The intended use of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.

Device Description

The Sechrist Series 3500HL Air-Oxygen Mixer is a precision pressure regulation and proportioning device which is designed to mix medical air with medical oxygen, for delivery to patients through a variety of respiratory care equipment.

The mixer receives air and oxygen at a nominal 50 psi via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi providing the pressures are within 20 psi of one another.

Two outlets for the mixed gas are provided. One is located on the side of the unit for the convenient connection of a flowmeter. The second outlet may be used to power other respiratory or cardiopulmonary care equipment requiring a controlled FI02.

The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) summary for the Sechrist Air-Oxygen Mixer does not describe traditional acceptance criteria in terms of quantitative performance metrics or a detailed study designed to prove the device meets those criteria.

Instead, the submission focuses on substantial equivalence to a previously cleared device (Sechrist Air-Oxygen Mixer K802226). The "performance standards" listed are quality assurance and regulatory compliance standards, not in-depth performance specifications of the device itself.

Therefore, many of the requested sections below will indicate "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission, which relies on a comparison to a predicate device rather than a de novo performance study.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) relies on substantial equivalence to a predicate, specific quantitative acceptance criteria for this new device are not explicitly stated in the document as performance targets for a study. The document focuses on showing that the changes made do not affect the intended use or fundamental scientific technology, implying the performance remains equivalent to the predicate.

For the purpose of illustrating what would be considered "acceptance criteria" based on the device description, I've inferred potential operating parameters as "acceptance criteria" and noted how the device description states it meets them. However, these are descriptive operational characteristics, not formal performance study acceptance criteria.

Acceptance Criteria (Inferred from Device Description)	Reported Device Performance (from Device Description)
Inlet Pressure Range	30 to 70 psi
Inlet Pressure Differential	Within 20 psi of one another
Gas Mixing Capability	Mixes medical grade air and oxygen at operator-selected ratios
Output Connections	Two outlets for mixed gas provided
Compatibility with Respiratory Equipment	Deliverable to patients through various types of respiratory care equipment
Quality System Compliance	ISO 9001, ISO 13485, EN 46001, 21CFR820 (QS Regulation)

Study Information

Since this is a substantial equivalence submission for minor modifications, a formal performance study as typically understood for a new device (especially one proving performance against specific acceptance criteria) was not conducted or detailed in this summary. The core "study" here is an analysis of the modifications to demonstrate they do not alter the fundamental safety and effectiveness or intended use compared to the predicate device.

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

Not Applicable / Not Provided. No dedicated "test set" of patient data or device performance data for a new study is mentioned, as the submission focuses on changes to an already cleared device.

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

Not Applicable / Not Provided. No new "ground truth" establishment was required for this substantial equivalence submission concerning modifications. The device's safety and effectiveness were established by the predicate device's clearance.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. No formal "test set" or adjudication process described as part of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This device is a breathing gas mixer, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.

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

Not Applicable. This is a hardware device; the concept of a standalone algorithm performance does not apply.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not Applicable / Not Provided explicitly. For a substantial equivalence claim, the "ground truth" effectively rests on the prior clearance of the predicate device (K802226), which implicitly established the safety and effectiveness of the device type. The current submission argues that the modifications do not negatively impact this established "truth."

8. The Sample Size for the Training Set

Not Applicable / Not Provided. No "training set" in the context of machine learning or complex algorithm development is relevant or mentioned for this device.

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

Not Applicable / Not Provided. As noted above, no training set or ground truth establishment for such a set is relevant to this device's submission.

Summary of the "Study" Proving Acceptance:

The "study" in this context is the analysis and comparison of the modified device against the predicate device (Sechrist Air-Oxygen Mixer K802226). The acceptance criteria for this type of submission are that the modifications:

Do not affect the intended use.
Do not alter the fundamental scientific technology of the device.
Do not raise new questions of safety or effectiveness.

The conclusion stated in the 510(k) summary (Section 1) serves as the "proof":

"Modifications made to the cleared device include flowmeter options and corresponding labeling changes made to the User's Manual that were not contained in the original 510(k). These changes do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared device."

This statement confirms that the device meets the implicit "acceptance criteria" for a special 510(k) submission, meaning it maintains substantial equivalence to its predicate. The detailed technical documentation submitted to the FDA (which is not fully available in this summary) would have provided the evidence for this claim (e.g., engineering analysis, risk assessment, potentially limited verification testing of the new flowmeter components, though not detailed here).

Summary

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AUG 10 1999

K992503

510(K) SUMMARY 7-13-99

Device Name:

Classification Name:	Breathing gas mixer
Common Name:	Gas Mixer
Proprietary Name:	Sechrist Air-Oxygen Mixer
Devices to whichEquivalence is Claimed:	Sechrist Air-Oxygen Mixer K802226
Contact:	Greg Godfrey, Vice PresidentQuality Assurance & Regulatory Affairs4225 E. La Palma AvenueAnaheim, CA 92807Phone: (714) 579-8400 Fax: (714) 579-0814

Indication for Use

Device Description

The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.

Performance Standards

A performance standard regulation under Section 514 of the Food, Drug and Cosmetic Act has not been promulgated for this device type. However, the device is designed and manufactured in accordance with the following national and international standards:

ISO 9001	Quality Assurance Standard
ISO 13485	Quality System Medical Devices
EN 46001	Application of ISO 9001 to manufacturer of medical devices
21CFR820	Quality Systems Regulation

: 天

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510(K) SUMMARY 7-13-99

Summary of Substantial Equivalence

Flowmeter options were added to enable the user to adjust and control the gas flow rate. Additional specifications, not specified in the original 510(k), were also added to the User's Manual and include the following: high and low flow mixer specifications, nominal supply pressure, and bleed flows for high and low flow mixer configurations. There have been no changes in the material, technology, or intended use of the device.

Conclusion

Modifications made to the cleared device include flowmeter options and corresponding labeling changes made to the User's Manual that were not contained in the original 510(k). These changes do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature, with three lines representing the wings and a wavy line representing the body. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 10 1999

Mr. Greq Godfrey Sechrist Industries, Inc. 4225 E. La Palma Avenue Anaheim, CA 92807

Re: K992503 Air-Oxygen Mixer Regulatory Class: II (two) Product Code: 73 BZR Dated: July 23, 1999 Received: July 27, 1999

Dear Mr. Godfrey:

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 reqistration, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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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Page 2 - Mr. Greg Godfrey

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 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/dsma/dsmamain.html".

Sincerely yours,

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

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Indications for Use Statement

510(k) Number (if known):_K802226

Device Name: Sechrist 3500/3500HL Series Air-Oxygen Mixer

Indications for Use:

The purpose of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	Jotwewkshausen 8.10.99

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter
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Division Sign-Off)
Division of Cardiovascular, Respiratory,and Neurological Devices

510(k) Number
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(Optional Format 1-1-96)

Sechrist Industries, Inc. Special 510(k) Air-Oxygen Mixer

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).