(285 days)
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Not Found
No
The device description and performance studies focus on the physical components and material biocompatibility of a manual resuscitator, with no mention of AI or ML capabilities.
Yes
The intended use of the device is to provide emergency respiratory support, which is a therapeutic intervention.
No
This device is described as a "manual resuscitator" intended to "provide emergency respiratory support." Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a disposable, single patient use manual resuscitator which includes physical components like a compression bag, valves, and a reservoir bag. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide "emergency respiratory support." This is a therapeutic function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a "manual resuscitator." This is a medical device used to assist breathing, not to perform in vitro tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, processing, or analyzing biological specimens (like blood, urine, tissue, etc.).
- Performance Studies: The performance studies described focus on the biocompatibility and physiochemical properties of the materials used in the device, which is typical for medical devices that come into contact with the patient or are used in a medical setting, but not specifically for IVDs.
In summary, the device's purpose and description clearly indicate it is a therapeutic medical device for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.
Product codes
73 BTM
Device Description
The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Child and Infant
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The resuscitator does not come in direct contact with the patient, although the following tests were performed on the vinyl compression bag, rubber reservoir bag and the silicone rubber lip valve.
| Item | Test | |
|---|---|---|
| A. | Rubber Compression Bag | 1. Cytotoxicity |
- Physiochemical (Elastomeric Closures)
- ASTM Protein Analysis |
| B. | Vinyl Reservoir Bag | 1. Cytotoxicity - Physiochemical (Elastomeric Closures) |
| C. | Silicone Rubber Lip Valve | 1. Cytotoxicity - Physiochemical (Elastomeric Closures)
- ASTM Protein Analysis |
The scoring (reactivity) for cytotoxicity of item A was noted as "slight" cyrotoxic and items B and C noted as "none" cytotoxic. In addition physiochemical tests were performed for items A B, and C to determine pertinent physiochemical extraction characteristics.
ASTM Protein analysis was performed on items A and C and the results were
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically 'KC963848'. The characters are handwritten in a clear, legible style. The sequence appears to be a code or identifier, possibly a serial number or reference number.
Image /page/0/Picture/1 description: The image shows the word "BriGam" in a bold, sans-serif font. The letters are black against a white background. The word appears to be a logo or brand name.
1
Post Office Box 1009
Morganton, N.C. 28680-1009
TEL. 704-437-0236 FAX. 704-437-7695
510(K) Summary for K963848
Submitter's Name: Address:
Phone #: FAX: Contact Person: Date Summary Prepared:
Proprietary Name: Common Name: Classification Name: Bill Brooks 65 Hanes Road Newland, NC 28657 (704) 733-8121 (704) 733-8741 Bill Brooks 12/17/96
JUL - 7 1997
Manual Resuscitator Manual Emergency Ventilator Manual Emergency Ventilator (per CFR section 868.5915)
Marketed Device to Whom we are claiming equivalence:
Our device is substantially equivalent to the currently marketed device by Mercury @
CPR Bag) Medical and Ambu Spur Resuscitator) Inc.
Description of the Device:
The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.
Intended Use: The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.
Technological Characteristics of our device compared to the predicate device:
The technological characteristics of Owens-BriGam Manual Resuscitator are substantial equivalent to Mercury Medical and Ambu Inc. Medical Resuscitator. BriGam's Manual Resuscitator is of generally the same form and intended to be used in the same manner as the substantially equivalent products as outlined in Exhibit E.
1
BriGam
Post Office Box 1009
Morganton, N.C. 28680-1009
TEL. 704-437-0236 FAX. 704-437-7695
Test Summary:
The resuscitator does not come in direct contact with the patient, although the following tests were performed on the vinyl compression bag, rubber reservoir bag and the silicone rubber lip valve.
| Item | Test | |
|---|---|---|
| A. | Rubber Compression Bag | 1. Cytotoxicity |
- Physiochemical (Elastomeric Closures)
- ASTM Protein Analysis |
| B. | Vinyl Reservoir Bag | 1. Cytotoxicity - Physiochemical (Elastomeric Closures) |
| C. | Silicone Rubber Lip Valve | 1. Cytotoxicity - Physiochemical (Elastomeric Closures)
- ASTM Protein Analysis |
The scoring (reactivity) for cytotoxicity of item A was noted as "slight" cyrotoxic and items B and C noted as "none" cytotoxic. In addition physiochemical tests were performed for items A B, and C to determine pertinent physiochemical extraction characteristics.
ASTM Protein analysis was performed on items A and C and the results were