleaning instructions .
Visual and performance testing was performed and compared pre and post- cleaning and ● found to be similar
. Discussion - The proposed mask can be cleaned as intended and meet the performance specifications

Environmental (Hot / cold exposure and drop test)

Test method was subjected the samples to 50℃ for 72 hours and 20℃ for 24 hours ●
. Pass / fail criteria was that they would meet the performance specifications which was performed after the cleaning durability
Discussion The proposed device met the performance specifications after conditioning . and cleaning.

Biocompatibility of Materials -

Materials were evaluated per ISO 10993-1. There are parts and thus their respective materials which have the following patient contact and duration.

Parts which are Externally communicating, Tissue - gas pathway contact, permanent duration require the following tests. They are the mask shell, assembly, pillow seals and mouth tray and tubing.

Cytotoxicity (tested per ISO 10993-5) ಂ
Sensitization (tested per ISO 10093-10) O
Irritation (tested per ISO 10993-10) ಂ
Genotoxicity (Tested per ISO 10993-3) O
Implantation (tested per ISO 10993-6) O
Pass / fail criteria was for the each respective ISO 10993 test o

Parts which are Surface communicating, Skin, permanent duration require the following tests. They are the headgear and chin strap.

Surface communicating, Skin, permanent duration .
- o Cytotoxicity (tested per ISO 10993-5)
- Sensitization (tested per ISO 10093-10) O
- Irritation (tested per ISO 10993-10) O
- Pass / fail criteria was for the each respective ISO 10993 test O

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510(k) Summary Page 6 of 6 3 1-Oct-12

Parts which are Surface communicating, Skin, limited duration require the following tests. They are the nut and bolt.

Cytotoxicity (tested per ISO 10993-5) o
Sensitization (tested per ISO 10093-10) O
Irritation (tested per ISO 10993-10) O
Pass / fail criteria was met for each respective ISO 10993 test o

Discussion -

All materials were tested according to ISO 10993-1 for the appropriate level of patient contact and duration and found pass the applicable ISO 10993-1 test requirements.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

NOV 1 2012

Airway Management, Incorporated C/O Paul Dryden President Promedic. Incorporated Bonita Springs, Florida 34134

Re: K122350

Trade/Device Name: Tap PAP Nasal Pillow Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 2, 2012 Received: August 3, 2012

Dear Mr. Dryden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Dryden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh. for

Anthony D. Watson, B.S., M.S., M.B.A.

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 Statement

Page 1 of 1

510(k) Number:

K122350

TAP PAP Nasal Pillow Mask Device Name:

Indications for Use:

The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.

Over-the-counter use _ Prescription Use XX or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ K 122350

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).