Infant Phototherapy Equipment

K210289 · Bistos Co., Ltd. · LBI · May 28, 2021 · General Hospital

Device Facts

• Record ID: K210289
• Device Name: Infant Phototherapy Equipment
• Applicant: Bistos Co., Ltd.
• Product Code: LBI · General Hospital
• Decision Date: May 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 are indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.

Device Story

Portable phototherapy system; delivers narrow-band high-intensity blue light (400-550 nm) via LEDs to treat neonatal hyperbilirubinemia. Comprised of control box, LED-embedded pad, disposable nonwoven cover, rechargeable battery, and AC/DC adapter. Used in hospital or home settings; operated by clinicians or caregivers. Device wraps around infant to provide treatment from underneath. Control box features LCD display for user settings (power, intensity level, run time). Provides two-level irradiance (High: 60±10 µW/cm²/nm; Low: 30±10 µW/cm²/nm). Alarms include low battery, pad connection, and high temperature. Treatment continues until bilirubin levels sufficiently drop. Benefits include non-invasive jaundice reduction.

Clinical Evidence

No clinical data were submitted. Substantial equivalence is supported by bench performance testing, including light intensity, temperature monitoring, battery operation, and alarm system verification, alongside compliance with electrical safety and biocompatibility standards.

Technological Characteristics

Blue LED phototherapy system; wavelength 455-465 nm. Materials: nonwoven spunbond pad cover (biocompatible per ISO 10993-5/10). Power: 100-240 Vac or 11.1V Li-ion Polymer battery. Dimensions: 120 x 455 mm. Standards: IEC 60601-1, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-50, IEC 62471. IP ratings: Control box IP21, Pad IP23, Adapter IP22. Connectivity: Standalone.

Indications for Use

Indicated for infants up to 3 months old and weighing less than 10 kg diagnosed with hyperbilirubinemia (neonatal jaundice).

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

• BiliBee (K072097)

Submission Summary (Full Text)

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May 28, 2021

Bistos Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114

Re: K210289

Trade/Device Name: Infant Phototherapy Equipment Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal phototherapy unit Regulatory Class: Class II Product Code: LBI Dated: April 9, 2021 Received: April 29, 2021

Dear Prithul Bom:

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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K210289

## Device Name

BiliTouch™ (model name: Motif Phototherapy Blanket); and Infant Phototherapy Equipment (model name: BT-450)

## Indications for Use (Describe)

The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.

The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# Traditional 510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### April 9, 2021 Date 510k summary prepared:

#### I. SUBMITTER

| Submitter's Name | Bistos Co., Ltd. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302,<br>Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do,<br>Korea (Zip. 13201) |
| Submitter's Telephone | [phone] |
| Contact person | Daeeun Kim ([e-mail]) / RA |

#### II. DEVICE

| Common Name | Neonatal phototherapy unit |
|--------------------------------------------------|---------------------------------------------------------------------------------------------|
| Trade/proprietary Name | Infant phototherapy equipment, model BT-450<br>BiliTouch™, model Motif Phototherapy Blanket |
| Regulation Name | Unit, Neonatal Phototherapy |
| Regulation Number | 21 CFR 880.5700 |
| Product Code | LBI |
| Regulatory Class | Class II |
| Regulation Medical Specialty/510(k) review Panel | General Hospital |

#### III. PREDICATE DEVICE

| Primary Predicate device | BiliBee |
|--------------------------|--------------------------------|
| | K072097 |
| | Illumination Technologies, LLC |

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#### IV. DEVICE DESCRIPTION

Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby.

Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used).

Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.

#### V. INDICATIONS FOR USE:

The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 are indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.

The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The intended use, design and functional characteristics between the Infant phototherapy equipment and the predicate device are substantially equivalent. The subject device and predicate device is intended to be used for the treatment of infants diagnosed with hyperbilirubinemia by delivering light to degrade bilirubin on the same operating principle.

Summary table of technological characteristics of the device compared to the predicate device:

| Device | K210289 | K072097 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | Infant phototherapy equipment,<br>BiliTouch™ | BiliBee |
| Model | BT-450, | |
| | Motif Phototherapy Blanket | |
| Manufacturer | Bistos Co., Ltd. | Illumination Technologies, LLC |
| Intended Use<br>/Indications for Use | The BiliTouchTM, model Motif<br>Phototherapy Blanket and Infant<br>Phototherapy Equipment, model<br>BT-450 are indicated for use to<br>treatment of infants diagnosed with<br>hyperbilirubinemia, commonly<br>known as neonatal jaundice, which<br>can cause a yellow discoloration of<br>the skin and the whites of the eyes.<br>The devices can be used in a<br>hospital or at home.<br>The device is designed to use for<br>patient population described in the<br>infant, who is age up to 3 months<br>and weight less than 10 kg | The intended use of the BiliBee<br>LED Phototherapy System is the<br>treatment of infants diagnosed<br>with hyperbilirubinemia,<br>commonly known as neonatal<br>jaundice, which can cause a<br>yellow discoloration of the skin<br>and the whites of the eyes. |
| Targeted population | Infant diagnosed with<br>hyperbilirubinemia | Infant diagnosed with<br>hyperbilirubinemia |
| Use environment | Home, Hospital | Home, Hospital |
| Type of device | blanket type device<br>wrapping the patient | Free standing device<br>underneath the patient |
| Visual Indicator | LCD | LCD |
| User control | 1. Power on/off<br>2. Intensity level up and down<br>3. Run time setting<br>- 30minutes increase<br>- 30minutes decrease | Power on/off |
| Configuration | 1. Control box which contains LCD<br>display and Battery<br>2. Pad which consists of LEDs to<br>emit light and is able to wrap<br>around a patient<br>3. Pad cover<br>4. Adapter | 1. AA battery pack<br>2. LED illuminator panel<br>3. Sheath<br>4. Adapter |
| Power | 1. AC adapter:<br>100-240 Vac, 50/60Hz, 2.0A<br>2. Battery:<br>11.1V Li-ion Polymer 4000mA<br>Charging time: | 1. AC adapter:<br>2. Battery:<br>Removable rechargeable<br>6 V battery(off-the-shelf<br>AA battery) |
| Cover | Disposable pad cover,<br>Which is made of white<br>nonwoven spunbond | The disposable sheath consists<br>of two pieces of synthetic woven<br>fabric sewn together on 3 of 4<br>sides. |
| Use duration | Not limited,<br>but the pad cover is intended to be<br>replaced every 24 hours | Treatment is intended to be applied<br>for 24 hours a day, and treatment<br>time is expected to range from 3<br>days to 3 weeks. |
| Eye shield | Using is recommended. | None |
| Weight | 1. Pad: 340 g<br>2. Control box: 370 g | 1. Light panel < 0.5 lb.(227 g)<br>2. Battery pack < 1 lb. (454 g) |
| Dimensions | 120 X 455 mm | 4 X 8 inch (102 X 203 mm) |
| Type of light | Blue light LED | Flexible LED array emitting blue<br>light |
| Lifetime of the lamp | 3 years | Not available |
| Illuminated area | 102 X 412 mm | 102 X 152 mm |
| Wavelength | 455~465 nm | @470mm |
| Light output | 2 level<br>- HIGH irradiance:<br>60±10 µW/cm²/nm<br>- LOW irradiance:<br>30±10 µW/cm²/nm | 1 level<br>- 60 ±10 µW/cm²/nm |
| Alarms | 1. Information signal for low battery<br>and Pad connection<br>2. Low priority alarm for high<br>temperature | 1. Audible low battery warning |
| Acoustic energy | 43 ±1 dBA | Not available |
| Thermal safety | Surface of PAD ≤ 40 °C | There is no publicly-available<br>information stating the predicate<br>device conducted thermal safety<br>testing in compliance with the<br>60601-2-50 standard as this<br>specific standard for infant<br>phototherapy equipment did not<br>yet exist when the predicate<br>device's 510(k) was submitted. |
| Operating<br>Environmental<br>condition | - Operating temperature: 15 °C to<br>30 °C (59 °F to 86 °F)<br>- Operating humidity: 5 % to 85 %<br>non-condensing<br>- Atmospheric pressure: 70 kPa to<br>106 kPa | Not available |
| Transport and storage<br>environmental<br>condition | - Operating temperature: 15 °C to<br>30 °C (59 °F to 86 °F)<br>- Operating humidity: 5 % to 85 %<br>non-condensing<br>- Atmospheric pressure: 70 kPa to<br>106 kPa | Not available |
| Electrical safety | IEC 60601-1<br>IEC 60601-1-8<br>IEC 60601-1-11<br>IEC 60601-2-50 | There is no publicly-available<br>information stating the predicate<br>device conducted electrical<br>safety testing in compliance with<br>the 60601-1 standard of the time.<br>Furthermore, the 60601-2-50<br>standard specific for infant<br>phototherapy equipment did not<br>yet exist when the predicate<br>device's 510(k) was submitted. |
| Electromagnetic<br>compatibility | IEC 60601-1-2 | There is no publicly-available<br>information stating the predicate<br>device conducted<br>electromagnetic compatibility<br>testing in compliance with the<br>60601-1-2 standard of the time. |
| Photobiological<br>safety | IEC 62471 | There is no publicly-available<br>information stating the predicate<br>device conducted photobiological<br>safety testing in compliance with<br>the IEC 62471 standard of the<br>time. |
| IP ratings | Control box: IP 21<br>Pad: IP 23<br>Power adapter: IP 22 | There is no publicly-available<br>information about the IP ratings. |

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#### SUMMARY OF NON-CLINICAL TESTS VII.

Infant phototherapy equipment complies with voluntary standards for biocompatibility (in vitro cytotoxicity, irritation and sensitization testing), electrical safety, EMC testing, home healthcare environment, alarm system and infant phototherapy equipment:

## Biocompatibility:

The components, pad cover, which are in direct contact with the user are identical to the predicate device. Testing was conducted in accordance with FDA Recognition # 2-245, ISO 10993-5:2009, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity and FDA Recognition # 2-174, ISO 10993-10:2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization.

# Electrical Safety:

Testing was conducted in accordance with FDA Recognition # 19-4, AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) and FDA Recognition # 19-14, IEC 60601-1-11:2015 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.

## Electromagnetic Compatibility:

Testing was conducted in accordance with FDA Recognition # 19-8, IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.

# Alarm system:

Testing was conducted in accordance with FDA Recognition # 5-76. IEC 60601-1-8: 2006 + AMD1:2012 IEC 60601-1-8 - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

Infant phototherapy equipment:

Testing was conducted in accordance with FDA Recognition # 6-387, IEC 60601-2-50:

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2009/AMD1:2016 - Part 2-50: Particular Requirements for the basic safety and essential performance of infant phototherapy equipment.

Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)

Bench performance tests including testing for battery-powered operating test, light intensity test and testing for temperature on the pad of the device and high temperature alarm were completed to verify that the infant phototherapy equipment demonstrate the specifications.

#### PERFORMANCE DATA : CLINICAL TESTING VIII.

No clinical data were submitted.

#### CONCLUSIONS IX.

Based on device characteristics compared in Substantial Equivalence Discussion (TAB. NO.11) and the results of electromagnetic and electric safety and performance testing demonstrate that the infant phototherapy equipment and BiliTouch™, model name BT-450 and Motif Phototherapy Blanket are as safe and effective as the predicate device, BiliBee, K072097.