(87 days)
Not Found
No
The summary describes a manual resuscitation device with no mention of AI or ML capabilities.
Yes
The device is described as a "manual resuscitation device to temporary ventilate neonate, newborn or infant" which aims to "temporarily augment ventilation insufficiency or ventilatory failure." This direct involvement in restoring or supporting a physiological function (ventilation) categorizes it as therapeutic.
No
The device is described as a "manual resuscitation device" and its purpose is to "temporary ventilate" or "temporarily augment ventilation insufficiency or ventilatory failure." This indicates a treatment or life support function, not a diagnostic one.
No
The device description clearly states it is a "manual resuscitation device" and a "medical device, which temporarily augment ventilation insufficiency or ventilatory failure," implying a physical hardware component for delivering ventilation. The predicate device is also a "Manual Resuscitation Bag," which is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "temporary ventilate neonate, newborn or infant". This is a direct therapeutic intervention on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device "temporarily augment ventilation insufficiency or ventilatory failure". Again, this describes a direct medical intervention.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly a manual resuscitation device, which falls under the category of medical devices used for patient support and treatment, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
Product codes
BTM
Device Description
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
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
neonate, newborn or infant
Intended User / Care Setting
hospital, transport, emergency and post hospital care environments
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logo for A Plus Medical. The logo consists of the letter "a" in a circle, followed by the words "A Plus Medical" in a bold font. Below the words "A Plus Medical" is the phrase "Solutions for Respiratory Care" in a smaller font. The logo is black and white.
K 112852 રું... 510(k) Summary
December 12, 2011 Date:
Owner:
A Plus Medical
5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 + 760-930-4025 Tel: + 760-930-0040 Fax:
Owner/Operator Number: 10023166
Official Contact:
Thomas C. Loescher + 760-930-4025 Tel: + 760-930-0040 Fax:
Trade Names: Bobs. Plus" Neonatal Resuscitation Bag Babs. Plus" N Bag
Common/Usual Name:
Manual Resuscitation Bag
Classification Name:
Device Name: Ventilator, Emergency, Manual (Resuscitator
Product Code: BTM
Regulation: CFR 868.5915
II
Device Class:
Device: Babs. Plus Neonatal Resuscitation Bag
Predicate Devices:
| Number: | K082092 |
|---|---|
| Product Name: | Dispo - Manual Resuscitation Bag |
| Manufacturer: | GaleMed Corporation |
| Product Codes: | 2328 |
Device Description:
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
Indications for Use:
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2 . +740-930-4025 Fax: +760-930-0040 ~ 13~~
JAN 1 3 2012
1
Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo consists of the letter "a" inside of a circle on the left, followed by the words "A Plus Medical" in bold font. Below "A Plus Medical" are the words "Solutions for Respiratory Care" in a smaller font.
Contraindications:
Body mass greater than 3.3 Kg.
Patient Population:
Patient populations of neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg.
Environment of Use:
Hospital, transport, emergency and post hospital care environments
Comparative of Technological Characteristics:
Babs. Plus" and predicate products conform to requirements set forth in ISO 10651-4:2002 entitled "Lung ventilators -Part 4: Particular requirements for opered resuscitators". A summary of critical performance attributes include:
| Item | Babi.Plus™ | Predicate |
|---|---|---|
| Patient Connector: | 15 mm I.D. | 15 mm I.D. / 22 mm O.D. |
| Face Mask: | Option offered, 15 mm O.D. | Option offered, 15 mm O.D. |
| Pressure Gauge Connector: | 4.0 mm O.D. tapered | None |
| Supplemental oxygen delivery: | VT-20 mls, Rate – 60 BPM: | |
| @ 2 LPM – 91%, @ 10 LPM – 99+% | ||
| VT-20 mls, Rate – 120 BPM: | ||
| @ 2 LPM – 91%, @ 10 LPM – 99+ % | ||
| VT-50 mls, Rate – 30 BPM: | ||
| @ 2 LPM – 75%, @ 10 LPM – 99+% | ||
| VT-50 mls, Rate – 60 BPM: | ||
| @ 2 LPM – 66%, @ 10 LPM – 99+% | VT-20 mls, Rate – 60 BPM: | |
| @ 2 LPM – 82%, @ 5 LM – 97% | ||
| @ 10 LPM – 98+% @ 15 LM – 99+% | ||
| VT-150 mls, Rate – 25 BPM: | ||
| @ 2 LPM – 50% @ 5 LM – 96% | ||
| @ 10 LPM – 98+% @ 15 LM – 99+% | ||
| Expiratory resistance: |