Predicate Devices

K992384 - Stevenson CPAP/Pro

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and physical properties of a mask, with no mention of AI or ML.

Therapeutic

Yes
The device is intended for individuals requiring CPAP or Bi-Level ventilator treatment, which are therapeutic medical interventions.

Diagnostic

No
The device, a nasal pillow mask, is intended for delivering CPAP or Bi-Level ventilator treatment, not for diagnosing medical conditions. Its purpose is to assist in therapy for individuals already diagnosed.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a dental appliance, mask frame, nasal pillows, and tubing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for delivering CPAP or Bi-Level ventilator treatment to individuals diagnosed with requiring such treatment. This is a therapeutic application, not a diagnostic one.
Device Description: The description details a mask and dental appliance designed to facilitate breathing support, not to analyze biological samples or provide diagnostic information.
Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
Performance Studies: The performance studies focus on the physical and functional performance of the mask in delivering air pressure and managing exhaled gases, not on diagnostic accuracy or analytical performance.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) to provide therapeutic support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

BZD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nostrils

Indicated Patient Age Range

adult (>661b/30kg)

Intended User / Care Setting

CPAP or Bi-Level ventilator treatment, single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing Summary -
Pressure Drop:

Standard test method of using a standard flow and measuring pressure drop
No pass / fail criteria, reportable values only
Results: The proposed device has a low pressure drop at 50 and 100 lpm. CPAP machines are able to supply the required flow at these low resistance values.

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. Should be comparable to the predicate.
Results: 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. Should be comparable to the predicate.
Results: 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

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).

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 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.

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 | Stevenson
CPAP/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 | Home
Hospital
Other 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 | Flow
50 lpm
100 lpm | Drop
0.2 cm H₂O
0.6 cm H₂O | Not available or reported | |
| Exhaust flow / Pressure | Pressure (cm H₂O)
6
10
20 | Flow (lpm)
23
30
42 | Pressure (cm H₂O)
6
10
20 | Flow (lpm)
15
21
33 |
| 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) | | |

3

. 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 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