(90 days)
Not Found
No
The device description and performance studies indicate a purely mechanical pressure manometer, with no mention of AI or ML technologies.
No.
The device's intended use is to monitor airway pressure by providing a visual indication of pressure, which is a diagnostic or monitoring function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
The device is described as a "mechanical pressure manometer indicator" that provides a "visual indication of airway pressure" for monitoring purposes, not for diagnosing a medical condition.
No
The device description explicitly states it is a "mechanical pressure manometer indicator" which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor airway pressure by providing a visual indication. This is a direct measurement of a physiological parameter (pressure) within the body's airway.
- Device Description: The device is a mechanical pressure manometer. It measures physical pressure.
- Lack of Biological Samples: There is no mention of the device interacting with or analyzing biological samples (like blood, urine, tissue, etc.). IVD devices are specifically designed to examine these types of samples to provide information about a person's health.
- Anatomical Site: The anatomical site is the airway, which is a part of the body, not a biological sample being tested in vitro (outside the body).
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases, conditions, or states of health. This device measures a physical parameter directly within the body's airway.
N/A
Intended Use / 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
Product codes
CAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
neonate, newborn, pediatric and adult
Intended User / Care Setting
Hospital, pre-hospital care, post-hospital care and home care.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 |
| Pressure Manometer | |
| Manufacturer: | A Plus Medical |
| Product Codes: | NA |
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 盤 +740-930-4025 Fax: +760-930-0040 ~ 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 +740-930-4025 Fax: +760-930-0040 ~ 14~#
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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 (800) 638-2041 or (301) 796-7100 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
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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