The Achieva Ventilator is intended to provide ventilatory support for pediatric (Patients should weigh no less than 11 lbs. (5 kg) and adult patients who require positive pressure mechanical ventilation. The ventilator is for use in home, institutional, and portable settings. The Achieva is contraindicated for use with anesthetic gases. This device is intended to be used on the order, and under the supervision, of a physician.

The Achieva Report Generator is a management and information tool, to aid in the care of patients requiring ventilatory support. The information displayed by the Report Generator software is intended to be used by healthcare professionals to supplement data obtained using established clinical procedures. The Achieva Report Generator allows users to download, view, and print ventilator performance data thave been stored in the ventilator's internal memory. Achieva Report Generator users can also capture and display a snapshot of real-time waveform data (pressure, peak flow, and volume).

Device Description

The Achieva Ventilator is a piston driven device which can deliver a wide range of volumes, inspiratory times, breath rates, oxygen concentrations, and PEEP levels. The Achieva has three operating modes (Assist/Control, SIMV, and Spontaneous) and six ventilation modes.

The Achieva Ventilator is available in four different models. The Achieva PSx and Achieva PS have pressure support capability. The Achieva PSx, Achieva PS, and Achieva X have an internal oxygen blender. The Achieva PSx and Achieva X have an internal modem.

The Achieva Ventilator is compatible with previously cleared Nellcor Puritan Bennett patient circuits and accessories. When AC power is unavailable, the Achieva can operate from an internal 24 VDC battery for approximately 4 hours (normal load) or an optional 24 VDC external battery for approximately 20 hours (normal load).

The Achieva Ventilator is also capable of downloading data to the Achieva Report Generator for purposes of displaying and archiving ventilator data with a computer.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Achieva Ventilator and Report Generator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a specific table summarizing "reported device performance" in terms of clinical outcomes or diagnostic metrics. Instead, it focuses on general performance claims and compliance with standards.

Here's a breakdown of what the document implies regarding acceptance and performance:

Acceptance Criteria (Implied)	Reported Device Performance (Summary from text)
Functional Performance (Ventilator): Deliver a wide range of volumes, inspiratory times, breath rates, oxygen concentrations, and PEEP levels. Operate in Assist/Control, SIMV, and Spontaneous modes with six ventilation modes. Internal oxygen blender (for certain models). Internal modem (for certain models). Compatibility with existing circuits/accessories. Battery operation for specified durations.	"All functions as defined in the published specifications were completely validated." The Achieva is a piston-driven device. Achieva PSx and Achieva PS have pressure support. Achieva PSx, Achieva PS, and Achieva X have internal oxygen blender. Achieva PSx and Achieva X have an internal modem. Compatible with previously cleared Nellcor Puritan Bennett patient circuits and accessories. Operates from internal 24 VDC battery for approx. 4 hours or optional external battery for approx. 20 hours (normal load). The Achieva "performs as intended according to its performance specification."
Functional Performance (Report Generator): Download, display, and archive ventilator data. Display and print stored data. Capture and display real-time waveform data (pressure, peak flow, volume).	"capable of downloading data to the Achieva Report Generator for purposes of displaying and archiving ventilator data with a computer." Allows users to "download, view, and print ventilator performance data" and "capture and display a snapshot of real-time waveform data (pressure, peak flow, and volume)."
Safety and Effectiveness: Substantial equivalence to predicate devices. Compliance with relevant medical device safety and performance standards (IEC 601-1, IEC 601-1-2, UL 2601-1, ASTM F1100-90, ASTM F1246-91). Demonstrated through non-clinical testing.	"The Achieva is substantially equivalent to the predicate devices." Complies with IEC 601-1, IEC 601-1-2, UL 2601-1, ASTM F1100-90 (partial), ASTM F1246-91 (partial). "Safety and efficacy were established through non-clinical testing."
Intended Use: Provide ventilatory support for pediatric (>= 11 lbs./5 kg) and adult patients. For home, institutional, and non-emergency transport settings. Not for use with anesthetic gases. Report Generator supplements data obtained via established clinical procedures.	The device meets its "Indications For Use" as stated.
Nonclinical Testing: Comprehensive testing including software, electrical, mechanical, environmental, and EMC. All functions in published specifications fully validated.	"The performance of the Achieva and its interface with the Achieva Report Generator was comprehensively tested (including software, electrical, mechanical, environmental and EMC). All functions as defined in the published specifications were completely validated."

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

Test Set Sample Size: Not applicable. The document explicitly states: "Clinical testing was not performed on the device."
Data Provenance: Not applicable. The "study" (non-clinical testing) was conducted internally by the manufacturer, Nellcor Puritan Bennett, Inc.

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

Not applicable, as no clinical testing with a "test set" and corresponding "ground truth" was performed. The evaluation relied on non-clinical engineering and performance testing against internal specifications and recognized standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical testing requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device's safety and effectiveness were established through non-clinical testing and substantial equivalence to predicate devices.

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

This question is slightly nuanced in the context of this device. The "Achieva Ventilator" is a standalone medical device in its primary function, delivering ventilation. Its performance was tested as a standalone system (or integrated with its Report Generator). The "Report Generator" software component, while processing data, is described as being used by "healthcare professionals to supplement data obtained using established clinical procedures," implying a human-in-the-loop context for interpretation of the data it generates. However, the performance of the software itself (e.g., its ability to accurately download, display, and archive data) would have been validated in a 'standalone' sense during the comprehensive non-clinical testing. There is no AI algorithm specifically detailed where 'standalone' performance in a diagnostic sense would be reported.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was defined by the device's published performance specifications and the requirements of relevant industry standards (IEC, UL, ASTM). The device was tested to ensure it met these predetermined functional and safety criteria.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and functionality are based on established engineering principles for mechanical ventilation, and its performance was validated through non-clinical testing against specifications, not through training on a dataset.

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

Not applicable, as there was no training set for an AI/ML algorithm.

Summary of the Study:

The primary "study" described in this 510(k) pertains to non-clinical performance testing. This comprehensive testing involved:

Software, electrical, mechanical, environmental, and EMC evaluations.
Validation of all functions as defined in the manufacturer's published specifications.
Demonstration of compliance with various international and national safety and performance standards, including IEC 601-1, IEC 601-1-2, UL 2601-1, ASTM F1100-90 (partial), and ASTM F1246-91 (partial).

The conclusion was that "The Achieva performs as intended according to its performance specification" and "The Achieva is substantially equivalent to the predicate devices." No clinical studies or human reader performance evaluations were conducted or deemed necessary for this 510(k) submission, relying instead on substantial equivalence and exhaustive non-clinical verification.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for Nellcor Puritan Bennett. The logo consists of a black square with a white swirl design on the left and the company name on the right. The company name is stacked vertically, with "NELLCOR" on top, "PURITAN" in the middle, and "BENNETT" on the bottom.

Jelicer Puntan Bennett Inc 800 Northwest Boulevard neapolis MN 554-1-2625

10 497 4979 Tol. Fron 612 694 3500 Direct 612 59-1 3600 Fax

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K 990177 ____________________________________________________________________________________________________________________________________________________

Submitter's Name:	Nellcor Puritan Bennett, Inc. (subsidiary of Mallinckrodt, Inc.)
Submitter's Address:	2800 Northwest Boulevard, Minneapolis, MN, 55441
Contact Person:	Cheryl Rosenberg
Phone Number:	(612) 694-3638
FAX Number:	(612) 694-3600
Summary Date:	January 14, 1999

Device Trade Name: Achieva Ventilator and Report Generator

Device Classification Names:

"Continuous Ventilator" (21 CFR 868.5895, Classification Number 73 CBK)

Predicate Devices:

The Achieva Ventilator is substantially equivalent to both the Nellcor Puritan Bennett Model LP10 Volume Ventilator (K903010) and the Hamilton Medical Amadeus Ventilator (K894316).

Device Description:

The Achieva Ventilator is compatible with previously cleared Nellcor Puritan Bennett patient circuits and accessories. When AC power is unavailable, the Achieva can operate

{1}------------------------------------------------

from an internal 24 VDC battery for approximately 4 hours (normal load) or an optional 24 VDC external battery for approximately 20 hours (normal load).

The Achieva Ventilator is also capable of downloading data to the Achieva Report Generator for purposes of displaying and archiving ventilator data with a computer.

Indications For Use:

The Achieva Ventilator is intended to provide ventilatory support for pediatric {Patients should weigh no less than 11 lbs. (5 kg)} and adult patients who require positive pressure mechanical ventilation. The ventilator is for use in home, institutional, and nonemergency transport settings.

The Achieva Ventilator is contraindicated for use with anesthetic gases.

The Achieva Report Generator software is intended to be used by healthcare professionals to supplement data obtained using established clinical procedures.

Nonclinical Performance:

The performance of the Achieva and its interface with the Achieva Report Generator was comprehensively tested (including software, electrical, mechanical, environmental and EMC). All functions as defined in the published specifications were completely validated.

The Achieva complies with the following standards (partial compliance where noted):

IEC 601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety) .
IEC 601-1-2 (Medical Electrical Equipment Part 1: General Requirements for ● Safety. 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests)
. UL 2601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
. ASTM F1100-90 (Standard Specification for Ventilators Intended for Use in Critical Care) (partial compliance)
ASTM F1246-91 (Standard Specification for Electrically Powered Home Care . Ventilators, Part 1-Positive-Pressure Ventilators and Ventilator Circuits) (partial compliance)

Clinical Performance:

Clinical testing was not performed on the device. Safety and efficacy were established through non-clinical testing.

Conclusions from Nonclinical Tests:

The Achieva performs as intended according to its performance specification. The Achieva is substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 8 1999

Ms. Cheryl Rosenberg Senior Requlatory Affairs Project Manager Mallinckrodt Inc. 2800 Northwest Boulevard Minneapolis, MN 55441-2625

K990177 Re: Nellcor Puritan Bennett Achieva Ventilator and Report Generator Regulatory Class: II (two) Product Code: CBK Dated: August 25, 1999 Received: August 26, 1999

Dear Ms. Rosenberg:

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 Druq 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 requlations.

{3}------------------------------------------------

Page 2 - Ms. Cheryl Rosenberg

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" (21CFR 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,

foams A Weckodran fer,

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

{4}------------------------------------------------

Indications For Use Statement

Achieva Ventilator and Report Generator Device Name:

Indications For Use:

Concurence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use __

510(k) number: K990177

ie am SA Weedon

reurnloqical Devices 5, (k) Number

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).