NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

K051869 · Natus Medical, Inc. · LBI · Oct 7, 2005 · General Hospital

Device Facts

• Record ID: K051869
• Device Name: NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
• Applicant: Natus Medical, Inc.
• Product Code: LBI · General Hospital
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Portable phototherapy system delivering high-intensity blue light (400-550 nm) via LEDs to treat neonatal hyperbilirubinemia; device placed under infant within bassinet, crib, warming table, or incubator. System comprises light source, mattress, disposable cover, bumper, and power supply. Operated by clinicians or caregivers in clinical or home settings. Blue light degrades bilirubin; LEDs emit no significant UV radiation. Output intensity adjustable via internal potentiometer; thermal protection circuit automatically disables LEDs if overheating occurs. Healthcare providers use device to provide phototherapy; can be used with overhead units for increased coverage. Benefits include effective bilirubin degradation without UV exposure risk.

Clinical Evidence

Bench testing only. Results of prototype testing to specifications were as expected; no new safety or effectiveness issues identified.

Technological Characteristics

Blue LED light source (400-550 nm, peak 450-470 nm); intensity 30-35 µW/cm²/nm. Materials: polycarbonate cover, polyurethane base, nonwoven spunlaced polyester mattress cover, foam bumper with cotton fabric. Electrical safety: EN 60601-1, UL 2601-1, CSA C22.2 601.1, EN 60601-2-50. Ingress protection: IPX4. Thermal safety: cooling fan and thermal protection circuit. Portable form factor.

Indications for Use

Indicated for treatment of neonatal hyperbilirubinemia in neonates.

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

• Medela Bilibed (K962612)
• Natus Blue Light Phototherapy Unit (K022196)

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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: [phone] FAX: [phone]

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

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

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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 neoBLUE<br>cozy LED<br>Phototherapy<br>System | Medela BiliBed<br>(K962612) | Natus Blue Light<br>Phototherapy Unit<br>(K022196) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | For the treatment of<br>neonatal<br>hyperbilirubinemia | For the treatment of<br>neonatal<br>hyperbilirubinemia | For the treatment of<br>neonatal<br>hyperbilirubinemia |
| Treatment Method | Underbaby<br>phototherapy | Underbaby<br>phototherapy | Overhead<br>phototherapy |
| Targeted Population | Neonates | Neonates | Neonates |
| Sites of Use | Clinical setting,<br>home-use | Clinical setting,<br>home-use | Clinical setting |
| Feature | Natus neoBLUE<br>cozy LED<br>Phototherapy<br>System | Medela BiliBed<br>(K962612) | Natus Blue Light<br>Phototherapy Unit<br>(K022196) |
| Specifications | | | |
| Type of Device | Free standing device | Free standing device | Free standing device |
| Type of Light | Blue light (LED) | Blue light<br>fluorescent | Blue light (LED) |
| Intensity | 30-35 µW/cm²/nm | Approx. 40-60 µW<br>/cm²/nm or more | 30 – 35 µW/cm²/nm |
| Height | <6.4 cm (2.5 in)<br>patient surface,<br>≤12.7 cm (5.0 in)<br>rest of device | 13.0 cm (5.1 in),<br>including baby<br>support | Not Applicable |
| Width and Length | 30.5 cm (12.0 in)<br>width x 64.8 cm<br>(25.5 in) length | 32.6 cm (12.8 in)<br>width x 63 cm<br>(24.8 in) length | Not Applicable |
| Weight | <4.3 kg (9.5 lbs) | 5 kg (11 lbs) | Not Applicable |
| Treatment area | Minimum 613 cm²<br>(95 in²) | Not Published | 1250 cm² (200 in²) |
| Materials | | | |
| Device | Polycarbonate cover<br>& polyurethane base | Aluminum frame,<br>plastic base | Not Applicable |
| Mattress | Polyurethane cover<br>with polyolefin<br>bubble cushioning | Polyurethane plastic | Not Applicable |
| Mattress Cover | Nonwoven<br>spunlaced polyester | Bilicombi – 100%<br>cotton or 100%<br>nonwoven<br>spunlaced fabric | Not Applicable |
| Patient side<br>cushioning/Jacket | Foam bumper<br>encased by 100%<br>cotton fabric | Bilicombi – 100%<br>cotton or 100%<br>nonwoven<br>spunlaced fabric | Not Applicable |
| Miscellaneous | | | |
| Shape | Oval with flat end at<br>foot area | Rectangle | Not Applicable |
| Portable | Yes with carrying<br>case | Yes with carrying<br>case | Not Applicable |
| Patient side<br>cushioning/Jacket | Foam bumper<br>encased by 100%<br>cotton fabric | Bilicombi – 100%<br>cotton or 100%<br>nonwoven<br>spunlaced fabric | Not Applicable |
| Feature | Natus neoBLUE<br>cozy LED<br>Phototherapy<br>System | Medela BiliBed<br>(K962612) | Natus Blue Light<br>Phototherapy Unit<br>(K022196) |
| Standards and Safety | | | |
| Electrical Safety | EN 60606-1<br>UL 2601-1<br>CSA C22.2 601.1<br>EN 60601-2-50 | UL 2601-1<br>IEC 529 | EN 60606-1<br>UL 2601-1<br>CSA C22.2 601.1<br>EN 60601-2-50 |
| Mechanical Safety | Disposable cover<br>acts as a diffuser to<br>minimize accidental<br>viewing of single<br>point light source | Not Applicable | Plastic diffuser<br>minimizes<br>accidental viewing<br>of single point light<br>source |
| Thermal Safety | Fan to cool<br>circuitry, minimize<br>device heating.<br>Thermal protection<br>circuit - turns off<br>LEDs if device gets<br>too warm. | Fan to cool | Fan to cool<br>circuitry, minimize<br>device heating |
| Radiation Safety | LED light source<br>emits no significant<br>ultraviolet light | Fluorescent light<br>sources may<br>produce minimal<br>ultraviolet light | LED light source<br>emits no significant<br>ultraviolet light |
| Ingress of Liquids | IPX4 | IPX1 | Not Applicable |
| Human Factors | | | |
| Controls and<br>Indicators | On/Off switch.<br>Overheat indicator<br>light | On/Off switch | On/Off switch.<br>High/Low intensity<br>switch. Positioning<br>light. |
| Compatibility with<br>environment or<br>other devices | Used inside<br>bassinet, open crib,<br>warmer table,<br>incubator | Used inside bassinet<br>and/or under radiant<br>warmer | Used in conjunction<br>with a bassinet,<br>open crib, warmer<br>table, 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).