(122 days)
Indicated for supplying compressed air for medical ventilators.
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.
The provided document describes a medical device (portable air compressor DK50 DS) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML or diagnostic device.
The document focuses on:
-
Device Description: A portable air compressor designed to supply air to medical ventilators.
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Indications for Use: Supplying compressed air for medical ventilators in hospital or sub-acute institution environments.
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Substantial Equivalence: A comparison of the DK50 DS with two predicate devices (K060781 - Ekom Model DK50 D and K041406 - Newport Model C250) based on specifications like output flow, power, alarms, and physical dimensions.
This is a 510(k) premarket notification for a traditional medical device (a portable air compressor), not an AI/ML-driven diagnostic or image analysis tool. Therefore, the concepts of acceptance criteria for diagnostic performance (like sensitivity, specificity), ground truth, test/training sets, expert adjudication, or MRMC studies are not applicable to the information provided.
The "acceptance criteria" discussed in the document are effectively the technical specifications and performance characteristics compared against the predicate devices to establish substantial equivalence.
Therefore, I cannot provide the requested information because it is not present in the given text.
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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 compressor21 CFR 868.6250 |
| Device: | DK50 DS |
| Predicate Devices: | K060781 - Ekom Model DK50 DK041406 - 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.
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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 deviceDK50 DS | Unmodified devicePredicate - K060781DK50 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 | < 51 dB(A) | < 51 dB(A) |
| Mode of operation | Continuous - S1 | Continuous - S1 |
| Separation of condensed water | Automatic | Automatic |
| Operating pressure of safety valve | 8 bar (116 psig) | 8 bar (116 psig) |
| Adjustment of pressure output | Pressure regulator | Pressure regulator |
| Alarm for cooling failure / hightemperature | Acoustic and optical if increase in internaltemperature > 80°C (176°F) | Acoustic and optical if increase ininternal temperature > 80°C (176°F) |
| Automatic turn-on pressure | When central distribution pressure < 2.8bar (40.6 psig) | When central distribution pressure < 2.8 bar (40.6 psig) |
| Output pressure | 3 bar (43.5 psig) | 3 bar (43.5 psig) |
| Output pressure indicator | Display | Pressure gauge |
| Alarm - loss of power | Yes | No, but instructions requireconnection to equipment with thisalarm |
| Indication of drying | LEDs | Pressure gauge |
| Alarm for low pressure | Internal when output pressure < 2.1 bar (30psig) | None instructions requireconnection to equipment with thisalarm |
| Air tank capacity | 2L | 5L |
| Pressure range | 5 to 6.5 bar (72.5 - 94 psig) | 5 to 7 bar (72.5 – 101.5 psig) |
| Dimensions (mm) | 510 x 480 x 470 mm (17.5 x 14 x 17 in.) | 500 x 530 x 870mm16 x 17 x 30.5 in |
| Weight | 30 kg (66 lbs) | 46 kg (101 lbs) |
Table 1 – Table of the Similarities and Modifications from Predicate vs. new Model
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510(k) Summary Page 3 of 3 12-Aug-09
| Model Name: | New deviceDK50 DS | Predicate - K041406Newport Model 250C |
|---|---|---|
| Specification | ||
| Alarm - loss of power | Yes | Red light and audible alarmwhen no power |
| Alarm for low pressure | Triggers when output pressure< 2.1 bar ((30 psig) | Triggers at 30 + 2 psig(2.0 $ ± $ 0.13 bar) |
Table 2. Comparison of Alarms between Predicate and Proposed Model
It is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.
Substantial Equivalence
The Ekom DK50 DS is viewed as substantially equivalent to the predicate devices because:
Indications -
- Identical to predicate K060781 Ekom DK50 D .
Technology -
Materials -
- The materials in patient contact are identical to predicate device, K060781 Ekom . DK50 D.
Environment of Use -
- Identical to predicate K060781 Ekom DK50 D �
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government authority.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ekmo S.R.O. C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
OCT 2 3 2009
Re: K091871
Trade/Device Name: Model DK50 DS Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: September 22, 2009 Received: September 23, 2009
Dear Mr. Dryden:
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.
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. Dryden
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Wh for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number: K091871 (To be assigned)
Device Name: Model DK50 DS
Indications for Use:
Indicated for supplying compressed air for medical ventilators.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulte
(Division Sign-Off) (Division Sign-chi)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091871
§ 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.