Skylife

K170585 · Neolight, LLC · LBI · Oct 27, 2017 · General Hospital

Device Facts

• Record ID: K170585
• Device Name: Skylife
• Applicant: Neolight, LLC
• Product Code: LBI · General Hospital
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.

Device Story

Skylife™ is a portable neonatal phototherapy system delivering high-intensity blue light (430-475 nm) via LEDs to treat unconjugated hyperbilirubinemia. The device is placed under the infant within a patient enclosure (bassinet, crib, incubator, or warming table). It consists of a light bed with modules, a GelMat, a disposable mattress cover, a controller, and a power supply. Caregivers select treatment intensity (Low, High, Very High) based on physician prescription. The device uses blue LEDs to degrade bilirubin in the skin. It includes thermal protection circuits to prevent overheating and fans for cooling. The system is intended for use in both clinical and home environments. By providing targeted phototherapy, it facilitates the reduction of bilirubin levels in jaundiced neonates.

Clinical Evidence

Bench testing only. Performance data included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), phototherapy safety (IEC 60601-2-50), home environment requirements (IEC 60601-1-11), and usability (IEC 62366). Biocompatibility testing per ISO 10993-5 and ISO 10993-10 confirmed materials are non-cytotoxic, non-sensitizing, and non-irritating. Human factors and usability studies with two user groups validated safe operation in clinical and home environments.

Technological Characteristics

Portable phototherapy unit; blue LED light source (430-475 nm); intensity 25 to >55 μW/cm²/nm. Materials: ABS bed casing, acrylic sheet, polyurethane gel mattress, polypropylene disposable cover. Electrical safety: IEC 60601-1, IEC 60601-2-50. Connectivity: Standalone. Cooling: Integrated fan and thermal protection circuit. Ingress protection: IP23.

Indications for Use

Indicated for treatment of neonatal unconjugated hyperbilirubinemia in neonates. Used in clinical or home settings within a patient enclosure (bassinet, crib, warming table, or incubator).

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

• neoBLUE cozy LED Phototherapy System (K051869)
• Ohmeda Medical Spot PT Lite Phototherapy System (K011549)

Submission Summary (Full Text)

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October 27, 2017

NeoLight. LLC % Paul E. Dryden Regulatory Consultant ProMedic, LLC 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K170585

Trade/Device Name: Skylife™ Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal phototherapy unit Regulatory Class: Class II Product Code: LBI Dated: September 23, 2017 Received: September 26, 2017

### Dear Paul E. Dryden:

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, listing 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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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)

#### K170585

Device Name

#### Skylife™

Indications for Use (Describe)

Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.

Type of Use (Select one or both, as applicable)

| XX Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="true" type="checkbox"/> |
|-------------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

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# 510(k) Summary NeoLight, LLC - Skylife™ Page 1 of 7

| Date Prepared | October 25, 2017 |
|--------------------|------------------------------------------------------------------------------------------------------|
| 1 – SUBMITTER | NeoLight, LLC.<br>1475 N Scottsdale Rd, Suite 200<br>Scottsdale AZ 85257<br>Telephone [phone] |
| 2 – CONTACT PERSON | Sivakumar Palaniswamy<br>Chief Technology Officer |

### 3 - DEVICE CLASSIFICATION

| Trade/Proprietary Name: | Skylife™ |
|-------------------------|-----------------------------------|
| Common Name: | Neonatal phototherapy device unit |
| Classification Name: | Neonatal phototherapy |
| Regulation: | (21 CFR 880.5700) |
| Product Code: | LBI |
| Regulatory Class: | II |

Telephone [phone]

### 4 - PREDICATE DEVICES

| Primary Predicate: | K051869 – neoBLUE cozy LED Phototherapy System, Natus Medical, Inc |
|----------------------|------------------------------------------------------------------------------|
| Secondary Predicate: | K011549 – Ohmeda Medical Spot PT Lite Phototherapy System, Ohmeda<br>Medical |

## 5 - DEVICE DESCRIPTION

Skylife™ is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. Skylife™ is designed to provide phototherapy treatment from underneath the baby. The system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator.

Skylife™ utilizes blue LEDs to achieve intensities from 25 uW/cm²/nm to >55 uW/cm²/nm, emitting light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin. Skylife™ utilizes blue LEDs in this range to achieve peak intensities between 25 to 35, and over 55 uw/cm²/nm at low, high settings. Skylife™ at the Very High setting provides an average intensity of 56.3 uw/cm/nm over the treatment area with peak at 72.4 uw /cm-/nm.

Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using Skylife™ can be applied at home or in a hospital.

Skylife™ consists of the following components: Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and power supply.

### 6 - INDICATIONS FOR USE

Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table, or an incubator. Skylife™ can be used in a clinical setting or in the home.

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# 510(k) Summary NeoLight, LLC - Skylife™ Page 2 of 7

# 7 - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The intended use, design, materials, and functional characteristics of Skylife™ and the predicate device are substantially equivalent. The subject device and predicate device provide phototherapy for treatment of neonatal unconjugated hyperbilirubinemia (jaundice), are portable, and intended for home and healthcare environment use. Both devices use the same operating principle to deliver light to degrade bilirubin. In both devices, the user (caregiver) selects the desired treatment intensity as prescribed by a physician.

The following table summarizes the technological characteristics of the subject device and predicate devices.:

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# 510(k) Summary NeoLight, LLC - Skylife™ Page 3 of 7

| Features | Subject Device-<br>Skylife™ | Primary Predicate Device-<br>neoBLUE cozy LED Phototherapy<br>System - K051869 | Secondary Predicate Device-<br>Ohmeda Medical Spot PT Lite<br>Phototherapy System - K011549 | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of neonatal<br>hyperbilirubinemia | Similar to the subject<br>device | Similar to the subject<br>device | |
| Indications for use | Skylife™ is intended for the treatment of<br>neonatal unconjugated hyperbilirubinemia. It is<br>designed to provide phototherapy treatment<br>from underneath the baby. Skylife™ must be<br>used within a patient enclosure, such as<br>bassinet, an open crib, a warming table or an<br>incubator. Skylife™ can be used in a clinical<br>setting or in the home. | The neoBLUE cozy phototherapy light is intended<br>for the treatment for neonatal hyperbilirubinemia.<br>It is designed to provide phototherapy treatment<br>from underneath the baby. The neoBLUE cozy<br>system must be used within a patient enclosure,<br>such as bassinet, an open crib, a warming table or<br>an incubator. The neoBLUE cozy system can be<br>used in a clinical setting or in the home. | The Spot PT Lite Phototherapy System provides<br>light therapy for the treatment of<br>hyperbilirubinemia, commonly known as neonatal<br>jaundice, during the newborn period in the<br>hospital. | |
| Treatment modes | Under-baby phototherapy | Under-baby phototherapy | Overhead neonatal, phototherapy device | |
| Targeted<br>population | Neonates | Neonates | Neonates | |
| Sites of use | Clinical setting and home use | Clinical setting and home use | Clinical setting | |
| | Specifications | | | |
| Type of device | Free standing device | Free standing device | Overhanging device | |
| Type of light | Blue light LED | Blue light LED | White metal halide Bulb | |
| Intensity | 25-35 $μW/cm^2/nm$ , Low setting<br>35-55 $μW/cm^2/nm$ , High setting<br>>55 $μW/cm^2/nm$ , Very high setting | 30 – 35 $μW/ cm^2/nm$ | 57.6 $μW/cm^2/nm$ ± 25% | |
| Height | 4.86 cm (1.913 in) | ≤ 12.7 cm (5.0 in) | Variable | |
| Width and length | 60.80 cm x 31.12 cm (23.94 in x 12.25 in) | 30.5 cm x 64.8 cm (12 in x 25.5 in) | 20 cm x 30 cm (7.9 in x 11.8 in) | |
| Weight | <4.99 kg (<11 lbs) | < 4.3 kg (9.5 lbs) | 4.2 kg (9.26 lbs) | |
| Treatment area | 769 $cm^2$ (119.2 $in^2$ ) | Minimum 613 $cm^2$ (95 $in^2$ ) | 315 $cm^2$ (48.8 $in^2$ ) | |
| Materials | | | | |
| Device/ bed | ABS bed casing with acrylic sheet | Polycarbonate cover and polyurethane base | Not Applicable | |
| Mattress (gel mat) | Polyurethane cover filled with polyurethane gel | Polyurethane cover with polyolefin bubble<br>cushioning | Not Applicable | |
| Mattress cover | Polypropylene fabric - disposable | Nonwoven spunlaced polyester - disposable | Not Applicable | |
| Patient side<br>cushioning | Polyester fiber cushion with polypropylene<br>fabric foot bumper and restrainers | Foam bumper encased<br>by 100% cotton fabric | Not Applicable | |
| Features | Subject Device-<br>Skylife™ | Primary Predicate Device -<br>neoBLUE cozy LED Phototherapy<br>System - K051869 | Secondary Predicate Device -<br>Ohmeda Medical Spot PT Lite<br>Phototherapy System - K011549 | |
| Miscellaneous | | | | |
| Shape | Rectangular | Oval with flat end at foot area | Rectangular with Goose neck for overhead treatment | |
| Portable | Portable | Portable | Requires a structure for installation | |
| Patient side | Polyester fiber cushion with polypropylene<br>fabric foot bumper and restrainers | Foam bumper encased by 100% cotton fabric | Overhead Device; no patient contact | |
| Applicable standards and Safety Features | | | | |
| Electrical safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-50 | EN 60606-1 UL 2601-1<br>EaveN 60606-1<br>CSA C22.2 601.1<br>EN 60601-2-50 | IEC 60601-1-2:2004;<br>UL 60601-1:2003: IEC 60601-1:1998:<br>CAN/CSA 601-1M90<br>Self-certified to IEC 60601-2-50, 2000 | |
| Mechanical safety | Disposable cover<br>Mattress acts as diffuser to minimize<br>accidental viewing of single point light source.<br>Disposable cover has restrainers to restrict<br>patient's movement | Disposable cover<br>Plastic diffuser acts as a diffuser to minimize<br>accidental viewing of single point light source | Overhead device; No<br>patient contact and always to be used with eye<br>mask | |
| Thermal safety | Fan to cool circuitry, minimize device heating.<br>Thermal protection circuit - turns off LEDs if<br>the device gets too warm. | Fan to cool circuitry, minimize device heating.<br>Thermal protection circuit - turns off LEDs if the<br>device gets too warm. | Has fan at bottom of the device for cooling<br>circuitry; Continuous monitoring required when<br>used with warming tables, incubator and radiant<br>warmers | |
| Radiation safety | LED light source emits no significant<br>ultraviolet light | LED light source emits no significant ultraviolet<br>light | Light source does not emit any significant<br>ultraviolet light | |
| Ingress of liquids | IP23 | IPX4 | Not Applicable | |
| Human Factors | | | | |
| Controls and<br>Indicators | On/Off switch.<br>Indicators Overheat<br>High/Low intensity light | On/Off switch.<br>Indicators Overheat<br>High/Low intensity light | On/Off switch.<br>Indicators Overheat | |
| Compatibility with<br>environment<br>and other<br>devices | Used inside bassinet, open<br>crib, warmer table, incubator | Used inside bassinet, open<br>crib, warmer table, incubator | Used along with bassinet, open crib, warmer table<br>incubator: Requires a support structure to mount | |
| | Subject device, Skylife™ System | Primary Predicate Device -<br>neoBLUE cozy LED | Secondary Predicate Device -<br>Ohmeda Medical Spot | Discussion |
| | | Phototherapy System -<br>K051869 | PT Lite Phototherapy System - K011549 | |
| Total number of LEDs/light | 14 | 480 | No LEDs, a metal halide bulb | Differences between the subject and the predicate devices: The construction of the device does not raise any questions related to safety and efficacy, since both the subject and predicates deliver light intensities in the similar ranges, at the patient's skin, to treat neonatal unconjugated |
| LED/light location | Two modules placed on the bed sides | Placed on one single panel | Above the bed on an adjustable gooseneck | efficacy, since both the subject and predicates deliver light intensities in the similar ranges, at the patient's skin, to treat neonatal unconjugated |
| Light orientation | Emitted upwards from sides of light bed | Emitted upwards from center of the bed | Emitted downwards from above towards the patient | hyperbilirubinemia. |
| Light intensity level | Three levels; Low, High, and Very High | One level | One level | |
| Wavelength | 430 – 475 nm<br>453 - 460 nm (typical peak) | 400 – 500 nm<br>450 - 475 nm (typical peak) | 350 – 700 nm<br>570 - 590 (typical peak) | Differences between the subject and the predicate devices: Wavelength range and peak wavelengths overlap. Hence this does not raise any questions for safety and efficacy. |

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# 510(k) Summary NeoLight, LLC - Skylife™ Page 4 of 7

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### 510(k) Summary NeoLight, LLC - Skylife™ Page 5 of 7

### 8 - DISCUSSION OF DIFFERENCES

Skylife™ specifically differs from the neoBLUE cozy Phototherapy System and Spot PT Lite Phototherapy System in the following areas:

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### 510(k) Summary NeoLight, LLC - Skylife™ Page 6 of 7

| Light<br>range | intensity | 25-55 and >55 μw/<br>cm²/nm (avg 56.3 μw/<br>cm²/nm, max 72.4 μw/<br>cm²/nm) | 30 – 35 μW/cm²/nm | 57.6 μW/cm²/nm ± 25%<br>(43.2 – 72 μW/cm²/nm) | Differences between the subject and predicates:<br>The subject device has an intensity range 25-55 and<br>>55 μw/cm²/nm. This range is higher than the range<br>of the predicates, and i which have an upper<br>intensity range of 72 μw/cm²/nm, based upon their<br>specification.<br><br>This difference does not raise new questions of<br>safety or effectiveness for the subject device. |
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The differences in the technological characteristics™ and the predicate device do not raise of safety or effectiveness.

# 9 - PERFORMANCE DATA

The following performance tests were performed. These included:

- Electrical safety and electromagnetic compatibility .
- Biocompatibility of patient contacting materials ●
- Human Factors Usability

#### Skylife™ was tested per the following standards:

- IEC 60601-1: 2005, 3rd Edition, Medical Electrical Equipments for basic safety and essential performance .
- IEC 60601-1-2: 2014, 4th 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, 2nd Edition, Medical Electrical Equipment Part 2-50: Medical electrical equipment Part 2-50: Particular requirements . for the safety of infant phototherapy equipment
- . IEC 60601-1-11: 2015, 2nd Edition, Medical Electrical Equipments for basic safety and essential performance-Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-6: 2010, 3rd Edition, General requirements for basic safety and essential performance Collateral standard: Usability .
- IEC 62366:2007, 1st Edition, Medical devices -- Application of usability engineering to medical devices ●

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### 510(k) Summary NeoLight, LLC - Skylife™ Page 7 of 7

- IEC 60601-1-8: 2006, Medical electrical equipment -- Part 1-8: General requirements for basic . safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
#### Biocompatibility of Materials -

ISO 10993-1 specifies the patient contacting materials as Surface Contact, Skin, Prolonged Contact (> 24 hours, < 30 days)

Testing included:

- . ISO 10993-5:2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices- Part 10: Tests for irritation and skin ● sensitization

Discussion - The materials tested were found to be non-cytotoxic, non-sensitizers, and non-irritants.

#### Human Factors and Usability -

The human factors and usability study was conducted with 2 user groups to validate the usability of Skylife™ in a healthcare and home environment. The results of the study support the instructions for successfully using the device as intended. The results of human factors and usability study substantiates the acceptability of the risks identified during the risk assessment activities.

# 10 - SUBSTANTIAL EQUIVALENCE CONCLUSION

Based on the performance testing and the supporting documentation, it can be concluded that Skylife™ is substantially equivalent to the predicate devices.