The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

Device Description

The device BiliLux is a configurable LED phototherapy light designed to reduce serum bilirubin concentration in premature babies and neonates with unconjuqated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation. The blue light of the phototherapy light lies within the wavelength range of 460 nm to 490 nm. The front panel has a display screen and keys to control functions and change settings. There are five intensity settings (20%, 60% 80% and 100% of nominal intensity). On the user interface, the user can see session time and any software errors that may occur.

The BiliLux phototherapy light can be placed directly on an incubator hood or be combined with a spring arm and trolley. An optional radiometer is also available to measure the phototherapeutic effective irradiance produced by the phototherapy light.

AI/ML Overview

The provided document is a 510(k) premarket notification for the BiliLux® Phototherapy Light. It describes the device, its intended use, and a comparison to a predicate device (NanoBlu™ 500).

However, the document explicitly states:

"No clinical testing was performed."
The discussion focuses on "Non-Clinical Studies," specifically bench testing and adherence to standards.

This means that there are no acceptance criteria, performance data, or studies related to clinical effectiveness or comparison with human readers as typically found in AI/ML device submissions. The document focuses on demonstrating substantial equivalence to a predicate device through technical specifications and compliance with standards.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of an AI/ML device, as this device is a phototherapy light and was not evaluated based on AI/ML performance.

If this was a misunderstanding and you were looking for information about a different type of device or performance evaluation, please provide a different document.

Summary

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May 1, 2018

Draeger Medical Systems, Inc. Gale Winarsky Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969

Re: K172656

Trade/Device Name: BiliLux® Phototherapy Light Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: March 26, 2018 Received: March 27, 2018

Dear Gale Winarsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172656

Device Name BiliLux® Phototherapy Light

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter's Name and Address:	Draeger Medical Systems Inc.3135 Quarry RoadTelford, PA 18969
Contact Person:	Gale WinarskyManager, Regulatory AffairsPhone: 215-660-2239Fax: 215-721-5424
Date prepared:	April 24, 2018
Device Name:
	Trade Name: BiliLux® Phototherapy Light
	Common Name: Phototherapy light or unitClassification Name: Neonatal phototherapy unit
	Regulation Number:

Requlation Number:

Product Code:

Class:

Legally Marketed Device Identification: Substantial equivalence is claimed to the predicate device, NanoBlu™ 500, K113206, Draeger Medical Systems Inc.

880.5700

LBI

Device Description:

Intended Use:

The BiliLux is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb.)

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Device Name	Device Under ReviewBiliLux (PT-LED)	Predicate DeviceNanoBlu™ 500	Comments
Image	Image: BiliLux (PT-LED)	Image: NanoBlu™ 500
Manufacturer	Draeger Medical Systems, Inc.	Draeger Medical Systems, Inc.	N/A
510(k)	K172656	K113206	N/A
Regulation #	880.5700	Same	N/A
Product Code	LBI	Same	N/A
Classification	II	Same	N/A
Indications for Use	The BiliLux phototherapy light isdesigned to reduce the serum bilirubinconcentration in premature babies andneonates with hyperbilirubinemia bymeans of phototherapeutic radiation. It isintended for use with patients up to 3months of age who weigh less than 10kg (22 lb).	The Draeger NanoBlu 500 LEDPhototherapy Light is intended to treatneonatal hyperbilirubinemia by providingphototherapeutic light to the body of thepatient. It is intended for use on therecommendation and under thesupervision of healthcare professionals.The Draeger NanoBlu 500 can be usedin a hospital. Additionally, this productcan be used with an under-babyphototherapy light to increase patientcoverage.	The indications for use of the BiliLux and thepredicate and reference devices are substantialequivalent. The differences do not raisequestions about the safety or effectiveness forthe subject device.
Environment of Use	The BiliLux phototherapy light can beused in hospital departments thatprovideneonatal and infant care, includingnurseries and Neonatal Intensive CareUnit (NICU) levels I-IV.	It is intended for use on therecommendation and under thesupervision of healthcare professionals.The Draeger NanoBlu 500 can be usedin a hospital.	Differences in environment of use are notclinically relevant. All three devices are for useon Neonates under the supervision of healthcareprofessional within a hospital environment.
Safety Standards	· IEC 60601-1· IEC 60601-1-2· IEC 60601-2-50	Same	Same
Physical Description
Light - Length	≤39 cm (15.4 in)	23.0 cm (9.06 in)	Differences in light length, width, height and
Light - Width	≤19 cm (7.5 in)	11.6 cm (4.57 in)	weight are not clinically relevant.
Light - Height	≤8 cm (3.1 in)	100.0 cm to 140.0 cm(39.37 in to 55.12 in)
Light - Weight (without options/acces≥ 1.2 kg (2.7 lb)	≥ 1.2 kg (2.7 lb)
Optional Trolley - weight	≤14.9 kg (32.8 lb)	9.0 kg (19.8 lb)	Differences in accessory weights are not
Arm - weight	≤1.5 kg (3.3 lb)		clinically relevant.
Technology
Expected service life of device	8 years	UNK	N/A
Light source lifetime	50,000 hours	20,000 hr	Light source lifetime is not clinically relevant.
Light bulb type	LED	Same	Same
Counter for running time of lights	Yes	Same	Same
Integrated white exam light	Yes	No	Same
Irradiance	100% irradiance setting, 460-490nmat 30cm: >85.5 µW/cm2/nmat 40cm: >50.1 µW/cm2/nmat 50cm: >33.4 µW/cm2/nm	100% irradiance setting, 400-550nmat 30cm: 45 to 65 µW/cm2/nmat 40cm: 30 to 45 µW/cm2/nmat 50cm: 20 to 30 µW/cm2/nm	The American Academy of Pediatrics (AAP)recommend optimal irradiance not less than 30µW/cm 2/nm 1.1 All devices meet thisrecommendation.
Wavelength	460 to 490 nm	400 to 550 nm	The AAP recommends the light sourcewavelength be in the blue-green spectrum (~460-490 nm).1 The device under review andpredicate device cover this range.
Intensity Settings	5 settings (20%, 40%, 60% 80% and100% of nominal intensity)	10 settings (10-100% in 10% increments)	Differences in Intensity Settings do not raise anynew questions of safety or effectiveness.
Effective surface area	at 40cm distance	UNK	AAP recommends maximal skin area exposure.
Width	30cm	UNK	Effective surface areas are similar and do not
Length	50cm	UNK	raise any new questions on safety oreffectiveness.
Audible noise	≤20 dB	<52 dB	Noise level is not functionally relevant tophototherapy. BiliLux introduces the lowestaudible noise in the patient environment.
Counter for running time of lights	Yes	Same	Same
Material (no implants)
Material used for indirect patient cont	N/A, no indirect contact parts	Same	Same
Material used for direct patient conta	N/A, no direct contact parts	Same	Same
Biocompatibility	N/A, no direct contact parts	Same	Same
Sterilization	N/A, not sterile	Same	Same
Electrical specification
Power requirement	100-240 V AC, 50/60 Hz, 0.42-0.22 A	100V~ to 240V~, 50/60 Hz, 50VA, 1.5A	Differences is in electrical specification are notclinically relevant.
Earth leakage current	<500 µA	< 100 uA	clinically relevant.
Operating conditions
Temperature	18 °C (64.4 °F) to 40 °C (104 °F)	18 °C (64.4 °F) to 28 °C (82.4 °F)	Differences in operating conditions are notclinically relevant.
Ambient pressure	700 hPa to 1100 hPa	700 hPa to 1060 hPa	clinically relevant.
Relative humidity	10% to 95% relative humidity,	Same
Storage/transportation conditions
Temperature	-20°C (-4°F) to 60 °C (140 °F)	5 °C to 55 °C (41 °F to 131 °F)	Differences in storage/transportation conditions
Ambient pressure	500 hPa to 1100 hPa	500 hPa to 1060 hPa	are not clinically relevant to phototherapy.
Relative humidity	10% to 95% relative humidity,	30% to 95% non-condensing

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¹PEDIATRICS Volume 128, Number 4, October 2011

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Discussion of Differences

Indications for Use: There are no substantive differences in the general indication for use statements between the device under review. predicate and reference devices. The premise of the patient population (age and weight) is provided with the indications for use for the BiliLux as additional information for the user.

Wavelength: The BiliLux emits light within the blue-green spectrum at the wavelength of 460-490nm. The predicate device emits light within the blue-green spectrum at the wavelength of 400-550nm. The recommended light source wavelength according to the American Academy of Pediatrics' is 460-490nm of which both the devices under review and the predi-cate device meet this recommendation.

Intensity Settings: The BiliLux has 5 intensity settings, 20%, 40, 60, 80% and 100% of total strength. The Nanoblu has 10 intensity settings from 10 to 100% in 10% increments of total strength and the neoBLUE compact LED Phototherapy System compact has two intensity settings, high and low. The difference in the intensity settings (5 versus 10 versus 2) does not raise any new questions of safety or effectiveness.

Effective Surface Area: The BiliLux has an effective surface area of 30 cm x 50 cm (1500 cm²) at 40 cm distance from the patient. Information regarding effective surface area of the predicate device is unknown and the reference device has an effective surface area of 700 cm². The AAP1 recommends maximal skin exposure for phototherapy treatment therefore the differences do not raise any new questions of safety or effectiveness.

The differences between the device under review (BillLux), the predicate device (NanoBlu, K113206) do not raise any new questions of safety or effectiveness.

Discussion of Non-Clinical Studies

The BiliLux was tested in accordance with applicable standards, guidance and internal design control procedures including performance testing, functional/operation testing, verification and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components.

Clinical Studies

No clinical testing was performed.

Biocompatibility

Not Applicable - The BiliLux has no direct or indirect patient contact.

Sterilization

Not Applicable - The BiliLux and accessories are non-sterile.

Reprocessing and Cleaning/Disinfection

The BiliLux was assessed in accordance with the FDA guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff, 2015. Macroscopic and microbiological validation with Oxycide was performed by an accredited laboratory pursuant to DIN EN ISO/IEC 17025 and provided in the submission.

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Standards and Guidance

According to the device features, the BiliLux was evaluated by the following Standards and Guidance.

Standards IEC 60601-1:2005 AMD1:2012 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-1-2:2001/AC:2010 & IEC 60601-1-2:2014 Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility-Requirements and Tests

IEC 60601-2-50:2009 Medical Electrical Equipment, Part 2-50 Particular Requirements for the Basic Safety and Essential Performance of Infant Phototherapy Equipment

IEC 60601-1-6:2010/AMD1:2013 Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability

IEC 62366:2007/AMD1:2014 Medical Devices - Application of Usability Engineering to Medical Devices

IEC 62304:2006 Medical Device Software Life-Cycle Processes

ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices

Guidance:

"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," 2005.

"Applying Human Factors and usability Engineering to Medical Devices, Guidance for Indus-try and Food and Drug Administration Staff," 2016.

Use of international Standard ISO 10993. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management process," 2016.

"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and food and Drug Administration Staff," 2015.

Conclusion Drawn from Non-Clinical Studies

The results of the non-clinical bench testing show that the BillLux phototherapy light meets the performance requirements of the standards and guidance mentioned above, does not raise new questions of the safety and effectiveness of cleared devices and is substantially equivalent to the predicate device K113206.

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).