BiliLux

K172656 · Draeger Medical Systems, Inc. · LBI · May 1, 2018 · General Hospital

Device Facts

• Record ID: K172656
• Device Name: BiliLux
• Applicant: Draeger Medical Systems, Inc.
• Product Code: LBI · General Hospital
• Decision Date: May 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

BiliLux is a configurable LED phototherapy light for treating neonatal hyperbilirubinemia. It houses 20 blue LEDs (460-490 nm) for therapy and 2 white LEDs for observation. Operated by clinicians in hospital settings (nurseries, NICU levels I-IV), the device is placed on an incubator hood or mounted on a trolley/spring arm. The user interface features a display screen and keys to adjust five intensity settings (20%-100%) and monitor session time. An optional radiometer measures effective irradiance. By delivering phototherapeutic radiation to the patient, the device reduces serum bilirubin concentration, aiding in the management of neonatal jaundice. It includes a running time counter for lights and provides audible alerts for software errors.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including performance verification, functional/operational testing, human factors/usability engineering, and reprocessing validation (microbiological/macroscopic) per FDA guidance.

Technological Characteristics

Configurable LED phototherapy unit. Light source: 20 blue LEDs (460-490 nm) and 2 white LEDs. Intensity: 5 settings (20-100%). Dimensions: ≤39x19x8 cm. Power: 100-240 V AC, 50/60 Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50, IEC 62304, ISO 14971. Non-sterile, no direct/indirect patient contact. Connectivity: Standalone with user interface for settings and error monitoring.

Indications for Use

Indicated for premature babies and neonates up to 3 months of age and weighing less than 10 kg (22 lb) with unconjugated hyperbilirubinemia to reduce serum bilirubin concentration via phototherapeutic radiation.

Regulatory Classification

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.

Predicate Devices

• NanoBlu™ 500 (K113206)

Reference Devices

• neoBLUE compact LED Phototherapy System

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div><span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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| Submitter's Name and Address: | Draeger Medical Systems Inc.<br>3135 Quarry Road<br>Telford, PA 18969 |
|-------------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Gale Winarsky<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | April 24, 2018 |
| Device Name: | |
| | Trade Name: BiliLux® Phototherapy Light |
| | Common Name: Phototherapy light or unit<br>Classification 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:

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

#### 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 Review<br>BiliLux (PT-LED) | Predicate Device<br>NanoBlu™ 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 is<br>designed to reduce the serum bilirubin<br>concentration in premature babies and<br>neonates with hyperbilirubinemia by<br>means of phototherapeutic radiation. It is<br>intended for use with patients up to 3<br>months of age who weigh less than 10<br>kg (22 lb). | The Draeger NanoBlu 500 LED<br>Phototherapy Light is intended to treat<br>neonatal hyperbilirubinemia by providing<br>phototherapeutic light to the body of the<br>patient. It is intended for use on the<br>recommendation and under the<br>supervision of healthcare professionals.<br>The Draeger NanoBlu 500 can be used<br>in a hospital. Additionally, this product<br>can be used with an under-baby<br>phototherapy light to increase patient<br>coverage. | The indications for use of the BiliLux and the<br>predicate and reference devices are substantial<br>equivalent. The differences do not raise<br>questions about the safety or effectiveness for<br>the subject device. |
| Environment of Use | The BiliLux phototherapy light can be<br>used in hospital departments that<br>provide<br>neonatal and infant care, including<br>nurseries and Neonatal Intensive Care<br>Unit (NICU) levels I-IV. | It is intended for use on the<br>recommendation and under the<br>supervision of healthcare professionals.<br>The Draeger NanoBlu 500 can be used<br>in a hospital. | Differences in environment of use are not<br>clinically relevant. All three devices are for use<br>on Neonates under the supervision of healthcare<br>professional within a hospital environment. |
| Safety Standards | · IEC 60601-1<br>· IEC 60601-1-2<br>· 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<br>(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, 460-490nm<br>at 30cm: >85.5 µW/cm2/nm<br>at 40cm: >50.1 µW/cm2/nm<br>at 50cm: >33.4 µW/cm2/nm | 100% irradiance setting, 400-550nm<br>at 30cm: 45 to 65 µW/cm2/nm<br>at 40cm: 30 to 45 µW/cm2/nm<br>at 50cm: 20 to 30 µW/cm2/nm | The American Academy of Pediatrics (AAP)<br>recommend optimal irradiance not less than 30<br>µW/cm 2/nm 1.1 All devices meet this<br>recommendation. |
| Wavelength | 460 to 490 nm | 400 to 550 nm | The AAP recommends the light source<br>wavelength be in the blue-green spectrum (~460-<br>490 nm).1 The device under review and<br>predicate device cover this range. |
| Intensity Settings | 5 settings (20%, 40%, 60% 80% and<br>100% of nominal intensity) | 10 settings (10-100% in 10% increments) | Differences in Intensity Settings do not raise any<br>new 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 or<br>effectiveness. |
| Audible noise | ≤20 dB | <52 dB | Noise level is not functionally relevant to<br>phototherapy. BiliLux introduces the lowest<br>audible 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 not<br>clinically 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 not<br>clinically 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.