The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

Device Description

The neoBLUE compact LED Phototherapy System utilizes a portable phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.

The neoBLUE compact LED Phototherapy System light consists of a lightweight plastic light enclosure which can be used independently by placing directly on top of an incubator, or with the arm, or with the arm and roll stand together. The arm can be attached to the pole mount accessory on most incubators and radiant warmers. The arm, when attached to the roll stand, can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

The neoBLUE compact LED Phototherapy System light is equipped with a treatment timer to track the total number of treatment hours per patient, a device timer to track the total number of operating hours for the blue LEDs, and an exam light.

AI/ML Overview

The provided text describes the neoBLUE Compact LED Phototherapy System and its substantial equivalence to predicate devices, not a study evaluating its performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories for a study are "Not Applicable" or "Not Provided" in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria for clinical performance or a clinical study to prove the device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with safety standards.

Feature/Test Category	Acceptance Criteria (Implied from Predicate/Standards)	Reported Device Performance (neoBLUE compact LED Phototherapy System)
Intended Use	Treatment of neonatal hyperbilirubinemia	Treatment of neonatal hyperbilirubinemia
Treatment Method	Overhead phototherapy	Overhead phototherapy
User	Healthcare professionals in a clinical setting	Healthcare professionals in a clinical setting
Sites of Use	Bassinet, incubator, open bed, radiant warmer	Bassinet, incubator, open bed, radiant warmer
Patient Population	Neonates	Neonates
Light Source	LEDs (blue)	Blue and white Light Emitting Diodes (LEDs)
Wavelength	Peak @ 440-470 nm (combined range of predicates)	Peak @ 450 to 470 nm
Intensity	Range overlapping with predicates (>20 to 50 μW/cm²/nm @ 40cm, 40-49 μW/cm²/nm @ 30-40cm)	10 – 55 μW/cm²/nm @ 35 cm
Intensity Settings	1 or 3 settings (from predicates)	2 settings (high, low)
Effective Treatment Area	Range overlapping with predicates (660 to 800 cm² @ 40cm)	700 cm² @ 35 cm height
Exam Light	Present on one predicate, absent on other	White Light Emitting Diodes (LEDs) (present)
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2	Compliance with IEC 60601-1, IEC 60601-1-2
Thermal Safety	Fan to cool, thermal protection circuit	Fan to cool circuitry, Thermal protection circuit
Radiation Safety	Minimal UV/IR light	LED light source produces minimal UV and IR light
Software Verification	Verified	Performed
Design Verification & Validation	Performed	Performed (includes device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective treatment area, usability)
Hazard Analysis	Performed	Performed
Human Factors Validation Testing	Performed	Performed

Note: The "acceptance criteria" here are implied from the comparison to predicate devices and the mention of standards compliance for safety and performance testing. There are no explicit, quantifiable clinical efficacy acceptance criteria provided within this document for a clinical study.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not Applicable. This document describes a premarket notification (510(k)) seeking substantial equivalence, not a clinical trial with a patient test set. Performance testing mentioned (electrical safety, LED performance, etc.) would be conducted on units of the device, not a patient sample.
Data Provenance: Not Applicable. No patient data or clinical data is mentioned for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical ground truth or expert adjudication for patient data is mentioned.

4. Adjudication method for the test set

Not Applicable. No patient test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a phototherapy system, not an AI-assisted diagnostic or interpretative tool for human readers. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a medical device (phototherapy system), not a standalone algorithm.

7. The type of ground truth used

Not Applicable. For the technical performance aspects, the "ground truth" would be established by reference standards, engineering specifications, and validated measurement methods, rather than clinical ground truth (pathology, expert consensus, outcomes data).

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2016

Natus Medical Incorporated Therese Leggiere Director, Quality and Regulatory Affairs 5900 First Avenue South Seattle, Washington 98108

Re: K160745

Trade/Device Name: neoBLUE Compact LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: November 7, 2016 Received: November 8, 2016

Dear Therese Leggiere:

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.

{1}------------------------------------------------

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160745

Device Name

neoBLUE compact LED Phototherapy System

Indications for Use (Describe)

The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K160745/S001 510(K) SUMMARY

Manufacturer's Name:	Natus Medical Incorporated5900 First Avenue SouthSeattle, WA 98108
Corresponding Official:	Therese LeggiereDirector, Quality and Regulatory Affairs
Telephone Number:E-mail:	206-268-5187therese.leggiere@natus.com
Preparation Date:	December 8, 2016
Trade Name:	neoBLUE Compact LED Phototherapy System
Common or Usual Name:	Neonatal Phototherapy Unit
Classification Name andNumber:	Neonatal Phototherapy Unit21 CFR 880.5700
	Product Code: LBI
Primary Predicate Device:	Medix MediLEDmini (K103735)
Secondary Predicate Device:	Medix MediLED (K083179)

Device Description

{4}------------------------------------------------

Intended Use

The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

The predicate device, K103735, indications for use statement is identical to the subject device, K160745, except the predicate indication statement contains a statement of efficacy of blue light for the treatment of hyperbilirubinemia. This is not appropriate for an indication for use statement in a 510(k) application. Therefore, there are no substantive differences in the indication for use statements between the subject and predicate devices.

DeviceCharacteristics	neoBLUE compact LEDPhototherapy SystemK160745	MedixMediLEDminiK103735	Medix MediLEDK083179
Intended Use	For the treatment of neonatalhyperbilirubinemia	same	same
TreatmentMethod	Overhead phototherapy	same	same
User	Healthcare professionals in aclinical setting	same	same
Sites of Use	The light can be used forinfants in a bassinet,incubator, open bed orradiant warmer	same	same
PatientPopulation	Neonates	same	same
Technology
Light Source	Blue and white LightEmitting Diodes (LEDs)	Blue Light EmittingDiodes (LEDs)	same
Wavelength	Peak @ 450 to 470 nm	Peak @ 440 to 460 nm	Peak @ 450 to 470 nm
Intensity	10 – 55 μW/cm²/nm @ 35cm	>20 to >50 μW/cm²/nm@40 cm	40 μW/cm²/nm @ 40 cm49 μW/cm²/nm @ 30 cm
Intensity Settings	2 settings (high, low)	3 settings (high,medium, low)	1 setting
EffectiveTreatment Area	700 cm² @ 35 cm height	660 cm² @ 40 cmheight	800 cm² @ 40 cm height
Exam Light	White Light EmittingDiodes (LEDs)	none	same
Operating	100 to 240 VAC	same	same
Voltage
OperatingFrequency	50 to 60 Hz	same	same
Controls	On/Off switch, exam lightswitch	On/Off switch	On/Off switch for treatment(blue) and viewing (white)LEDs
	Two levels of intensity	Three levels of intensity	One level of intensity
	Treatment timer displayand reset button	Treatment counter thatcan be reset	same
Configurations
Light enclosureused alone	Light can be used alone ontop of an incubator	Same	Light is not separable from theintegrated arm and roll base
Light enclosureused attached toarm	Light can be attached to anoptional arm for use withincubator and//or radiantwarmer	Same	Similar - Light is attached tothe arm for use with incubatorand/or radiant warmer. Thelight/arm configuration isintegrated with the roll base
Light enclosureused attached toarm and rollstand	Light is attached to the armand the arm attached to aroll stand	Similar - Light isattached to the arm andthe arm attached to aradiant warmer	Similar - Light is attached tothe arm and the arm attachedto the roll base. The light, armand base are an integrated unitand not separable.
Light positioning	Light can be positionedover the infant in abassinet, incubator, openbed or radiant warmer	Similar - Light can bepositioned over theinfant in an incubatorand/or radiant warmer	Same
Safety Standards
MechanicalSafety	No moving parts in contactwith the subject	same	same
Electrical Safety	IEC 60601-1IEC 60601-1-2IEC 60601-2-50	same	same
Thermal Safety	Fan to cool circuitryThermal protection circuit	same	same
Radiation Safety	LED light source producesminimal UV and IR light	same	same

Substantial Equivalence Discussion

{5}------------------------------------------------

Discussion of Differences

Blue and White LEDs

Both predicates and the neoBLUE compact LED Phototherapy System use the same fundamental technology; blue light LED phototherapy for neonates. Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of

{6}------------------------------------------------

light by bilirubin. The secondary predicate, K083179 and the neoBLUE compact both contain white LEDs for use as an exam light.

Blue and white LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no UV exposure to the infant; nor do they emit significant energy in the infrared (IR) region of the spectrum. minimizing concern about excessive warming of the infant

All three devices utilize LEDs as the light source. The MediLEDmini uses only blue LEDs during phototherapy treatment, whereas the MediLED and the neoBLUE compact LED Phototherapy System both use blue mixed with white LEDs. The design of the neoBLUE compact LED Phototherapy System incorporates the white LEDs to soften the visual impact of blue light, and for use as an optional exam light before or after phototherapy. As white LEDs also emit blue light, all blue light intensity is included in the total blue light intensity measurement. Therefore, the difference in the LEDs does not raise any new questions of safety or effectiveness.

Intensity Settings

The neoBLUE compact LED Phototherapy System compact has two intensity settings, high and low. The predicate devices have one or three settings (high, medium and low). The difference in the intensity settings (1 versus 2 versus 3) does not raise any new questions of safety or effectiveness.

Treatment Area

The treatment area for the neoBLUE compact LED Phototherapy System is between the range of the treatment area of the predicates, slightly larger than the MediLEDmini and slightly smaller than the MediLED: 660 cm² @ 40 cm height for the MediLEDmini; 700 cm² @ 35 cm height for the neoBLUE compact LED Phototherapy System; and 800 cm2 @ 40 cm height for the MediLED. This does not raise any new questions of safety or effectiveness.

The differences between the predicate devices, K103735 and K083179, do not raise any new questions of safety or effectiveness.

Performance Testing

According to the device features, the testing for the following standards were considered required for the device:

IEC 60601-1:2005/@2012 and A1:2012 Medical Electrical Equipment Part 1 General . Requirements for Basic Safety and Essential Performance
. IEC 60601-1-2: Edition 4.0 2014-02: Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances – 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

In addition to the compliance of voluntary standards, the following performance testing was necessary to make a substantially equivalent decision:

. Software Verification

{7}------------------------------------------------

Design Verification and Validation ●
- Device power O
- Electrical safety O
- Indicators O
- O LED performance
- Intensity levels O
- Intensity range O
- о Effective treatment area
- o Usability
. Hazard Analysis
Human Factors Validation Testing ●

The compliance to applicable standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. The compliance with relevant standards in addition to the software validation, design verification and validation, hazard analysis and human factors validation is adequate for the determination of substantial equivalence.

Clinical Tests

Not Applicable

Conclusions

The neoBLUE compact LED Phototherapy System has the same intended use and similar technological characteristics as the cleared devices. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted models do not raise new questions of safety and effectiveness as that of cleared device.

In the other words, those engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device. Therefore, we conclude that the neoBLUE compact LED Phototherapy System is substantially equivalent to the MediLEDmini (K103735) and Medix MediLED (K083179).

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).