neoBLUE blanket LED Phototherapy System

K182178 · Natus Medical Incorporated · LBI · Dec 13, 2018 · General Hospital

Device Facts

• Record ID: K182178
• Device Name: neoBLUE blanket LED Phototherapy System
• Applicant: Natus Medical Incorporated
• Product Code: LBI · General Hospital
• Decision Date: Dec 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Portable phototherapy system; treats neonatal hyperbilirubinemia. Inputs: electrical power (100-240V AC). Operation: blue LED (400-550 nm) light box transmits light via fiber optic cable to fiber optic blanket pad; pad placed under patient. Used in hospital or home; operated by medical staff or trained caregivers. Output: intensive blue light (≥30µW/cm²/nm) for bilirubin degradation. Includes thermal monitoring sensors for LED and lens interface. Benefits: effective, portable treatment for jaundice; improved reliability via glass lens, UV-cured adhesive, and high-frequency welded joints.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety, LED performance, intensity levels, and usability testing per IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, and 60601-2-50.

Technological Characteristics

Blue LED light source (400-550 nm, peak 450-475 nm); fiber optic blanket pad (PVC); glass lens; UV-cured optical adhesive; polycarbonate/aluminum light box; vinyl tubing; 12 VDC power supply. Thermal monitoring via dual sensors. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-50, AIM 7351731.

Indications for Use

Indicated for treatment of unconjugated hyperbilirubinemia in premature babies and neonates up to 3 months of age, weighing < 22 lb (10 kg). Contraindicated in patients with congenital porphyria, family history of porphyria, or concomitant use of photosensitizing agents.

Regulatory Classification

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.

Predicate Devices

• neoBLUE blanket LED Phototherapy System (K103589)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary K182178

| Manufacturer's Name: | Natus Medical Incorporated<br>5900 First Avenue South<br>Seattle, WA 98108 |
|----------------------------------|----------------------------------------------------------------------------|
| Corresponding Official: | Judy Buckham<br>Senior Regulatory Affairs Specialist |
| Telephone Number:<br>Fax Number: | 206 268 5187<br>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<br>Attribute | neoBLUE® blanket LED<br>Phototherapy System<br>K103589 | neoBLUE® blanket LED<br>Phototherapy System<br>Updated Device | Discussion of Differences |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | For the treatment of neonatal<br>hyperbilirubinemia. It can be<br>used in the clinical setting or in<br>the home. | The neoBLUE blanket LED<br>Phototherapy System is indicated<br>for the treatment of<br>unconjugated hyperbilirubinemia<br>in a hospital environment, and<br>administered by trained<br>professional medical staff, on the<br>order of a physician, or in the<br>home environment administered<br>by a trained caregiver. The<br>neoBLUE blanket device<br>provides intensive phototherapy<br>underneath the patient and can<br>be used with a bassinet, open<br>bed, radiant warmer, incubator,<br>or while holding the patient. | The differences in the Indications for Use<br>statement do not raise different questions<br>about the safety or effectiveness of the<br>updated device. The statement was revised<br>from that of the predicate to be more<br>descriptive of the use environment.<br>Additionally, the statement was updated to<br>indicate the use from "treatment of<br>hyperbilirubinemia" to the more specific<br>"treatment of unconjugated<br>hyperbilirubinemia." |
| Intended Use | For the treatment of neonatal<br>hyperbilirubinemia. It can be<br>used in the clinical setting or in<br>the home. | The neoBLUE blanket LED<br>Phototherapy System is for the<br>treatment of unconjugated<br>hyperbilirubinemia in premature<br>babies and neonates. It is<br>intended for use with patients up<br>to 3 months of age, weighing less<br>than 22 lb (10 kg). | The differences in the Intended Use<br>statement do not raise questions about the<br>safety or effectiveness of the updated<br>device. This change provides more specific<br>information related to the patient population. |
| Contraindications | none | Congenital porphyria or a<br>family history of porphyriaConcomitant use of drugs<br>or agents that are<br>photosensitizers | Two contraindications published in AAP<br>Guidelines were added to the User Manual<br>Neither of these raise questions about the<br>safety or effectiveness of the updated<br>device. |
| Sites of Use | Clinical setting or home use | Clinical setting or home use | Same |
| Device<br>Attribute | neoBLUE® blanket LED<br>Phototherapy System<br>K103589 | neoBLUE® blanket LED<br>Phototherapy System<br>Updated Device | Discussion of Differences |
| Device Components | • Light Box<br>• Fiber optic blanket (2 sizes)<br>• Blanket mattress (2 sizes)<br>• Disposable mattress cover<br>• Power cord | • Light Box<br>• Fiber optic blanket (2 sizes)<br>• Blanket mattress (2 sizes)<br>• Disposable mattress cover<br>• Power cord | Same |
| Light source | Single "Large Format" Blue<br>LED coupled to fiber optic<br>blanket | Single "Large Format" Blue LED<br>coupled to fiber optic blanket | Same |
| Expected LED life | >20,000 hours | >20,000 hours | Same |
| Treatment<br>Wavelength | Blue wavelength 400-550 nm<br>Peak @ 450-475 nm | Blue wavelength 400-550 nm<br>Peak @ 450-475 nm | Same |
| neoBLUE blanket<br>LED Phototherapy<br>System Light Intensity | >30 μW/cm²/nm for both<br>blanket sizes. Factory set at<br>30-35 μW/cm²/nm | ≥30 μW/cm²/nm for both blanket<br>sizes. Factory set at 35 ± 5<br>μW/cm²/nm | There were no design changes made to the<br>intensity of the system, just a clarification to<br>the specification. |
| Light Box Materials | Polycarbonate light box<br>enclosure and aluminum<br>handle | Polycarbonate light box<br>enclosure and aluminum handle | Same |
| Fiber optic Blanket | Large:<br>9.5 x 14.5 in (24.1 x 36.8 cm) | Large:<br>9.5 x 14.5 in (24.1 x 36.8 cm) | Same |
| Dimensions | Small:<br>6.75 x 12.75 in (17.1 x 32.4cm) | Small:<br>6.75 x 12.75 in (17.1 x 32.4cm) | Same |
| Fiber optic Blanket<br>Materials | Polyvinyl Chloride (PVC) | Polyvinyl Chloride (PVC) | Same<br>Note: the materials of the Blanket Pad are<br>not patient contacting. |
| Fiber optic cable<br>sheath material | Silicone tubing | Vinyl tubing | Vinyl accommodates the high frequency<br>welding required for high frequency welded<br>joint and does not accumulate dust as<br>silicone does |
| Blanket Mattress | Polyurethane cover with<br>polyolefin bubble cushioning | Polyurethane cover with<br>polyolefin bubble cushioning | Same<br>Note: The materials of the mattress are not<br>intended for patient contact. |
| Disposable Mattress<br>Cover | Non-woven polypropylene | Non-woven polypropylene | Same<br>Note: the materials of the mattress cover are<br>patient contacting |
| Device<br>Attribute | neoBLUE® blanket LED<br>Phototherapy System<br>K103589 | neoBLUE® blanket LED<br>Phototherapy System<br>Updated Device | Discussion of Differences |
| Adjustable light<br>output | Yes – adjustable to ≥55<br>$μ$ W/cm²/nm | Yes - adjustable to 50 to 60<br>$μ$ W/cm²/nm. | There were no design changes made to the<br>light box. The upper limit was added to the<br>specification to align with the AAP<br>Guidelines. |
| Thermal Monitoring<br>Circuit | One temperature sensor -<br>temperature sensor installed to<br>detect overheating condition of<br>the LED. | Two temperature sensors - one<br>temperature sensor installed to<br>detect overheating condition of<br>the LED, and one to detect a<br>pending overheating condition<br>of internal lens interface | The addition of the additional sensor does<br>not raise questions about the safety or<br>effectiveness of the updated device. The<br>additional sensor indicates if the pad is<br>approaching the end of useful life. |
| Optic lens | Acrylic lens | Glass lens | Provides more consistent and efficient light<br>transmission from the LED to the fiber optic<br>cable |
| Adhesive material<br>used to bond fiber<br>optics together inside<br>tip of fiber optic cable | Two component epoxy | UV cured optical adhesive | The new adhesive material is longer lasting<br>and more durable than the two part epoxy<br>and improves reliability. |
| Connection of the<br>fiber optic cable to<br>the light box | No handle | New handle grip | The addition of a handle grip does not raise<br>questions about the safety or effectiveness<br>of the updated device. It aids in the ease of<br>connection and increased durability. |
| Pad/tubing<br>connection | Heat shrink tubing | High frequency welded joint | Welded joint eliminates crevices and folds in<br>the joint for ease of cleaning |
| Power Supply to Light<br>Box | Mains powered:<br>100-240 Volts at either 50 or 60<br>Hz. This external power supply<br>provides 12 VDC to the light<br>box | Mains powered:<br>100-240 Volts at either 50 or 60<br>Hz. This external power supply<br>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.