The neoBLUE blanket LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home.

Device Description

A neonatal phototherapy system composed of a mobile light box coupled to a fiberoptic blanket. The re-usable fiberoptic blanket is covered with a mattress and a disposable cover.

AI/ML Overview

The provided information describes a medical device, the neoBLUE blanket LED Phototherapy System, and its non-clinical testing for regulatory approval. However, no acceptance criteria or studies proving the device meets those criteria are explicitly stated in a quantifiable manner that fits the table format requested. Clinical trials are noted as "Not Applicable," and the reported device performance is primarily a list of tests passed and measurements taken, rather than a formal set of acceptance criteria with corresponding results demonstrating compliance.

Therefore, the following response will extract the relevant information from the provided text, but it will be largely descriptive for points that cannot be directly populated in the requested format due to the nature of the source document.

Acceptance Criteria and Device Performance

The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a specific set of numerical acceptance criteria for performance with corresponding study results in the typical sense for AI/medical imaging devices. The "reported device performance" in this context refers to the successful completion and outcomes of specified non-clinical tests.

Acceptance Criteria Category	Specific Criteria (Implicit from Tests Performed)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 for patient-contacting materials (mattress, disposable cover)	Mattress and disposable cover passed Cytotoxicity, Sensitization, and Skin Irritation tests.
Spectral Output	Measurement of peak wavelength and overall spectrum	Peak wavelength of 460 nm (from device description)
Light Irradiance	Sufficient light output for intensive phototherapy	>30 μW/cm²/nm achieved for both large and small blankets.
Effective Surface Treatment Area	Measurement of the area of light emission	504 cm² for the large blanket, 296 cm² for the small blanket.
Electrical Safety	Compliance with IEC 60601-1 (2nd edition) and 60601-1-2 (EMI/EMC)	Tested to ensure compliance with all appropriate sections of IEC 60601-1 and IEC 60601-1-2.
Phototherapy Safety and Performance	Compliance with IEC 60601-2-50 (1st edition)	Tested to ensure compliance with all appropriate sections of IEC 60601-2-50.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document describes non-clinical bench testing and biocompatibility testing of device components, not a test set of patient data.
- Data Provenance: Not applicable, as this refers to physical device characteristics and materials testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a phototherapy system, and its tests relate to physical and electrical performance, and material safety, not diagnostic accuracy based on expert interpretation.
Adjudication method for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not described here.
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:
- No. The document explicitly states "Clinical Tests Performed: Not Applicable." Therefore, no MRMC study or AI-related comparative effectiveness study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a treatment system, not an algorithm, and its performance is evaluated through physical and electrical bench tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Standardized laboratory test results (e.g., cytotoxicity, sensitization, skin irritation assays) against established safety limits.
- For performance metrics (irradiance, effective surface area, spectral output): Direct physical measurements using calibrated equipment.
- For electrical safety: Compliance with international standards (IEC 60601 series).
The sample size for the training set:
- Not applicable. The device is a hardware phototherapy system, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.

Summary

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MAY 1 3 2011

5 – Summary of Safety and Effectiveness

As required by 21 CFR, part 807.92

a)	1.	Submitted By:	Natus Medical IncorporatedOlympic Medical Division5900 First Avenue SouthSeattle, WA 98108
		Contact:	Julie Freed, Ph.D.Senior Regulatory Affairs SpecialistP (206) 268-5170F (206) 268-5104
		Date SummaryPrepared:	May 10, 2011
	2.	Proprietary Name:	neoBLUE® blanket LED Phototherapy System
		Common/UsualName:	Neonatal phototherapy unit
		Classification:	Class 2, Product Code LBI, 21CFR Part 880.5700
	3.	Predicate Device(s):	Olympic Bili-Lite Pad (K901987)Natus neoBLUE cozy LED Phototherapy System (K051869)BiliSoft Phototherapy System (K053568)
	4.	Device Description:	A neonatal phototherapy system composed of a mobile lightbox coupled to a fiberoptic blanket. The re-usable fiberopticblanket is covered with a mattress and a disposable cover.
	5.	Intended Use:	The neoBLUE blanket LED Phototherapy System is intendedfor the treatment of neonatal hyperbilirubinemia. It can beused in the clinical setting or in the home.
	6.	TechnologicalCharacteristics:	The mobile light box is composed of a single "Large Format"LED (light-emitting diode) with a peak wavelength of 460 nm.A custom optic directs light from the LED into the fiberopticblanket. The power supply for the light box is exterior to thelight box and is connected by a cable.The fiberoptic blanket is composed of high performance plasticoptical fibers enclosed in a vinyl material. A polyurethanemattress is placed on top of the fiberoptic blanket. Adisposable cover made of non-woven polypropylene is placedon top of the mattress. The fiberoptic blanket generatessufficient light output to provide intensive phototherapy(>30μW/cm²/nm). This light output is achieved for both thelarge blanket and the small blanket.Accessories sold with the neoBLUE blanket include themattress, the disposable covers, and a pole mounting clamp.
b)	1.	Non-clinical TestingPerformed:	Biocompatibility tests performed per ISO 10993 for patientcontacting materials (mattress and disposable cover).Bench tests performed to measure spectral output, lightirradiance and effective surface treatment area.Electrical safety tests performed per IEC 60601-1 (2nd edition)and 60601-1-2 (EMI/EMC).Phototherapy safety and performance tests performed per IEC60601-2-50 (1st edition).
	2.	Clinical TestsPerformed:	Not Applicable
	3.	Testing Summary:	The mattress and disposable cover passed Cytotoxicity,Sensitization and Skin Irritation tests.The neoBLUE blanket LED Phototherapy System has beentested to ensure compliance with all appropriate sections ofIEC 60601-1, IEC 60601-1-2 and IEC 60601-2-50.Using the method described in IEC 60601-2-50, the effectivesurface treatment area was measured to be 504 cm2 for thelarge blanket and 296 cm2 for the small blanket.In conclusion, data from the non-clinical tests and acomparison of the technology, device specifications, intendeduse, target population and other device features demonstratesthat the neoBLUE blanket LED Phototherapy System issubstantially equivalent to the predicate devices listed inSection 3.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAY 1 3 2011

Dr. Julie Freed Senior Regulatory Affairs Specialist Natus Medical Incorporated Olympic Medical Division 5900 First Avenue South Seattle, Washington 98108

Re: K103589

Trade/Device Name: NeoBLUE Blanket LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: LBI Product Code: II Dated: May 4, 2011 Received: May 5, 2011

Dear Dr. Freed:

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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Page 2- Dr. Freed

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely · yours,

ho for

Anthony D. Watson, B.S., M.S., M.B.A. . Director

Division of Anesthesiology, General Hospital, 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):

Device Name: neoBLUE blanket LED Phototherapy System

Indications for Use:

The neoBLUE blanket LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home.

Prescription Use x Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rdlc Ch 5/1/1

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103589

Page 1 of 1

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).