NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR

K990177 · Nellcor Puritan Bennett, Inc. · CBK · Nov 18, 1999 · Anesthesiology

Device Facts

• Record ID: K990177
• Device Name: NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 18, 1999
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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 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 Story

Piston-driven ventilator delivering controlled volumes, inspiratory times, breath rates, oxygen concentrations, and PEEP levels; operates in Assist/Control, SIMV, and Spontaneous modes. Models include pressure support (PS/PSx) and internal oxygen blending (PSx/PS/X). Internal modem in PSx/X models. Powered by AC or internal 24 VDC battery (approx. 4 hours). Used in home, institutional, and transport settings under physician supervision. Achieva Report Generator software allows healthcare professionals to download, display, and print stored ventilator performance data and real-time waveforms (pressure, peak flow, volume) via computer. Facilitates clinical management by providing archived data for patient care review.

Clinical Evidence

No clinical data. Safety and efficacy were established through comprehensive non-clinical testing, including software, electrical, mechanical, environmental, and EMC validation. The device demonstrated compliance with IEC 601-1, IEC 601-1-2, UL 2601-1, and partial compliance with ASTM F1100-90 and ASTM F1246-91.

Technological Characteristics

Piston-driven positive pressure ventilator. Energy source: AC or 24 VDC battery. Connectivity: Internal modem (select models) and data download capability to PC. Compliance: IEC 601-1, IEC 601-1-2, UL 2601-1, ASTM F1100-90, ASTM F1246-91. Software: Report generator for data management and waveform display.

Indications for Use

Indicated for pediatric (≥5 kg) and adult patients requiring positive pressure mechanical ventilation in home, institutional, or nonemergency transport settings. Contraindicated for use with anesthetic gases.

Regulatory Classification

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.

Predicate Devices

• Nellcor Puritan Bennett Model LP10 Volume Ventilator (K903010)
• Hamilton Medical Amadeus Ventilator (K894316)

Submission Summary (Full Text)

{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: | [phone] |
| FAX Number: | [phone] |
| 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 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

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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).

#### 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