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.

AI/ML Overview

This document is a 510(k) summary for the Fanem Infant Phototherapy Bilitron Sky 5006. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, the NanoBlu 500 by Drager.

Here's an analysis of the provided text in the context of acceptance criteria and a study to prove it:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values. Instead, it compares the subject device's features to those of its predicate device, implying that meeting the predicate device's characteristics constitutes acceptance.

Here's a summary of the comparative features, which act as de facto acceptance criteria based on substantial equivalence:

Feature	Acceptance Criteria (Predicate Device: NanoBlu 500)	Reported Device Performance (Subject Device: Bilitron Sky 5006)
Intended Use	For the treatment of neonatal hyperbilirubinemia	For the treatment of neonatal hyperbilirubinemia
Target Population	Neonates	Neonates
Type	Freestanding device	Freestanding device
Mounting Hardware	Roll stand, 3 legs w/casters, 3 locking	Roll stand, 3 legs w/casters
Light Attachment	Lights mounted in enclosure	Lights mounted in enclosure
Light Source	Light Emitting Diodes (LED)	Light Emitting Diodes (LED)
Wavelength	400-550 nm	400-550 nm
Operating Voltage	90 VAC to 240 VAC	100-240V
Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50	IEC 60601-1, IEC 60601-1-2:2001, IEC 60601-2-50

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical testing for the Infant Phototherapy Bilitron Sky 5006. However, it does not specify any "test set" in the context of clinical studies, nor does it provide details about sample sizes, data provenance (country of origin), or whether data was retrospective or prospective. The testing mentioned appears to be related to engineering and safety standards rather than clinical performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The submission is for a medical device (phototherapy unit), and the "ground truth" concept usually refers to a diagnostic or prognostic performance in AI/clinical studies. For this device, regulatory approval is based on equivalence to existing technology and adherence to recognized standards, not on diagnostic accuracy established by expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. There's no mention of a clinical test set or adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or conducted. This type of study is typically used for diagnostic devices or AI algorithms where human interpretation plays a significant role and the goal is to measure the impact of the new technology on reader performance. The Fanem Infant Phototherapy Bilitron Sky 5006 is a therapeutic device, not a diagnostic one.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study (algorithm only) was not mentioned or conducted. This concept is relevant for AI algorithms or automated diagnostic systems. The Fanem device is a physical phototherapy unit.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI models (e.g., pathology, outcomes data, expert consensus) is not directly applicable to this submission. The "truth" for this device is its adherence to specified physical and electrical characteristics and its ability to emit light within the therapeutic spectrum, validated through non-clinical testing and comparison to an established predicate device. The efficacy of phototherapy itself for neonatal hyperbilirubinemia is a well-established medical principle.

8. Sample Size for the Training Set

There is no mention of a training set or its sample size. This is a medical device, not an AI model, so the concept of a training set is not pertinent.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this information is not applicable.

Summary

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510(k) Summary

510(k) Number:	K131196
Date of Submission:	February 19, 2014
Submitter:	Fanem LtdaRau Arthur Carl Schmidt, 186-CEP:07222-050Cumbics Guarulhos SP Brazil
	Telephone: 55 11 6412-3743Fax: 55 11 6412-2199
Official Contact:	Tara ConradTechLink International Consulting18851 NE 29th AvenueSuite 720Aventura, FL 33180
	Telephone: (305) 377-0077
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

Device Description

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Brasil . India . Jordania

Device Comparison Table

Features	Subject Device	Predicate Device
	Infant PhototherapyBilitron Sky 5006 byFanemK131196	NanoBlu 500 by DragerK113206
Intended Use	For the treatment ofneonatalhyperbilirubinemia	For the treatment ofneonatalhyperbilirubinemia
Target Population	Neonates	Neonates
Type	Freestanding device	Freestanding device
Mounting Hardware	Roll stand, 3 legsw/casters	Roll stand, 3 legsw/casters, 3 locking
Light Attachment	Lights mounted inenclosure	Lights mounted inenclosure
Light Source	Light Emitting Diodes(LED)	Light Emitting Diodes(LED)
Wavelength	400-550 nm	400-550 nm
Operating Voltage	100-240V	90 VAC to 240 VAC
Standards	IEC 60601-1IEC 60601-1-2:2001IEC 60601-2-50	IEC 60601-1IEC 60601-1-2IEC 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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

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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

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		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)

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

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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).