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.

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.

AI/ML Overview

The provided text describes the Air-Shields Duo-Lite™ Phototherapy System, a medical device for treating neonatal hyperbilirubinemia. The submission is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a device meets novel acceptance criteria through a clinical study. Therefore, some of the requested information, such as sample size for test and training sets, number of experts for ground truth, adjudication methods, and MRMC studies, is not applicable to this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the device performs comparably to predicate devices in key specifications, rather than setting specific numerical thresholds for a novel device. The Duo-Lite™ compares its performance against several predicate devices. The critical performance metric highlighted is irradiance.

Acceptance Criteria (Implied by Predicate Comparison)	Reported Duo-Lite™ Performance
Achieves therapeutic irradiance for phototherapy.	Irradiance (400 - 520 Nm) @ 43 cm: ≥10 µW/cm²/nm (White light) ≥20 µW/cm²/nm (Blue light)
Low UV and IR output.	"also indicate low UV and IR output."
Meets specified bulb life.	Bulb Life: 1,000 Hrs
Line Voltage compatibility.	Line Voltage: 120 Vac
Power Consumption within acceptable limits.	Power Consumption: 350W
Leakage Current within acceptable limits.	Leakage Current: <300µA

2. Sample Size Used for the Test Set and Data Provenance

This is a non-clinical test of the device's physical performance, not a study involving patient data. Therefore, typical "sample size" and "data provenance" as applied to clinical studies are not applicable.
The tests involved measurements of the Duo-Lite™ Phototherapy System under various configurations (filter color, voltage, distance). The data provenance is from an "outside test house" for spectral irradiance measurements and "in-house laboratory" for mattress mapping.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" here is the physical performance of the device (e.g., spectral irradiance) as measured by specialized equipment and methodologies, not human expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical device performance test, not a clinical study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating the physical and functional equivalence of the device to existing predicate devices through engineering specifications and non-clinical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The "standalone performance" in this context refers to the intrinsic physical performance of the device itself (e.g., its irradiance output). The "spectral irradiance measurements conducted by an outside test house" and "Mattress mapping done in our in-house laboratory" represent this standalone assessment of the device's output. There is no algorithm or human-in-the-loop component relevant to these performance tests.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing is the objective, measurable physical properties and output of the device, obtained through:

Spectral irradiance measurements: Using specialized photometers/spectroradiometers.
Mattress mapping: To assess the distribution of irradiance.
Engineering specifications: (e.g., bulb life, voltage, power consumption) as verified by testing or design.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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SEP 2 4 1997

K971256

510(k) Summary

April 2, 1997

Submitter: Air-Shields, Inc. 330 Jacksonville Road Hatboro, PA 19040 215-675-5200 Contact: Marci L. Goldfinger

1. 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:

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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.

1. 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.

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Air-Shields Duo-Lite™ Phototherapy System 510(k) Summary

Product Comparison Matrix

ProductFeature	Air-ShieldsDUO-LITE™	Air-ShieldsMicro-Lite®	Air-ShieldsFluoro-Lite®	OhmedaSpot PT Lamp	OlympicModel 66	OlympicModel 33	DragerPT 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 - 20µW/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/orWhite	White	Blue and/orWhite	Blue and/orWhite	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
PowerConsumption	350W	300W	140W	80 - 100W	160 - 180W	160 - 180W	120W
Leakage Current	<300µA	<100µA	<100µA	<100µA	<100µA	<100µA	<300µA
CommunicationPort	Yes	No	No	No	No	No	No

FIGURE #1

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with a human figure in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1997

Ms. Marci L. Goldfinger Director, Quality Assurance and Regulatory Affairs Air Shields, Incorporated 330 Jacksonville Road Hatboro, Pennsylvania 19040-2211

Re : K971256 Duo-Lite Phototherapy System Trade Name: Requlatory Class: II Product Code: BLI Dated: July 10, 1997 Received: July 11, 1997

Dear Ms. Goldfinger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Goldfinger

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Clus. L/or
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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510(k) Number (if known): _ K 97 | 25

Device Name:

Duo-Lite™ Phototherapy System

Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Um LAEMMAR & TXC

Division of Dental, Infection Control, and General Hospital Devices

Prescription Use (Per 21 C R 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Image /page/5/Picture/16 description: The image is a black and white abstract pattern. The pattern is made up of small, irregular shapes that are arranged in a random order. The shapes are mostly black, but there are also some white shapes. The overall effect is one of chaos and disorder. The image is not very clear, and it is difficult to make out any specific details.

Regulation Number and Section

§ 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).