BIRD V.I.P. GOLD/STERLING

K993449 · Bird Products Corp. · CBK · Dec 20, 1999 · Anesthesiology

Device Facts

• Record ID: K993449
• Device Name: BIRD V.I.P. GOLD/STERLING
• Applicant: Bird Products Corp.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 20, 1999
• Decision: ST
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.

Device Story

The V.I.P. Gold/Sterling is a microprocessor-controlled ventilator for institutional use in neonatal, infant, and pediatric patients. It functions as a self-contained pneumatic system providing respiratory support. New features include Pressure Control mode with variable rise time, Volume Assured Pressure Support, flow triggering in volume modes, decelerating waveform, and inspiratory/expiratory hold. The device integrates volume monitoring capabilities previously found in the Partner IIi monitor. Clinicians operate the device to manage patient ventilation; output includes real-time monitoring data and controlled respiratory support. The device assists in treating respiratory failure or insufficiency, allowing clinicians to adjust tidal volume, inspiratory time, and peak flow to optimize patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-based pneumatic ventilator system. Features include Pressure Control mode, Volume Assured Pressure Support, flow triggering, decelerating waveform, and inspiratory/expiratory hold. Expanded control settings for tidal volume, inspiratory time, and peak flow. Integrates volume monitoring functionality. Institutional use only.

Indications for Use

Indicated for neonatal, infant, and pediatric patients experiencing respiratory failure or respiratory insufficiency. Contraindicated for emergency medical transport or home use.

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

• Bird 8400Sti (K930474)
• Siemens Servo 300 A Ventilator (K970839)
• Bird Partner Volume Monitor (K901885)
• Bird Partner Volume Monitor (K915488)

Submission Summary (Full Text)

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

DEC 20 1999

K993449

## 510(k) Summary

### BIRD V.I.P. GOLD/STERLING INFANT /PEDIATRIC VENTILATOR

Bird Products Corporation. 1100 Bird Center Drive Palm Springs, California 92262 Contact: Neil Battiste Phone Number [phone] FAX [phone]

1. CLASSIFICATION NAME: COMMON/USUAL NAME: TRADE/PROPRIETARY NAME: Ventilator, Continuous Neonatal/Infant/Pediatric Ventilator BIRD V.I.P. GOLD/STERLING Infant/Pediatric Ventilator

- ESTABLISHMENT REGISTRATION NUMBER: 2021710 2.
- 3 PRODUCT CLASSIFICATION Class II
- ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL(73 CBK) 4.

| Bird 8400Sti | (K930474) |
|--------------------------------|---------------------|
| Bird Products Corporation | |
| Siemens Servo 300 A Ventilator | (K970839) |
| Siemens | |
| Bird Partner Volume Monitor | (K901885) (K915488) |
| Bird Products Corporation | |

The additions to the ventilator will be:

The addition of Pressure Control mode of ventilation with Variable Rise Time, Volume Assured Pressure Support, Flow Triggering in Volume modes, a decelerating waveform, Inspiratory Pause and Inspiratory/ Expiratory Hold.

The V.I.P Bird ventilator is a self-contained unit, combining an advanced pneumatic system with microprocessor -based technology. The result is a state-of-the-art ventilator system capable of providing excellent patient monitoring. Packaged in a compact lightweight unit, the V.I.P. Bird Gold/Sterling will incorporate all previous function of the V.I.P. Bird and the addition of Pressure Control mode of ventilation with Variable Rise Time, Volume Assured Pressure Support, Flow Triggering in Volume modes and a decelerating waveform. Other enhancements include expanded control setting range for Tidal Volume, improved resolution for the Inspiratory Time and Peak Flow controls. These specifications also include the volume monitoring functions of the Partner IIi.

## Statement of Intended use:

"The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use."

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

Image /page/1/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 its wings spread, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 1999

Mr. Darryl L. Shelby Bird Products Corp. 1100 Bird Center Drive Palm Springs, CA 92262

Re: K993449 Bird V.I.P. Gold/Sterling Regulatory Class: II (two) 73 СВК Product Code: Dated: November 22, 1999 November 23 1999 Received:

Dear Mr. Shelby:

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, Druq, 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 régulatory 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.

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

#### Page 2 - Mr. Darryl L. Shelby

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 [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"(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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Joanne Hill, Arcshewan-far,

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

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

# Statement of Intended use:

"The VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatic patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use."

Lon A. Wickersham

(Divisio Division of Cardiovas and Neu rological I 510(k) Numbe

FOR Press