VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0

K102377 · A Plus Medical · CAP · Nov 18, 2010 · Anesthesiology

Device Facts

• Record ID: K102377
• Device Name: VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
• Applicant: A Plus Medical
• Product Code: CAP · Anesthesiology
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.

Device Story

Single patient use mechanical pressure manometer; monitors airway pressure. Input: gas pressure from respiratory circuit. Operation: gas pressure compresses internal spring; spring compression correlates to graduated markings on housing. Output: visual pressure reading on scale. Used in hospital, pre-hospital, and home care environments; operated by clinicians or caregivers. Provides real-time visual feedback of airway pressure to assist healthcare providers in monitoring respiratory status; aids in clinical decision-making regarding ventilation management.

Clinical Evidence

Bench testing only. Accuracy of pressure measurement compared to an electronic pressure measurement device; results confirmed accuracy within ± 0.1 cm H2O, demonstrating performance equivalent to predicate devices.

Technological Characteristics

Mechanical pressure manometer; single patient use. Sensing principle: linear spring compression proportional to gas pressure. Pressure ranges: 0-60 cm H2O and 0-15 cm H2O. Form factor: disposable housing with graduated markings. No electronic components, software, or external energy source.

Indications for Use

Indicated for monitoring airway pressure in all patient populations, including neonates, newborns, pediatric, and adult patients, in hospital, pre-hospital, post-hospital, and home care settings.

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

• 1st Response Disposable Manometer (K961318)
• vent.Plus Hyperinflation Bag System with Pressure Manometer (K092687)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for A Plus Medical. The logo features the letter A with a plus sign above it, followed by the words "A Plus Medical" in bold font. Below the company name is the tagline "Solutions for Respiratory Care" in a smaller font.

#### 5.0. 510(k) Summary

Date: August 17, 2010

## Owner:

..

ﻓ

A Plus Medical 5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 Tel: + 760-930-4025

Fax:

Owner/Operator Number:

10023166

# Official Contact:

Thomas C. Loescher

+ 760-930-4025 Tel: Fax: + 760-930-0040

- Trade Names: ¥€ Ω½×Plus™ Disposable Pressure Manometer
## Common/Usual Name:

Pressure Manometer

## Classification Name:

Device Name: Resuscitator, Manual, Non Self-Inflating Device Name: Monitor, Airway Pressure Product Code: CAP Regulation: CFR 868.2600 Device Class: | I

# Device:

VEMIS.P/US Disposable Pressure Manometer

## Predicate Devices:

| Number: | K961318 |
|----------------|--------------------------------------|
| Product Name: | 1st Response Disposable Manometer |
| Manufacturer: | Smiths Medical (Intertech Resources) |
| Product Codes: | 008201 |

| Number: | K092687 |
|----------------|----------------------------------------------------------------|
| Product Name: | vent.Plus Hyperinflation Bag System with<br>Pressure Manometer |
| Manufacturer: | A Plus Medical |
| Product Codes: | NA |

5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 盤 [phone] Fax: [phone] ~ 13~#

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo features the letter A in a stylized font, with a small circle above it. To the right of the A is the text "A Plus Medical" in a bold, sans-serif font. Below the company name is the text "Solutions for Respiratory Care" in a smaller font.

## Device Description:

Single patient use mechanical pressure manometer indicator compresses a spring to a position where the force exerted by the gas equals the force exerted by the compressed spring combinations and graduated marking on individual housings allow the device to be offered in 0 - 60 cm H2O and 0 - 15 cm H2O pressure ranges.

## Indications for Use:

Intended for use where monitoring airway pressure is desired by providing a visual indication of airway pressure and may be used on all patient populations in the hospital, post-hospital and home care environments

#### Contraindications:

None identified.

#### Patient Population:

Patient populations of neonate, newborn, pediatric and adult.

#### Environment of Use:

Hospital, pre-hospital care, post-hospital care and home care.

#### Comparative of Technological Characteristics:

Testing was performed to document the accuracy of pressurement of the predicate and proposed device to an electronic pressure measurement device of ± 0.1 cm HzO. The A Plus Medical device is substantially equivalent in indications for use, environment of use, patient population, material and function to the identified predicate. Bench testing confirmed that the A Plus Medical device and predicate device have similar performance characteristics and the accuracy of the pressure manometer is equivalent to the predicate under identical test conditions.

## Similarities and Differences:

#### Similarities:

Both are single patient mechanical devices that use a linear spring to which force is applied to measure airway pressure and are of similar construction. Each may be used on all patient populations in the pre-hospital, and home care environments where the measuring of airway pressure is desired.

## Differences:

The proposed device is offered in three (3) different pressure ranges (0-60 cm H30 and 0-15 cm H30) while the predicate is offered as a 0-60 cm H-0 device.

#### Conclusion:

The VEREE.Plus" Pressure Manometer is substantially equivalent to the identified predicates.

The Years.Plus Pressure Manometer and the identified predicates have substantially equivalent performance.

The WEN.Plus Pressure Manometer and the identified predicates are made from substantially equivalent material, intended use, patient populations and environment of use.

> 5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2 [phone] Fax: [phone] ~ 14~#

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing the bird's body and wings.

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

Mr. Thomas C. Loescher -President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008

NOV 1 8 2010

Re: K102377

:

Trade/Device Name: VentiPlus™ Disposable Pressure Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: August 20, 2010 Received: August 20, 2010

Dear Mr. Loescher:

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.

{3}------------------------------------------------

Page 2- Ms. Loescher

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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony 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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for A Plus Medical. The logo features a stylized "a" with two dots above it, followed by the text "A Plus Medical" in bold, and the text "Leaders for Respiratory Care" in a smaller font below. The logo is black and white.

# Indications for Use Statement

K102377 NOV 1 8 2010

510(k) Number: Device Name: Indications for Use: K102377

VEBLA. Plus" Disposable Pressure Manometer

Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

L. A. Hutter

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

510(k) Number: K102377