(333 days)
NOT FOUND
No
The description focuses on the mechanical function of providing compressed air and mentions standard control features like standby and alarms based on temperature and pressure. There is no mention of AI, ML, or any learning or adaptive capabilities.
No.
The device's intended use is to supply compressed air to a medical respiratory ventilator or anesthesia machine, which are therapeutic devices themselves. The Compressor Mini facilitates the function of therapeutic devices but does not directly provide therapy.
No
Explanation: The device's intended use is to provide compressed air for medical respiratory ventilators or anesthesia machines. It is not described as analyzing or interpreting biological data or images for diagnosis.
No
The device description clearly describes a physical compressor with components like a compressor mechanism, filters, and pressure/temperature alarms, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide compressed air for medical respiratory ventilators or anesthesia machines. This is a supportive function for medical equipment used in patient care, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the mechanical function of providing compressed air, including capacity, pressure, noise level, and alarm parameters. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description 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 prognosis of a disease or condition
The Compressor Mini is a medical device that supports the function of other medical devices (ventilators and anesthesia machines) used in patient treatment. It does not perform any diagnostic testing itself.
N/A
Intended Use / Indications for Use
The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 -- 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.
Product codes
BTI
Device Description
Compressor Mini will provide a supply of dry and filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vimin at 50-64 psi (350 - 450 kPa).
The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use.
It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air.
The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.
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
healthcare providers, physicians, nurses and technicians. Compressor Mini is to be used only for bedside application within the hospital environment.
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)
ALRECO 40400 Allan Rehnström AB K951926
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K02354
SEP - 5 2003
| SIEMENS | | Document Type
510(k) Notification | Page
19 |
|----------------------------------------------------|--|--------------------------------------|-----------------|
| Obiect/Subiect
Compressor Mini - 510(k) Summary | | Doc-ID
EVU-113162 | Issue no.
01 |
510(K) Summary as required by section 807.92(c) 1 October 2002
Subscribers Name & Address: F.1
Siemens-Elema AB Electromedical Systems Division, Life Support Systems Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: +46 8 730 7000 Fax: +46 8 98 78 38 Official Correspondent: Richard Flynn.
(Manager Regulatory Affairs/Quality Assurance, Siemens Medical Solutions USA, Inc. /S.S.G. -R.A. 16 Electronics Avenue Danvers, MA USA 01923) Veronica Ekström
Contact Person for this submission:
F.2 Trade Name:
Device name: Compressor Mini
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Compressor Mini | BTI | II | 21.CFR.868.6250 |
F.3 Predicate Device Identification:
Compressor Mini is a first time application. Substantial equivalence to a predicate device, ALRECO 40400 Allan Rehnström AB K951926, is claimed.
F.4 Device Description:
Compressor Mini will provide a supply of dry and filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vimin at 50-64 psi (350 - 450 kPa).
The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use.
It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air.
The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.
1
| | Document Type
510(k) Notification | Page | |
|----------------------------------------------------|--------------------------------------|----------------------|-----------------|
| Object/Subject
Compressor Mini - 510(k) Summary | | 20 | |
| | | Doc-ID
EVU-113162 | Issue no.
01 |
Intended Use of the Device: F.5
The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is to be used only for bedside application within the hospital environment. Compressor Mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.
F.6 Summary of technological characteristics of Device and Predicate Device
The functionality for the Compressor mini is equivalent to the ALRECO 40400. Compressor mini and ALRECO 40400 have the same technological characteristics, intended use, materials, method of operation, performance claims and energy source but the compressor mini is scaled down for smaller size.
The differences are:
- A more compact design and lighter weight. ●
- Less power consumption.
- Lower continuous flow and smaller built-in reservoir, since the Compressor Mini is . designed to supply only one ventilator with compressed air. The Compressor Compact could support multiple ventilators.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.
SEP - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens-Elema AB C/O Mr. Timothy W. Capehart Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923
Re: K023354
Trade Name: Compressor Mini, 115 V, Model 64 81 779 EH81E Regulation Number: 868.6250 Regulation Name: Compressor, Air, Portable Regulatory Class: II Product Code: BTI Dated: August 8, 2003 Received: August 15, 2003
Dear Mr. Capehart:
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 such 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.
3
Page 2 -Mr. Timothy W. Capehart
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours
Qui- S. Lyon
Susan Runner, DDS, Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K023354
Device Name: Compressor Mini
Indications For Use:
The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 -- 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
----------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(21 CFR 868.6250)
OR
Over-The-Counter Use
E. Antrach for JXH
General Hospital.
510(k) Number: K023354