(122 days)
Not Found
No
The description details a mechanical air compressor with standard control logic based on pressure sensing and air consumption. There is no mention of AI or ML algorithms for control, analysis, or any other function.
No.
The device is an air compressor that supplies compressed air to medical ventilators; it does not directly treat a medical condition.
No
This device is described as an air compressor for medical ventilators, meaning it supplies air for the operation of other medical equipment. It does not perform any diagnostic functions or analyze medical data to diagnose conditions.
No
The device description clearly outlines a physical air compressor with mechanical and electrical components, including a piston compressor, electric motor, filters, pressure regulator, air tank, and control unit. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "supplying compressed air for medical ventilators." This is a device that provides a physical resource (compressed air) to another medical device (a ventilator).
- Device Description: The description details a mechanical system for compressing and filtering air. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a medical device, but its function is to support the operation of another medical device (a ventilator), not to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indicated for supplying compressed air for medical ventilators.
Product codes (comma separated list FDA assigned to the subject device)
BTI
Device Description
The Ekom model DK50 DS is a portable air compressor designed to supply air to medical equipment, i.e., ventilators.
The Model DK50 DS contain an oil-free piston compressor driven by a low maintenance single phase electric motor. Compressed air is cooled where condensed water is separated into a vessel. Incoming air passes through 2 filters and undergoes double filtration as it passes through the system. Constant output pressure is maintained by a pressure regulator. There is a built-in air tank which allows peak air consumption of 200 Lpm.
The device may be used as a standby source of air. In this configuration, the respiratory equipment is supplied with compressed air from the facilities central air distribution. Air pressure in this central distribution is sensed by the Ekom pressure sensor. If the pressure is sufficient, the compressor stays in the STANDBY mode. If the pressure falls the compressor automatically starts and becomes the main air supply.
When the compressor is used as the main source, the control unit determines its operation according to the current need for air. If air consumption is zero, the device switches to STANDBY.
The compressor is equipped with indicators for output pressure, operation hours, power status, drying efficiency and battery condition as well as acoustic and optic alarms to warn of high operating temperature, low output pressure and loss power.
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
Not Found
Intended User / Care Setting
Hospital or sub-acute institution
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
510(k) Summary Page 1 of 3 12-Aug-09
OCT 28 2009
EKOM spol s.r.o. Priemyselna 5031/18 921 01 Piestany SLOVAKIA
Tel - +011 421 33 7967246 Fax - +011 421 33 7967223
| Official Contact: | Ernest Koppon - Quality and Regulatory Manager |
|---|---|
| Proprietary or Trade Name: | DK50 DS |
| Common/Usual Name: | Portable air compressor |
| Classification Name/Code: | BTI - portable air compressor |
| 21 CFR 868.6250 | |
| Device: | DK50 DS |
| Predicate Devices: | K060781 - Ekom Model DK50 D |
| K041406 - Newport Model C250 |
Device Description:
The Ekom model DK50 DS is a portable air compressor designed to supply air to medical equipment, i.e., ventilators.
The Model DK50 DS contain an oil-free piston compressor driven by a low maintenance single phase electric motor. Compressed air is cooled where condensed water is separated into a vessel. Incoming air passes through 2 filters and undergoes double filtration as it passes through the system. Constant output pressure is maintained by a pressure regulator. There is a built-in air tank which allows peak air consumption of 200 Lpm.
The device may be used as a standby source of air. In this configuration, the respiratory equipment is supplied with compressed air from the facilities central air distribution. Air pressure in this central distribution is sensed by the Ekom pressure sensor. If the pressure is sufficient, the compressor stays in the STANDBY mode. If the pressure falls the compressor automatically starts and becomes the main air supply.
When the compressor is used as the main source, the control unit determines its operation according to the current need for air. If air consumption is zero, the device switches to STANDBY.
The compressor is equipped with indicators for output pressure, operation hours, power status, drying efficiency and battery condition as well as acoustic and optic alarms to warn of high operating temperature, low output pressure and loss power.
1
510(k) Summary Page 2 of 3 12-Aug-09
Indications for Use:
Indicated for supplying compressed air for medical ventilators.
Environment of Use:
Hospital or sub-acute institution
Summary of substantial equivalence:
| Model Name: | Modified device
DK50 DS | Unmodified device
Predicate - K060781
DK50 D |
|-------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Specification | | |
| Output flow | Max. 40 Lpm | Max. 40 Lpm |
| Peak Flow | 200 Lpm for 2 sec | 200 Lpm for 2 sec |
| Power | 120V /60 Hz | 120V /60 Hz |
| Nominal current (amps) | 5.6 A | 5.6 A |
| Air filtration | 5 micron | 5 micron |
| Pressure dew point @ 40 Lpm 20°C | 5°C below ambient temperature | 5°C below ambient temperature |
| Outlet connection | DISS | DISS |
| Sound level | 80°C (176°F) | Acoustic and optical if increase in
internal temperature > 80°C (176°F) |
| Automatic turn-on pressure | When central distribution pressure