BEAR CUB 750 PSV

K992788 · Bear Medical Systems, Inc. · CBK · Sep 16, 1999 · Anesthesiology

Device Facts

• Record ID: K992788
• Device Name: BEAR CUB 750 PSV
• Applicant: Bear Medical Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BEAR CUB 750 PSV Infant Ventilator is intended to provide clinically accepted features for the ventilation management of a patient population ranging from the small neonate (500 grams and larger) to a small pediatric patient (up to 30 kilograms). The etiologies to which these devices may be applied consistent with current clinical practices include: Hyaline Membrane Disease Respiratory Distress Syndrome Low Surfactant Syndrome Chronic Lung Disease of the Neonate/Pediatric Patient Neurological Impairment Pulmonary Hypoplasia Persistent Pulmonary Hypertension Meconium Aspiration

Device Story

BEAR Cub 750 PSV is a modified infant ventilator building on the BEAR Cub 750vs platform. It provides mechanical ventilation support in clinical settings for neonates and small pediatric patients. New functionality includes four additional modes: Flow Cycle Assist Control, Flow Cycle SIMV, SIMV/PSV, and PSV. System enhancements include digital PEEP, monitored inspired tidal volume, low minute volume alarm, audible volume limit silence, and CPAP/PSV backup. The device calculates the Low Inspiratory Pressure threshold. Clinicians use the ventilator to manage respiratory support; output data assists in monitoring patient ventilation status and adjusting therapy to improve patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infant ventilator; provides mechanical ventilation via multiple modes (AC, SIMV, PSV, CPAP). Features digital PEEP, tidal volume monitoring, and calculated pressure threshold alarms. Connectivity and specific software architecture are not detailed. Device is a modification of the existing BEAR Cub 750vs platform.

Indications for Use

Indicated for ventilation management of neonates (≥500g) to small pediatric patients (up to 30kg) with respiratory conditions including Hyaline Membrane Disease, Respiratory Distress Syndrome, Low Surfactant Syndrome, Chronic Lung Disease, Neurological Impairment, Pulmonary Hypoplasia, Persistent Pulmonary Hypertension, and Meconium Aspiration.

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

• Siemens Servo 300 A Ventilator (K970839)
• V.I.P. Bird Ventilator (K895541)
• Baby Log 8000 Plus Ventilator (K974176)

Submission Summary (Full Text)

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K992788

SEP 1 6 1999

# 510(k) Summary BEAR Cub 750 PSV Infant Ventilator

Bear Medical Systems, Inc. 1100 Bird Center Drive Palm Springs, California 92262

## Contact:

Neil Battiste Phone Number [phone] FAX [phone]

August 13, 1999 Date:

| 1. | TRADE/PROPRIETARY NAME: | BEAR Cub 750 PSV Infant Ventilator |
|----|-----------------------------------------------------|-------------------------------------|
| | CLASSIFICATION NAME: | Ventilator, Continuous (Respirator) |
| | COMMON/USUAL NAME: | Neonatal/Infant Ventilator |
| 2. | ESTABLISHMENT REGISTRATION NUMBER: | 2022747 |
| 3. | PRODUCT CLASSIFICATION | Class II |
| 4. | ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK) | |

#### Predict Device

| Siemens Servo 300 A Ventilator | (K970839) |
|--------------------------------|-----------|
| V.I.P. Bird Ventilator | (K895541) |
| Baby Log 8000 Plus Ventilator | (K974176) |

#### Device Description

The BEAR CUB 750 PSV Infant ventilators is a modification from the BEAR CUB 750 vs. The BEAR CUB 750 PSV Infant ventilators incorporate all previous (3) three modes with the addition of (4) four new modes. The additional modes are, Flow Cycle Assist Control, Flow Cycle SIMV, SIMVPSV, and PSV. The BEAR CUB 750 PSV Infant ventilators incorporate all previous function for the Bear Cub 750vs with the addition of, digital PEEP, monitored inspired tidal volume, a low minute volume alarm, an audible silence for the volume limit, CPAP/PSV back up function and the Low Inspiratory Pressure threshold was changed to a calculated threshold function.

## Statement of Intended use:

The BEAR CUB 750 PSV Infant Ventilator is intended to provide clinically accepted features for the ventilation management of a patient population ranging from the small neonate (500 grams and larger) to a small pediatric patient (up to 30 kilograms).

The etiologies to which these devices may be applied consistent with current clinical practices include:

- Hyaline Membrane Disease Respiratory Distress Syndrome Low Surfactant Syndrome Chronic Lung Disease of the Neonate/Pediatric Patient Neurological Impairment Pulmonary Hypoplasia Persistent Pulmonary Hypertension Meconium Aspiration

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1999

Mr. Darryl L. Shelby Bear Medical Systems, Inc. 1100 Bird Center Drive Palm Springs, CA 92262

Re: K992788 BEAR Cub 750 PSV Infant Ventilator Regulatory Class: II (two) Product Code: 73 CBK Dated: August 11, 1999 Received: August 19, 1999

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 In addition, FDA may publish further announcements requlatory action. 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. 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 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" (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,

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Intended use:

The BEAR CUB 750 PSV Infant Ventilator is intended to provide ventilators support for a patient we to 2 The BEAK COD 750 F SV Intain Ventiator is Incenter to a small pediatric patient up to 30 kilograms.

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(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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