The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.

Device Description

The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia.

The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "neoBLUE® blanket LED Phototherapy System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical or standalone performance studies with acceptance criteria for an AI/ML device.

Therefore, many of the requested details regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert involvement for ground truth, and MRMC studies are not present in this document. The device in question is a phototherapy system, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the available information and an explanation of why other requested information is not applicable:

1. A table of acceptance criteria and the reported device performance:

The document describes performance specifications that the device meets, rather than acceptance criteria for an AI/ML model's output. The criteria are related to the physical and functional characteristics of the phototherapy system.

Acceptance Criteria (Performance Specification)	Reported Device Performance
Light Spectrum Range	400 – 550 nm (peak wavelength 450-475 nm)
Light Intensity (Intensive Phototherapy definition)	≥30 µW/cm²/nm (for both blanket sizes)
Factory Set Intensity	35 ± 5 µW/cm²/nm
Adjustable Light Output Range	50 to 60 µW/cm²/nm (adjustable)
Expected LED Life	>20,000 hours
Operating Temperature (Light Box)	41° to 86° F (5 to 30°C)
Operating Humidity (Light Box)	10% to 90%, non-condensing
Operating Temperature (Blanket)	41° to 100° F (5 to 38°C)
Operating Humidity (Blanket)	10% to 90%, non-condensing
Storage Temperature	32° to 122° F (0 to 50°C)
Storage Humidity	10% to 90%, non-condensing
Altitude / Atmospheric pressure	700 hPa to 1060 hPa

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document explicitly states "Clinical Tests: N/A" and focuses on non-clinical engineering and performance testing of the physical medical device (phototherapy unit), not a software or AI/ML-based diagnostic system that would require a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, expert consensus, and qualifications of experts are relevant for AI/ML models that interpret medical images or data. The neoBLUE blanket LED Phototherapy System is a physical device delivering light therapy, not an interpretive AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The neoBLUE blanket LED Phototherapy System is a therapeutic device, not an diagnostic AI assistant.

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

This information is not applicable as there is no algorithm/AI in this medical device. Its performance is based on its physical specifications and light output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable. For this physical device, "ground truth" relates to measurable physical properties and operational performance tested against engineering specifications and recognized standards (e.g., light intensity measurements, electrical safety).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable for the same reason as point 8.

Summary of the Study Proving Device Meets Acceptance Criteria (Non-Clinical):

The study proving the device meets its performance specifications (which serve as "acceptance criteria" for a physical device) was based on non-clinical tests and design verification and validation.

Type of Study: Non-clinical tests, design verification and validation.
Purpose: To ensure the device meets performance specifications and demonstrates equivalence to the predicate device (K103589).
Tests Performed: Specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.
Standards Applied: Where appropriate, testing was performed to recognized international and industry standards, including:
- IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-04 (Particular Requirements For The Basic Safety And Essential Performance Of Infant Phototherapy Equipment)
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (General Requirements For Basic Safety And Essential Performance)
- IEC 60601-1-11:2015 (Second Edition) (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 60601-1-6:2010, AMD1:2013 (Usability)
- IEC 60601-1-2 ED 4.0: 2014-02 (Electromagnetic disturbances)
- An AIM Standard 7351731 Rev 2.0: 2017-02-03 (Electromagnetic disturbances)
Conclusion: The verification and validation summary and risk analysis documentation supported the conclusion that the device is as safe and effective as the predicate device and is substantially equivalent.

No human data, expert review of images, or AI/ML model performance evaluation was part of this submission, as it is for a physical phototherapy device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2018

Natus Medical Incorporated Judy Buckham Sr. Regulatory Affairs Specialist 5900 First Avenue South Seattle, Washington 98108

Re: K182178

Trade/Device Name: neoBLUE® blanket LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: November 12, 2018 Received: November 13, 2018

Dear Judy Buckham:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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.

Sapana Patel -S

For 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) K182178

Device Name neoBLUE® blanket LED Phototherapy System

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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510(k) Summary K182178

Manufacturer's Name:	Natus Medical Incorporated5900 First Avenue SouthSeattle, WA 98108
Corresponding Official:	Judy BuckhamSenior Regulatory Affairs Specialist
Telephone Number:Fax Number:	206 268 5187206 268 5104
Summary Date:	12 December 2018
Trade Name:	neoBLUE® blanket LED Phototherapy System
Common or Usual Name:	Neonatal Phototherapy Unit
Regulation Name :	Unit, Neonatal Phototherapy
Regulation Number:	21 CFR 880.5700
Product Code:	LBI
Predicate Device:	K103589 neoBLUE blanket LED Phototherapy System

Device Description:

The neoBLUE blanket LED Phototherapy System is for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. It is intended for use with patients up to 3 months of age, weighing less than 22 lb (10 kg).

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Natus Medical Incorporated

neoBLUE blanket LED Phototherapy System Traditional 510(k)

The spectrum range of the blue LED light corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin.

The neoBLUE blanket device can be directly connected to nominal voltages readily available throughout the world as the external power supply provided with this device is rated for use with 100-240 Volts at either 50 or 60 Hz. This external power supply provides 12 VDC to the light box, and pluqs in to a receptacle at the rear of the light box.

Environment

Operating temperature/Humidity:

Light box: 41° to 86° F (5 to 30°C)/10% to 90%, non-condensing ●
Blanket: 41° to 100° F (5 to 38°C) / 10% to 90% non-condensing ●

Storage temperature/humidity:32° to 122° F (0 to 50°C) / 10% to 90%, non-condensing Altitude / Atmospheric pressure: 700 hPa to 1060 hPa

Indications for Use:

The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBLUE blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.

Technoloqical Characteristics:

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Predicate Comparison Table

DeviceAttribute	neoBLUE® blanket LEDPhototherapy SystemK103589	neoBLUE® blanket LEDPhototherapy SystemUpdated Device	Discussion of Differences
Indications for Use	For the treatment of neonatalhyperbilirubinemia. It can beused in the clinical setting or inthe home.	The neoBLUE blanket LEDPhototherapy System is indicatedfor the treatment ofunconjugated hyperbilirubinemiain a hospital environment, andadministered by trainedprofessional medical staff, on theorder of a physician, or in thehome environment administeredby a trained caregiver. TheneoBLUE blanket deviceprovides intensive phototherapyunderneath the patient and canbe used with a bassinet, openbed, radiant warmer, incubator,or while holding the patient.	The differences in the Indications for Usestatement do not raise different questionsabout the safety or effectiveness of theupdated device. The statement was revisedfrom that of the predicate to be moredescriptive of the use environment.Additionally, the statement was updated toindicate the use from "treatment ofhyperbilirubinemia" to the more specific"treatment of unconjugatedhyperbilirubinemia."
Intended Use	For the treatment of neonatalhyperbilirubinemia. It can beused in the clinical setting or inthe home.	The neoBLUE blanket LEDPhototherapy System is for thetreatment of unconjugatedhyperbilirubinemia in prematurebabies and neonates. It isintended for use with patients upto 3 months of age, weighing lessthan 22 lb (10 kg).	The differences in the Intended Usestatement do not raise questions about thesafety or effectiveness of the updateddevice. This change provides more specificinformation related to the patient population.
Contraindications	none	Congenital porphyria or afamily history of porphyriaConcomitant use of drugsor agents that arephotosensitizers	Two contraindications published in AAPGuidelines were added to the User ManualNeither of these raise questions about thesafety or effectiveness of the updateddevice.
Sites of Use	Clinical setting or home use	Clinical setting or home use	Same
DeviceAttribute	neoBLUE® blanket LEDPhototherapy SystemK103589	neoBLUE® blanket LEDPhototherapy SystemUpdated Device	Discussion of Differences
Device Components	• Light Box• Fiber optic blanket (2 sizes)• Blanket mattress (2 sizes)• Disposable mattress cover• Power cord	• Light Box• Fiber optic blanket (2 sizes)• Blanket mattress (2 sizes)• Disposable mattress cover• Power cord	Same
Light source	Single "Large Format" BlueLED coupled to fiber opticblanket	Single "Large Format" Blue LEDcoupled to fiber optic blanket	Same
Expected LED life	>20,000 hours	>20,000 hours	Same
TreatmentWavelength	Blue wavelength 400-550 nmPeak @ 450-475 nm	Blue wavelength 400-550 nmPeak @ 450-475 nm	Same
neoBLUE blanketLED PhototherapySystem Light Intensity	>30 μW/cm²/nm for bothblanket sizes. Factory set at30-35 μW/cm²/nm	≥30 μW/cm²/nm for both blanketsizes. Factory set at 35 ± 5μW/cm²/nm	There were no design changes made to theintensity of the system, just a clarification tothe specification.
Light Box Materials	Polycarbonate light boxenclosure and aluminumhandle	Polycarbonate light boxenclosure and aluminum handle	Same
Fiber optic Blanket	Large:9.5 x 14.5 in (24.1 x 36.8 cm)	Large:9.5 x 14.5 in (24.1 x 36.8 cm)	Same
Dimensions	Small:6.75 x 12.75 in (17.1 x 32.4cm)	Small:6.75 x 12.75 in (17.1 x 32.4cm)	Same
Fiber optic BlanketMaterials	Polyvinyl Chloride (PVC)	Polyvinyl Chloride (PVC)	SameNote: the materials of the Blanket Pad arenot patient contacting.
Fiber optic cablesheath material	Silicone tubing	Vinyl tubing	Vinyl accommodates the high frequencywelding required for high frequency weldedjoint and does not accumulate dust assilicone does
Blanket Mattress	Polyurethane cover withpolyolefin bubble cushioning	Polyurethane cover withpolyolefin bubble cushioning	SameNote: The materials of the mattress are notintended for patient contact.
Disposable MattressCover	Non-woven polypropylene	Non-woven polypropylene	SameNote: the materials of the mattress cover arepatient contacting
DeviceAttribute	neoBLUE® blanket LEDPhototherapy SystemK103589	neoBLUE® blanket LEDPhototherapy SystemUpdated Device	Discussion of Differences
Adjustable lightoutput	Yes – adjustable to ≥55$μ$ W/cm²/nm	Yes - adjustable to 50 to 60$μ$ W/cm²/nm.	There were no design changes made to thelight box. The upper limit was added to thespecification to align with the AAPGuidelines.
Thermal MonitoringCircuit	One temperature sensor -temperature sensor installed todetect overheating condition ofthe LED.	Two temperature sensors - onetemperature sensor installed todetect overheating condition ofthe LED, and one to detect apending overheating conditionof internal lens interface	The addition of the additional sensor doesnot raise questions about the safety oreffectiveness of the updated device. Theadditional sensor indicates if the pad isapproaching the end of useful life.
Optic lens	Acrylic lens	Glass lens	Provides more consistent and efficient lighttransmission from the LED to the fiber opticcable
Adhesive materialused to bond fiberoptics together insidetip of fiber optic cable	Two component epoxy	UV cured optical adhesive	The new adhesive material is longer lastingand more durable than the two part epoxyand improves reliability.
Connection of thefiber optic cable tothe light box	No handle	New handle grip	The addition of a handle grip does not raisequestions about the safety or effectivenessof the updated device. It aids in the ease ofconnection and increased durability.
Pad/tubingconnection	Heat shrink tubing	High frequency welded joint	Welded joint eliminates crevices and folds inthe joint for ease of cleaning
Power Supply to LightBox	Mains powered:100-240 Volts at either 50 or 60Hz. This external power supplyprovides 12 VDC to the lightbox	Mains powered:100-240 Volts at either 50 or 60Hz. This external power supplyprovides 12 VDC to the light box	Same

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Natus Medical Incorporated neoBLUE blanket LED Phototherapy System Traditional 510(k)

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Natus Medical Incorporated neoBLUE blanket LED Phototherapy System Traditional 510(k)

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No design changes were made to the device with respect to intensity output, however, the intensity specification statements were updated to ensure design inputs were clear and unambiguous, and to align the statements with the recommendations of the American Association of Pediatrics. The design changes made to the device were intended to improve the reliability and usability of the neoBLUE blanket, thus increasing the lifetime of the device. These differences do not raise any different questions of safety or effectiveness.

Clinical Tests: N/A

Nonclinical Tests:

Design verification and validation were performed to ensure that the neoBLUE blanket LED Phototherapy System meets its performance specifications and demonstrates equivalence to the specified predicate device, including specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.

Where appropriate, testing was performed to recognized standards, including:

Medical Electrical Equipment Part 2-50: Particular Requirements For The Basic . Safety And Essential Performance Of Infant Phototherapy Equipment |IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-041
. Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint)
. Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11:2015 (Second Edition) for use in conjunction with IEC 60601-1:2012 (Third Edition) + A1:2012
Medical electrical equipment Part 1-6: General requirements for basic safety . and essential performance – Collateral standard: Usability IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)
Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests [IEC 60601-1-2 ED 4.0: 2014-02]
Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances -

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Requirements and tests [An AIM Standard 7351731 Rev 2.0: 2017-02-03]

Conclusions:

The verification and validation summary and risk analysis documentation provided in this 510(k) support the conclusion that the neoBLUE blanket LED Phototherapy system is as safe and as effective as the predicate device cleared under K103259 and determined to be substantially equivalent.

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).