(80 days)
K 951126
No
The summary describes a basic air compressor and explicitly states that AI, DNN, or ML were not found in the document.
No
The device is an air compressor that supplies medical ventilators. It does not directly treat a disease or condition itself.
No
Explanation: The device is an air compressor for medical ventilators, which is a supportive device, not one that gathers or analyzes data for diagnosis.
No
The device description explicitly states it is an "electric" device that "produces compressed air," 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:
- Intended Use: The intended use is "Air compressor supplying compressed air for medical ventilators." This describes a device that provides a necessary resource (compressed air) for another medical device (a ventilator).
- Device Description: The description confirms it produces compressed air from the environment.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other substances to perform tests.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This air compressor does not perform any such function. It is a supporting device for a medical treatment device (the ventilator).
N/A
Intended Use / Indications for Use
Air compressor supplying compressed air for medical ventilators.
Product codes
73 BTI
Device Description
The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.
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
Not Found
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)
Dräger Medical Air Compressor- Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc.
Reference Device(s)
K 951126
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
K982789
Dräger
OCT 2 9 1998
file: 510kstate.RTF Date: Feb. 1998 Author: Frank Clanzett
510(k) SUMMARY Summary of Safety and Effectiveness
APPLICANTS NAME AND ADDRESS: Drager Inc. . . . . . Critical Care Systems
3136 Quarry Road Telford , PA 18969
APPLICANTS TELEPHONE NUMBER: (215)-721-6917
APPLICANTS FACSIMILE NUMBER: (215)-721-6915
APPLICANTS CONTACT PERSON: Harald Kneuer Regulatory Affairs Manager
DATE THE SUMMARY WAS PREPARED: MArch, 1998
DEVICE NAME:
Trade Name: Common Name: Classification Name: Product Code:
Medical Air Compressor "Model 98" Medical Air Compressor Compressor, Air, Protable (per 21CFR868.6250) 73 BTI
LEGALLY MARKETED DEVICE TO WHICH DRÄGER IS CLAIMING SUBSTANTIAL EQUIVALENCE:
Dräger Medical Air Compressor- Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc.
Page 1 of 3
1
DESCRIPTION OF THE DEVICE
The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.
.. . . .
INTENDED USE OF THE DEVICE
The device is an air compressor supplying compressed air for medical ventilators.
: 上一篇: 上一篇:
| Specification | Medical Air Compressor
(K 951126) | Medical Air
Compressor Modell 98 |
|--------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended use | Air compressor supplying
compressed air for medical
respirators | Air compressor supplying
compressed air for medical
respirators |
| Safety: | | |
| High temperature alarm? | Yes | Yes |
| Audible alarm? | Yes | Yes |
| Visible alarm? | Yes | Yes |
| Main Fuses? | Yes | Yes |
| Performance
characteristics | | |
| Dew point depression:
below room temperature? | Yes | Yes |
| Air quality:
Dust and oil free? | Yes | Yes |
| Installed filter? | Yes | Yes |
| Standby-Mode? | Yes | Yes |
| Operating Characteristics | All operating characteristics of both devices are substantial
equivalent | |
COMPARISON OF THE DEVICES
2
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:
The compressor functions of the Dräger Medical Air Compressor " Model 90" is substantial equivalent to the predicate device Dräger Medical Air Compressor.
The "Model 98" integrates the same functions and performances that are presently performed by the predicate Dräger Medical Air Compressor.
The "Model 98" fulfils the same standards as the Dräger Medical Air Compressor.
Therefore the device under review is substantial equivalent to the predicate devices concerning safety, efficiency and the intended use.
Fllly
Frank Clanzett Regulatory Affairs Dräger Medizintechnik
PASSES OF ACTION OF THE COLLECTION OF CONSULTION OF
3
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 stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 29 1998
Mr. Harald Kneuer Drager, Inc. Critical Care Systems 3136 Quarry Road Telford, PA 18969
Re: K982789 Medical Air Compressor, Model #8413419 Regulatory Class: II (two) Product Code: 73 BTI Dated: August 7, 1998 Received: August 10, 1998
Dear Mr. Kneuer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Harald Kneuer
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Intended Use Statement of the Dräger Medical Air Compressor Model 98
Air compressor supplying compressed air for medical ventilators.
R. Degenhart.
Rainer Degenhart
Rainer Deg nhart (project manager)
May 1998
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K98278 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
:
・
(Optional Format 1-2-96)