(39 days)
K893713, K# unknown, K# unknown
Not Found
No
The summary describes a simple, disposable infant hood for oxygen delivery and makes no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as being for "patients who need to be placed in an oxygen enriched environment," which indicates it is used for medical treatment or therapy.
No
The device description indicates it is used to place patients in an oxygen-enriched environment, and its intended use is for oxygen delivery, not for diagnosing medical conditions.
No
The device description explicitly states "Disposable Infant hood with drape," indicating a physical hardware 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 place patients in an oxygen-enriched environment. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a disposable infant hood with a drape. This is a physical device used for delivering oxygen, not for analyzing biological samples.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for providing respiratory support, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device indicated for patients who need to be placed in an oxygen enriched environment.
Product codes
BYL, FOG
Device Description
Disposable Infant hood with drape
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
Neonates and pediatrics
Intended User / Care Setting
Hospital, ICU ( neonatal and pediatric), respiratory therapy and transport isolettes / incubators
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)
Performance Testing: Yes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K893713, K# unknown, K# unknown
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5700 Nonpowered oxygen tent.
(a)
Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
0
Image /page/0/Picture/1 description: The image shows the logo for ProMedic, Inc. The text "ProMedic, Inc." is written in a serif font. To the right of the text is a stylized drawing of a lightbulb.
150
Non-Confidential Summary of Safety and Effectiveness June 3, 1996
page 1 of 3
| ProMedic, Inc.
6329 W. Waterview Ct.
McCordsville, IN 46055 | Tel - 317-335-3780
Fax - 317-335-9270 |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Official contact: | Paul Dryden, President |
| Proprietary or Trade Name: | Burlew Infant Hood |
| Common/Usual Name: | Infant hood |
| Classification Name: | 73 BYL or FOG - Infant oxygen tent / hood
Subsection 868.5700 |
| Intended device: | Disposable Infant hood with drape |
| Predicate devices: | Nova Health Systems - K893713
Sunnydale - K# unknown
Utah Medical - Disposa-Hood - K# unknown |
| Device description: | |
Indicated use:
The device indicated for patients who need to be placed in an oxygen enriched environment.
Target Population:
Neonates and pediatrics
Environment of use:
Hospital, ICU ( neonatal and pediatric), respiratory therapy and transport isolettes / incubators
page 3 of 23
1
Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996
page 2 of 3
Comparison to predicate devices:
| Attribute | Burlew
Intended device | Nova / Sunnydale
Tent | Utah Medical
Disposa-Hood |
|------------------------------------------------------------------------|---------------------------|--------------------------|------------------------------|
| Use
Intended for use with patient
for an oxygen rich environment | Yes | Yes | Yes |
| Intended for use in RT | Yes | Yes | Yes |
| Indicated for use in ICU | Yes | Yes | Yes |
| Intended to be used in transport | Yes | No | No |
| Indicated for single patient use | Yes | Yes | Yes |
| Indicated for use with
neonate and pediatric | Yes | Yes | Yes |
| Design
Clear patient area | Yes | Yes | Yes |
| Fittings for connection
to oxygen source | Yes | Yes | Yes |
| Different sizes | Yes | Yes | Yes |
| Flexible drape to cover patient | Yes | Yes | No |
| Collapsible for easy storage | Yes | No | No |
| Panel removable for
easy patient access | Yes | Yes | No |
| Materials
Plexiglas /
polycarbonate hood | Yes | No | Yes |
| PVC drape | Yes | Yes | No |
| Performance Testing | Yes | Yes | Yes |
page 4 of 23
2
Non-Confidential Summary of Safety and Effectiveness (continued) June 3, 1996
page 3 of 3
Differences
The only difference in the intended device is that it incorporates the feature of the two predicate into one device - a rigid patient hood and flexible body drape.
Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device.
page 5 of 23