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

Device Description

The Air Oxygen Mixer is a pneumatically controlled low flow ( up to 30 lpm maximum flow ) air oxygen mixing device.

AI/ML Overview

This document describes the SK Med Air Oxygen Mixer, which is a pneumatically controlled low-flow air-oxygen mixing device. The submission is a 510(k) premarket notification. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence to a predicate device, which is the Bird Low Flow Air/Oxygen Microblender. The study described is a series of bench and environmental laboratory tests designed to show that the new device is as safe and effective as the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) submission are implicitly demonstrating that the new device is "as safe and effective" as the predicate device. For this device, this translates to:

Aspect	Acceptance Criteria (Implicit from Predicate)	Reported Device Performance
Oxygen Concentration Control	Uses 2 pneumatic pressure regulators & mechanical mix valve to control oxygen concentration in the delivered gas mixture (same as Bird Low Flow Microblender).	The Air Oxygen Mixer uses 2 pneumatic pressure regulators and a mechanical mix valve to control oxygen concentration, matching the predicate.
Low Gas Supply Alarms	Activates audio alarm if air and oxygen supply pressures differ by more than 20 PSIG (Bird Low Flow Microblender functionality, though with noted limitations).	Uses two pressure switches to monitor air and oxygen supplies; activates appropriate audio-visual alarms with dedicated LED indicators for low air and low oxygen if supplies fall below threshold. Also monitors battery for low voltage.
Overall Safety & Effectiveness	Must be as safe and effective as the Bird Low Flow Microblender.	Extensive bench & environmental laboratory testing (including Hi/Lo Temperature, Humidity, Shock/Vibration) demonstrated the Air Oxygen Mixer is as safe and effective as the Bird Low Flow Microblender.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical sample size. The testing involved "extensive bench & environmental laboratory testing." For a device like this, the "test set" would likely be exemplar units of the device itself undergoing various performance and stress tests, rather than a human subject or clinical data set.
Data Provenance: The testing was conducted in a "bench & environmental laboratory." There is no mention of country of origin for the data or whether it was retrospective or prospective, though bench testing is inherently prospective for the device being tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable for a 510(k) submission based on bench testing of a device like an air oxygen mixer. Ground truth for device performance would be established through engineering specifications, regulatory standards, and comparison to the predicate device's known performance characteristics.
The "experts" would be the engineers and technicians conducting the testing, validating the device's output against established standards or the predicate's performance. Their qualifications are not specified but would be implicit in their roles within the development and testing team.

4. Adjudication Method for the Test Set

Not applicable in the context of clinical expert adjudication. For bench testing, adjudication would involve the engineers and quality control personnel reviewing test results against predefined specifications and predicate comparability data. There is no mention of a specific adjudication method like "2+1" for disagreement resolution.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging devices or AI-driven diagnostic tools involving human interpretation of data. The SK Med Air Oxygen Mixer is a mechanical device, and its evaluation does not involve "human readers" or "AI assistance" in this clinical sense.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a mechanical air-oxygen mixer, not an algorithm or AI system. Its performance is inherent in its physical and pneumatic operation.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, regulatory standards, and the established performance characteristics of the predicate device (Bird Low Flow Air/Oxygen Microblender). The primary goal was to show that the new device meets or exceeds these established benchmarks for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. As a mechanical device whose performance is demonstrated through bench and environmental testing, there is no "training set" in the context of machine learning or AI. Prototyping and iterative design might involve multiple units, but this is distinct from a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the relevant context.

Summary

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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

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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.

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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.

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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

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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)

Over-The-Counter-Use (Optional Format 1-2-96)

M. Puye

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi

510(k) Number

Regulation Number and Section

§ 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).