The Sechrist Millennium Infant Ventilator is an electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator. It is designed to ventilate neonatal to pediatric patients in Assist/Control, Synchronous Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP), and Standby modes. In addition, pressure triggered ventilation and spontaneous breathing is also provided.

The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control.

The electronically controlled subsystem uses the respiratory rate and inspiratory time control inputs to activate or deactivate the exhalation valve. The electronic subsystem also includes the pressure trigger sensing and manual breath functions.

Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to fully answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided document is a 510(k) summary for a medical device (ventilator), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of why the information is not present and what can be inferred:

Acceptance Criteria and Reported Device Performance: This document states, "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators." This strongly indicates that there are no specific, quantitative acceptance criteria for this device that would be reported in a table. The primary method of demonstrating safety and effectiveness for a 510(k) submission, especially when no performance standards exist, is via substantial equivalence to a legally marketed predicate device.
Study Details: Since the submission is based on substantial equivalence, a formal performance study proving the device meets specific acceptance criteria in the manner described by your questions (e.g., sample size, ground truth, expert consensus, MRMC studies) is typically not part of the 510(k) summary. Instead, the submission would rely on internal testing to ensure the device performs as intended and similarly to its predicate.

Based on the provided text, I can respond to your questions as follows:

A table of acceptance criteria and the reported device performance
Not applicable. The document states, "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators." Therefore, specific, quantitative acceptance criteria for device performance are not provided. The submission relies on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable to theirs.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary demonstrating substantial equivalence. It does not describe a clinical or performance study with a test set, sample size, or data provenance in the context of proving specific acceptance criteria.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical or performance study involving expert-established ground truth for a test set is described in this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance study involving adjudication of a test set is described in this 510(k) summary.
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. MRMC studies, especially those involving AI assistance, are typically for diagnostic devices or those requiring human interpretation of output. This device is a ventilator, and the summary does not mention any AI components or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electro-pneumatic ventilator. The summary does not provide details of any standalone algorithm performance testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described as having been used for a performance study in this 510(k) summary.
The sample size for the training set
Not applicable. No training set is mentioned as part of this 510(k) submission.
How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is mentioned in this 510(k) submission.

In summary: The provided text is a 510(k) summary for a ventilator that primarily focuses on demonstrating substantial equivalence to existing predicate devices. It explicitly states that no performance standards have been established for infant ventilators. Therefore, the document does not include information about specific acceptance criteria, detailed performance studies, sample sizes, ground truth establishment, or expert involvement as would be found for a device requiring such studies to prove performance against specified criteria.

Summary

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NOV 1 0 1999

510(K) SUMMARY 9-21-99

Device Name:

Classification Name:	Continuous ventilator
Common Name:	Infant ventilator
Proprietary Name:	Millennium
Devices to whichEquivalence is Claimed:	Model IV-100B K833982AV.I.P. Bird Infant Ventilator K895541/K901885
Contact:	Greg Godfrey, Vice PresidentQuality Assurance & Regulatory Affairs4225 E. La Palma AvenueAnaheim, CA 92807Phone: (714) 579-8400 Fax: (714) 579-0814

Indication for Use

The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.

Device Description

The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control.

Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.

Performance Standards

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators.

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510(K) SUMMARY 9-21-99

Summary of Substantial Equivalence

There are no significant changes in the intended use, performance specifications, or principal of operation of the Millennium Infant Ventilator. Existing technology, consistent with that used in comparative ventilators, has been incorporated into the design of this device. Cosmetic enhancements were made to the displays and packaging of the device. The addition of a trigger mechanism provides the ability to synchronize ventilation and includes SIMV and trigger sensitivity. Additional enhancements, not available on the cleared device, include CPAP+ backup, standby, breath type display, high rate alarm, and an hour meter.

Conclusion

Modifications made to the device 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 devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

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

Re: K993167 Millennium™ Infant/Pediatric Ventilator Requlatory Class: II (two) Product Code: 73 CBK Dated: October 12, 1999 Received: October 14, 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 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Requlation (QS) for Medical Devices: General regulation (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 requlation may result in requlatory 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 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/dsma/dsmamain.html".

Sincerely yours,

Jean H. Westerduin fro,

Celia M. Witten, Ph.D., M.D. Acting 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): ±833982A-_K 99 3167

Device Name: Sechrist Millennium Infant Ventilator

Indications for Use:

The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.

(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) OR

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

(Optional Format 1-1-96)

foAweitesher

Sechrist Industries, Inc. Special 510(k) Millennium Infant Ventilator

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).