NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

K103589 · Natus Medical Incorporated · LBI · May 13, 2011 · General Hospital

Device Facts

• Record ID: K103589
• Device Name: NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
• Applicant: Natus Medical Incorporated
• Product Code: LBI · General Hospital
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Neonatal phototherapy system; treats hyperbilirubinemia. Composed of mobile light box with single large-format LED (460 nm peak wavelength) coupled to fiberoptic blanket. Light directed via custom optic into fiberoptic blanket; blanket generates intensive phototherapy (>30μW/cm²/nm). Used in clinical or home settings. System includes mattress and disposable non-woven polypropylene cover. Benefits patient by providing effective light therapy for bilirubin reduction. No complex software or algorithmic processing described.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMI/EMC (IEC 60601-1-2), and phototherapy performance (IEC 60601-2-50). Bench tests confirmed effective surface treatment areas of 504 cm2 (large) and 296 cm2 (small) and irradiance >30μW/cm²/nm.

Technological Characteristics

Mobile LED light box (460 nm peak); fiberoptic blanket (high-performance plastic optical fibers in vinyl); polyurethane mattress; non-woven polypropylene disposable cover. External power supply. Connectivity: None. Sterilization: Not specified. Energy source: Electrical. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50, ISO 10993.

Indications for Use

Indicated for the 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

• Olympic Bili-Lite Pad (K901987)
• Natus neoBLUE cozy LED Phototherapy System (K051869)
• BiliSoft Phototherapy System (K053568)

Submission Summary (Full Text)

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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 Incorporated<br>Olympic Medical Division<br>5900 First Avenue South<br>Seattle, WA 98108 |
|----|----|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Contact: | Julie Freed, Ph.D.<br>Senior Regulatory Affairs Specialist<br>P [phone]<br>F [phone] |
| | | Date Summary<br>Prepared: | May 10, 2011 |
| | 2. | Proprietary Name: | neoBLUE® blanket LED Phototherapy System |
| | | Common/Usual<br>Name: | Neonatal phototherapy unit |
| | | Classification: | Class 2, Product Code LBI, 21CFR Part 880.5700 |
| | 3. | Predicate Device(s): | Olympic Bili-Lite Pad (K901987)<br>Natus neoBLUE cozy LED Phototherapy System (K051869)<br>BiliSoft Phototherapy System (K053568) |
| | 4. | Device Description: | A neonatal phototherapy system composed of a mobile light<br>box coupled to a fiberoptic blanket. The re-usable fiberoptic<br>blanket is covered with a mattress and a disposable cover. |
| | 5. | Intended Use: | The neoBLUE blanket LED Phototherapy System is intended<br>for the treatment of neonatal hyperbilirubinemia. It can be<br>used in the clinical setting or in the home. |
| | 6. | Technological<br>Characteristics: | The mobile light box is composed of a single "Large Format"<br>LED (light-emitting diode) with a peak wavelength of 460 nm.<br>A custom optic directs light from the LED into the fiberoptic<br>blanket. The power supply for the light box is exterior to the<br>light box and is connected by a cable.<br><br>The fiberoptic blanket is composed of high performance plastic<br>optical fibers enclosed in a vinyl material. A polyurethane<br>mattress is placed on top of the fiberoptic blanket. A<br>disposable cover made of non-woven polypropylene is placed<br>on top of the mattress. The fiberoptic blanket generates<br>sufficient light output to provide intensive phototherapy<br>(>30μW/cm²/nm). This light output is achieved for both the<br>large blanket and the small blanket.<br><br>Accessories sold with the neoBLUE blanket include the<br>mattress, the disposable covers, and a pole mounting clamp. |
| b) | 1. | Non-clinical Testing<br>Performed: | Biocompatibility tests performed per ISO 10993 for patient<br>contacting materials (mattress and disposable cover).<br>Bench tests performed to measure spectral output, light<br>irradiance and effective surface treatment area.<br>Electrical safety tests performed per IEC 60601-1 (2nd edition)<br>and 60601-1-2 (EMI/EMC).<br>Phototherapy safety and performance tests performed per IEC<br>60601-2-50 (1st edition). |
| | 2. | Clinical Tests<br>Performed: | Not Applicable |
| | 3. | Testing Summary: | The mattress and disposable cover passed Cytotoxicity,<br>Sensitization and Skin Irritation tests.<br>The neoBLUE blanket LED Phototherapy System has been<br>tested to ensure compliance with all appropriate sections of<br>IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-50.<br>Using the method described in IEC 60601-2-50, the effective<br>surface treatment area was measured to be 504 cm2 for the<br>large blanket and 296 cm2 for the small blanket.<br>In conclusion, data from the non-clinical tests and a<br>comparison of the technology, device specifications, intended<br>use, target population and other device features demonstrates<br>that the neoBLUE blanket LED Phototherapy System is<br>substantially equivalent to the predicate devices listed in<br>Section 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 [phone] or [phone] 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

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