(125 days)
No
The device is a simple mechanical pressure manometer with a spring and float mechanism, and the description contains no mention of AI or ML.
No
The device provides visual indication of airway pressure for monitoring purposes and does not directly treat or prevent a condition.
Yes
Explanation: The device provides "visual indication of a patient's airway pressure," which is a measurement of a physiological parameter. This measurement informs clinicians about the patient's condition during ventilation, aiding in diagnosis (e.g., detecting excessively high or low pressures that could indicate problems) and monitoring of treatment effectiveness.
No
The device description clearly outlines physical components like a flexible nipple, clear housing, float, and spring, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Besmed disposable pressure manometer measures airway pressure during ventilation. This is a direct measurement of a physiological parameter within the patient's respiratory system, not an analysis of a specimen taken from the patient.
- Intended Use: The intended use clearly states it provides a visual indication of a patient's airway pressure during ventilation and is attached to ventilation devices. This aligns with monitoring a physiological function, not analyzing a biological sample.
Therefore, this device falls under the category of a medical device used for monitoring physiological parameters, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, including neonates to adults. Home. Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.
Product codes
CAP
Device Description
The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.
The device consists of:
-
- A flexible nipple for attachment to a sampling / pressure port.
-
- Clear housing with a printed pressure scale
-
- A float with indicator
-
- Spring
When positive pressure is present in the ventilation device, the 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.
Besmed intends offer three (3) models / styles of their disposable pressure manometer.
They are identical in design, function and materials. The differences are:
- Pressure range .
- 0 0 60 cm H2O
- 0 40 cm H2O
- · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design
- Note the accuracy and performances are identical
- . Indicator strip
.
- O All models have the pressure range embossed on the housing
- o A color strip / indicator may also be included to indicate the pressure
It is a single patient, disposable, packaged non-sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
neonates to adults
Intended User / Care Setting
Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.
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)
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 of pressure across the full pressure range to meet the pass / fail criteria
- Comparative accuracy testing showed no statistical difference in accuracy performance . between the proposed device and the predicate, K003497 - EMS
- . Age testing simulated to be equivalent to 5 years
- . Environmental testing at high and low temperatures (MIL-STD-810E)
- Mechanical testing Drop test .
All testing demonstrated that the proposed device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
- ± 1 cm H₂O from 0-10 cm H₂O
- ± 2 cm H₂O from 10-40 cm H₂O
- ± 3 cm H₂O above 40 cm H₂O
Predicate Device(s)
K003497 - Engineered Medical Systems - Pressure Monitor
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).
0
JUN 1 9 2014
510(k) Summary Page 1 of 4
| Date Prepared: | 19-Jun-2014 | |
|---|---|---|
| Besmed Health Business Corp. | ||
| No. 5, Lane 116, Wu-Kong 2nd Rd, | ||
| Wu-Ku District, New Taipei City, Taiwan | Tel - 011-886-2-2290-3959 | |
| Fax - 011-886-2-2299-9076 | ||
| Official Contact: | Winnie Chung | |
| Regulatory Affairs Associate | ||
| Proprietary or Trade Name: | Disposable Pressure Manometer | |
| Common/Usual Name: | Airway Pressure Monitor | |
| Classification Name: | 21CFR 868.2600 | |
| CAP - Airway Pressure Monitor | ||
| Class II | ||
| Predicate Devices: | K003497 - Engineered Medical Systems - Pressure Monitor |
Device Description:
The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.
The device consists of:
-
- A flexible nipple for attachment to a sampling / pressure port.
-
- Clear housing with a printed pressure scale
-
- A float with indicator
-
- Spring
When positive pressure is present in the ventilation device, the 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.
Besmed intends offer three (3) models / styles of their disposable pressure manometer.
They are identical in design, function and materials. The differences are:
- Pressure range .
- 0 0 60 cm H2O
- 0 40 cm H2O
- · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design
- Note the accuracy and performances are identical
- . Indicator strip
.
- O All models have the pressure range embossed on the housing
- o A color strip / indicator may also be included to indicate the pressure
1
510(k) Summary Page 2 of 4 19-Jun-2014
It is a single patient, disposable, packaged non-sterile device.
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, including neonates to adults. 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 Besmed Disposable Pressure Manometer with the identified predicate and demonstrates that the device can be found to be 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 - EMS pressure manometer.
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 predicate - K003497 - EMS pressure manometer.
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. It has markings to indicate the pressure observed as well as a fixed leak to avoid over pressurization.
Environment of Use -
The environments of use are identical to predicate - K003497 - EMS pressure manometer. Discussion - The environments of use are identical to the predicate - K003497 - EMS pressure manometer.
Patient Population -
The patient population is defined as patient where the clinician wants to measure or monitor circuit or airway pressure. The specific patient population is the same as the device to which it is attached which could be neonates to adults.
Discussion - The patient populations are equivalent to the predicate - K003497 - EMS pressure manometer.
2
510(k) Summary
| Attribute | Predicate | Proposed |
|---|---|---|
| EMS – K003497 Pressure Manometer | Besmed DPM | |
| 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. | 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 | Patient that the clinician desires to | |
| monitor or measure pressure, neonates to | ||
| adults | Patient that the clinician desires to | |
| monitor or measure pressure. | ||
| Environments of use | Home, Physician office, Hospital, Sub- | |
| acute Institutions, Emergency services or | ||
| anywhere measurement of airway | ||
| pressure is desired. | Home, Physician office, Hospital, Sub- | |
| acute Institutions, Emergency services or | ||
| anywhere measurement of airway | ||
| pressure is desired. | ||
| Prescriptive | Yes | Yes |
| Single patient, disposable | Yes | Yes |
| Connects to a sampling | ||
| port of any device, i.e. | ||
| resuscitator, etc. | 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. | 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. | ||
| Basic components | Housing | |
| Float | ||
| Spring | ||
| Pressure markings | ||
| Fixed leak in the unit | Housing | |
| Float | ||
| Spring | ||
| Pressure markings | ||
| Fixed leak in the unit | ||
| Pressure range | 0 - 50 cm H₂O | 0 - 60 cm H₂O |
| Models | Only one | Three 0-40, 0-60 with indicator stripe |
| 0-60 with embossed pressure but no | ||
| indicated stripe | ||
| Performance testing | Accuracy | |
| • ± 1 cm H₂O from 0-10 cm H₂O | ||
| • ± 2 cm H₂O from 10-40 cm H₂O | ||
| • ± 3 cm H₂O above 40 cm H₂O | Accuracy | |
| • ± 1 cm H₂O from 0-10 cm H₂O | ||
| • ± 2 cm H₂O from 10-40 cm H₂O | ||
| • ± 3 cm H₂O above 40 cm H₂O | ||
| Age Testing – 5 years | ||
| Pre and post- exposure | ||
| Environmental Testing | ||
| High / Low and Humidity conditions | ||
| Drop test | ||
| Biocompatibility | • External Communication (Indirect | |
| contact) for all materials not in | ||
| direct contact | ||
| • Tissue communicating | ||
| • Limited duration ( |