(28 days)
Not Found
No
The document describes a ventilator with added modes and functions, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is an infant ventilator used for the ventilation management of patients with various respiratory conditions, which is a therapeutic function.
No.
This device is a ventilator, which is a therapeutic device used to support breathing, not diagnose conditions. Its intended use is to manage ventilation for patients, not to identify or diagnose diseases.
No
The device description clearly describes a physical ventilator with hardware components and modifications, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for ventilation management of patients. This involves providing respiratory support directly to the patient.
- Device Description: The description details a ventilator, a medical device that assists or replaces breathing. It mentions modes of ventilation, alarms, and pressure settings, all related to direct patient care.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to directly treat a patient's respiratory function.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Siemens Servo 300 A Ventilator (K970839), V.I.P. Bird Ventilator (K895541), Baby Log 8000 Plus Ventilator (K974176)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 (760) 778-7341 FAX (760) 778-7288
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
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human profile.
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.
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 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" (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,
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.
lM.P.R
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
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