(122 days)
Not Found
No
The description focuses on the hardware components and light delivery mechanism, with no mention of AI or ML for data analysis, decision-making, or control.
Yes
The device is indicated for the treatment of unconjugated hyperbilirubinemia, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is indicated for the treatment of unconjugated hyperbilirubinemia, not for diagnosis. It uses light therapy to treat the condition.
No
The device description explicitly lists multiple hardware components: a light box, fiber optic blanket, mattress, disposable covers, and power supply. It is a physical system delivering light therapy.
Based on the provided information, the neoBLUE blanket LED Phototherapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- neoBLUE blanket Function: The neoBLUE blanket LED Phototherapy System is a therapeutic device. It directly treats a condition (unconjugated hyperbilirubinemia) by applying light to the patient's skin. It does not analyze any biological samples.
The description clearly outlines its function as a phototherapy system for treating a medical condition, which falls under the category of therapeutic devices, not diagnostic ones.
N/A
Intended Use / Indications for Use
The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia.
The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.
The spectrum range of the blue LED light corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin.
The neoBLUE blanket device can be directly connected to nominal voltages readily available throughout the world as the external power supply provided with this device is rated for use with 100-240 Volts at either 50 or 60 Hz. This external power supply provides 12 VDC to the light box, and pluqs in to a receptacle at the rear of the light box.
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
premature babies and neonates. It is intended for use with patients up to 3 months of age, weighing less than 22 lb (10 kg).
Intended User / Care Setting
trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver.
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)
Nonclinical Tests:
Design verification and validation were performed to ensure that the neoBLUE blanket LED Phototherapy System meets its performance specifications and demonstrates equivalence to the specified predicate device, including specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.
Where appropriate, testing was performed to recognized standards, including:
- Medical Electrical Equipment Part 2-50: Particular Requirements For The Basic . Safety And Essential Performance Of Infant Phototherapy Equipment |IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-041
- . Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint)
- . Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11:2015 (Second Edition) for use in conjunction with IEC 60601-1:2012 (Third Edition) + A1:2012
- Medical electrical equipment Part 1-6: General requirements for basic safety . and essential performance – Collateral standard: Usability IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)
- Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests [IEC 60601-1-2 ED 4.0: 2014-02]
- Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [An AIM Standard 7351731 Rev 2.0: 2017-02-03]
Conclusions:
The verification and validation summary and risk analysis documentation provided in this 510(k) support the conclusion that the neoBLUE blanket LED Phototherapy system is as safe and as effective as the predicate device cleared under K103259 and determined to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K103589 neoBLUE blanket LED Phototherapy System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2018
Natus Medical Incorporated Judy Buckham Sr. Regulatory Affairs Specialist 5900 First Avenue South Seattle, Washington 98108
Re: K182178
Trade/Device Name: neoBLUE® blanket LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: November 12, 2018 Received: November 13, 2018
Dear Judy 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sapana Patel -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182178
Device Name neoBLUE® blanket LED Phototherapy System
Indications for Use (Describe)
The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBlue blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.
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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3
510(k) Summary K182178
| Manufacturer's Name: | Natus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108 |
|----------------------------------|----------------------------------------------------------------------------|
| Corresponding Official: | Judy Buckham
Senior Regulatory Affairs Specialist |
| Telephone Number:
Fax Number: | 206 268 5187
206 268 5104 |
| Summary Date: | 12 December 2018 |
| Trade Name: | neoBLUE® blanket LED Phototherapy System |
| Common or Usual Name: | Neonatal Phototherapy Unit |
| Regulation Name : | Unit, Neonatal Phototherapy |
| Regulation Number: | 21 CFR 880.5700 |
| Product Code: | LBI |
| Predicate Device: | K103589 neoBLUE blanket LED Phototherapy System |
Device Description:
The neoBLUE blanket LED Phototherapy System is a portable phototherapy system that consists of five components: the neoBLUE blanket phototherapy light box, fiber optic blanket with attached cable, blanket mattress, disposable mattress covers, and power supply. The neoBLUE blanket LED Phototherapy System delivers a narrow band of high-intensity blue light via a blue light emitting diode (LED), in order to provide treatment for neonatal hyperbilirubinemia.
The neoBLUE blanket LED Phototherapy System is for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. It is intended for use with patients up to 3 months of age, weighing less than 22 lb (10 kg).
4
Natus Medical Incorporated
neoBLUE blanket LED Phototherapy System Traditional 510(k)
The portable neoBLUE blanket light box contains a blue LED which emits light in the range of 400 – 550 nm (peak wavelength 450-475 nm). This blue light is directed through an optical fiber cable to the fiber optic blanket pad. The fiber optic blanket pad is composed of high performance optical fibers enclosed in a vinyl material. A polyurethane mattress is placed on top of the fiber optic blanket, and a disposable polypropylene cover is placed around the blanket pad and mattress. The fiber optic blanket generates sufficient light output to provide intensive phototherapy which is defined as ≥30µW/cm²/nm.
The spectrum range of the blue LED light corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin.
The neoBLUE blanket device can be directly connected to nominal voltages readily available throughout the world as the external power supply provided with this device is rated for use with 100-240 Volts at either 50 or 60 Hz. This external power supply provides 12 VDC to the light box, and pluqs in to a receptacle at the rear of the light box.
Environment
Operating temperature/Humidity:
- Light box: 41° to 86° F (5 to 30°C)/10% to 90%, non-condensing ●
- Blanket: 41° to 100° F (5 to 38°C) / 10% to 90% non-condensing ●
Storage temperature/humidity:32° to 122° F (0 to 50°C) / 10% to 90%, non-condensing Altitude / Atmospheric pressure: 700 hPa to 1060 hPa
Indications for Use:
The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBLUE blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.
Technoloqical Characteristics:
5
Predicate Comparison Table
| Device
Attribute | neoBLUE® blanket LED
Phototherapy System
K103589 | neoBLUE® blanket LED
Phototherapy System
Updated Device | Discussion of Differences |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | For the treatment of neonatal
hyperbilirubinemia. It can be
used in the clinical setting or in
the home. | The neoBLUE blanket LED
Phototherapy System is indicated
for the treatment of
unconjugated hyperbilirubinemia
in a hospital environment, and
administered by trained
professional medical staff, on the
order of a physician, or in the
home environment administered
by a trained caregiver. The
neoBLUE blanket device
provides intensive phototherapy
underneath the patient and can
be used with a bassinet, open
bed, radiant warmer, incubator,
or while holding the patient. | The differences in the Indications for Use
statement do not raise different questions
about the safety or effectiveness of the
updated device. The statement was revised
from that of the predicate to be more
descriptive of the use environment.
Additionally, the statement was updated to
indicate the use from "treatment of
hyperbilirubinemia" to the more specific
"treatment of unconjugated
hyperbilirubinemia." |
| Intended Use | For the treatment of neonatal
hyperbilirubinemia. It can be
used in the clinical setting or in
the home. | The neoBLUE blanket LED
Phototherapy System is for the
treatment of unconjugated
hyperbilirubinemia in premature
babies and neonates. It is
intended for use with patients up
to 3 months of age, weighing less
than 22 lb (10 kg). | The differences in the Intended Use
statement do not raise questions about the
safety or effectiveness of the updated
device. This change provides more specific
information related to the patient population. |
| Contraindications | none | Congenital porphyria or a
family history of porphyriaConcomitant use of drugs
or agents that are
photosensitizers | Two contraindications published in AAP
Guidelines were added to the User Manual
Neither of these raise questions about the
safety or effectiveness of the updated
device. |
| Sites of Use | Clinical setting or home use | Clinical setting or home use | Same |
| Device
Attribute | neoBLUE® blanket LED
Phototherapy System
K103589 | neoBLUE® blanket LED
Phototherapy System
Updated Device | Discussion of Differences |
| Device Components | • Light Box
• Fiber optic blanket (2 sizes)
• Blanket mattress (2 sizes)
• Disposable mattress cover
• Power cord | • Light Box
• Fiber optic blanket (2 sizes)
• Blanket mattress (2 sizes)
• Disposable mattress cover
• Power cord | Same |
| Light source | Single "Large Format" Blue
LED coupled to fiber optic
blanket | Single "Large Format" Blue LED
coupled to fiber optic blanket | Same |
| Expected LED life | >20,000 hours | >20,000 hours | Same |
| Treatment
Wavelength | Blue wavelength 400-550 nm
Peak @ 450-475 nm | Blue wavelength 400-550 nm
Peak @ 450-475 nm | Same |
| neoBLUE blanket
LED Phototherapy
System Light Intensity | >30 μW/cm²/nm for both
blanket sizes. Factory set at
30-35 μW/cm²/nm | ≥30 μW/cm²/nm for both blanket
sizes. Factory set at 35 ± 5
μW/cm²/nm | There were no design changes made to the
intensity of the system, just a clarification to
the specification. |
| Light Box Materials | Polycarbonate light box
enclosure and aluminum
handle | Polycarbonate light box
enclosure and aluminum handle | Same |
| Fiber optic Blanket | Large:
9.5 x 14.5 in (24.1 x 36.8 cm) | Large:
9.5 x 14.5 in (24.1 x 36.8 cm) | Same |
| Dimensions | Small:
6.75 x 12.75 in (17.1 x 32.4cm) | Small:
6.75 x 12.75 in (17.1 x 32.4cm) | Same |
| Fiber optic Blanket
Materials | Polyvinyl Chloride (PVC) | Polyvinyl Chloride (PVC) | Same
Note: the materials of the Blanket Pad are
not patient contacting. |
| Fiber optic cable
sheath material | Silicone tubing | Vinyl tubing | Vinyl accommodates the high frequency
welding required for high frequency welded
joint and does not accumulate dust as
silicone does |
| Blanket Mattress | Polyurethane cover with
polyolefin bubble cushioning | Polyurethane cover with
polyolefin bubble cushioning | Same
Note: The materials of the mattress are not
intended for patient contact. |
| Disposable Mattress
Cover | Non-woven polypropylene | Non-woven polypropylene | Same
Note: the materials of the mattress cover are
patient contacting |
| Device
Attribute | neoBLUE® blanket LED
Phototherapy System
K103589 | neoBLUE® blanket LED
Phototherapy System
Updated Device | Discussion of Differences |
| Adjustable light
output | Yes – adjustable to ≥55
$μ$ W/cm²/nm | Yes - adjustable to 50 to 60
$μ$ W/cm²/nm. | There were no design changes made to the
light box. The upper limit was added to the
specification to align with the AAP
Guidelines. |
| Thermal Monitoring
Circuit | One temperature sensor -
temperature sensor installed to
detect overheating condition of
the LED. | Two temperature sensors - one
temperature sensor installed to
detect overheating condition of
the LED, and one to detect a
pending overheating condition
of internal lens interface | The addition of the additional sensor does
not raise questions about the safety or
effectiveness of the updated device. The
additional sensor indicates if the pad is
approaching the end of useful life. |
| Optic lens | Acrylic lens | Glass lens | Provides more consistent and efficient light
transmission from the LED to the fiber optic
cable |
| Adhesive material
used to bond fiber
optics together inside
tip of fiber optic cable | Two component epoxy | UV cured optical adhesive | The new adhesive material is longer lasting
and more durable than the two part epoxy
and improves reliability. |
| Connection of the
fiber optic cable to
the light box | No handle | New handle grip | The addition of a handle grip does not raise
questions about the safety or effectiveness
of the updated device. It aids in the ease of
connection and increased durability. |
| Pad/tubing
connection | Heat shrink tubing | High frequency welded joint | Welded joint eliminates crevices and folds in
the joint for ease of cleaning |
| Power Supply to Light
Box | Mains powered:
100-240 Volts at either 50 or 60
Hz. This external power supply
provides 12 VDC to the light
box | Mains powered:
100-240 Volts at either 50 or 60
Hz. This external power supply
provides 12 VDC to the light box | Same |
6
Natus Medical Incorporated neoBLUE blanket LED Phototherapy System Traditional 510(k)
7
Natus Medical Incorporated neoBLUE blanket LED Phototherapy System Traditional 510(k)
8
No design changes were made to the device with respect to intensity output, however, the intensity specification statements were updated to ensure design inputs were clear and unambiguous, and to align the statements with the recommendations of the American Association of Pediatrics. The design changes made to the device were intended to improve the reliability and usability of the neoBLUE blanket, thus increasing the lifetime of the device. These differences do not raise any different questions of safety or effectiveness.
Clinical Tests: N/A
Nonclinical Tests:
Design verification and validation were performed to ensure that the neoBLUE blanket LED Phototherapy System meets its performance specifications and demonstrates equivalence to the specified predicate device, including specific testing for device power, electrical safety, indicators, LED performance, intensity levels, intensity range, effective area, and usability.
Where appropriate, testing was performed to recognized standards, including:
- Medical Electrical Equipment Part 2-50: Particular Requirements For The Basic . Safety And Essential Performance Of Infant Phototherapy Equipment |IEC 60601-2-50:2009 +A1 / ED 2.1: 2016-041
- . Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint)
- . Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11:2015 (Second Edition) for use in conjunction with IEC 60601-1:2012 (Third Edition) + A1:2012
- Medical electrical equipment Part 1-6: General requirements for basic safety . and essential performance – Collateral standard: Usability IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)
- Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests [IEC 60601-1-2 ED 4.0: 2014-02]
- Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances -
9
Requirements and tests [An AIM Standard 7351731 Rev 2.0: 2017-02-03]
Conclusions:
The verification and validation summary and risk analysis documentation provided in this 510(k) support the conclusion that the neoBLUE blanket LED Phototherapy system is as safe and as effective as the predicate device cleared under K103259 and determined to be substantially equivalent.