(300 days)
Not Found
No
The summary describes a standard phototherapy device and does not mention any AI or ML components or functionalities.
Yes
The device is described as "intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient." The explicit mention of "treat" indicates a therapeutic purpose.
No.
The device is intended for treatment (phototherapy for neonatal hyperbilirubinemia), not for diagnosis.
No
The device description explicitly states it consists of a "lamp unit" and can be "hood mounted or trolley mounted," indicating it is a physical hardware device that emits light for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient." This describes a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a lamp unit that emits light for treatment. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a therapeutic device.
N/A
Intended Use / 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.
Product codes
LBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body of the patient
Indicated Patient Age Range
neonatal
Neonates
Intended User / Care Setting
healthcare professionals
hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission includes testing results of the Infant Phototherapy Bilitron Sky 5006.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 |
| Rau Arthur Carl Schmidt, 186-CEP:07222-050 | |
| Cumbics Guarulhos SP Brazil | |
| Telephone: 55 11 6412-3743 | |
| Fax: 55 11 6412-2199 | |
| Official Contact: | Tara Conrad |
| TechLink International Consulting | |
| 18851 NE 29th Avenue | |
| Suite 720 | |
| Aventura, 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
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 | ||
| Bilitron Sky 5006 by | ||
| Fanem | ||
| K131196 | NanoBlu 500 by Drager | |
| K113206 | ||
| 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 | Roll stand, 3 legs | |
| w/casters, 3 locking | ||
| 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 | 100-240V | 90 VAC to 240 VAC |
| Standards | IEC 60601-1 | |
| IEC 60601-1-2:2001 | ||
| IEC 60601-2-50 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| 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
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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.
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 (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.
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)
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Digitally signed by Richard C. Chapman Date: 2014.02.20 12:35:48 -05'00'
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