(112 days)
K.082092, K082092
No
The summary describes a mechanical device (PEEP valve) with modifications for MR compatibility. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device functions by elevating the pressure in a patient's lungs, which is a therapeutic intervention aimed at improving respiratory function.
No
The device is a valve used to regulate pressure in the lungs, which is a therapeutic or support function, not for diagnosing a medical condition. The intended use "to evaluate end lung pressure" refers to assessing the mechanical outcome of the valve's function, not for diagnostic purposes of a disease.
No
The device description clearly states it is a physical valve with components made of specific materials, and the performance studies involve physical testing (MR conditional, leakage, pressure/resistance, drop test, environmental conditions, transportation, age testing). There is no mention of software as the primary or sole 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 "evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions." This describes a device used to manage and monitor a physiological parameter (lung pressure) directly on a patient.
- Device Description: The device is a "positive end expiratory pressure (PEEP) valve" which is a mechanical device used in respiratory support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is used to directly influence and measure a physiological function within the body.
N/A
Intended Use / Indications for Use
Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults.
Product codes
BYE
Device Description
The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environments of use. Otherwise the PEEP valves are identical.
Galemed disposable adjustable PEEP valves elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation.
The Galemed disposable adjustable PEEP valve for use in MR environments is identical to our predicate, K082092, disposable PEEP valve, except we have replaced the materials in 2 components, a push rod and the springs to materials which are less magnetic. Other than these 2 changes, the device is identical to the predicate. These changes / modifications have been evaluated and demonstrated that they do not alter nor change the performance or safety profile of the new device as compared to the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
neonates to adults
Intended User / Care Setting
hospital, transport, emergency, and post hospital 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing -
We have performed the following performance data and testing:
- MR conditional in accordance with ASTM F2052-02 in a 3 Tesla MR suite. According to ASTM F2052-02 the proposed device should not deflect more than 45 degree, the proposed device did not deflect this far and thus met the requirements.
- Leakage: The device was pressurized and leakage measured before and after age testing. It met the pass /fail criteria.
- Pressure / Resistance Accuracy: The device was tested for repeatability and accuracy after being subjected to a number of conditions; it met its performance specifications criteria.
- Drop test: The device was dropped and tested for leakage and pressure / resistance. It met the pass /fail criteria.
- Environmental Conditions: The device was subjected to high and low temperature conditions and then tested, it met its performance specifications criteria.
- Transportation: The device was subjected to transportation testing and then tested it met its performance specifications criteria.
- Age testing: The device was age testing and then evaluated it met its performance specifications criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).
0
K133957
APR 1 4 2014
510(k) Summary Page 1 of 4 12-Feb-14
Galemed Corp. Amoy Export Processing Zone, 39 Section 3, Haijing East Road Xiamen, Fujian Province, China
| Official Contact: | Enhe Liu, QA Director |
|---|---|
| Proprietary or Trade Name: | Disposable Adjustable PEEP Valve |
| Common/Usual Name: | PEEP Valve |
| Classification Name: | BYE - Attachment, breathing, positive end expiratory |
| pressure | |
| 21 CFR 868.5965 | |
| Predicate Devices: | K082092 - Galemed PEEP valve |
| K081266 - Mercury Medical - PEEP Valve MR |
Device Description
The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environments of use. Otherwise the PEEP valves are identical.
Galemed disposable adjustable PEEP valves elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation.
The Galemed disposable adjustable PEEP valve for use in MR environments is identical to our predicate, K082092, disposable PEEP valve, except we have replaced the materials in 2 components, a push rod and the springs to materials which are less magnetic. Other than these 2 changes, the device is identical to the predicate. These changes / modifications have been evaluated and demonstrated that they do not alter nor change the performance or safety profile of the new device as compared to the predicates.
Modifications to Proposed Device compared to Predicate
The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environment of use. Otherwise the PEEP valves are identical.
Indications for Use
Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults.
1
510(k) Summary Page 2 of 4 12-Feb-14
Environment of Use
Hospital, extended care facilities, emergency medical services, and patient transport
May be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Contraindications
Contraindicated in individuals not requiring elevated end expiratory pressure therapy
Predicate Device Comparison:
The proposed disposable adjustable PEEP valves are identical to our predicate Galemed PEEP valves, K082092, except for a change in materials for the rod and the springs to less magnetic materials.
Comparative Table 1 discusses the major features of the proposed device and the legally marketed predicate device.
The Galemed Disposable Adjustable PEEP Valve is viewed as substantially equivalent to the predicate device based upon the following:
Indications -
-
Indicated as a Single patient use adjustable positive end expiratory pressure (PEEP) . valve for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions.
Discussion - The indications for use are identical for the proposed and predicate device, Galemed PEEP Valve, K082092. -
The addition of the indications for use in a Magnetic Resonance (MR) environment, not . to exceed a 3.0 Tesla static magnetic field is new but testing has demonstrated that the device meets the recognized standard as a MR conditional device.
Discussion - The indications for use as MR Conditional is identical for the proposed and predicate device, Mercury Medical, PEEP Valve, K081266.
Technology -
- The technology of the use as a, spring actuated valve, which when placed into a circuit or . manual resuscitator, provides positive end expiratory pressure for the patient is identical to the predicates.
Discussion - There are no differences in technology between the proposed device and the predicates - Galemed PEEP Valve, K082092 and Mercury Medical, PEEP Valve, K081266.
Materials -
- The materials are identical to predicate with the exception of a change in the spring . material.
2
510(k) Summary Page 3 of 4 12-Feb-14
- According to ISO 10993-1 the proposed device would be considered External . communicating, Tissue / mucosal, limited duration (