BURLEW INFANT HOOD

K962182 · Promedic, Inc. · FOG · Jul 15, 1996 · Anesthesiology

Device Facts

• Record ID: K962182
• Device Name: BURLEW INFANT HOOD
• Applicant: Promedic, Inc.
• Product Code: FOG · Anesthesiology
• Decision Date: Jul 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5700
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The device indicated for patients who need to be placed in an oxygen enriched environment.

Device Story

Disposable infant hood with flexible drape; provides oxygen-enriched environment for neonates/pediatrics. Used in hospitals, neonatal/pediatric ICUs, respiratory therapy, and transport isolettes/incubators. Device features rigid hood (Plexiglas/polycarbonate) and flexible PVC drape; collapsible for storage; includes oxygen source fittings and removable panel for patient access. Clinicians place patient within hood to facilitate oxygen delivery. Benefits include controlled oxygen environment and ease of patient access.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Plexiglas/polycarbonate hood, PVC drape. Design: Rigid hood with flexible drape, oxygen source fittings, removable access panel, collapsible form factor. Single-patient use.

Indications for Use

Indicated for neonates and pediatric patients requiring an oxygen-enriched environment.

Regulatory Classification

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.

Predicate Devices

• Nova Health Systems (K893713)
• Sunnydale (K# unknown)
• Utah Medical Disposa-Hood (K# unknown)

Submission Summary (Full Text)

{0}

K962182
ProMedic, Inc.
JUL 15 1996

Non-Confidential Summary of Safety and Effectiveness
June 3, 1996

page 1 of 3

ProMedic, Inc. Tel - 317-335-3780
6329 W. Waterview Ct. Fax - 317-335-9270
McCordsville, IN 46055

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

6329 W. Waterview Court • McCordsville, IN 46055-9501
317-335-3780 • 317-335-9270 Fax

{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 | | | |
| None applicable | Yes | Yes | Yes |

page 4 of 23

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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.

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