(134 days)
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.
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
The provided text describes a 510(k) premarket notification for a medical device called the "Airborne Phototherapy Light". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and studies in the manner typically seen for novel AI/ML-driven devices or those undergoing rigorous clinical efficacy trials.
Therefore, the information required to answer your specific questions about acceptance criteria, test set details, expert ground truth, MRMC studies, standalone performance, training set details, and specific effect sizes is not present in the provided document.
This document is a marketing clearance notification for a phototherapy light for neonatal hyperbilirubinemia. The "performance testing" mentioned refers to compliance with electrical and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50), which are general safety and performance requirements for a device of this type, not specific outcome-based acceptance criteria or a study proving its efficacy for treatment in a clinical sense.
The core argument for clearance is substantial equivalence based on:
- Similar indications for use (treatment of neonatal hyperbilirubinemia).
- Similar environment for use (hospital/institution).
- Similar patient population (neonatal).
- Similar technology (blue light-emitting diodes - LEDs).
- Compliance with relevant safety standards.
The discussion about irradiance levels (5 µW/cm²/nm resulting in a 15% decrease of serum bilirubin) refers to published guidelines from the American Academy of Pediatrics, not to a performance study conducted on the Airborne Phototherapy Light itself. The device's irradiance is stated to be within the therapeutic range suggested by these guidelines, even if slightly less than the predicates.
In summary, this document does not contain the information needed to fill out your request because it's a regulatory submission for a device demonstrating substantial equivalence to existing, well-understood technology, not a novel device requiring extensive performance studies as you've outlined.
To answer your request, if this were a document about a software with AI/ML components for diagnosis or treatment, it would typically include a dedicated section on clinical performance testing, often with a detailed statistical analysis plan, acceptance criteria, and specific study results. This document does not describe such a study.
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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 Biomedical8206 Cross Park DriveAustin, Texas 78754 |
|---|---|
| Corresponding Official: | Amy PieperDirector 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 Phototherapy21 CFR 880.5700Product Code: LBI |
| Predicate Device: | Atom Medical – Bili-Therapy Spot Type – K103828Draeger 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
| ProposedAirborne Phototherapy Light | PredicateK103828 Bili-TherapySpot Type | PredicateK113206 NanoBlu 500 | |
|---|---|---|---|
| Indications forUse | The Airborne Observation &Phototherapy Light System isintended to be used in one of twomodes: observation light modeor phototherapy light mode. Theobservation light mode utilizeswhite light and is intended to beused as auxiliary lighting thatsupplements the ambientlighting. The phototherapy lightmode utilizes blue light and isintended to be used in thetreatment of neonatalhyperbilirubinemia. | The Bili-Therapy SpotType is a phototherapyunit intended for thetreatment of neonatalhyperbilirubinemia. | The Drager NanoBlu 500 LEDPhototherapy Light is intended totreat neonatal hyperbilirubinemiaby providing phototherapeuticlight to the body of the patient. Itis intended for use on therecommendation and under thesupervision of healthcareprofessionals. Additionally, thisproduct can be used with anunder-baby phototherapy light toincrease patient coverage. |
| Environment forUse | Hospital or institution | Hospital or institution | Hospital or institution |
| PatientPopulation | Neonatal | Neonatal | Neonatal |
| Prescriptive | yes | yes | yes |
| PatientConnection | 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 |
| IrradiationIntensity | 12-27 µW/cm²/nm | 30-40 µW/cm²/nm | Minimum 40 µW/cm²/nm |
| Sound level | < 60dB | 60 dB or less | Not published |
| PowerRequirements | 8.9V @ 420mA or 80-264VAC,50-60Hz | Rated voltage 120VAC,Power consumption30VA, frequency 50/60Hz | 90 VAC to 240 VAC OperatingVoltage |
| Electrical Safety | IEC 60601-1IEC 60601-1-2IEC 60601-2-50 | IEC 60601-1IEC 60601-1-2IEC 60601-2-50 | IEC 60601-1IEC 60601-1-2IEC 60601-2-50 |
Discussion of Differences
The indications for use of the Airborne Phototherapy Light therapy as blue light while the predicate (K113206) refers to the "phototherapeutic light." This addition does not raise any new questions of safety or effectiveness, since the phototherapeutic light for treatment of hyperbilirubinemia is considered within the "blue" light spectrum.
The indications for use of the Airborne Phototherapy Light states the addition of a white light mode for use as auxillary lighting which is not in the intended use of the predicates (K103828, K113206). This addition does not raise any new questions of safety or effectiveness as this mode is for auxillary lighting needs, not treatment of hyperbilirubinemia.
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The irradiance delivered by the Airborne Phototherapy Light is slightly less than the irradiance delivered by the predicate devices; however, the effect on the patient of the irradiance delivered is within 10% of the predicate devices. According to the American Academy of Pediatrics Guidelines for the Treatment of Hyperbilirubinemia, irradiance levels as low as 5 µW/cm /nm result in a 15% decrease of serum bilirubin in the first 24 hours of use. Therefore the while the irradiance levels for the AirBorne Phototherapy Light are slightly lower, they are within the levels required for a therapeutic effect per the American Academy of Pediatrics Guidelines for the Treatment of Hyperbilirubinemia.
The differences between the Airborne Phototherapy Light and the predicates do not raise any new questions of safety and effectiveness.
Performance Testing
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 and thus can be found to be substantially equivalent to the predicate devices.
In addition to compliance with the relevant standards, a usability risk analysis was performed indicating that all the critical tasks for the Airborne Phototherapy Light are minor in severity, thus human factors testing is not need.
Clinical and Non Clinical Tests
No other clinical or nonclinical testing was performed.
Conclusions
In regards to intended use and technology, the Airborne Phototherapy Light is substantially equivalent to the listed predicates in indications for use, patient population, environment for use, technical characteristics and compliance with international standards.
Any differences between the Airborne Phototherapy Light and the predicates do not raise any new questions of safety and effectiveness. Therefore, the subject device is considered substantially equivalent to the Bili-Therapy Spot Type cleared under K103828 and the Drager NanoBlu 500 LED Phototherapy Light cleared under K113206.
§ 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).