Disposable Pressure Manometer (DPM)

K143148 · Westmed, Inc. · CAP · Aug 11, 2015 · Anesthesiology

Device Facts

• Record ID: K143148
• Device Name: Disposable Pressure Manometer (DPM)
• Applicant: Westmed, Inc.
• Product Code: CAP · Anesthesiology
• Decision Date: Aug 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2

Intended Use

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.

Device Story

Disposable pressure manometer provides visual airway pressure indication during ventilation; attaches to resuscitation bags, hyperinflation bags, CPAP masks, or circuits. Device consists of clear housing, internal spring, and indicator float. Positive pressure in ventilation circuit compresses spring, moving float along printed scale to display pressure (0-60 cm H2O). Used in hospitals, clinics, home, and emergency settings by clinicians. Provides real-time visual feedback to assist in monitoring ventilation pressures; helps prevent over-pressurization via integrated fixed leak. Single-patient use; non-sterile.

Clinical Evidence

Bench testing only. Testing included accuracy and repeatability across the full pressure range (0-60 cm H2O), real-time and accelerated aging (1 year), mechanical drop testing, environmental testing, and positional orientation testing. Biocompatibility testing performed per ISO 10993-1:2009 (cytotoxicity, sensitization, intracutaneous reactivity). All samples met pass/fail criteria with accuracy of ± 3 cm H2O.

Technological Characteristics

Materials: Polycarbonate (housing, float, cover), SUS 304 stainless steel (spring). Sensing principle: Mechanical spring-loaded float. Form factor: Disposable, single-patient use. Pressure range: 0-60 cm H2O. Accuracy: ± 3 cm H2O. Connectivity: None (mechanical). Sterilization: Non-sterile.

Indications for Use

Indicated for patients requiring airway or circuit pressure monitoring during ventilation. No specific age or gender restrictions. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• Engineered Medical Systems - Pressure Monitor (K003497)

Reference Devices

• Mercury Medical – Pressure Monitor (K954486)
• Ambu DPM (K040991)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>5580 South Nogales Highway<br>Tucson, AZ 85706 |
| | Tel – 520-294-7987<br>Fax - 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 868.2600<br>CAP – Airway Pressure Monitor<br>Class II |
| Predicate Device: | K003497 - Engineered Medical Systems - Pressure Monitor |
| Reference Device: | K954486 - Mercury Medical – Pressure Monitor<br>We cite this reference device, as it has the identical<br>indications for use with a pressure range of 0 to 80 cm H2O.<br>K040991 – Ambu DPM<br>We cite this reference device, as it has the identical<br>indications for use with a pressure range of 0 to 60 cm H2O<br>and 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
- 2. A float with indicator and
- 3. 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.

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

#### Indications for Use:

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.

#### 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's<br>airway pressure during ventilation. It may be<br>attached to the manometer port or proximal<br>port on ventilation devices such as<br>resuscitation bags, hyperinflation bags,<br>CPAP mask, or CPAP circuits. | To provide visual indication of a patient's<br>airway pressure during ventilation. It may be<br>attached to the manometer port or proximal<br>port on ventilation devices such as<br>resuscitation bags, hyperinflation bags, CPAP<br>mask, or CPAP circuits. |
| Patient population | Patients that the clinician desires to monitor<br>or measure pressure | Patients that the clinician desires to monitor or<br>measure pressure |
| Environments of use | Home, Physician office, Hospital, Sub-acute<br>Institutions, Emergency services or anywhere<br>measurement of airway pressure is desired. | Home, Physician office, Hospital, Sub-acute<br>Institutions, Emergency services or anywhere<br>measurement of airway pressure is desired. |
| Prescriptive | Yes | Yes |
| Single patient use,<br>disposable, non-sterile | Yes | Yes |
| Connects to a sampling<br>port of any device, i.e.<br>resuscitator, etc. | It may be attached to the manometer port or<br>proximal port on ventilation devices such as<br>resuscitation bags, hyperinflation bags,<br>CPAP mask, or CPAP circuits. | It may be attached to the manometer port or<br>proximal port on ventilation devices such as<br>resuscitation bags, hyperinflation bags, CPAP<br>mask, or CPAP circuits. |
| Basic components | Housing<br>Float<br>Spring<br>Pressure markings<br>Fixed leak in the unit | Housing<br>Float<br>Spring<br>Pressure markings<br>Fixed leak in the unit |
| Pressure range | 0 – 50 cm H2O<br>Reference K040991 Ambu 60 cm H2O<br>K954486 Mercury Medical 80 cmH2O | 0 - 60 cm H2O |
| Models | Only one | Only one |
| Performance testing | Accuracy (K003497)<br>• ± 1 cm H2O from 0-10 cm H2O<br>• ± 2 cm H2O from 10-40 cm H2O<br>• ± 3 cm H2O above 40 cm H2O<br>Reference device K040991<br>• +/- 2 cm H2O up to 30 cm H2O<br>• +/- 3 cm H2O at 40 cm H2O<br>• +/- 5 cm H2O at 60 cm H2O | Accuracy and Repeatability<br>• ± 3 cm H2O up to 60 cm H2O<br>Age Testing - 1 year<br>Drop test |
| Materials | Polycarbonate<br>Stainless steel | Housing / Float / Cover - Polycarbonate<br>Spring - SUS 304 |
| Biocompatibility | | External Communication; Tissue<br>communicating; Limited duration (<24 hours)<br>Tested per ISO 10993-5 and 10993-10 |