The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer 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 and heart bypass oxygenation equipment.

Device Description

The Sechrist Model Series 3500CP-G Air/Oxygen Mixer is a precision pressure regulation and proportioning device which is intended to mix medical grade air and medical grade oxygen. The mixer receives pressurized 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. The air/oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses.

AI/ML Overview

The provided 510(k) summary for the Sechrist 3500CP-G Air/Oxygen Mixer does not contain information about a study conducted to prove the device meets specific acceptance criteria based on numerical performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through adherence to established quality system standards and verification of the device's intended function.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of submission.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Function as a precision pressure regulation and proportioning device to mix medical grade air and oxygen.	The device receives pressurized air and oxygen at nominal 50 psi via D.I.S.S. inlet connections. It operates satisfactorily with inlet pressures of 30 to 70 psi, provided pressures are within 20 psi of one another. It provides two outlets for mixed gas and is configured with zero to three flowmeters. (This describes the design and operational parameters, implying it meets the functional requirements of a gas mixer).
Mix medical grade air and medical grade oxygen at operator-selected ratios.	Description confirms this as the primary function ("intended to mix medical grade air and medical grade oxygen at operator selected ratios").
Delivery of mixed gases to patients through various types of respiratory care and heart bypass oxygenation equipment.	Indications for Use explicitly state this as the purpose of the device. The 510(k) summary also explicitly extended the indications to include cardiopulmonary bypass purposes, aligning with predicate devices.
Adherence to relevant quality system standards.	The device is designed and manufactured in accordance with ISO 9001, ISO 13485, EN 46001, and 21 CFR 820 Quality System Regulation.
Substantial equivalence to predicate devices for its intended use.	The primary conclusion of the 510(k) is that "The device is substantially equivalent to the devices previously cleared under the above referenced 510(k) numbers." This is the overarching "acceptance criteria" for a 510(k) clearance.

Study Information (Based on the provided text):

Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This 510(k) relies on demonstrating substantial equivalence to predicate devices and adherence to design/manufacturing standards, rather than a clinical performance study with a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No specific "test set" with "ground truth" derived from experts is mentioned for this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- Not applicable. This is a submission for a hardware device (gas mixer), not an AI/software device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided in the context of a performance study. The "ground truth" for this device's performance would be its ability to physically mix gases within specified tolerances, which would be verified through engineering testing and quality control during manufacturing, not typically a "ground truth" established by experts in a clinical study sense for a 510(k) submission like this.
The sample size for the training set:
- Not applicable/Not provided. Training sets are relevant for machine learning algorithms, which is not the case here.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary of the 510(k) Approach:

The 510(k) for the Sechrist 3500CP-G Air/Oxygen Mixer demonstrates its acceptability through:

Substantial Equivalence: Comparing the device's design, indications for use, and technological characteristics to legally marketed predicate devices (K802226, K992503, K841789, K863902, K901253). The key "study" here is the comparative analysis showing that the new device is functionally the same or very similar to existing cleared devices.
Adherence to Standards: Compliance with established national and international quality management system standards (ISO 9001, ISO 13485, EN 46001, 21 CFR 820). This implies that the design, manufacturing, and performance verification processes are robust, reducing the need for a separate detailed clinical performance study in this context.
Device Description: A detailed description of the device's function and operational parameters, which are presumed to be consistent with those of the predicate devices.

This type of submission typically relies on design verification and validation testing performed by the manufacturer, which demonstrates the device meets its own specifications, rather than a clinical study establishing performance against a "ground truth" in a patient population. These internal tests would verify parameters like pressure regulation accuracy, mixing ratio accuracy, and flow characteristics, but the 510(k) summary itself does not detail the results of these internal tests.

Summary

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K623745

510(k) SUMMARY

Device Name:

JAN 1 7 2003

Classification Name:	Breathing Gas Mixer
Common Name:	Gas Mixer
Proprietary Name:	Sechrist 3500CP-G Air/Oxygen Mixer

Devices to which

Equivalence is Claimed:	K802226 Sechrist Air/Oxygen Mixer
	K992503 Sechrist Air/Oxygen Mixer
	K841789 Sechrist Air/Oxygen Mixer (Shiley, Inc.)
	K863902 Modified Sarns Membrane Oxygenator (Sarns, Inc./3M)
	K901253 (PBS) Portable Bypass System, Model 1000Bio-Medicus
Contact:	Greg Godfrey, Vice President,Quality Assurance & Regulatory Affairs4225 E. La Palma Ave.Anaheim, CA 92807Phone: (714) 579-8400Fax: (714) 579-0814

Indications for Use:

Device Description:

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 wit the following national and international standards:

ISO 9001	Quality Assurance Standard
ISO 13485	Quality System Standard, Medical Devices

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510(k) SUMMARY

Application of ISO 9001 to manufacture of medical devices EN 46001 21 CFR 820 Quality System Regulation

Summarv of Substantial Equivalence:

The Sechrist 3500CP-G (3500/3500HL Model Series) was originally cleared under 510(k)'s K802226 and K992503 to mix Medical Grade Air and Medical Grade Oxygen at operator selected ratios, for delivery through various types of respiratory care equipment.

The indications for use were revised to include the use of the 3500CP-G Sechrist Air/Oxygen Mixer to provide mixed Medical Grade Air and Medical Grade Oxygen for cardiopulmonary bypass purposes. This use was previously cleared for the Sechrist Air/Oxygen Mixer under 510(k) Numbers K841789, by Shiley, Inc., K863902, by Sarns Inc., and K901253, Bio-Medicus.

Conclusion:

The device is substantially equivalent to the devices previously cleared under the above referenced 510(k) numbers.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Sechrist Industries, Inc. c/o Mr. Greg Godfrey 4225 E. La Palma Avenue Anaheim, CA 92807

Re: K023745

Sechrist 3500CP-G Air/Oxygen Mixer Regulation Number: 21 CFR 870.4300 Regulation Name: CPB Gas Control Unit Regulatory Class: Class II (two) Product Code: DTX Dated: November 4, 2002 Received: November 7, 2002

Dear Mr. Godfrey:

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.

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Page 2 – Mr. Greg Godfrey

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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Voleg Till
Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D Director Division of Cardiovascular 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): __

Sechrist 3500CP-G Air/Oxygen Mixer Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

Over-The-Counter

(Optional Format 1-1-96

Odetteer

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K023745

Regulation Number and Section

§ 870.4300 Cardiopulmonary bypass gas control unit.

(a)
Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.(b)
Classification. Class II (performance standards).