(134 days)
Not Found
No
The summary describes a standard LED phototherapy device with observation and treatment modes, and there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is intended for the "treatment of neonatal hyperbilirubinemia," which is a medical condition, making it a therapeutic device.
No
The device is described as a phototherapy light system intended for treatment (phototherapy for neonatal hyperbilirubinemia) and observation (auxiliary lighting), not for diagnosis.
No
The device description explicitly states it is an "LED phototherapy (and observation) light" and mentions mounting it on an incubator hood, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Airborne Phototherapy Light System is a medical device that uses light therapy (phototherapy) applied externally to the body to treat a condition (neonatal hyperbilirubinemia). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "treatment of neonatal hyperbilirubinemia" and as "auxiliary lighting." Neither of these involves in vitro testing.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.
Product codes
LBI
Device Description
The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light has both white and blue LED lights that are designed to serve as an observation light or a phototherapy light for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. The phototherapy light can be used for infants in incubators by mounting it on the hood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Neonatal
Intended User / Care Setting
Hospital or institution / Prescriptive
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
Testing was performed to confirm compliance to the following standards:
- IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
- IEC 60601-1-2, Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility
- IEC 60601-2-50, Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Infant Phototherapy Equipment
The Airborne Phototherapy Light met all the performance requirements as outlined above in the standards.
Key Metrics
Irradiation Intensity: 12-27 µW/cm²/nm
Sound level:
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2016
International Biomedical Ms. Amy Pieper Director of Regulatory Affairs 8206 Cross Park Dr. Austin, Texas 78754
Re: K160238
Trade/Device Name: Airborne Phototherapy Light Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: March 30, 2016 Received: April 27, 2016
Dear Ms. Pieper:
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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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K160238
Device Name Airborne Phototherapy Light
Indications for Use (Describe)
The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K160238 510(K) SUMMARY
| Manufacturer's Name: | International Biomedical
8206 Cross Park Drive
Austin, Texas 78754 |
|---------------------------------|----------------------------------------------------------------------------------------------------|
| Corresponding Official: | Amy Pieper
Director of Regulatory |
| Telephone Number: | (512) 873-0033 |
| Fax Number: | (512) 873-9090 |
| Preparation Date: | June 10, 2016 |
| Trade Name: | Airborne Phototherapy Light |
| Common or Usual Name: | Neonatal Phototherapy Unit |
| Classification Name and Number: | Unit, Neonatal Phototherapy
21 CFR 880.5700
Product Code: LBI |
| Predicate Device: | Atom Medical – Bili-Therapy Spot Type – K103828
Draeger Medical Systems – NanoBlu 500 - K113206 |
Device Description
The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light has both white and blue LED lights that are designed to serve as an observation light or a phototherapy light for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. The phototherapy light can be used for infants in incubators by mounting it on the hood
Intended Use
The AirBorne Observation & Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia
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Substantial Equivalence Discussion
| | Proposed
Airborne Phototherapy Light | Predicate
K103828 Bili-Therapy
Spot Type | Predicate
K113206 NanoBlu 500 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Airborne Observation &
Phototherapy Light System is
intended to be used in one of two
modes: observation light mode
or phototherapy light mode. The
observation light mode utilizes
white light and is intended to be
used as auxiliary lighting that
supplements the ambient
lighting. The phototherapy light
mode utilizes blue light and is
intended to be used in the
treatment of neonatal
hyperbilirubinemia. | The Bili-Therapy Spot
Type is a phototherapy
unit intended for the
treatment of neonatal
hyperbilirubinemia. | The Drager NanoBlu 500 LED
Phototherapy Light 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. Additionally, this
product can be used with an
under-baby phototherapy light to
increase patient coverage. |
| Environment for
Use | Hospital or institution | Hospital or institution | Hospital or institution |
| Patient
Population | Neonatal | Neonatal | Neonatal |
| Prescriptive | yes | yes | yes |
| Patient
Connection | none | none | none |
| Technology | Blue light-emitting diodes
(LEDs) | Blue light-emitting diodes
(LEDs) | Blue light-emitting diodes
(LEDs) |
| Wavelength | 400-500 nm | Peak 450 to 475 nm | 400-550 nm |
| Irradiation
Intensity | 12-27 µW/cm²/nm | 30-40 µW/cm²/nm | Minimum 40 µW/cm²/nm |
| Sound level |