(328 days)
Not Found
No
The device description focuses on mechanical components and pressure control, with no mention of AI or ML algorithms for decision-making or data analysis.
Yes
The device is described as an "exhalation valve" used to "control Inspiratory pressure and expel the expired air from a patient being ventilated," which directly impacts the patient's respiratory function and supports ventilation, a therapeutic intervention.
No
Explanation: The device is a component of a ventilation system designed to control inspiratory pressure and expel expired air. Its function is to facilitate breathing, not to diagnose a condition or disease.
No
The device description clearly details physical components like valves, tubes, and connectors, 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:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an exhalation valve used in a breathing system for patients undergoing ventilation. Its function is to control inspiratory pressure and expel expired air. This is a mechanical function related to respiratory support, not the analysis of biological samples.
- Intended Use: The intended use is to assist in the ventilation of patients, not to diagnose or monitor a medical condition through the analysis of samples.
- Device Description: The description focuses on the mechanical components and operation of the valve within a breathing circuit.
- Performance Studies: The performance studies described relate to the mechanical and functional aspects of the valve (resistance to flow, pressure ratio, leakage, etc.), not the accuracy of diagnostic measurements from biological samples.
Therefore, the exhalation valve described is a medical device used for respiratory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. A pediatrics is defined as 10 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
Double limb breathing systems comprising of an inspiratory and expiratory limb is commonly used for respiratory care. To reduce waste and clutter single limb breathing systems can be used with an exhalation valve to dispel exhaled air from the patient. Some ventilator designs or specifications do not require proximal pressure monitoring; airway pressure is monitored inside the ventilator. There are three variants of the exhalation valve in this submission.
Exhalation valve with proximal pressure port (1924501 & 1924504): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. A pressure monitor line and exhalation valve control line directly connects the valve to the ventilator. Via exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases yet allowing for a single limb breathing system to be used instead of a double limb system. The pressure line monitors the pressure in the valve body. The patient end of the exhalation valve has a swivel connector end.
Exhalation valve without proximal proximal prossure port (1923500): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. An exhalation valve control line directly connects the valve to the ventilator. Via the exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases vet allowing for a single limb breathing system to be used instead of a double limb system. The patient end of the exhalation valve has a swivel connector end.
Different ventilators require valves which work with different pressure ratios. The MKIII exhalation valve (1923500 and 1924501) has a 1:1.5 pressure ratio which caters for the majority of ventilators. However, there are markets which have applications for ratio of 1:1, and 1:2. The MK3b exhalation valve (1924504) has a 1:2 pressure ratio. The pressure ratio is the pressure difference between the control line pressure and the pressure that will be generated on the patient side of the valve.
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
adults/pediatrics. A pediatrics is defined as 10 kg in weight. The product is not for use in neonates.
Intended User / Care Setting
used by a physician within hospitals and for home care use.
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 test results are submitted to confirm product safety and substantial equivalence to predicate device. Resistance to Flow, Pressure Ratio, Leakage and Tapers when compared to the legally marketed device were tested.
The resistance to flow through the valve is the same for both predicate and the subject valve.
The pressure ratio for the MK3b and predicate device are exactly the same, meaning it will provide the same performance on the ventilators.
The subject and predicate valve have the same principal of operation.
The leakage in the balloon and the main body is slightly higher in the predicate device than the subject devices, however this leakage is minimal. Intersurgical's internal requirement is for devices to leak less than 5ml/min, however most standard requirements are much larger than this. There is no standard requirement for exhalation valves. The less leakage the more efficient the device will be.
The trigger feature is an additional function which the predicate device is unable to perform, this is a benefit with the new valves and does not alter the intended use, it just means the subject valves can be used on more ventilators. The new valves are validated for patient trigged spontaneous breaths.
The predicate device was previously validated for 24 hours whereas the subject device have been shown to work without any impairment to the performance for 30 days. The predicate device has not been tested for this duration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to Flow:
- MK3 Exhalation Valve (1923500 non-ported and 1924501 ported): 0.6 mbar at 10L/min, 0.9 mbar at 30L/min
- MK3b Exhalation Valve (1924504 ported): 0.6 mbar at 10L/min, 0.9 mbar at 30L/min
- Predicate Exhalation Valve (1922500 K984481): 0.6 mbar at 10L/min, 1.0 mbar at 30L/min
Pressure Ratio:
- MK3 Exhalation Valve (1923500 & 1924501): 1:1.5
- MK3b Exhalation Valve (1924504): 1:2
- Predicate Exhalation Valve (1922500 K984481): 1:2
Leakage:
- MK3 Exhalation Valve (1923500 non-ported and 1924501 ported):
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).
0
JUN 0 4 2014
Section 5 510(k) Summary
510K Submitter Address and Establishment Registration Number:
Registration Number: 1319447 Name: INTERSURGICAL INCORPORATED 417 Electronics Parkwav Address: Liverpool, NY 13088 Date: May 2, 2014 Contact Person: Michael Zalewski - VP RAIQA/CS Phone Number: 315-451-2900 X 202 Fax Number: 315-451-3696
Classification: 21 CFR 868.5870, Classification Name: Non-rebreathing Valve, Classification Product Code: 73 CBP, Device Class: II, 510K Submission: Traditional.
Predicate Device:
The 1923500 & 1924501 MK3 exhalation valve and the 1924504 MK3b exhalation valves are substantially equivalent to the Intersurgical 1922500 exhalation valve (K984481). The predicate device can be used on a single limb breathing systems. The valve sits on a T-piece connected at the patient end of the breathing tube. When the patient inspires, pressure applied via the exhalation line inflates the valve membrane causing it to close off the exhalation port. Then when the patient exhales the pressure on the membrane is released allowing the exhaled air to escape. The predicate valve has a 1:2 pressure ratio similar to the MKIIIb. The device is for single patient use on adults and pediatrics.
The function of all three valves is the same, however the MK3 and MK3b can seal with a low inspiratory drive in order that the ventilator can trigger a spontaneous breath. IPPB machines in the past had no requirement for PEEP control. however ventilators are generally now fitted with controllable PEEP modes
The predicate device is aesthetically different to the MK3 and MK3b, the MK3 valves are now inline, reducing the need for additional connectors.
Description of Device:
Double limb breathing systems comprising of an inspiratory and expiratory limb is commonly used for respiratory care. To reduce waste and clutter single limb breathing systems can be used with an exhalation valve to dispel exhaled air from the patient. Some ventilator designs or specifications do not require proximal pressure monitoring; airway pressure is monitored inside the ventilator. There are three variants of the exhalation valve in this submission.
1
Description of Device:
Exhalation valve with proximal pressure port (1924501 &1924504)
A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. A pressure monitor line and exhalation valve control line directly connects the valve to the ventilator. Via exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases yet allowing for a single limb breathing system to be used instead of a double limb system. The pressure line monitors the pressure in the valve body. The patient end of the exhalation valve has a swivel connector end.
Exhalation valve without proximal proximal prossure port (1923500)
A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. An exhalation valve control line directly connects the valve to the ventilator. Via the exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases vet allowing for a single limb breathing system to be used instead of a double limb system. The patient end of the exhalation valve has a swivel connector end.
Different ventilators require valves which work with different pressure ratios. The MKIII exhalation valve (1923500 and 1924501) has a 1:1.5 pressure ratio which caters for the majority of ventilators. However, there are markets which have applications for ratio of 1:1, and 1:2. The MK3b exhalation valve (1924504) has a 1:2 pressure ratio. The pressure ratio is the pressure difference between the control line pressure and the pressure that will be generated on the patient side of the valve.
Indications for Use:
The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.
2
Technology Characteristics Summary
The intended use of the Intersurgical Exhalation Valves is comparable to the referenced predicate device. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for resistance to flow, pressure ratio and leakage when compared to the legally marketed devices.
Non-clinical test results are submitted to confirm product safety and substantial equivalence to predicate device.
| Characteristic
Compared | MK3 Exhalation Valve
-1923500 non-ported
and 1924501 ported | MK3b Exhalation
Valve - 1924504
ported | Predicate Exhalation
Valve 1922500
K984481 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:
Target population | Adult/pediatric patient
using a single limb
breathing tube. | Adult/pediatric patient
using a single limb
breathing tube. | Adult/pediatric patient
using a single limb
breathing tube. |
| Indications for use
Product has been designed
and validated for 30 days
whereas predicate product
was not. It is an
improvement on the
product, the performance
remains comparable to the
predicate. | The exhalation valves
are used to control
Inspiratory pressure and
expel the expired air
from a patient being
ventilated via a single
limb breathing system.
The exhalation valve and
single limb breathing
systems are used with
adults/pediatrics and
prescribed by a
physician. The device
can be used within
hospitals and for home
care use. It is a single
patient use device and
can be used for a
maximum of 30 days. | The exhalation valves
are used to control
Inspiratory pressure and
expel the expired air
from a patient being
ventilated via a single
limb breathing system.
The exhalation valve
and single limb
breathing systems are
used with
adults/pediatrics and
prescribed by a
physician. The device
can be used within
hospitals and for home
care use. It is a single
patient use device and
can be used for a
maximum of 30 days. | A one-way valve that
prevents the escape of
inspiratory gases and
rebreathing of of
expired gases while
providing a means of
egress for expired gases.
Fits all 22 male T-pieces
and allows for the use of
PEEP valve as the gases
exit the valve via a
22mm port.
Recommended change:
every 24 hours or more
frequently if visible
deterioration is
observed. Single patient
use. |
Device Comparison Table
3
Device Comparison Table
| Characteristic
Compared | MK3 Exhalation Valve
3500 non-ported
1924531 DOI | 3b.Exhalation
11:48 | Predicate Exhala
Valve 1922500 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Where used | Hospital and home | Hospital and home | Hospital and home |
| Product Labeling | Breathing circuit
with
exhalation valve. | Breathing circuit with
exhalation valve. | Breathing
circuit
with
exhalation valve. |
| Single Use or Reusable? | Single Patient Use | Single Patient Use | Single Patient Use |
| Design
and
Performance: | | | |
| Flow
Resistance
to
at
10L/min in mbar | 0.6 | 0.6 same body as MK3 | 0.6 |
| Resistance
to
Flow
at
30L/min in mbar | 0.9 | 0.9 same body as MK3 | 1.0 |
| Pressure Ratio | 1:1.5 | 1:2 | 1:2 |
| Leakage
balloon
in
ml/min | 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) |
| Anya C. Harry -S |
| 2014.06.04 |
| 05:38:03 -04'00' |