(113 days)
The neoBLUE® LED Phototherapy System is indicated for the treatment of hyperbilirubinemia for neonates and infants in a hospital environment, and administered by trained, professional medical staff, on the order of a licensed medical practitioner. The light can be used with a bassinet, incubator, open bed, or radiant warmer.
The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand.
The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The light can be used independently of the roll stand, and can be placed directly on an incubator with a flattopped surface.
This document describes the Natus Medical Incorporated neoBLUE® LED Phototherapy System (K160305).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one might see for an AI algorithm's diagnostic accuracy. Instead, the document focuses on compliance with established medical device standards and functional specifications for a phototherapy unit.
However, based on the non-clinical testing section, the implicit acceptance criteria are compliance with relevant safety and performance standards for medical electrical equipment and phototherapy devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards Compliance | |
| IEC 60601-2-50:2009-03 Edition 2 (Infant Phototherapy Equipment) | Passed all testing and complies. |
| IEC 60601-1:2005/(R)2012 and C1:2009/(R)2012 (General Requirements for Basic Safety) | Passed all testing and complies. |
| IEC 60601-1-2: 2007/(R)2012 (Electromagnetic Compatibility) | Passed all testing and complies. |
| IEC 60601-1-6:2013-10 Edition 3.1 (Usability) | Passed all testing and complies. |
| Performance Specifications | |
| Intensity Setting (High) | 35 µW/cm²/nm at 12 inches (30.5 cm) |
| Intensity Setting (Low) | 15 µW/cm²/nm at 12 inches (30.5 cm) |
| Light Emission Spectrum | Blue LEDs emit 400-550 nm (peak 450-475 nm) |
| Non-significant UV/IR emission | Reduce risk of skin damage and excessive warming |
| Equivalence to Predicate Device | |
| Therapeutic Output | Same as predicate (K022196) |
| Functional Design Considerations | Separation of light source from roll stand for independent use; addition of timer for LED working hours |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a phototherapy system and not a diagnostic AI algorithm that relies on a "test set" of patient data for performance evaluation in the typical sense. The testing performed was for compliance with electrical, safety, and performance standards, and for demonstrating substantial equivalence to a predicate device through engineering and design validation. The provenance in this context would refer to internal validation procedures and results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable. The device's performance is not evaluated against a "ground truth" derived from expert consensus on patient data. Instead, it is evaluated against established engineering specifications, safety standards, and functional requirements.
4. Adjudication Method
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessment where discrepancies need to be resolved (e.g., in clinical trials or diagnostic accuracy studies involving multiple readers). This document describes the regulatory clearance of a medical device based on compliance with standards and functional testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The neoBLUE® LED Phototherapy System is a treatment device, not a diagnostic AI tool intended to assist human readers in interpreting medical images or data. Therefore, an MRMC study related to reader performance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a standalone phototherapy unit; it is not an algorithm, and its function does not involve human interpretation of its output in the way an AI diagnostic tool would.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Compliance with recognized international and national standards for medical electrical equipment and infant phototherapy.
- Engineering specifications for light intensity, wavelength, and safety.
- Demonstration of substantial equivalence to a legally marketed predicate device (K022196 Natus Blue Light Phototherapy Unit) in terms of intended use, operating principles, and therapeutic output.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2016
Natus Medical Incorporated Ms. Judy Buckham Regulatory Affairs Specialist 5900 First Avenue South Seattle, Washington 98108
Re: K160305
Trade/Device Name: neoBLUE® LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI. Dated: April 14, 2016 Received: April 18, 2016
Dear Ms. Buckham:
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 (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)
Device Name
neoBLUE® LED Phototherapy System
Indications for Use (Describe)
Indications for Use: The neoBLUE® LED Phototherapy System is indicated for the treatment of hyperbilirubinemia for neonates and infants in a hospital environment, and administered by trained, professional medical staff, on the order of a licensed medical practitioner. The light can be used with a bassinet, incubator, open bed, or radiant warmer.
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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K160305 510(K) SUMMARY
| Manufacturer'sName: | Natus Medical Incorporated5900 First Avenue SouthSeattle, WA 98108 |
|---|---|
| CorrespondingOfficial: | Judy BuckhamRegulatory Affairs Specialist |
| Telephone | 206 268 5187 |
| Number:Fax Number: | 206 268 5104 |
| Preparation Date: | April 14, 2016 |
| Trade Name: | neoBLUE® LED Phototherapy System |
| Common or UsualName: | Neonatal Phototherapy Unit |
| ClassificationName and Number: | Unit, Neonatal Phototherapy21 CFR 880.5700Product Code: LBI |
| Predicate Device: | K022196 Natus Blue Light Phototherapy Unit |
Device Description
The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand.
The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The light can be used independently of the roll stand, and can be placed directly on an incubator with a flattopped surface.
Intended Use
The neoBLUE LED Phototherapy System is indicated for the treatment of hyperbilirubinemia for neonates and infants in a hospital environment, and administered by trained, professional medical staff, on the order of a licensed medical practitioner. The light can be used with a bassinet, incubator, open bed, or radiant warmer.
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The indications for use of the predicate (K022196) reference the phototherapy system as emitting "blue light." The indications for use for the subject device (neoBLUE LED Phototherapy System) do not include this statement because the system emits blue and yellow light. Removal of this sentence does not raise new questions of safety or effectiveness.
Technological Characteristics
The neoBLUE light has intensity settings, high and low, which are factory callbrated to provide intensity of 35 µW/cm²/nm at the high setting and 15 µW/cm²/nm at the low setting at a distance of 12 inches (30.5 cm) from the light enclosure to the baby. The light output can also be adjusted to accommodate different distances.
Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, reducing the potential risk of skin damage. In addition. blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, minimizing concern about excessive warming of the infant.
The blue LEDs in the device produce the same therapeutic output as in the predicate. Yellow LEDs were intermixed with the blue LEDs in the new device so that the light output visually appears less blue in color, the light source was separated from the roll stand for independent use, and a timer was added to record the cumulative number of working hours for the LED lights.
Clinical Tests
N/A
Nonclinical Tests
The neoBLUE LED Phototherapy System passed all testing and complies with the following referenced standards:
- IEC 60601-2-50:2009-03 Edition 2; Medical Electrical Equipment Part 2-50: Particular . Requirements for the Basic Safety and Essential Performance of Infant Phototherapy Equipment
- IEC 60601-1:2005/(R)2012 and C1:2009/(R)2012; Medical Electrical Equipment -Part 1: ● General Requirements for Basic Safety
- IEC 60601-1-2: 2007/(R)2012; Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-6:2013-10 Edition 3.1: Medical Electrical Equipment Part 1-6: General . Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
In addition to compliance with the relevant standards, design verification and validation testing was performed to ensure that the neoBLUE LED Phototherapy System meets its performance specifications and demonstrates equivalence to the predicate device (K022196).
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Conclusions
The performance verification/validation testing data and risk analysis documentation provided in this 510(k) support the conclusion that the neoBLUE LED Phototherapy system performs as intended and is substantially equivalent to the predicate device.
The neoBLUE LED Phototherapy System is substantially equivalent to the Natus Blue Light Phototherapy Unit cleared under K022196.
§ 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).