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

Device Description

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

Blue LEDs emit light in the range of 400 -- 550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. As with all phototherapy lights, protective eyeshades must be used to protect the infant's eyes from excessive light exposure.

LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the biomedical engineer can adjust the output of the LEDs using the potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours.

The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "neoBLUE cozy LED Phototherapy System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical efficacy studies with predefined acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain explicit acceptance criteria and a study proving the device meets those criteria in the traditional sense of an AI/software efficacy study. Instead, it demonstrates that the new device is as safe and effective as already legally marketed predicate devices.

However, I can extract information related to the device's performance based on the comparison provided:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Since this is a 510(k) and not a clinical trial, "acceptance criteria" are not explicitly stated as performance metrics to be met by a study. Instead, the substantial equivalence is based on comparing the new device's features and specifications to those of predicate devices. The "reported device performance" are the specifications of the new device.

Feature	Implied "Acceptance Criteria" (from Predicate)	Reported Device Performance (Natus neoBLUE cozy LED Phototherapy System)
Intended Use	For the treatment of neonatal hyperbilirubinemia	For the treatment of neonatal hyperbilirubinemia
Treatment Method	Underbaby phototherapy (Medela BiliBed) / Overhead phototherapy (Natus Blue Light)	Underbaby phototherapy
Targeted Population	Neonates	Neonates
Sites of Use	Clinical setting, home-use (Medela BiliBed) / Clinical setting (Natus Blue Light)	Clinical setting, home-use
Type of Light	Blue light fluorescent (Medela BiliBed) / Blue light (LED) (Natus Blue Light)	Blue light (LED)
Intensity	Approx. 40-60 µW/cm²/nm or more (Medela BiliBed) / 30-35 µW/cm²/nm (Natus Blue Light)	30-35 µW/cm²/nm
Dimensions (Height)	13.0 cm (5.1 in) (Medela BiliBed)	<6.4 cm (2.5 in) patient surface, ≤12.7 cm (5.0 in) rest of device
Dimensions (W x L)	32.6 cm (12.8 in) width x 63 cm (24.8 in) length (Medela BiliBed)	30.5 cm (12.0 in) width x 64.8 cm (25.5 in) length
Weight	5 kg (11 lbs) (Medela BiliBed)	<4.3 kg (9.5 lbs)
Treatment Area	Not Published (Medela BiliBed) / 1250 cm² (200 in²) (Natus Blue Light)	Minimum 613 cm² (95 in²)
Electrical Safety	EN 60606-1, UL 2601-1, CSA C22.2 601.1, EN 60601-2-50 (Natus Blue Light)	EN 60606-1, UL 2601-1, CSA C22.2 601.1, EN 60601-2-50
Thermal Safety	Fan to cool circuitry, minimize device heating (Natus Blue Light)	Fan to cool circuitry, minimize device heating. Thermal protection circuit - turns off LEDs if device gets too warm.
Radiation Safety	LED light source emits no significant ultraviolet light (Natus Blue Light)	LED light source emits no significant ultraviolet light
Ingress of Liquids	IPX1 (Medela BiliBed)	IPX4

Regarding "study that proves the device meets the acceptance criteria" and other related points:

The document explicitly states: "This submission includes the results of testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the nonclinical testing."

This indicates that a study was performed internally to verify the device's specifications (e.g., light intensity, safety features, dimensions, weight, electrical standards compliance) matched the design and were comparable to the predicate devices. However, the details for most of your specific questions are not provided in this 510(k) summary.

Here's a breakdown based on the provided text, and what is not mentioned:

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

Sample Size: Not specified. The testing was on "prototype devices," suggesting a small number of devices rather than a large clinical "test set" of patients.
Data Provenance: Not specified, but generally, testing for 510(k) submissions of this nature would be conducted in a laboratory or engineering setting by the manufacturer (Natus Medical, Inc., USA). This would be retrospective in the sense that the device was fully designed before testing.

3. 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 hardware phototherapy unit, not an AI/software device requiring expert interpretation of results to establish "ground truth." The ground truth for device performance is based on direct physical measurements and engineering standards (e.g., light intensity, temperature, electrical safety).

4. Adjudication method for the test set:

Not Applicable. As above, no "test set" in the context of expert review or consensus 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:

No. This is a hardware medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant to this submission.

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

Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

For the physical and functional aspects of the device, the "ground truth" would be established through:
- Engineering specifications and measurements: E.g., light intensity measured by a radiometer, temperature measured by a thermometer, dimensions measured by calipers.
- Compliance with recognized standards: Electrical safety (EN 60606-1, UL 2601-1, etc.), ingress protection (IPX4).
- Biological/Physiological understanding: The efficacy relies on the known spectral absorption of light by bilirubin.

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. No training set as it's not an AI/ML device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Ms. Luanne Ng Regulatory/Clinical Affairs Manager Natus Medical, Incorporated 1501 Industrial Road San Carlos. California 94070

Re: K051869

Trade/Device Name: NEOBLUE COZY LED PHOTOTHERAP Y SYSTEM Regulation Number: 21 CFR 880.5700 · Regulation Name: Neonatal phototherapy unit Regulatory Class: II Product Code: LBI Dated: October 21, 2005 Received: October 24, 2005

Dear Ms. Ng:

This letter corrects our substantially equivalent letter of October 7, 2005.

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 (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.

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 - Ms. Ng

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sajette Y. Michael Omd

Chiu Lin, Ph.D. 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 STATEMENT

510(k) Number (if known):

Device Name: neoBLUE cozy™ LED Phototherapy System

INDICATIONS FOR USE: The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Supbart B) (21 CFR 801 Subpart C)

(PLEASE DONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anten Dm

Division of Anesthesiology, General Hospital, Infection Contion Dental Devices

3 10(k) Number ..

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8 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter

Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 Phone: 650-802-6400 FAX: 650-802-0401

Contact: Luanne Ng Regulatory/Clinical Affairs Manager Date Prepared: July 7, 2005 Device Names Classification name Unit, Neonatal Phototherapy Common name Phototherapy Light Trade Name Natus® ncoBLUE cozy systemPhototherapy Unit

Predicate Devices

Medela Bilibed, K962612 Natus Blue Light Phototherapy Unit, K022196

Device Description

LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the biomedical engineer can adjust the output of the LEDs using the

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potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours.

The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.

Intended Use

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

Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450-470 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. As with all phototherapy lights, protective eyeshades. must be used to protect the infant's eyes from excessive light exposure

The neoBLUE cozy system can be used in conjunction with an overhead phototherapy light for more patient surface area coverage. A simple blanket may be placed over the patient during phototherapy treatment with the neoBLUE cozy system to praced or the surroundings from stray blue light.

Comparison with Predicate Device

The neoBLUE cozy system, the Medela BiliBed and the Natus Blue Light Phototherapy Unit have the same intended use of treatment of neonatal hyperbilirubinemia and use the same operating principle of delivery of light to degrade bilirubin. See the Comparison Table below for details.

Feature	Natus neoBLUEcozy LEDPhototherapySystem	Medela BiliBed(K962612)	Natus Blue LightPhototherapy Unit(K022196)
Intended Use	For the treatment ofneonatalhyperbilirubinemia	For the treatment ofneonatalhyperbilirubinemia	For the treatment ofneonatalhyperbilirubinemia
Treatment Method	Underbabyphototherapy	Underbabyphototherapy	Overheadphototherapy
Targeted Population	Neonates	Neonates	Neonates
Sites of Use	Clinical setting,home-use	Clinical setting,home-use	Clinical setting
Feature	Natus neoBLUEcozy LEDPhototherapySystem	Medela BiliBed(K962612)	Natus Blue LightPhototherapy Unit(K022196)
Specifications
Type of Device	Free standing device	Free standing device	Free standing device
Type of Light	Blue light (LED)	Blue lightfluorescent	Blue light (LED)
Intensity	30-35 µW/cm²/nm	Approx. 40-60 µW/cm²/nm or more	30 – 35 µW/cm²/nm
Height	<6.4 cm (2.5 in)patient surface,≤12.7 cm (5.0 in)rest of device	13.0 cm (5.1 in),including babysupport	Not Applicable
Width and Length	30.5 cm (12.0 in)width x 64.8 cm(25.5 in) length	32.6 cm (12.8 in)width x 63 cm(24.8 in) length	Not Applicable
Weight	<4.3 kg (9.5 lbs)	5 kg (11 lbs)	Not Applicable
Treatment area	Minimum 613 cm²(95 in²)	Not Published	1250 cm² (200 in²)
Materials
Device	Polycarbonate cover& polyurethane base	Aluminum frame,plastic base	Not Applicable
Mattress	Polyurethane coverwith polyolefinbubble cushioning	Polyurethane plastic	Not Applicable
Mattress Cover	Nonwovenspunlaced polyester	Bilicombi – 100%cotton or 100%nonwovenspunlaced fabric	Not Applicable
Patient sidecushioning/Jacket	Foam bumperencased by 100%cotton fabric	Bilicombi – 100%cotton or 100%nonwovenspunlaced fabric	Not Applicable
Miscellaneous
Shape	Oval with flat end atfoot area	Rectangle	Not Applicable
Portable	Yes with carryingcase	Yes with carryingcase	Not Applicable
Patient sidecushioning/Jacket	Foam bumperencased by 100%cotton fabric	Bilicombi – 100%cotton or 100%nonwovenspunlaced fabric	Not Applicable
Feature	Natus neoBLUEcozy LEDPhototherapySystem	Medela BiliBed(K962612)	Natus Blue LightPhototherapy Unit(K022196)
Standards and Safety
Electrical Safety	EN 60606-1UL 2601-1CSA C22.2 601.1EN 60601-2-50	UL 2601-1IEC 529	EN 60606-1UL 2601-1CSA C22.2 601.1EN 60601-2-50
Mechanical Safety	Disposable coveracts as a diffuser tominimize accidentalviewing of singlepoint light source	Not Applicable	Plastic diffuserminimizesaccidental viewingof single point lightsource
Thermal Safety	Fan to coolcircuitry, minimizedevice heating.Thermal protectioncircuit - turns offLEDs if device getstoo warm.	Fan to cool	Fan to coolcircuitry, minimizedevice heating
Radiation Safety	LED light sourceemits no significantultraviolet light	Fluorescent lightsources mayproduce minimalultraviolet light	LED light sourceemits no significantultraviolet light
Ingress of Liquids	IPX4	IPX1	Not Applicable
Human Factors
Controls andIndicators	On/Off switch.Overheat indicatorlight	On/Off switch	On/Off switch.High/Low intensityswitch. Positioninglight.
Compatibility withenvironment orother devices	Used insidebassinet, open crib,warmer table,incubator	Used inside bassinetand/or under radiantwarmer	Used in conjunctionwith a bassinet,open crib, warmertable, incubator

051860

2.55

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Summary of Nonclinical Testing

This submission includes the results of testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the nonclinical testing .

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Conclusion

Based on the data and the information presented in this submission, the neoBLUE cozy LED Phototherapy System is substaintially equivalent to the currently marketed Medela BiliBed and the Natus Blue Light Phototherapy Unit (for the blue LED light only).

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).