Each model of the ZOLL 731 Series of Ventilators is in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an " label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers

Pulse Oximetry (SpO2)

The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

Device Description

The ZOLL 731 Series Ventilators family (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc. and reviewed and cleared under K111473) consists of AEV, EMV+ and Eagle II models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (> 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV)/ Positive Pressure Ventilation (PPV).

As part of the current submission we are proposing to revise the device software to accomplish the following:

Introduce Bilevel Mode Functionality
Expanded Leak Compensation Functionality
Introduce Start Menu Functionality
. Expanded Parameter Ranges
. Introduce Plateau Pressure (Pplat) Functionality
. Introduce Automatic Tubing Compensation Functionality
Change Oxygen Supply Pressure Alarm Logic
Introduce Inverse I:E Ratio Functionality ●

No hardware changes were made to the 731 Series Ventilators for the proposed software change.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ZOLL 731 Series Ventilators, focusing on software changes that introduce new functionalities. The document primarily focuses on non-clinical evidence to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a specific table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values in the traditional sense of a clinical or analytical performance study. Instead, the acceptance criteria are implicitly tied to the successful completion of various engineering and software validation tests, and compliance with recognized standards.

The document states:
"Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all of its functional requirements and performance specifications."
and
"The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61."

Therefore, the reported device performance is that these tests were passed and compliance was achieved, demonstrating that the device meets its design, performance, and safety specifications and is substantially equivalent to predicate devices.

Example Interpretation of Acceptance Criteria and Performance (as implied by the document):

Acceptance Criteria (Implied)	Reported Device Performance
Software functionality meets design requirements and specifications	"Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators... met all of its functional requirements and performance specifications."
Software performs as well as indicated predicate devices	"Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices..."
Compliance with relevant international safety standards	"The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61." "Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards."
Usability meets user requirements and intended use	"Usability testing was performed, where appropriate, to ensure that the proposed functionalities meet the user requirements and can be used as intended."
Software deemed "major" level of concern (FDA Guidance)	"Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submission for Software Contained Medical Devices'. The software for this device was considered as a 'major' level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify a "test set" in the context of clinical data for performance evaluation. All testing mentioned is non-clinical (software verification/validation, safety testing, usability testing). Therefore, details like sample size for a test set (e.g., number of patients), country of origin, or whether it was retrospective/prospective are not applicable or provided.

3. 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):

This information is not provided. Since no clinical "test set" requiring ground truth establishment by experts is described, this detail is not relevant to the presented evidence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided because no clinical "test set" or expert adjudication process is described in the document.

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 MRMC study was conducted or reported. The device is a ventilator with software updates, not an AI-assisted diagnostic tool for human readers.

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

The device is a medical device (ventilator) with software as an integral component, not a standalone algorithm in the typical sense applied to AI/ML devices. The performance evaluation focuses on the integrated system (ventilator with new software). The software's performance was validated as part of the overall device performance through non-clinical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for the non-clinical testing described. For software verification and validation, the "ground truth" would be the pre-defined functional and performance specifications, and for safety, it would be compliance with published standards.

8. The sample size for the training set:

Not applicable. The document describes software updates to a medical device, not a machine learning or AI algorithm that requires a "training set" of data.

9. How the ground truth for the training set was established:

Not applicable, as no training set for an AI/ML algorithm is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 2, 2017

Zoll Medical Corporation Chuck Kolifrath Regulatory Affairs Manager 269 & 271 Mill Road Chelmsford, Massachusetts 01824-4105

Re: K162832

Trade/Device Name: 731 Series Ventilators Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: July 13, 2017 Received: July 14, 2017

Dear Chuck Kolifrath:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Mark S. Fellman -S

for CDR Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162832

Device Name 731 Series Ventilators

Indications for Use (Describe)

Ventilation

Pulse Oximetry (SpO2)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the word "ZOLL" in a sans-serif font. The letters are a light blue color. A small registered trademark symbol is located to the right of the second "L".

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.

978-421-9655 978-421-0025 Main Fax

510(k) Summary

Sponsor Information:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824

Contact Person: Chuck Kolifrath Regulatory Affairs Manager Phone Number: (978) 421-9786

Date of Summary: July 13th, 2017

Device Name and Classification:

Common Name: Transport Ventilator

Device Name: 731 Series Ventilators

Classification Name: Ventilator, Continuous, Facility Use (21 CFR 868.5895) Oximeter (21 CFR 870.2700)

Product Code: CBK, DQA

Predicate Device:

731 Series Ventilators (K111473) CareFusion ReVel Ventilator (K070594) Hamilton T1 Ventilator (K120670) CareFusion Avea Ventilator (K103211)

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Device Description:

As part of the current submission we are proposing to revise the device software to accomplish the following:

Introduce Bilevel Mode Functionality
Expanded Leak Compensation Functionality
Introduce Start Menu Functionality
. Expanded Parameter Ranges
. Introduce Plateau Pressure (Pplat) Functionality
. Introduce Automatic Tubing Compensation Functionality
Change Oxygen Supply Pressure Alarm Logic
Introduce Inverse I:E Ratio Functionality ●

No hardware changes were made to the 731 Series Ventilators for the proposed software change.

Indications for Use:

Ventilation

Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.

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Pulse Oximetry (SpO2)

The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

Comparison of Technological Characteristics:

Apart from the changes introduced as part of the proposed software release, the cleared functionality between proposed 731 Series Ventilator and the currently marketed 731 Series Ventilator (K111473) remains the same.

The table below lists the functionalities introduced with the proposed software update and identifies the predicate to which substantial equivalence has been established.

Proposed Functionality	731 SeriesVentilators(K111473)	CareFusionReVelVentilator(K070594)	Hamilton T1Ventilator(K120670)	CareFusionAveaVentilator(K103211)
Bilevel ModeFunctionality	✓
Leak CompensationFunctionality		✓
Start Menu Functionality	✓
Expanded ParameterRanges			✓
Plateau Pressure (Pplat)Functionality			✓
Automatic TubingCompensationFunctionality				✓
Oxygen Supply PressureAlarm Logic	✓
Inverse I:E RatioFunctionality		✓

No hardware changes were made to the 731 Series Ventilators for the proposed software change.

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Substantial Equivalence - Non-Clinical Evidence:

The following performance data were provided in support of substantial equivalence determination:

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained Medical Devices". The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient.

Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all of its functional requirements and performance specifications.

Safety testing per the international recognized standards

The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61.

Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards.

Electrical Safety and electromagnetic compatibility (EMC)

The proposed 731 Series Ventilators involves a software-only change to the 731 Series Ventilators (reviewed and cleared by the agency under K111473). The Electromagnetic Compatibility & Electrical Safety evaluation, established with the predicate 731 Series Ventilators (K111473) was not impacted by the proposed change.

Usability Testing

Usability testing was performed, where appropriate, to ensure that the proposed functionalities meet the user requirements and can be used as intended.

Substantial Equivalence -Clinical Evidence:

Clinical evidence was not necessary to show substantial equivalence.

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Conclusion:

As part of the change control process, the subject device has undergone the appropriate verification, validation and safety testing, all of which confirms that the device meets its design, performance, and safety specifications. Performance data demonstrates that the features and functions of the subject device is substantially equivalent to those of the indicated commercially distributed devices.

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).