The 700 Series Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.

Device Description

The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients, with the provision of nebulization functionality, through use of an optional accessory, the EasyNeb Nebulizer. The nebulization functionality is implemented by: a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators. The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation. The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.

AI/ML Overview

This document describes the 700 Series Ventilator, which includes an optional EasyNeb Nebulizer accessory. The original text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for novel performance claims.

Based on the provided text, the device is a continuous ventilator intended for pediatric and adult patients. The key new feature is the nebulization functionality through the EasyNeb Nebulizer, which is controlled by modifications to the ventilator's software.

Here's an analysis of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria or detailed reported device performance in a table format. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the device meets safety and effectiveness standards comparable to those already marketed.

Instead of performance metrics, the document highlights compliance with regulatory guidance and international standards for design, testing, and quality.

Acceptance Criteria (Implied)	Reported Device Performance (Summary from text)
Safety and Effectiveness for Intended Use (Overall)	"The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." "In summary Puritan-Bennett Corp. has demonstrated the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, to be safe and effective." "The technical characteristics of the 700 Series Ventilator do not introduce new questions regarding safety or effectiveness of critical care ventilators."
Nebulization Functionality without affecting ventilator performance or patient data	The EasyNeb Nebulizer "is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data." (This is a design claim, not a measured performance reporting, but implies a performance goal.)
Compliance with Regulatory Guidance for Software Design	"Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 29 1998, as a guidance and per internal company requirements." (This implies a process-based acceptance criterion for software quality, not a functional performance metric).
Compliance with Environmental Testing Standards	"Environmental testing was conducted using FDA's Reviewers Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline and per internal company requirements." (Similar to software, this is a process/compliance criterion).
Compliance with International Standards	"The 700 Series Ventilator and EasyNeb Nebulizer device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive." (This indicates that the device met the requirements of these standards, which encompass various safety and performance aspects, but specific performance values are not detailed in this summary).

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify a sample size for any test set (e.g., for clinical trials or formal performance testing with human subjects or specific clinical data).

The term "test set" in the context of device performance usually refers to data used to evaluate a device's effectiveness. This 510(k) summary focuses on demonstrating equivalence through design, functionality descriptions, and compliance with standards rather than presenting results from a specific clinical performance test set.

Data provenance is also not mentioned.

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

This information is not provided in the document. Given the nature of a continuous ventilator and nebulizer (which are physical devices with mechanical and software functions), the "ground truth" for performance would likely come from instrumental measurements and technical testing to verify specifications, rather than expert consensus on interpretive data like medical imaging.

4. Adjudication Method for the Test Set

Since no specific test set or clinical evaluation requiring adjudication is described, an adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is typically performed for interpretive medical devices (like imaging AI diagnostics) to compare the performance of human readers with and without AI assistance. The 700 Series Ventilator and EasyNeb Nebulizer are not interpretive devices in this sense. Therefore, an MRMC comparative effectiveness study was not conducted or mentioned in the provided text. No effect size for human readers improving with AI assistance is reported.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study. The "algorithm" here would refer to the ventilator's control software and the nebulizer's activation logic. The performance of these components is evaluated as part of the integrated device's overall functionality and compliance with standards, rather than as a separate "algorithm only" study as one might see for an AI diagnostic tool.

7. Type of Ground Truth Used

For a device like a ventilator and nebulizer, the "ground truth" would be established through:

Engineering specifications and measurements: Verifying parameters like tidal volume delivery, breath rate, oxygen concentration, nebulization rate, power control, and timing.
Compliance with recognized standards: Meeting the functional and safety requirements defined by standards like EN60601-1.
Verification and validation testing: This would involve testing the software and hardware against design requirements to ensure it performs as intended.

The document generally refers to "combined testing and analysis of results" and "verification and validation testing" without specifying the exact nature of the "ground truth" for each test.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The 700 Series Ventilator is a rule-based or deterministic medical device, not an AI/machine learning system that requires a "training set" in the conventional sense. Its software controls are programmed based on engineering principles and medical requirements, not learned from data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

K990897

SUBMITTER:	Nellcor Puritan Bennett Ireland,a subsidiary of Mallinckrodt Inc.,
on behalf of:	Puritan-Bennett Corp.,a subsidiary of Mallinckrodt Inc.
DATE:	16 March 1999
COMMON NAME:	Continuous Ventilator
PROPRIETARY NAME:	700 Series Ventilator
CONTACT:	Robbie Walsh, Regulatory Affairs ManagerNellcor Puritan Bennett Ireland,Mervue,Galway.Ireland.Tel: + 353 91 753771Fax: + 353 91 770156
CLASSIFICATION:	Class II per 21 CFR 868.5895Continuous Ventilator

PREDICATE DEVICES:

Puritan-Bennett Corp. is claiming substantial equivalence to the following two predicate medical devices:

Predicate Device	510(k) Number	Classification
Siemens ServoVentilator 300	K902859	Class II,Continuous Ventilatorper 21 CFR 868.5895
Siemens Servo UltraNebulizer 345	K960854	Class II,Nebulizerper 21 CFR 868.5630

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A Device Description:

The nebulization functionality is implemented by:

a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators.

The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation.

The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.

Intended Use: B

The intended use is provided below;

Purpose and function of device:

· The 700 Series Ventilator is intended to provide continuous ventilation to patients requiring respiratory support.
· It offers nebulization functionality through use of an optional accessory, the EasyNeb Nebulizer
This product is intended for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions.

Intended patient population:

· The intended patient population includes pediatric and adult patients (tidal volume 0.04 - 2 L) who require continuous respiratory support.
Intended for patients who require either invasive or non-invasive . ventilation.

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Intended environment of use:

· The 700 Series Ventilator is intended for use in hospitals and hospital type facilities which provide respiratory care for patients requiring respiratory support.
· The 700 Series Ventilator may be used during hospital and hospital type facility transport
· The 700 Series Ventilator is not to be used in the presence of flammable anesthetics
· The 700 Series Ventilator is intended for sale by or on the order of a physician only.
· This product is intended for operation by trained and qualified clinicians only.

C Substantial Equivalence

The intended use of the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, is the same as that for a standard, currently marketed critical care ventilator. The materials and design of these device are similar to those of the predicate devices. The technical characteristics of the 700 Series Ventilator do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with the 700 Series Ventilator and EasyNeb Nebulizer provides similar information as the predicate devices.

Information provided in the 510(k) submission supports the determination of substantial equivalence. Software design and development, (including verification and validation testing. test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 29 1998, as a guidance and per internal company requirements. Environmental testing was conducted using FDA's Reviewers Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline and per internal company requirements. The 700 Series Ventilator and EasyNeb Nebulizer device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive.

The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.

In summary Puritan-Bennett Corp. has demonstrated the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles a stylized bird or eagle with three wing-like shapes.

Public Health Service

MAR 1 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robbie Walsh Nellcor Puritan Bennett Ireland Mervue Galway Ireland

Re: K990897 700 Series Ventilator incorporating EasyNeb Nebulizer Regulatory Class: II (two) Product Code: CAF, CBK December 10, 1999 Dated: December 16, 1999 Received:

Dear Mr. Walsh:

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 Regulation (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 regulation 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. Robbie Walsh

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 requlation (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,

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number:	K990897
Device Name:	700 Series Ventilator System (incorporating the EasyNebNebulizer as an optional accessory)
Indication for Use:	The 700 Series Ventilator System is used to providecontinuous ventilation to patients requiring respiratory support.This device is used for a wide range of patients from pediatricto adult and for a wide variety of clinical conditions. It also hasthe capability to provide nebulization through use of an optionalaccessory, the EasyNeb Nebulizer.

Prescription Use: Yes (Per 21 CFR 801.109)

L.A.Ketron
(Division Sign-off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).