(173 days)
Air-Shields Micro-Lite™ Phototherapy System, Air-Shields Fluoro-Lite® Phototherapy Unit, Ohmeda Spot Phototherapy Lamp, Olympic 66 and 33, Drager PT4000
Not Found
No
The description focuses on the physical components, light output, and user-selectable options (white/blue light, timer). There is no mention of any algorithms, data processing for decision making, or learning capabilities.
Yes
The device is designed to provide phototherapy, which is a well-established treatment modality for elevated bilirubin levels in infants (hyperbilirubinemia).
No
The DUO-LITE™ Phototherapy System is designed to provide treatment (phototherapy) to reduce elevated bilirubin levels in infants, not to diagnose them.
No
The device description clearly outlines physical hardware components including bulbs, filters, a power supply, a selector switch, and a digital counter, and provides physical dimensions and weight.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The DUO-LITE™ Phototherapy System directly treats infants with elevated bilirubin levels by applying light to their skin. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for "providing treatment in the form of Phototherapy" to reduce bilirubin levels. This is a therapeutic function, not a diagnostic one.
Therefore, the DUO-LITE™ Phototherapy System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DUO-LITE™ Phototherapy System is designed to provide treatment in the form of Phototherapy to those infants that have been identified as having elevated bilirubin levels (hyperbilirubinemia). Phototherapy as a means for reducing bilirubin levels is a well established treatment modality. The output of the light has been optimized for maximum absorption by the skin in order to reduce the bilirubin levels as quickly as possible.
The DUO-LITE™ Phototherapy System provides the option to select white or blue light via a selector switch. This provides the caregiver with the option to give high output phototherapy for some infants (or early in the treatment cycle) followed by more moderate phototherapy for other infants (or later in the treatment cycle). By contrast, other phototherapy lamp products give the option of either White or Blue light which needs to be set up by an engineer in advance of the treatment. The DVO-LITE™ has combined these two light sources into one housing for the convenience of the caregiver.
The DUO-LITE™ Phototherapy System can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System, or positioned over an open warming bed or crib.
Product codes
BLI
Device Description
The DUO-LITE™ Phototherapy System provides light output for maximum absorption by the infant's skin in order to reduce bilirubin levels. The DUO-LITE™ is designed for use in conjunction with a variety of other products. Perhaps the most common application is when placed on the hood of an incubator, or fitted to a rail system and appitioned over the hood of the incubator. The DUO-LITT:" can also be mounted to a mobile stand, thus extending its applications to use with Open Warmers and Open Bassinets.
The product is L 23 x W 10 x H 5 (inches) and weighs approximately 15 Lbs. It is available in 100, 120 and 220/240V 50/60 Hz. The DUO-LITE™ is comprised of three 75W quartz halogen bulbs. The light emitted from these bulbs is filtered through IR/UV and Dichroic filters. The output of the bulbs is dependent on the driving voltage which is regulated by the internal power supply.
The user can select the use of White light or Blue light using the selector switch on the front of the lamp housing. The different color lights give different therapeutic outputs depending on the individual needs of the patient. Adjacent to the On/Off switch is a digital counter which can be set to display exposure time and bulb life remaining.
The DU1)-LIT!:" uses quartz halogen technology since the irradiance remains constant over the life of the bulb. By way of comparison, fluorescent bulbs degrade rapidly over the course of time and as such need to be continually monitored to ensure the output is therapeutically acceptable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Infants
Intended User / Care Setting
Caregiver / Hospital - can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System, or positioned over an open warming bed or crib.
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)
Non-clinical tests: A report on the spectral irradiance measurements conducted by an outside test house on the Duo-Lite™ Phototherapy System. The spectral irradiance was measured and recorded from 250 to 1100nm for the following configurations:
| Filter Color | Voltage | Distance |
|---|---|---|
| Blue | 120V | 17" |
| Blue | 132V | 17" |
| White | 120V | 17" |
| White | 132V | 17" |
| Blue | 120V | 15.75" |
| Blue | 132V | 15.75" |
| White | 120V | 15.75" |
| White | 132V | 15.75" |
| The results were as expected for a device of this type across this bandwidth and also indicate low UV and IR output. Mattress mapping done in our in-house laboratory support our peak irradiance specifications. The data supports our claim of substantial equivalence to similar phototherapy devices already on the market. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Air-Shields Micro-Lite™ Phototherapy System, Air-Shields Fluoro-Lite® Phototherapy Unit, Ohmeda Spot Phototherapy Lamp, Olympic 66 and 33, Drager PT4000.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).
0
SEP 2 4 1997
510(k) Summary
April 2, 1997
- Submitter: Air-Shields, Inc. 330 Jacksonville Road Hatboro, PA 19040 215-675-5200 Contact: Marci L. Goldfinger
-
- Device Trade Name: Duo-Lite™ Phototherapy System Device Classification Name: Neonatal Phototherapy Unit Device Common Name: Phototherapy Unit
3. Predicate Devices:
The Air-Shields DU0-LITE™ Phototherapy System, Air-Shields Micro-Lite™ Phototherapy System, Air-Shields Fluoro-Lite® Phototherapy Unit, Ohmeda Spot Phototherapy Lamp, Olympic 66 and 33, and Drager PT4000.
4. Device Description:
The DUO-LITE" Phototherapy System provides light output for maximum absorption by the infant's skin in order to reduce bilirubin levels. The DUO-LITE™ is designed for use in conjunction with a variety of other products. Perhaps the most common application is when placed on the hood of an incubator, or fitted to a rail system and appitioned over the hood of the incubator. The DUO-LITT:" can also be mounted to a mobile stand, thus extending its applications to use with Open Warmers and Open Bassinets.
The product is L 23 x W 10 x H 5 (inches) and weighs approximately 15 Lbs. It is available in 100, 120 and 220/240V 50/60 Hz. The DUO-LITE™ is comprised of three 75W quartz halogen bulbs. The light emitted from these bulbs is filtered through IR/UV and Dichroic filters. The output of the bulbs is dependent on the driving voltage which is regulated by the internal power supply.
The user can select the use of White light or Blue light using the selector switch on the front of the lamp housing. The different color lights give different therapeutic outputs depending on the individual needs of the patient. Adjacent to the On/Off switch is a digital counter which can be set to display exposure time and bulb life remaining.
The DU1)-LIT!:" uses quartz halogen technology since the irradiance remains constant over the life of the bulb. By way of comparison, fluorescent bulbs degrade rapidly over the course of time and as such need to be continually monitored to ensure the output is therapeutically acceptable.
1
Page 2 Air-Shields Duo-Lite™ Phototherapy System 510(k) Summary
5. Statement of Intended Use:
The DUO-LITL:™ Phototherapy System is designed to provide treatment in the form of Phototherapy to those infants that have been identified as having elevated bilirubin levels (hyperbilirubinemia). Phototherapy as a means for reducing bilirubin levels is a well established treatment modality. The output of the light has been optimized for maximum absorption by the skin in order to reduce the bilirubin levels as quickly as possible.
The DUO-LITE™ Phototherapy System provides the option to select white or blue light via a selector switch. This provides the caregiver with the option to give high output phototherapy for some infants (or early in the treatment cycle) followed by more moderate phototherapy for other infants (or later in the treatment cycle). By contrast, other phototherapy lamp products give the option of either White of Blue light which needs to be set up by an engineer in advance of the treatment. The DUO-LITE™ has combined these two light sources into one housing for the convenience of the caregiver.
The DU()-LITE:TM Phototherapy System can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System, or positioned over an open warming bed or crib.
-
- Comparison Matrix: Refer to Figure #1
7. Discussion of Non-clinical tests submitted:
Submitted in the 510(k) is a report on the spectral irradiance measurements conducted by an outside test house on the Duo-Lite™ Phototherapy System. The spectral irradiance was measured and recorded from 250 to 1100nm for the following configurations:
| Filter Color | Voltage | Distance |
|---|---|---|
| Blue | 120V | 17" |
| Blue | 132V | 17" |
| White | 120V | 17" |
| White | 132V | 17" |
| Blue | 120V | 15.75" |
| Blue | 132V | 15.75" |
| White | 120V | 15.75" |
| White | 132V | 15.75" |
The results were as expected for a device of this type across this bandwidth and also indicate low UV and IR output. Mattress mapping done in our in-house laboratory support our peak irradiance specifications. The data supports our claim of substantial equivalence to similar phototherapy devices already on the market.
2
Air-Shields Duo-Lite™ Phototherapy System 510(k) Summary
Product Comparison Matrix
| Product
Feature | Air-Shields
DUO-LITE™ | Air-Shields
Micro-Lite® | Air-Shields
Fluoro-Lite® | Ohmeda
Spot PT Lamp | Olympic
Model 66 | Olympic
Model 33 | Drager
PT 4000 |
|------------------------------|---------------------------------------------------|----------------------------|-----------------------------|------------------------|--------------------------------|--------------------------------|-------------------------|
| Type | Freestanding | Freestanding | Freestanding | Freestanding | Freestanding | Freestanding | Freestanding |
| Size (inches) | | | | | | | |
| Height on Stand | 55 - 65 | 55 - 65 | 38.5 - 56 | 57 - 91 | 49 - 65 | 42 - 61 | 42 - 64 |
| L x W | 21 x 17 | 21 x 17 | 27 x 13 | 12 x 6.25 | 26 x 11 | 25 x 19 | 21.3 x 11.2 |
| Weight (on stand) | 66 Lbs | 56.5 Lbs | 86 Lbs | 40 Lbs | 54 Lbs | 52 Lbs | 45.7 Lbs |
| Angle Adjustment | 0 - 45° | 0 - 45" | +/-90° | Multi Directional | 0 - 90' | 0 - 60' | 0 - 30" |
| Irradiance
(400 - 520 Nm) | ≥10 (White)
≥20 (Blue)
µW/cm²/nm
@ 43 cm | >9µW/cm²/nm
@ 43 cm | >12µW/cm²/nm
@ 39 cm | 4 - 20
µW/cm²/nm | 4 - 9 (White)
4 - 20 (Blue) | 4 - 9 (White)
4 - 20 (Blue) | >13µW/cm²/nm
@ 40 cm |
| Bulb | | | | | | | |
| Type | Quartz Halogen | Quartz Halogen | Fluorescent | Quartz Halogen | Fluorescent | Fluorescent | Fluorescent |
| Number | 3 x 75W | 3 x 50W | 4 x 20W | 1 x 250W | 4 x 20W | 8 x 20W | 6 x 20W |
| Life | 1,000 Hrs | 1,000 Hrs | 500 Hrs | 500 Hrs | 200 Hrs | 200 Hrs | 1,000Hrs |
| Color | Blue or White | White | Blue and/or
White | White | Blue and/or
White | Blue and/or
White | Blue |
| Procedure Timer | Yes | Yes | Optional | No | Optional | Optional | Yes |
| Line Voltage | 120 Vac | 120 Vac | 120 Vac | 115 Vac | 115 Vac | 120 Vac | 110 - 115 Vac |
| Power
Consumption | 350W | 300W | 140W | 80 - 100W | 160 - 180W | 160 - 180W | 120W |
| Leakage Current |