To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits.

For patients that the clinician desires to monitor or measure airway or circuit pressure.

Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

Device Description

The Westmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.

The device consists of:

1. Clear housing with a printed pressure scale
1. A float with indicator and
1. Spring

It functions by reacting to the positive present in the ventilation device. When pressure is in the device the float moves up or down to indicate the pressure of the system. This manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range -0-60 cm H2O. The performance characteristics are that the measured pressures are accurate to:

- 3 cm H2O up to 60 cm H2O
  It is a single patient, disposable, packaged non-sterile device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Disposable Pressure Manometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Westmed, Inc. for this device)	Reported Device Performance (Westmed DPM)
Accuracy: ± 3 cm H₂O up to 60 cm H₂O	± 3 cm H₂O up to 60 cm H₂O
Repeatability: (Implicitly met by accuracy testing)	Confirmed through testing
Age Testing: Passed after real-time and simulated 1-year	Passed after real-time and simulated 1-year
Mechanical Testing: Survived Drop test	Passed Drop test
Environmental Testing: (No specific criteria given)	Passed Environmental testing
Positional Testing: (No specific criteria given)	Passed Positional testing

Note: The predicate device K003497 had different accuracy criteria:

± 1 cm H₂O from 0-10 cm H₂O
± 2 cm H₂O from 10-40 cm H₂O
± 3 cm H₂O above 40 cm H₂O
The proposed device set its own accuracy criteria, consistent with reference devices (K040991 Ambu, K954486 Mercury Medical) for a wider pressure range.

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

Sample Size for Test Set: The document states that "All samples met the pass/fail criteria" for Accuracy and Repeatability, Aging, Mechanical, Environmental, and Positional Orientation tests. It also mentions "Samples were dropped," "Samples which had real-time aging and samples in accelerated aging were pressurized," and "Each sample was tested multiple times." However, the exact number of samples (N) used for the test set is not explicitly stated in the provided text.
Data Provenance: Not specified, but likely from in-house testing by Westmed, Inc. No mention of geographical origin or whether it's retrospective or prospective is made.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. This device is a measurement tool (manometer), and ground truth for its performance is established by comparison to a calibrated standard (digital manometer), not expert interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Ground truth for a physical measurement device's accuracy and performance is typically determined against established calibration standards and engineering specifications, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a physical medical device (disposable pressure manometer) used for objective measurement, not an AI or diagnostic imaging device that requires human interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: Yes, in essence. The documented "Non-Clinical Testing Summary" details the performance of the Westmed DPM device itself, including its accuracy, repeatability, and resilience to aging, mechanical stress, environmental conditions, and positional changes. This testing is performed on the device without a human in the loop, directly measuring its output against a digital manometer.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the device's accuracy and repeatability was established by comparison with a digital manometer (implicitly, a calibrated standard). The "Summary: Accuracy and Repeatability" section states: "Samples were pressurized across the range and confirmed with the digital manometer."

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. Its functionality is based on mechanical principles (spring and float), not learned patterns.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked one behind the other.

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

August 11, 2015

Westmed, Inc. C/O Paul E. Dryden Consultant Pro Medic Inc., 2430 Woodsage Dr. Bonita Springs, FL 34134-2958

Re: K143148

Trade/Device Name: Disposable Pressure Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway pressure manometer Regulatory Class: II Product Code: CAP Dated: July 9, 2015 Received: July 13, 2015

Dear Paul E. 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.

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

We have prepared the Indications for Use statement utilizing Form 3881.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Disposable Pressure Manomter (DPM) Indications for Use (Describe)

To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits.

Patient Population: For patients that the clinician desires to monitor or measure airway or circuit pressure.

Environments for use: Home, Physician office. Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Date Prepared:	06-Aug-2015
Company	Westmed, Inc.5580 South Nogales HighwayTucson, AZ 85706
	Tel – 520-294-7987Fax - 520-294-2780
Official Contact:	Diana Upp, Vice President RA / QA
Proprietary or Trade Name:	Disposable Pressure Manometer
Common/Usual Name:	Airway Pressure Monitor
Classification Name:	21CFR 868.2600CAP – Airway Pressure MonitorClass II
Predicate Device:	K003497 - Engineered Medical Systems - Pressure Monitor
Reference Device:	K954486 - Mercury Medical – Pressure MonitorWe cite this reference device, as it has the identicalindications for use with a pressure range of 0 to 80 cm H2O.K040991 – Ambu DPMWe cite this reference device, as it has the identicalindications for use with a pressure range of 0 to 60 cm H2Oand the accuracy range consistent with the proposed device.

Device Description:

The Westmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.

The device consists of:

1. Clear housing with a printed pressure scale
1. A float with indicator and
1. Spring

- 3 cm H2O up to 60 cm H2O
  It is a single patient, disposable, packaged non-sterile device.

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510(k) Summary Page 2 of 4 06-Aug-2015

Indications for Use:

For patients that the clinician desires to monitor or measure airway or circuit pressure.

Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

Substantial Equivalence Discussion:

Table 1 compares the key features of the proposed Westmed DPM with the identified predicate and demonstrates that the proposed device is substantially equivalent.

In summary, one can conclude that substantial equivalence is met based upon the following:

Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate -K003497.

Discussion – Each device is indicated for use to measure pressure in a circuit or airway.

Technology and construction -

The design, components, shape, size, etc. are equivalent to the predicates - K003497. Discussion – The design is simple housing with a float that sits on a spring that goes up or down based upon the pressure in the device. There are markings to indicate the pressure observed as well as a fixed leak to avoid over pressurization. There are no differences in the technological characteristics of the proposed device, predicate and reference devices. The only differences related to the measured pressure ranges: 0-50 cm H2O for the predicate K003467; 0-80 cm H2O for the reference K954486; and the proposed which is 0-60 cm H2O; the accuracy range of the reference K040991. The differences in measured pressure range and accuracy across the pressure range do not raise any new safety or effectiveness concerns.

Environment of Use –

The environments of use are identical to predicate - K003497 - EMS pressure manometer. Discussion - The environments of use are identical to the predicates - K003497.

Patient Population -

The patient population is defined as patients where the clinician wants to measure or monitor circuit or airway pressure. Therefore there is no specific patient population. Discussion - The patient populations are equivalent to the predicates - K003497.

Non-Clinical Testing Summary -

We performed a number of tests including comparative pressure accuracy and the results demonstrated equivalent performance demonstrating the proposed device is equivalent to the -K003497 – EMS pressure manometer.

Testing included:

· Accuracy and Repeatability across the full pressure range

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510(k) Summary

Page 3 of 4

06-Aug-2015
Age testing real-time and simulated to 1 year
Mechanical testing Drop test ●
Environmental testing .
Positional testing

Summary:

Accuracy and Repeatability
- O Samples were pressurized across the range and confirmed with the digital manometer
. Aging, Mechanical, Environmental, Positional Orientation, and Accuracy
- Samples were dropped o
- Samples which had real-time aging and samples in accelerated aging were o pressurized to various pressures and confirmed via digital manometer
- Each sample was tested multiple times o

All samples met the pass/fail criteria

· + 3 cm H2O up to 60 cm H2O
All testing demonstrated that the proposed device is substantially equivalent to the predicate and reference devices.

Biocompatibility

Based upon G95-1 and ISO 10993-1:2009 the proposed device would be considered as having the following patient contact classification:

External Communication (Indirect contact) for all materials .
Tissue contact ●
Limited duration (<24 hours)

We performed the following ISO 10993-1 tests:

Cytotoxicity; Sensitization; Intracutaneous Reactivity / Irritation ●
The test requirements were met for the materials to be considered as non-reactive.

Discussion of Differences:

The construction, design, basic materials of the proposed device is similar to the predicate. That is having a housing with a spring and float whereby when pressurized the float moves up or down to indicate the pressure within the system.

The only difference between the proposed device and the predicate is that the maximum displayed pressure is up to 60 cmH2O vs. 50 cmH2O. The devices to which these devices are attached can generate higher pressures but their typical operating range can be as high as 80 cmH2O (reference K954486). The difference in a higher maximum pressure does not raise any new safety and effectiveness issues. It should be noted that the reference device, K040991 Ambu Pressure Monitor has a pressure range up to 60 cm H2O and the accuracy across the pressure range equivalent to the proposed device.

Substantial Equivalence Conclusion:

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device to be as safe and as effective as predicate and thus can be considered as substantially equivalent.

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510(k) Summary Page 4 of 4

06-Aug-2015

Table 1 - Comparison to Predicates

Attribute	Predicate	Proposed
	EMS – K003497 Pressure Manometer	Westmed DPM
Indications for Use	To provide visual indication of a patient'sairway pressure during ventilation. It may beattached to the manometer port or proximalport on ventilation devices such asresuscitation bags, hyperinflation bags,CPAP mask, or CPAP circuits.	To provide visual indication of a patient'sairway pressure during ventilation. It may beattached to the manometer port or proximalport on ventilation devices such asresuscitation bags, hyperinflation bags, CPAPmask, or CPAP circuits.
Patient population	Patients that the clinician desires to monitoror measure pressure	Patients that the clinician desires to monitor ormeasure pressure
Environments of use	Home, Physician office, Hospital, Sub-acuteInstitutions, Emergency services or anywheremeasurement of airway pressure is desired.	Home, Physician office, Hospital, Sub-acuteInstitutions, Emergency services or anywheremeasurement of airway pressure is desired.
Prescriptive	Yes	Yes
Single patient use,disposable, non-sterile	Yes	Yes
Connects to a samplingport of any device, i.e.resuscitator, etc.	It may be attached to the manometer port orproximal port on ventilation devices such asresuscitation bags, hyperinflation bags,CPAP mask, or CPAP circuits.	It may be attached to the manometer port orproximal port on ventilation devices such asresuscitation bags, hyperinflation bags, CPAPmask, or CPAP circuits.
Basic components	HousingFloatSpringPressure markingsFixed leak in the unit	HousingFloatSpringPressure markingsFixed leak in the unit
Pressure range	0 – 50 cm H2OReference K040991 Ambu 60 cm H2OK954486 Mercury Medical 80 cmH2O	0 - 60 cm H2O
Models	Only one	Only one
Performance testing	Accuracy (K003497)• ± 1 cm H2O from 0-10 cm H2O• ± 2 cm H2O from 10-40 cm H2O• ± 3 cm H2O above 40 cm H2OReference device K040991• +/- 2 cm H2O up to 30 cm H2O• +/- 3 cm H2O at 40 cm H2O• +/- 5 cm H2O at 60 cm H2O	Accuracy and Repeatability• ± 3 cm H2O up to 60 cm H2OAge Testing - 1 yearDrop test
Materials	PolycarbonateStainless steel	Housing / Float / Cover - PolycarbonateSpring - SUS 304
Biocompatibility		External Communication; Tissuecommunicating; Limited duration (<24 hours)Tested per ISO 10993-5 and 10993-10

Regulation Number and Section

§ 868.2600 Airway pressure monitor.

(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).