(359 days)
No
The description focuses on basic digital pressure measurement and display, with no mention of AI/ML terms or functionalities.
No.
The device is solely for measuring airway pressure and does not perform any therapeutic function.
No
Explanation: The device measures physical parameters (airway pressure) but does not diagnose a medical condition or disease. Its purpose is to monitor pressure in other respiratory care devices.
No
The device description explicitly mentions a "digital display," "front panel," "right button," and "mechanism," indicating the presence of physical hardware components beyond just software.
Based on the provided information, the Gio Digital Manometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "measure airway pressure in respiratory care devices". This is a measurement of a physiological parameter (pressure within the airway) in a living patient, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device measures pressure directly from the airway or connected respiratory devices. It doesn't process or analyze biological samples.
- Lack of IVD Characteristics: The description doesn't mention any components or functions related to sample collection, preparation, or analysis of biological materials, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Gio Digital Manometer's function falls under the category of a medical device used for monitoring a physiological parameter during respiratory care.
N/A
Intended Use / Indications for Use
The Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.
Product codes (comma separated list FDA assigned to the subject device)
CAP
Device Description
The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated.
The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all patient populations
Intended User / Care Setting
hospital, and post hospital environments.
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)
Performance evaluation concludes that the Gio Digital Monometer meet the requirements of IEC 60601-1 associated with battery powered equipment. The Gio Digital Monometer has similar intended use, patient populations and environment of use and equivalent performance to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy is within +/- 0.4 of reading.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
AUG 2 2 2013
Image /page/0/Picture/1 description: The image shows the logo for Galemed. The logo features the word "galemed" in a bold, sans-serif font, with the first letter "g" in lowercase and the rest of the letters in uppercase. Below the word "galemed" is the tagline "Caring for life" in a smaller, italicized font. The logo is set against a dark, abstract shape that resembles a bean or a kidney.
510(k) Summary 18.0
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
Date: 08/21/2012
18.1 Submitter Information
GaleMed Corporation 87 Li-gong 2nd Road, Wu-Jia, I-Lan, Taiwan 268 Contact Person: Alvin Lee Tel: + 886 3 990 8618 Fax: + 886 3 990 8245
Owner/Operator Number: 8043316
18.2 Name of Device
Proprietary Names: Gio Digital Pressure Monometer Common Name: Monitor, Airway Pressure Classification Name: monitor, airway pressure (includes gauge and/or alarm)
Product Code: CAP
Regulation Number: 868.2600
Device Class 2
Substantially equivalent to: 18.3
The Gio Digital Monometer is equivalent to Respironics' pressure manometer (K904935). Other related predicate device:
| 510(k) | Device Name | Type | Pressure Ranges |
|---|---|---|---|
| K08178 | NS Series Airway Pressure Monitors | Balanced Spring | 0 - 60 cm H2O |
| K992101 | Criterion 40 | Digital Manometer | 5 - 99 cm H2O |
| K110119 | NF-009 Pressure Manometer | Balanced Spring | -20 to 80 cmH2O |
Comparison to Predicate Devices 18.4
- Both devices use pressure sensor and displays the pressure reading digitally on an LCD . screen.
- Pressure measuring ranges differ. The Gio Digital Pressure Monometer is available in . four different measuring ranges.
- Display units differ. The Gio Digital Pressure Monometer provides the option to . displaying valued in three different units of pressure.
Design, Materials and Intended Use
The Gio Digital Monometer, principles of operation and intended use are essentially equivalent to the predicate device already cleared by FDA.
Description of the device 18.5
The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated.
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Image /page/1/Picture/1 description: The image shows the logo for Galemed. The logo features the word "galemed" in a stylized font, with the tagline "Caring for life" underneath. The logo also includes a graphic element, which is an oval shape to the left of the word "galemed".
The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges. Each device is easily recognized by their colors (see Figure 1). All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.
| Image: Gio 1 gauge showing 15.0 | Image: Gio 2 gauge showing 35.0 | Image: Gio 3 gauge showing -20.0 | Image: Gio 4 gauge showing -50.0 |
|---|---|---|---|
| Gio 1 | Gio 2 | Gio 3 | Gio 4 |
| Color | Color | Color | Color |
| Pink | Blue | Purple | Turquoise |
| Pressure Range | Pressure Range | Pressure Range | Pressure Range |
| 0 to 30 cmH2O | 0 to 80 cmH2O | -30 to 100 cmH2O | -60 to 0 cmH2O |
Figure 8
Intentionally Left Blank
18.6 Technology
Both the Gio Digital Manometer and the predicate (K904935), convert a signal from a pressure transducer into a signal that is displayed on the LCD panel as a digital pressure value.
Intended Use of the Device: 18.7
The Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.
Performance Summary 18.8
- Meets ISO 60601-1 requirements for battery powered equipment .
- Accuracy is within ± 0.4 of reading. .
18.9 Conclusion
Performance evaluation concludes that the Gio Digital Monometer meet the requirements of IEC 60601-1 associated with battery powered equipment. The Gio Digital Monometer has similar intended use, patient populations and environment of use and equivalent performance to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for Galemed. The logo features the word "galemed" in a stylized font, with the tagline "Caring for life" underneath. The logo has a modern and professional design. The logo is black and white.
Attachment A
- Test Report 1106005001 "IEC/EN 60601-1 Medical electrical equipment" .
- Test Report T110603212-E "CE EMC Test Report for Digital pressure meter . Model GB30
- Test Report 101004 "Measurement accuracy test" .
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Deliberately Left Blank
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the caduceus in a circular fashion. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
GaleMed Corporation C/O Mr. Tom Shanks MDVentures 29201 Via Norte TEMECULA CA 92591
Re: K122627
Trade/Device Name: Gio Digital Monometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: August 13, 2013 Received: August 20, 2013
Dear Mr. Shanks:
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.
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Page 2 - Mr. Shanks
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/5 description: The image shows the text "Mary S. Runner -S" in a large, bold font. The words "Mary" and "Runner" are in a standard font, while the "S." is in a slightly different, bolder font. The "-S" at the end is also in a bold font and slightly smaller than the other words. The text is arranged horizontally and is the main focus of the image.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Concurrence & Template History Page [THIS PAGE IS INCLUDED IN IMAGE COPY ONLY]
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Indications for Use Statement
K122627 510(k) Number:
Device Name: Gio Digital Monometer
Indications for Use:
The Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subparts D) | |
| or | |
| Over-the-counter use | |
| (21 CFR 807 Subpart C) |
Lester W. Schultheis.Jr
2013.08.22 114:29:41 204'00'
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Respiratory, Infection Control and | |
| Dental Devices | |
| 510(k) Number: | K122627 |