bili-hut

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | <div> <span> <svg height="16" width="16"> <polygon points="0,0 0,16 16,16 16,0" style="fill:lightgray;stroke:black;stroke-width:1"></polygon> <polyline points="2,8 6,12 14,4" style="fill:none;stroke:black;stroke-width:2"></polyline> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg height="16" width="16"> <polygon points="0,0 0,16 16,16 16,0" style="fill:white;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ # 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. {4}------------------------------------------------ ### 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 - 2. Nest components - a. Nest - b. Nest liner (intended patient contact) - c. Nest mattress - d. Nest mattress cover (intended patient contact) - 3. 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ ### 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™<br>(K190899) | Ultra Bili Light™<br>Model 2000 (K974830) | Discussion | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tradename | bili-hut™ | Ultra Bili Light™ Model<br>2000 | N/A | | 510(k) Number | K190899 | K974830 | N/A | | Manufacturer | Little Sparrows<br>Technologies, Inc. | Physician Engineering<br>Products, Inc. | N/A | | Regulation Name | Neonatal phototherapy<br>unit | Neonatal phototherapy<br>unit | Same | | Intended Use | For treatment of<br>neonatal<br>hyperbilirubinemia | For treatment of<br>neonatal<br>hyperbilirubinemia | Same | | Indications for<br>Use | The bili-hut™ provides<br>phototherapy for the<br>treatment of neonatal<br>hyperbilirubinemia,<br>commonly known as<br>neonatal jaundice,<br>during the newborn<br>period in the clinical or<br>home setting. | The intended use of<br>the portable Ultra Bili<br>Light™ model 2000 is<br>to provide Home<br>Phototherapy treatment<br>for Neonatal<br>Hyperbilirubinemia. | Similar: both<br>devices are<br>indicated for<br>treatment of<br>neonatal hyper-<br>bilirubinemia in the<br>hospital or home<br>setting using blue<br>light phototherapy.<br>See SE discussion<br>#1. | | Environment of<br>Use | Clinical or home setting | Clinical or home setting | Same<br>See SE discussion<br>#1. | | Use Intent | Multi-patient with<br>disposables | Multi-patient with<br>disposables | Same | | Prescription Use /<br>Over-The-<br>Counter Use | Prescription Use | Prescription Use | Same | | Device | bili-hut™<br>(K190899) | Ultra Bili Light™<br>Model 2000 (K974830) | Discussion | | Disposable /<br>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 of<br>Operation | 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.<br>See SE discussion #2. | | Light Source<br>Wavelength | 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™<br>(K190899) | Ultra Bili Light™<br>Model 2000 (K974830) | Discussion | | Average<br>irradiance of<br>intended<br>treatment area | 45 μW/cm²/nm | 60 μW/cm²/nm | Similar; both<br>devices deliver<br>therapeutic<br>irradiance at an<br>intensity average<br>above 30<br>μW/cm²/nm. | | Intended Patient-<br>contact<br>Material(s) | Nest mattress cover<br>(single-use) covering<br>nest mattress:<br>Polypropylene<br>Nonwoven<br>Nest liner (single-use)<br>covering nest:<br>Polypropylene<br>Nonwoven | Nonwoven spunlaced<br>polyester pad on top of<br>a vinyl covered foam<br>cushion | Similar; both<br>devices use<br>polyester material<br>and a nonwoven<br>material as the<br>intended patient-<br>contact material.<br>The bili-hut™ nest<br>mattress cover and<br>nest liner materials<br>were tested for<br>biocompatibility.<br>Although not an<br>intended patient-<br>contact material,<br>the bili-hut™ nest<br>mattress material<br>was also tested for<br>biocompatibility. | | FEATURES | | | | | Dimensions | 16 in W (40.6 cm)<br>25 in L (63.5 cm)<br>12 in H (30.5 cm) | 22.8 in W (58 cm)<br>18.1 in L (46 cm)<br>18.1 in H (46 cm) | Similar; both<br>devices are built to<br>fit into a standard<br>crib or hospital<br>grade bassinet. | | Weight | 14 lbs (6.3kg) with the<br>perch accessory and 8<br>lbs (3.6kg) without the<br>perch accessory | 14 lb (6.5 kg) | Similar; both<br>devices are<br>lightweight enough<br>for the caregiver to<br>easily carry and<br>maneuver. | | Device | bili-hut™<br>(K190899) | Ultra Bili Light™<br>Model 2000 (K974830) | Discussion | | SAFETY | | | | | Mechanical<br>Safety | Four fastening<br>mechanisms ensure the<br>device is redundantly<br>secured. The nest holds<br>the newborn in place<br>and prevents any falling<br>items from causing the<br>shell to collapse onto<br>the newborn. | Built-in tray holds<br>newborn. Fits inside<br>crib, not bassinet.<br><i>BabyFace Shield</i> or<br>eye patches protect<br>newborns' eyes.<br>Two Sidewings are<br>locked into place with a<br>Crosspanel to hold the<br>top of the suit-case up. | Similar; both<br>devices contain<br>redundant<br>fastening<br>mechanisms in the<br>event of fastening<br>mechanism failure. | | Thermal Safety | Device material in<br>contact with the<br>newborn is non-<br>conductive, fabric-<br>covered foam. LEDs are<br>out of reach of newborn<br>(~6 in, or ~15 cm, from<br>newborn's chest to<br>interior of shell) and<br>they are placed behind<br>a plastic component.<br>The bili-hut™ has an<br>over temperature<br>shutoff circuit that<br>detects the temperature<br>of the interior surface of<br>the bili-hut™ shell<br>when it is higher than<br>43°C (109.4°F) as per<br>Clause 201.11.1.2.2 of<br>IEC 60601-2-50 (2009).<br>If the circuit is triggered,<br>it turns off the treatment<br>lights. Also, a yellow<br>indicator light appears<br>on the top of the shell; it<br>is referred to as the<br>"Environment High<br>Temperature Warning." | Heating pad under<br>newborn is turned on if<br>Baby Tray is below<br>75°F (24°C).<br>Thermal protection<br>circuit sounds a<br>beeper, flashes the<br>treatment lights and<br>eventually turns off the<br>treatment lights if Baby<br>Tray is over 98°F<br>(36.7°C). | Different; both<br>devices contain<br>measures to<br>protect the infant<br>from overheating in<br>the event that the<br>environment is too<br>warm. The <b>bili-hut™</b> does not<br>include a heating<br>feature.<br>See SE discussion<br>#3. | | Device | bili-hut™™<br>(K190899) | Ultra Bili Light™™<br>Model 2000 (K974830) | Discussion | | Visible Light<br>Radiation Safety | Newborn's eyes will be<br>protected from harmful<br>blue light through the<br>use of separate eye<br>protection (i.e. user-<br>selected protective eye<br>covers or goggles). | The BabyFace Shield<br>(K882291) or eye<br>patches protect the<br>newborn's eyes from<br>harmful blue light. | Similar; both<br>devices require<br>external patient eye<br>protection. | | Ultraviolet Light<br>Radiation Safety | LED light source emits<br>no UV light. | UV-blocking plastic<br>sheet (UV Lens) covers<br>fluorescent bulbs. | Different; bili-hut™™<br>emits no UV light<br>whereas predicate<br>device filters out<br>the UV light.<br>See SE discussion<br>#2. | | HUMAN FACTORS | | | | | Controls and<br>indicators | • On-off switch<br>• Hour meter (Timer<br>tracks total hours of<br>LED use)<br>• High temperature<br>indicator light<br>(Environment High<br>Temperature<br>Warning) | • On-off switch<br>• Hour meter<br>• Low/high<br>temperature<br>indicator lights<br>• 2,000-hour bulb<br>change indicator | Similar; with the<br>bili-hut™™ use of<br>LEDs, a "bulb<br>change" indicator is<br>not applicable. | | Compatibility with<br>environment | Used inside crib or on<br>hospital cart with the<br>perch (hospital bassinet<br>stand insert).<br>Also can be used on a<br>table with approximate<br>dimensions of 2 ft x 4 ft<br>in the home setting. | Used inside crib or on<br>specialized hospital<br>cart | Similar; the bili-<br>hut™™ is able to be<br>used on various<br>surfaces in the<br>hospital and home<br>settings. | | Device | bili-hut™<br>(K190899) | Ultra Bili Light™<br>Model 2000 (K974830) | Discussion | | COMPLIANCE WITH STANDARDS | | | | | Electrical Safety<br>Testing | 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.<br>See SE discussion #4. | | Electromagnetic<br>Compatibility<br>(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.<br>See SE discussion #4. | ## Table 5-1: Comparison Table, Ultra Bili Light™ Model 2000 vs. bili-hut™ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ | Device | bili-hut™<br>(K190899) | Ultra Bili Light™<br>Model 2000 (K974830) | Discussion | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility<br>Testing | • Cytotoxicity (ISO<br>10993-5:2009), MTT<br>Method, MEM with<br>10% FBS Extract<br>• Sensitization (ISO<br>10993-10:2010),<br>Guinea Pig<br>Maximization Test,<br>0.9% Sodium<br>Chloride Injection<br>Extract<br>• Sensitization (ISO<br>10993-10:2010),<br>Guinea Pig<br>Maximization Test,<br>Cottonseed Oil<br>Extract<br>• Skin Irritation (ISO<br>10993-10:2010),<br>intracutaneous<br>injection, 0.9%<br>Sodium Chloride<br>Injection Extract<br>• Skin Irritation (ISO<br>10993-10:2010),<br>intracutaneous<br>injection, Cottonseed<br>Oil Extract | LST could not locate<br>any publicly-available<br>information stating the<br>predicate device<br>underwent<br>biocompatibility testing<br>to confirm the patient<br>contact materials were<br>in compliance with the<br>ISO 10993 standards<br>of the time. However, it<br>is reasonable to<br>assume biocompatible<br>materials were used. | Different; the<br>Sponsor assumes<br>that the predicate<br>device is<br>constructed of<br>biocompatible<br>materials.<br>See SE discussion<br>#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 {13}------------------------------------------------ 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 {14}------------------------------------------------ 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. {15}------------------------------------------------ ### 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.