The bill-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.

Device Description

The bili-hut™ is a modular, portable blue LED-based phototherapy device intended to treat neonatal hyperbilirubinemia, commonly known as infant jaundice. The bili-hut™ consists of the assembled hut (shell with light source, base mattress, base), nest components (nest, nest liner, nest mattress, nest mattress cover), and power supply. It has an optional accessory, the perch, which is a bassinet stand insert. Features include a timer for total LED use and an Environment High Temperature Warning with automatic shutoff. The principle of operation is phototherapy using blue light to break down bilirubin. The device is powered by a 12V medical grade power supply and uses an LED light array. The materials include fabric-based, plastic, metal, and electronic components.

AI/ML Overview

The bili-hut™ device is a phototherapy unit for treating neonatal hyperbilirubinemia (infant jaundice). The provided text describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device, the Ultra Bili Light™ Model 2000 (K974830).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized standards and performance characteristics comparable to the predicate device. The performance data is primarily non-clinical.

Acceptance Criteria / Performance Characteristic	bili-hut™ Reported Performance	Predicate Device (Ultra Bili Light™ Model 2000) Performance	Discussion/Compliance
Intended Use	For treatment of neonatal hyperbilirubinemia in clinical or home setting.	For treatment of neonatal hyperbilirubinemia in clinical or home setting (initially Home, later clarified to include Clinical).	Similar.
Principle of Operation	Phototherapy with blue light to decrease bilirubin blood levels.	Phototherapy with blue light to decrease bilirubin blood levels.	Similar.
Energy Source	Blue light LED	Blue light fluorescent	Different technology, but both deliver therapeutic irradiance above 30 µW/cm²/nm. No new safety/effectiveness questions raised.
Light Source Wavelength	430-490 nm	430-500 nm	Similar; within AAP recommended range (430-490 nm).
Average Irradiance of Intended Treatment Area	45 µW/cm²/nm	60 µW/cm²/nm	Similar; both exceed AAP standard for high intensity phototherapy (> 30 µW/cm²/nm).
Output Peak Wavelength	463 nm	Not explicitly stated, implied within 430-500 nm range	Within accepted therapeutic range.
Peak Irradiance	58 µW/cm²/nm	Not explicitly stated, implied by average irradiance.	Consistent with therapeutic requirements.
Effective Treatment Area	170 in² (1097 cm²)	Not explicitly stated.	Adequate for neonatal treatment.
Biocompatibility of Patient-Contact Materials	Passed Cytotoxicity, Sensitization (2 methods), Skin Irritation (2 methods) tests per ISO 10993 standards for polypropylene nonwovens (nest liner, nest mattress cover).	Assumed biocompatible, but no publicly available testing data for predicate.	bili-hut™ tested to current ISO 10993 standards.
Thermal Safety (Over-temperature shutoff)	Device material contacting newborn non-conductive, fabric-covered foam. LEDs out of reach. Over-temperature shutoff at 43°C (109.4°F) per IEC 60601-2-50.	Heating pad for cold conditions. Thermal protection circuit (beeper, flashing lights, shutoff) for over 98°F (36.7°C).	Both protect from overheating. bili-hut™ does not have a heating feature. bili-hut™ compliant with newer IEC standard, hence different cutoff temperature. No new safety/effectiveness questions raised.
Visible Light Radiation Safety	Requires separate eye protection (user-selected protective eye covers or goggles).	Requires BabyFace Shield or eye patches to protect eyes.	Similar; both require external eye protection.
Ultraviolet Light Radiation Safety	LED light source emits no UV light.	UV-blocking plastic sheet covers fluorescent bulbs.	Different. bili-hut™ inherently emits no UV; predicate filters it. No new safety/effectiveness questions raised.
Electrical Safety Testing	Conformance to AAMI ES60601-1:2005 + A1, IEC 60601-1-6 Ed 3.1 2013, IEC 62366-1 Ed 1.0 2015, IEC 60601-1-11 Ed 2.0 2015, IEC 60601-2-50 Ed 2.1 2016.	No publicly available information for predicate to current standards.	bili-hut™ tested to current, FDA-recognized standards.
Electromagnetic Compatibility (EMC) Testing	Conformance to IEC 60601-1-2 Edition 4.0 2014.	No publicly available information for predicate to current standards.	bili-hut™ tested to current, FDA-recognized standards.
Usability/Human Factors	Conformance to IEC 60601-1-6 and IEC 62366-1.	Not explicitly stated for predicate device, implied by general design.	bili-hut™ tested to current standards.
Device Power, Indicators, LED Performance, System Irradiance, System Light Intensity, Accelerated Lifetime	Bench performance tests completed to verify requirements met.	Implied functional for predicate.	bili-hut™ verified to meet device requirements and specifications.

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 primarily discusses non-clinical bench testing.

Biocompatibility testing: The "sample size" here refers to the materials tested (disposable covers and nest mattress). The studies were likely performed in a laboratory setting by certified testing facilities. The provenance would be the testing lab.
Electrical Safety, EMC, and Bench Performance tests: These are performed on the device itself. The "sample size" is the device(s) tested. These are laboratory tests, not human data.

There is no mention of a clinical test set or human data used to evaluate the device's performance in treating hyperbilirubinemia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as there was no clinical test set for which ground truth would be established by experts. The performance evaluation was primarily through non-clinical bench testing against established engineering and medical device standards.

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

Not applicable as no clinical test set 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

Not applicable. The bili-hut™ is a phototherapy device, not an AI-assisted diagnostic or interpretative system requiring human readers.

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

Not applicable. The bili-hut™ is a medical device, not an algorithm. Its performance as a standalone phototherapy unit was assessed via bench testing against engineering and medical device standards, and comparison to a predicate device.

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

For the non-clinical and bench performance tests, the "ground truth" or reference points were:

Recognized international and FDA-recognized standards: (e.g., AAMI ES60601-1, IEC 60601-1-x series, ISO 10993 series).
American Academy of Pediatrics (AAP) standards: Specifically for therapeutic irradiance (irradiance > 30 µW/cm²/nm) and peak wavelength (430-490 nm).
Predicate device characteristics: The Ultra Bili Light™ Model 2000 (K974830) served as a benchmark for comparison to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable as this is a medical device, not an AI/machine learning algorithm requiring a training set.

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

Not applicable.

Summary

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September 5, 2019

Little Sparrows Technologies, Inc. Erica Kontson Product Engineer 176 Mystic Valley Parkway Winchester, Massachusetts 01890

Re: K190899

Trade/Device Name: bili-hut™ Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: August 7, 2019 Received: August 8, 2019

Dear Erica Kontson:

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

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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 (OS) 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 Alan Stevens 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) K190899

Device Name bili-hut™M

Indications for Use (Describe)

The bill-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.

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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510(k) Summary

K190899

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

I. SUBMITTER

Little Sparrows Technologies, Inc. 176 Mystic Valley Parkway Winchester, MA 01890 USA

Phone:(781) 725-2460

Contact Person: Erica Kontson Phone: (781) 725-2460 Email: erica@littlesparrowstech.com Date Summary Prepared: August 21, 2019

II. DEVICE

Trade or Proprietary Name:	bili-hut™
Common or Usual Name:	Infant phototherapy (blue light) medical device
Classification Name:	Neonatal phototherapy unit
Regulatory Class:	II
Product Code:	LBI
Regulation Number:	21 CFR 880.5700

III. PREDICATE DEVICE

510(k) Number:	K974830
Device Name and Model:	Ultra Bili Light™™ Model 2000
Manufacturer Name:	Physician Engineering Products, Inc.
Regulation Number:	21 CFR 880.5700
Classification Name:	Neonatal phototherapy unit

IV. DEVICE DESCRIPTION

The bili-hut™ is a modular, portable blue LED-based phototherapy device intended to treat neonatal hyperbilirubinemia, commonly known as infant jaundice.

The expected duration of treatment with the bili-hut™ is 48-72 hours, including interruptions for feeding, changing diapers and routine infant care as needed. The duration and method of treatment for each patient is decided by the prescribing clinician based on the baby's bilirubin levels and any other relevant medical history.

The bili-hut™ is used in the clinical or home setting.

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Components and Optional Accessorv: The bili-hut™ consists of the following components:

1. Assembled hut
- a. Shell (includes the light source blue LEDs)
- b. Base mattress
- c. Base
1. Nest components
- a. Nest
- b. Nest liner (intended patient contact)
- c. Nest mattress
- d. Nest mattress cover (intended patient contact)
1. Power supply

The bili-hut™ has an optional accessory, the perch, which is a bassinet stand insert providing a treatment surface for the device in the hospital setting with the use of a hospital grade bassinet stand.

Features: The bili-hut™ features a timer which tracks the total use of the blue LED treatment lights in hours. The timer does NOT track individual patient treatment times. The device also has an Environment High Temperature Warning (EHTW) which is triggered at 43°C (109.4°F) when the bili-hut™ is placed in extremely high environmental temperature conditions. This feature turns off the blue treatment lights and alerts the user with a yellow indicator light on top of the shell.

Principle of Operation: Phototherapy is the principle of operation for the bili-hut™; the neonate is treated with blue light to decrease bilirubin blood levels by breaking down the bilirubin so it can pass out of the neonate's body. The bili-hut™ has one mode of operation; it is selected by the user with the on/off switch. The device is powered by a 12 V medical grade power supply and utilizes an LED light array to deliver therapeutic treatment. The average irradiance exceeds the American Academy of Pediatrics (AAP) standards1 for high intensity phototherapy; an irradiance greater than 30 µW/cm²/nm. Similarly, the bili-hut™ output average peak wavelength is consistent with the AAP standard wavelength 430-490 nm. Neither the output intensity nor the output wavelength are adjustable for the billi-hut™. Like other neonatal phototherapy devices, the blue phototherapy light from the bili-hut™ converts the yellow bilirubin pigment into a form that can naturally pass through the body, thus lowering the level of bilirubin in the infant's body.

Materials: The bili-hut™ is comprised of fabric-based, plastic, metal and electronic materials. Fabric materials include nylon, vinyl, polyester, cotton, polyethylene foam,

1 American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Clinical Practice Guideline. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics 2004;114:297-316.

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hook & loop (Velcro) and polvpropylene nonwovens. Plastic materials include polycarbonate, thermal polyurethane, nylon resin, high density polyethylene (HDPE) and styrene-butadiene rubber (SBR). Metal materials include aluminum, metalized polyethylene terephthalate (PET), zinc-plated steel and nickel. Electronic materials include components from printed circuit boards (PCBs), light emitting diodes (LED) and the power supply. The intended patient contact bili-hut™ components (disposable nest cover and disposable nest mattress liner) are comprised of polypropylene nonwovens, which are expected to be in contact with the patient throughout the duration of treatment (decided upon the prescribing clinician's discretion, usually 48-72 hrs).

Patient Contact Component	Material
nest liner	polypropylene nonwoven
nest mattress cover	polypropylene nonwoven

The bili-hut™ is not to be used to treat a patient who is in an incubator or under a radiant warmer because it was not designed to be used with these two types of medical devices. Furthermore, Little Sparrows Technologies recommends that the bili-hut™ be used for patients with a birthweight of more than 2500 grams (5.5 pounds) and with a gestational age of greater than or equal to 35 weeks. However, the prescribing clinician defines the need for phototherapy with each patient.

Performance Specifications: The following are key performance specifications and features of the bili-hut™:

Output peak wavelength:463 nm .
. Average irradiance: 45 µW/cm²/nm
Effective treatment area: 170 in2 (1097 cm²) ●
Peak irradiance: 58 µW/cm²/nm ●
Cleanable with a hospital grade disinfectant ●
. Environment High Temperature Warning indicator light associated with an automatic shutoff circuit to indicate when the device is used in an environment with a temperature that is too high

V. INDICATIONS FOR USE

Indications for Use: The bili-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Ultra Bili Light™ Model 2000 (K974830) and billi-hut™ are substantially equivalent as summarized in Table 5-1.

Device	bili-hut™(K190899)	Ultra Bili Light™Model 2000 (K974830)	Discussion
Tradename	bili-hut™	Ultra Bili Light™ Model2000	N/A
510(k) Number	K190899	K974830	N/A
Manufacturer	Little SparrowsTechnologies, Inc.	Physician EngineeringProducts, Inc.	N/A
Regulation Name	Neonatal phototherapyunit	Neonatal phototherapyunit	Same
Intended Use	For treatment ofneonatalhyperbilirubinemia	For treatment ofneonatalhyperbilirubinemia	Same
Indications forUse	The bili-hut™ providesphototherapy for thetreatment of neonatalhyperbilirubinemia,commonly known asneonatal jaundice,during the newbornperiod in the clinical orhome setting.	The intended use ofthe portable Ultra BiliLight™ model 2000 isto provide HomePhototherapy treatmentfor NeonatalHyperbilirubinemia.	Similar: bothdevices areindicated fortreatment ofneonatal hyper-bilirubinemia in thehospital or homesetting using bluelight phototherapy.See SE discussion#1.
Environment ofUse	Clinical or home setting	Clinical or home setting	SameSee SE discussion#1.
Use Intent	Multi-patient withdisposables	Multi-patient withdisposables	Same
Prescription Use /Over-The-Counter Use	Prescription Use	Prescription Use	Same
Device	bili-hut™(K190899)	Ultra Bili Light™Model 2000 (K974830)	Discussion
Disposable /Reusable	Reusable device with disposable covers (nest mattress cover & nest liner) and disposable mattress	Reusable device with disposable mattress and cover	Same; bili-hut™ includes disposable covers for the patient-contact surfaces (the nest mattress cover & nest liner)
TECHNOLOGICAL CHARACTERISTICS
Principle ofOperation	Phototherapy: neonate is treated with blue light to decrease bilirubin blood levels by breaking down the bilirubin so it can pass out of the neonate's body	Phototherapy: neonate is treated with blue light to decrease bilirubin blood levels by breaking down the bilirubin so it can pass out of the neonate's body	Similar
Energy Source	Blue light LED	Blue light fluorescent	Different; both devices deliver therapeutic irradiance at an intensity average above 30 μW/cm²/nm. The use of LED treatment lights vs. fluorescent lights does not raise new questions of safety or effectiveness.See SE discussion #2.
Light SourceWavelength	430-490 nm	430-500 nm	Similar; the bili-hut™ light source is within the range recommended by the AAP (430-490 nm)
Device	bili-hut™(K190899)	Ultra Bili Light™Model 2000 (K974830)	Discussion
Averageirradiance ofintendedtreatment area	45 μW/cm²/nm	60 μW/cm²/nm	Similar; bothdevices delivertherapeuticirradiance at anintensity averageabove 30μW/cm²/nm.
Intended Patient-contactMaterial(s)	Nest mattress cover(single-use) coveringnest mattress:PolypropyleneNonwovenNest liner (single-use)covering nest:PolypropyleneNonwoven	Nonwoven spunlacedpolyester pad on top ofa vinyl covered foamcushion	Similar; bothdevices usepolyester materialand a nonwovenmaterial as theintended patient-contact material.The bili-hut™ nestmattress cover andnest liner materialswere tested forbiocompatibility.Although not anintended patient-contact material,the bili-hut™ nestmattress materialwas also tested forbiocompatibility.
FEATURES
Dimensions	16 in W (40.6 cm)25 in L (63.5 cm)12 in H (30.5 cm)	22.8 in W (58 cm)18.1 in L (46 cm)18.1 in H (46 cm)	Similar; bothdevices are built tofit into a standardcrib or hospitalgrade bassinet.
Weight	14 lbs (6.3kg) with theperch accessory and 8lbs (3.6kg) without theperch accessory	14 lb (6.5 kg)	Similar; bothdevices arelightweight enoughfor the caregiver toeasily carry andmaneuver.
Device	bili-hut™(K190899)	Ultra Bili Light™Model 2000 (K974830)	Discussion
SAFETY
MechanicalSafety	Four fasteningmechanisms ensure thedevice is redundantlysecured. The nest holdsthe newborn in placeand prevents any fallingitems from causing theshell to collapse ontothe newborn.	Built-in tray holdsnewborn. Fits insidecrib, not bassinet.BabyFace Shield oreye patches protectnewborns' eyes.Two Sidewings arelocked into place with aCrosspanel to hold thetop of the suit-case up.	Similar; bothdevices containredundantfasteningmechanisms in theevent of fasteningmechanism failure.
Thermal Safety	Device material incontact with thenewborn is non-conductive, fabric-covered foam. LEDs areout of reach of newborn(~6 in, or ~15 cm, fromnewborn's chest tointerior of shell) andthey are placed behinda plastic component.The bili-hut™ has anover temperatureshutoff circuit thatdetects the temperatureof the interior surface ofthe bili-hut™ shellwhen it is higher than43°C (109.4°F) as perClause 201.11.1.2.2 ofIEC 60601-2-50 (2009).If the circuit is triggered,it turns off the treatmentlights. Also, a yellowindicator light appearson the top of the shell; itis referred to as the"Environment HighTemperature Warning."	Heating pad undernewborn is turned on ifBaby Tray is below75°F (24°C).Thermal protectioncircuit sounds abeeper, flashes thetreatment lights andeventually turns off thetreatment lights if BabyTray is over 98°F(36.7°C).	Different; bothdevices containmeasures toprotect the infantfrom overheating inthe event that theenvironment is toowarm. The bili-hut™ does notinclude a heatingfeature.See SE discussion#3.
Device	bili-hut™™(K190899)	Ultra Bili Light™™Model 2000 (K974830)	Discussion
Visible LightRadiation Safety	Newborn's eyes will beprotected from harmfulblue light through theuse of separate eyeprotection (i.e. user-selected protective eyecovers or goggles).	The BabyFace Shield(K882291) or eyepatches protect thenewborn's eyes fromharmful blue light.	Similar; bothdevices requireexternal patient eyeprotection.
Ultraviolet LightRadiation Safety	LED light source emitsno UV light.	UV-blocking plasticsheet (UV Lens) coversfluorescent bulbs.	Different; bili-hut™™emits no UV lightwhereas predicatedevice filters outthe UV light.See SE discussion#2.
HUMAN FACTORS
Controls andindicators	• On-off switch• Hour meter (Timertracks total hours ofLED use)• High temperatureindicator light(Environment HighTemperatureWarning)	• On-off switch• Hour meter• Low/hightemperatureindicator lights• 2,000-hour bulbchange indicator	Similar; with thebili-hut™™ use ofLEDs, a "bulbchange" indicator isnot applicable.
Compatibility withenvironment	Used inside crib or onhospital cart with theperch (hospital bassinetstand insert).Also can be used on atable with approximatedimensions of 2 ft x 4 ftin the home setting.	Used inside crib or onspecialized hospitalcart	Similar; the bili-hut™™ is able to beused on varioussurfaces in thehospital and homesettings.
Device	bili-hut™(K190899)	Ultra Bili Light™Model 2000 (K974830)	Discussion
COMPLIANCE WITH STANDARDS
Electrical SafetyTesting	AAMI ES60601-1:2005 + A1, IEC 60601-1-6 Edition 3.1 2013, IEC 62366-1 Ed. 1.0 2015, IEC 60601-1-11 Edition 2.0 2015; and IEC 60601-2-50 Edition 2.1 2016	There is no publicly-available information stating the predicate device underwent electrical safety testing in compliance with the 60601-1 standard of the time. Furthermore, the 60601-2-50 standard specific for infant phototherapy equipment did not yet exist at the time the predicate device's 510(k) was submitted.	Different; the predicate device likely underwent some type of electrical safety testing and the bili-hut™ underwent electrical safety testing to current standards.See SE discussion #4.
ElectromagneticCompatibility(EMC) Testing	IEC 60601-1-2 Edition 4.0 2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests	There is no publicly-available information stating the predicate device underwent electrical safety testing in compliance with 60601-1-2 of the time (1st edition). Furthermore, the 60601-2-50 standard specific for infant phototherapy equipment did not yet exist at the time the predicate device's 510(k) was submitted.	Different; the predicate device likely underwent some type of EMC testing and the bili-hut™ underwent EMC testing to current standards.See SE discussion #4.

Table 5-1: Comparison Table, Ultra Bili Light™ Model 2000 vs. bili-hut™

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Device	bili-hut™(K190899)	Ultra Bili Light™Model 2000 (K974830)	Discussion
BiocompatibilityTesting	• Cytotoxicity (ISO10993-5:2009), MTTMethod, MEM with10% FBS Extract• Sensitization (ISO10993-10:2010),Guinea PigMaximization Test,0.9% SodiumChloride InjectionExtract• Sensitization (ISO10993-10:2010),Guinea PigMaximization Test,Cottonseed OilExtract• Skin Irritation (ISO10993-10:2010),intracutaneousinjection, 0.9%Sodium ChlorideInjection Extract• Skin Irritation (ISO10993-10:2010),intracutaneousinjection, CottonseedOil Extract	LST could not locateany publicly-availableinformation stating thepredicate deviceunderwentbiocompatibility testingto confirm the patientcontact materials werein compliance with theISO 10993 standardsof the time. However, itis reasonable toassume biocompatiblematerials were used.	Different; theSponsor assumesthat the predicatedevice isconstructed ofbiocompatiblematerials.See SE discussion#4.

SE Discussion #1 (Indications for Use / Environment of Use):

Both the bili-hut™ and Ultra Bili Light™ Model 2000 indications for use include treatment of neonatal hyperbilirubinemia. The bili-hut™ Indications for Use include treatment in the clinical and the home setting. The Ultra Bili Light™ Model 2000 Indications for Use, as per K974830's clearance letter states: "The intended use of the portable Ultra Bili Light model 2000 is to provide Home Phototherapy treatment for Neonatal Hyperbilirubinemia." Thus, upon clearance, it was used only for treatment in the home environment. However, Physician Engineered Products, Inc. used the Ultra Bili Light™ Model 2000 as the predicate device for their Bright Embrace Model SBL60 and the 510(k) summary for the Bright Embrace Model SBL60 (K110550) states the Ultra Bili Light™ Model 2000 "sites of use" include both

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the clinical and home-use settings. This difference does not raise any new or different questions of safety or effectiveness for the subject device.

SE Discussion #2 (Eneray Source: Blue Light LED vs. Blue Light Fluorescent);

The bili-hut™ uses blue LED treatment lights and the Ultra Bili Light™ Model 2000 uses a blue fluorescent light source. Both provide an average irradiance greater than 30 µW/cm²/nm. The use of LED lights does not raise any new safety or efficacy concerns compared to the use of fluorescent lights.

SE Discussion #3 (Thermal Safetv):

The Ultra Bili Light™ Model 2000 includes a heating pad that is turned on if the Baby Tray is below 75°F (24°C). The bili-hut™ does not include a warming feature because the assembled hut was designed to minimize convective heat loss from the newborn during treatment. The bili-hut™ assembled hut is not designed to act as a warmer, but it is designed to contain the heat produced by the newborn as if the newborn were swaddled.

Both devices contain measures to protect the infant from overheating. However, the bili-hut™ cut-off temperature, 43°C (109.4°F), is higher than the Ultra Bili Light™ Model 2000 cut-off temperature, 98°F (36.7°C). The bili-hut™ over-temperature (Environment High Temperature Warning) was designed to be compliant with clause 201.11.1.2.2 of IEC 60601-2-50 (2009). The first edition of IEC 60601-2-50 had not yet been published at the time of the predicate device's submission so that most likely explains the difference from the predicate device's temperature cut-off. This difference does not raise any new or different questions of safety or effectiveness for the subject device.

SE Discussion #4 (Electrical Safety Testing, Electromagnetic Compatibility (EMC) Testina) and Biocompatibilitv Testing):

The bili-hut™ has undergone electrical safety testing and EMC testing to confirm compliance with current internationally-recognized standards, all of which are FDArecognized. The bili-hut™ has undergone biocompatibility testing for the patient contact components (nest liner and nest mattress cover) in compliance with the ISO 10993 standards. Refer to Section VII for further details about the electrical safety testing, EMC testing and biocompatibility testing. This difference does not raise any new or different questions of safety or effectiveness for the subject device.

VII. PERFORMANCE DATA - NON-CLINICAL TESTING

The expected duration of treatment with the bill-hut™ is 48-72 hours. Using ISO 10993-1:2009, this Nature of Body Contact is categorized as "Surface Device / Skin" with a "B – Prolonged (> 24hrs to 30 days)" Contact Duration for all patient-contact materials. Therefore, the following biocompatibility tests were conducted on the disposable covers and nest mattress; the bili-hut™ disposable covers and nest

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mattress passed all of these tests:

Cytotoxicity (ISO 10993-5:2009), MTT Method, MEM with 10% FBS Extract; .
Sensitization (ISO 10993-10:2010), Guinea Pig Maximization Test, 0.9% . Sodium Chloride Injection Extract;
Sensitization (ISO 10993-10:2010), Guinea Pig Maximization Test, . Cottonseed Oil Extract;
Skin Irritation (ISO 10993-10:2010), intracutaneous injection, 0.9% Sodium . Chloride Injection Extract; and
Skin Irritation (ISO 10993-10:2010), intracutaneous injection, Cottonseed Oil . Extract.

Electrical safety and EMC testing were conducted to establish conformance with the following voluntary, FDA-recognized standards:

. FDA Recognition # 19-4, AAMI ES60601-1:2005 + A1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance,
FDA Recognition # 5-89, IEC 60601-1-6 Edition 3.1 2013 Medical electrical . equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability,
FDA Recognition # 5-114, IEC 62366-1 Ed. 1.0 2015 Medical devices Part . 1: Application of usability engineering to medical devices,
FDA Recognition # 19-14, IEC 60601-1-11 Edition 2.0 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,
. FDA Recognition # 6-387, IEC 60601-2-50 Edition 2.1 2016 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]; and
FDA Recognition # 19-8, IEC 60601-1-2 Edition 4.0 2014 Medical electrical . equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.

Bench performance tests including testing for device power, electrical safety, performance of indicators, LED performance, system irradiance, system light intensity, accelerated lifetime and human factors/usability were completed to verify that the bili-hut™ met its device requirements and specifications and to support the substantial equivalence of the bili-hut™ to the predicate device Ultra Bili Light™ Model 2000.

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VIII. PERFORMANCE DATA - CLINICAL TESTING

No clinical data were submitted to support the substantial equivalence of the bilihut™ to the predicate device Ultra Bili Light™ Model 2000.

IX. CONCLUSIONS

Based on device characteristics compared in Table 5-1 and the results of Little Sparrows Technologies' performance testing demonstrate that the bili-hut™ is substantially equivalent to the predicate device Ultra Bili Light™ Model 2000.

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).