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.

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.

AI/ML Overview

This document is an FDA 510(k) Premarket Notification summary for the BiliTouch™ (Motif Phototherapy Blanket) and Infant Phototherapy Equipment (BT-450). It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" for an AI/algorithm's performance or "reported device performance" in the typical sense of metrics like accuracy, sensitivity, and specificity for diagnostics. Instead, it describes compliance with various safety and performance standards for a medical device (infant phototherapy equipment).

However, we can infer some "acceptance criteria" and "reported performance" from the "Summary table of technological characteristics of the device compared to the predicate device" and the "SUMMARY OF NON-CLINICAL TESTS" section.

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance (Compliance/Result)
Biocompatibility	Compliance with ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Irritation/Sensitization) for components in contact with user.	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. (Implied successful compliance).
Electrical Safety	Compliance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012 (IEC 60601-1) & IEC 60601-1-11:2015.	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. (Implied successful compliance).
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014.	Testing was conducted in accordance with FDA Recognition # 19-8, IEC 60601-1-2:2014. (Implied successful compliance).
Alarm System	Compliance with IEC 60601-1-8: 2006 + AMD1:2012.	Testing was conducted in accordance with FDA Recognition # 5-76. IEC 60601-1-8: 2006 + AMD1:2012. (Implied successful compliance).
Infant Phototherapy Equipment Specifics	Compliance with IEC 60601-2-50: 2009/AMD1:2016.	Testing was conducted in accordance with FDA Recognition # 6-387, IEC 60601-2-50: 2009/AMD1:2016. (Implied successful compliance).
Software Verification and Validation	Compliance with FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).	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). (Implied successful compliance).
Bench Performance Tests (Battery, Light Intensity, Temperature, Alarms)	To demonstrate specifications.	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. (Implied successful verification).
Wavelength	455~465 nm (matching predicate)	455~465 nm
Light Output (Irradiance)	HIGH: 60±10 µW/cm²/nm; LOW: 30±10 µW/cm²/nm	HIGH: 60±10 µW/cm²/nm; LOW: 30±10 µW/cm²/nm
Thermal Safety (PAD Surface)	≤ 40 °C	Surface of PAD ≤ 40 °C
Acoustic Energy	Not explicitly stated an acceptance range, but reported.	43 ±1 dBA
IP Ratings	Control box: IP 21; Pad: IP 23; Power adapter: IP 22	Control box: IP 21; Pad: IP 23; Power adapter: IP 22

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical data were submitted." This implies that the 'test set' for demonstrating the device's safety and effectiveness was based purely on non-clinical, bench testing and adherence to recognized standards, rather than patient data. Therefore, there is no information on sample size, country of origin, or retrospective/prospective nature of a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable as no clinical data or expert-adjudicated ground truth was used for assessing the device's performance in a diagnostic or AI context. The assessment was based on compliance with device performance standards rather than a clinical ground truth derived from expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is Not Applicable as no clinical data requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was Not Done. The device is an Infant Phototherapy Equipment, which is a physical device delivering light therapy, not an AI or imaging diagnostic aid that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is Not Applicable as the device is not an algorithm for diagnosis or image interpretation. It is a phototherapy device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the purpose of this 510(k), where "No clinical data were submitted," the "ground truth" for the device's performance is established by its compliance with internationally recognized electrical, mechanical, biocompatibility, and phototherapy-specific safety and performance standards (e.g., IEC 60601 series, ISO 10993) and successful completion of internal bench performance tests.

8. The sample size for the training set

This section is Not Applicable. As stated, "No clinical data were submitted." The device is a physical medical device, not a software algorithm that requires a training set of data.

9. How the ground truth for the training set was established

This section is Not Applicable as there was no training set in the context of an AI/algorithm development.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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 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)

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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

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,Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do,Korea (Zip. 13201)
Submitter's Telephone	+82 (31) 7500340
Contact person	Daeeun Kim (dekim@bistos.co.kr) / RA

II. DEVICE

Common Name	Neonatal phototherapy unit
Trade/proprietary Name	Infant phototherapy equipment, model BT-450BiliTouch™, 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

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

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

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,BiliTouch™	BiliBee
Model	BT-450,
	Motif Phototherapy Blanket
Manufacturer	Bistos Co., Ltd.	Illumination Technologies, LLC
Intended Use/Indications for Use	The BiliTouchTM, model MotifPhototherapy Blanket and InfantPhototherapy Equipment, modelBT-450 are indicated for use totreatment of infants diagnosed withhyperbilirubinemia, commonlyknown as neonatal jaundice, whichcan cause a yellow discoloration ofthe skin and the whites of the eyes.The devices can be used in ahospital or at home.The device is designed to use forpatient population described in theinfant, who is age up to 3 monthsand weight less than 10 kg	The intended use of the BiliBeeLED Phototherapy System is thetreatment of infants diagnosedwith hyperbilirubinemia,commonly known as neonataljaundice, which can cause ayellow discoloration of the skinand the whites of the eyes.
Targeted population	Infant diagnosed withhyperbilirubinemia	Infant diagnosed withhyperbilirubinemia
Use environment	Home, Hospital	Home, Hospital
Type of device	blanket type devicewrapping the patient	Free standing deviceunderneath the patient
Visual Indicator	LCD	LCD
User control	1. Power on/off2. Intensity level up and down3. Run time setting- 30minutes increase- 30minutes decrease	Power on/off
Configuration	1. Control box which contains LCDdisplay and Battery2. Pad which consists of LEDs toemit light and is able to wraparound a patient3. Pad cover4. Adapter	1. AA battery pack2. LED illuminator panel3. Sheath4. Adapter
Power	1. AC adapter:100-240 Vac, 50/60Hz, 2.0A2. Battery:11.1V Li-ion Polymer 4000mACharging time:	1. AC adapter:2. Battery:Removable rechargeable6 V battery(off-the-shelfAA battery)
Cover	Disposable pad cover,Which is made of whitenonwoven spunbond	The disposable sheath consistsof two pieces of synthetic wovenfabric sewn together on 3 of 4sides.
Use duration	Not limited,but the pad cover is intended to bereplaced every 24 hours	Treatment is intended to be appliedfor 24 hours a day, and treatmenttime is expected to range from 3days to 3 weeks.
Eye shield	Using is recommended.	None
Weight	1. Pad: 340 g2. Control box: 370 g	1. Light panel < 0.5 lb.(227 g)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 bluelight
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- HIGH irradiance:60±10 µW/cm²/nm- LOW irradiance:30±10 µW/cm²/nm	1 level- 60 ±10 µW/cm²/nm
Alarms	1. Information signal for low batteryand Pad connection2. Low priority alarm for hightemperature	1. Audible low battery warning
Acoustic energy	43 ±1 dBA	Not available
Thermal safety	Surface of PAD ≤ 40 °C	There is no publicly-availableinformation stating the predicatedevice conducted thermal safetytesting in compliance with the60601-2-50 standard as thisspecific standard for infantphototherapy equipment did notyet exist when the predicatedevice's 510(k) was submitted.
OperatingEnvironmentalcondition	- Operating temperature: 15 °C to30 °C (59 °F to 86 °F)- Operating humidity: 5 % to 85 %non-condensing- Atmospheric pressure: 70 kPa to106 kPa	Not available
Transport and storageenvironmentalcondition	- Operating temperature: 15 °C to30 °C (59 °F to 86 °F)- Operating humidity: 5 % to 85 %non-condensing- Atmospheric pressure: 70 kPa to106 kPa	Not available
Electrical safety	IEC 60601-1IEC 60601-1-8IEC 60601-1-11IEC 60601-2-50	There is no publicly-availableinformation stating the predicatedevice conducted electricalsafety testing in compliance withthe 60601-1 standard of the time.Furthermore, the 60601-2-50standard specific for infantphototherapy equipment did notyet exist when the predicatedevice's 510(k) was submitted.
Electromagneticcompatibility	IEC 60601-1-2	There is no publicly-availableinformation stating the predicatedevice conductedelectromagnetic compatibilitytesting in compliance with the60601-1-2 standard of the time.
Photobiologicalsafety	IEC 62471	There is no publicly-availableinformation stating the predicatedevice conducted photobiologicalsafety testing in compliance withthe IEC 62471 standard of thetime.
IP ratings	Control box: IP 21Pad: IP 23Power adapter: IP 22	There is no publicly-availableinformation about the IP ratings.

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

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:

{9}------------------------------------------------

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.

Regulation Number and Section

§ 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).