(77 days)
Not Found, Not Found, Not Found
Not Found
No
The document describes a pneumatically controlled oxygen mixing device and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is described as providing "oxygen therapy," which indicates a therapeutic purpose.
No
The device is described as an "Air Oxygen Mixer" used to "provide oxygen therapy". This indicates a therapeutic function, not a diagnostic one. Its purpose is to deliver air and oxygen, not to detect, identify, or monitor medical conditions.
No
The device description explicitly states it is a "pneumatically controlled low flow... air oxygen mixing device," indicating it is a hardware device that mixes gases.
Based on the provided information, the SK Med Air Oxygen Mixer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide oxygen therapy to patients (infants and the perinatal population) in a hospital environment. This involves delivering gases directly to the patient's respiratory system.
- Device Description: The device is described as a pneumatically controlled mixing device for air and oxygen.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The SK Med Air Oxygen Mixer does not interact with or analyze biological specimens.
The device is clearly intended for direct patient care and respiratory support, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SK Med Air Oxygen Mixer is intended for use with the infant and The SK Med An Oxygen Maxer in a hospital environment. Its indications for use are perilative population in a noops. I the Bird Low Flow Air Oxygen exactly the same as the predicate device i.e. the Bird Love Flow with exactly the same as the provide oxygen therapy in conjunction with: - Oxygen Hoods - · Resuscitation Bags - Masks - · Nasal Cannulas
Product codes
73 BZR
Device Description
The Air Oxygen Mixer is a pneumatically controlled low flow ( up to 30 lpm maximum flow ) air oxygen mixing device.
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
infant and perilative population
Intended User / Care Setting
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
In order to verify Safety, Effectiveness (performance), and Environmental Characteristics (including Hi/Lo Temperature, Humidity, Shock/Vibration), the Air Oxygen Mixer was subjected to extensive bench & environmental laboratory testing. The results of the testing have demonstrated that the Air Oxygen Mixer is as safe and effective as the Bird Low Flow Microblender.
Key Metrics
Not Found
Predicate Device(s)
The Bird Low Flow Air/Oxygen Microblender
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).
0
1. Name: SK MED
Address: 16000 Sherman Way #224
FEB - 5 1998
Van Nuys
CA 91406
Phone: (818) 785-8349
FAX: (818) 785-8349
Contact: Dipak Ghosh
June 28, 1997 Date:
2. Device Name:
Air Oxygen Mixer
3. Predicate Device:
The Bird Low Flow Air/Oxygen Microblender is a predicate device that has been on the market since the early 1970's.
4. Description of the Device:
The Air Oxygen Mixer is a pneumatically controlled low flow ( up to 30 lpm maximum flow ) air oxygen mixing device.
5. Intended Use:
The Air Oxygen Machine has the same intended use as the predicate device i.e. the Bird Air Oxygen Microblender. It is used to provide respiratory care in conjunction with:
- Oxygen Hoods
- · Resuscitation Bags
- Masks
- Nasal Cannulas
1
6. Technology Characteristics:
Mixer: The Air Oxygen Mixer, like the Bird Low Flow Microblender, uses 2 pneumatic pressure regulators and a mechanical mix valve to control oxygen concentration in the delivered gas mixture.
Alarms: The Air Oxygen Mixer uses two pressure switches to monitor air and oxygen supplies. If either air or oxygen or both gas supplies fall below a specified threshold, appropriate audio-visual alarms are activated. There is a dedicated LED indicator for low air and low oxygen supply pressure resp. The LEDs are powered by a 9 Volt battery. The battery itself is monitored by a low voltage indicator LED.
The Bird Low Flow Microblender activates an audio alarm if the air and oxygen supply pressures differ by more than 20 PSIG. There is no indication of which gas supply is low. Moreover, if both supplies are low, there is no alarm at all.
Testing:
In order to verify Safety, Effectiveness (performance), and Environmental Characteristics (including Hi/Lo Temperature, Humidity, Shock/Vibration), the Air Oxygen Mixer was subjected to extensive bench & environmental laboratory testing. The results of the testing have demonstrated that the Air Oxygen Mixer is as safe and effective as the Bird Low Flow Microblender.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB = 5 1998
Mr. Dipak Ghosh SK Med 16000 Sherman Way #224 91460 Van Nuvs, CA
K974372 Re: Air Oxygen Mixer II (two) Regulatory Class: Product Code: 73 BZR Dated: November 19, 1997 Received: November 20, 1997
Dear Mr. Ghosh:
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 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 assumptions. Failure to comply with the GMP regulation may result in 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.
3
This letter will allow you to begin 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 regulation (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/dsmamain.html".
Sincerely yours,
Center for Devices and Radiological Health
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation
Enclosure
4
Page
510(k) NUMBER (IF KNOWN): K974372
DEVICE NAME: AIR OXYGEN MIXER
INDICATIONS FOR USE:
FEB.2, 1998
The SK Med Air Oxygen Mixer is intended for use with the infant and The SK Med An Oxygen Maxer in a hospital environment. Its indications for use are perilative population in a noops. I the Bird Low Flow Air Oxygen
exactly the same as the predicate device i.e. the Bird Love Flow with exactly the same as the provide oxygen therapy in conjunction with:
- Oxygen Hoods
- · Resuscitation Bags
- Masks
- · Nasal Cannulas
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
M. Puye
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi
510(k) Number