INFANT PHOTOTHERAPY BILITRON SKY 5006

K131196 · Fanem Lda · LBI · Feb 20, 2014 · General Hospital

Device Facts

• Record ID: K131196
• Device Name: INFANT PHOTOTHERAPY BILITRON SKY 5006
• Applicant: Fanem Lda
• Product Code: LBI · General Hospital
• Decision Date: Feb 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Fanem Infant Phototherapy Bilitron Sky 5006 is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.

Device Story

Infant Phototherapy Bilitron Sky 5006 is a hospital-based phototherapy unit for treating neonatal hyperbilirubinemia (jaundice). The device consists of a lamp unit containing LEDs that emit blue light (400-550 nm) to degrade bilirubin in the patient's skin. It is designed for use with infants in bassinets, incubators, open beds, or radiant warmers. The unit is either hood-mounted or trolley-mounted (roll stand with casters). Healthcare professionals operate the device to provide phototherapeutic light to the patient's body. The device does not involve complex software or automated analysis; it functions as a light delivery system to facilitate clinical treatment of jaundice.

Clinical Evidence

Bench testing only.

Technological Characteristics

LED-based phototherapy unit; wavelength 400-550 nm; operating voltage 100-240V; mounting options include hood or trolley (3-leg roll stand with casters). Complies with IEC 60601-1, IEC 60601-1-2:2001, and IEC 60601-2-50.

Indications for Use

Indicated for the treatment of neonatal hyperbilirubinemia in neonates under the supervision of healthcare professionals.

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

• NanoBlu 500 (K113206)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for FANEM. The logo consists of a stylized symbol to the left of the word "FANEM" in bold, sans-serif font. A small registered trademark symbol is located to the upper right of the word "FANEM".

# 510(k) Summary

| 510(k) Number: | K131196 |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Date of Submission: | February 19, 2014 |
| Submitter: | Fanem Ltda<br>Rau Arthur Carl Schmidt, 186-CEP:07222-050<br>Cumbics Guarulhos SP Brazil |
| | Telephone: [phone]<br>Fax: [phone] |
| Official Contact: | Tara Conrad<br>TechLink International Consulting<br>18851 NE 29th Avenue<br>Suite 720<br>Aventura, FL 33180 |
| | Telephone: [phone] |
| Common Name: | Neonatal Phototherapy Unit |
| Trade Name: | Infant Phototherapy Bilitron Sky 5006 |
| Classification: | Class II |
| Product Code: | LBI |
| Classification Panel: | General Hospital |
| Regulation Numbers: | 21 CFR §880.5700 |
| Substantial Equivalence: | NanoBlu 500 K113206 |

## Indications for Use

The Fanem Infant Phototherapy Bilitron Sky 5006 is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.

#### Device Description

The Fanem Infant Phototherapy Billtron Sky 5006 is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. They system can be used for infants in bassinets, incubators, open beds or radiant warmers. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum. The Infant Phototherapy Bilitron Sky 5006 consists of a lamp unit and can be hood mounted or trolley mounted.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "FANEM" in bold, black letters. To the left of the word is a symbol that looks like a plus sign with small, gear-like shapes on each end. A small, circled R symbol is located to the upper right of the word "FANEM", indicating that it is a registered trademark. The text and symbol are all in black against a white background.

Brasil . India . Jordania

# Device Comparison Table

| Features | Subject Device | Predicate Device |
|-------------------|-----------------------------------------------------------------|--------------------------------------------------------|
| | Infant Phototherapy<br>Bilitron Sky 5006 by<br>Fanem<br>K131196 | NanoBlu 500 by Drager<br>K113206 |
| Intended Use | For the treatment of<br>neonatal<br>hyperbilirubinemia | For the treatment of<br>neonatal<br>hyperbilirubinemia |
| Target Population | Neonates | Neonates |
| Type | Freestanding device | Freestanding device |
| Mounting Hardware | Roll stand, 3 legs<br>w/casters | Roll stand, 3 legs<br>w/casters, 3 locking |
| Light Attachment | Lights mounted in<br>enclosure | Lights mounted in<br>enclosure |
| Light Source | Light Emitting Diodes<br>(LED) | Light Emitting Diodes<br>(LED) |
| Wavelength | 400-550 nm | 400-550 nm |
| Operating Voltage | 100-240V | 90 VAC to 240 VAC |
| Standards | IEC 60601-1<br>IEC 60601-1-2:2001<br>IEC 60601-2-50 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-50 |

## Substantial Equivalence

The Infant Phototherapy Bilitron Sky 5006 and the NanoBlu 500 have the same intended use (treatment of hyperbilirubinemia), the same operating principle (delivery of blue light to degrade bilirubin), and are similar in their hardware configuration.

# Non-Clinical Testing

This submission includes testing results of the Infant Phototherapy Bilitron Sky 5006.

## Conclusion

Based on the data and information presented in this submission, the Infant Phototherapy Bilitron Sky 5006 is substantially equivalent to the currently legally marketed NanoBlu 500.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is printed in black and white.

Public Health Service

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

February 20, 2014

Fanem Ltda C/O Ms. Tara Conrad TechLink International Consulting 18851 NE 29TH Avenue, Suite 720 Aventura, FL 33180

Re: K131196

Trade/Device Name: Infant Phototherapy Bilitron Sky 5006 Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: October 29, 2013 Received: January 22, 2014

Dear Ms. Conrad:

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.

{3}------------------------------------------------

Page 2 - Ms. Conrad

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/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.

Image /page/3/Picture/7 description: The image shows the name "Kwame Ulmer-s" in a stylized font. The letters are large and bold, with the name split into two lines. Behind the name is a geometric design that includes a maze-like pattern, a circle, and a triangle. The design appears to be textured or patterned, adding depth to the image.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

for

Enclosure

{4}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K131196

Device Name

Infant Phototherapy Bilitron Sky 5006

| | A 4000 all all all all a differ the call of the call color de clicity the color different of the contractive described the | |
|--|----------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | | Indications for Use (Describe) |

The Fanem Infant Phototherapy Bilition Sky 5006 is intended to treat neonatal hyperbillrubinemia by providing phototherapeutic light to the body of the patient. It is intended for use in the recommendation and under the supervision of healthcare professionals.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE CHILIFOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/4/Picture/13 description: The image shows the FDA logo. The logo is a stylized version of the letters "FDA". The letters are made up of thick, parallel lines. The letters are arranged in a horizontal line, with the "F" on the left, the "D" in the middle, and the "A" on the right.

Digitally signed by Richard C. Chapman Date: 2014.02.20 12:35:48 -05'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.