Neonatal Phototherapy System

K200031 · Avalon Biomedical (Shenzhen) Limited · LBI · Oct 5, 2020 · General Hospital

Device Facts

• Record ID: K200031
• Device Name: Neonatal Phototherapy System
• Applicant: Avalon Biomedical (Shenzhen) Limited
• Product Code: LBI · General Hospital
• Decision Date: Oct 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.

Device Story

Wearable phototherapy system for neonatal hyperbilirubinemia; treats neonates in clinical or home settings. System comprises light source, fiber optic panels, swaddle, strap, and disposable covers. Light source emits narrow-band blue LED light (400-500 nm, peak 455±10 nm) transmitted via fiber optic bundle to panels. Bilirubin absorbs blue light, converting to water-soluble waste products for excretion. Device allows kangaroo care; no eye protection required. Healthcare provider prescribes therapy; device operated by clinicians or parents. Output is fixed-intensity blue light; irradiance >30 µW/cm²/nm. Benefits include effective bilirubin reduction and potential for home-based treatment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and phototherapy performance (IEC 60601-2-50).

Technological Characteristics

Materials: 100% cotton (swaddle), non-woven polypropylene (disposable cover), TPU (fiber optic panels). Energy: Blue LED (400-500 nm, peak 455±10 nm). Power: 100-240 VAC to 15 VDC adapter. Connectivity: Standalone. IP22 rated. Standards: ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50, IEC 60601-1-11.

Indications for Use

Indicated for treatment of unconjugated hyperbilirubinemia in neonates with gestational age ≥38 weeks and weight 2500-4500 grams. Contraindicated in cases of congenital porphyria, family history of porphyria, or concomitant use of photosensitizing drugs/agents.

Regulatory Classification

Identification

A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.

Predicate Devices

• Bili-Tx (K070180)

Submission Summary (Full Text)

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October 5, 2020

Avalon Biomedical (Shenzhen) Limited Eva Zhu Regulatory Affairs Manager 805 Building 4, Yinxing Zhije, 1301-74, GuanGuang Road, XinLan Community Shenzhen, 518110 China

Re: K200031

Trade/Device Name: Neonatal Phototherapy System, Model: KANGALITE Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: August 31, 2020 Received: September 3, 2020

Dear Eva Zhu:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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

Enclosure

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# Indications for Use

510(k) Number (if known) K200031

Device Name

Neonatal Phototherapy System, Model: KANGALITE

Indications for Use (Describe)

The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.

Contraindication

The Neonatal Phototherapy System, Model: KANGALITE should NOT be used in cases of:

(a) Congenital porphyria or a family history of porphyria

(b) Concomitant use of drugs or agents that are photosensitizers

A use that does not take into account these contraindications may lead to an ineffective treatment or to potential risks to the patient's health.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

# K200031

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

## Date: October 5, 2020

#### 1. Submitter:

Submitter: Avalon Biomedical (Shenzhen) Limited Address: 805, Building 4, Yinxing Zhijie, 1301-74, GuanGuang Road, XinLan Community, GuanLan Street, Longhua District, 518110, Shenzhen, China Contact Person: Eva Zhu, Regulatory Affairs Manager Phone: [phone] Email: [e-mail]

#### 2. De vice Name

Trade or Proprietary Name: Neonatal Phototherapy System, KANGALITE™ Common or Usual Name: Neonatal Phototherapy System Classification Name: Neonatal phototherapy unit

Device Class: II Product Code: LBI Panel: General Hospital Regulation Number: 21 CFR 880.5700

#### 3. Predicate Device:

510(k) Number: K070180 Device Name and Model: Bili-Tx Manufacturer Name: Respironics Inc.

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Image /page/4/Picture/1 description: The image shows the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, and the words "AVALON" and "BIOMEDICAL" on the right. The word "AVALON" is in a larger, bolder font than the word "BIOMEDICAL". The color of the text is also blue.

## 4. Indications for Use:

The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.

#### Contraindication

The Neonatal Phototherapy System, Model: KANGALITE should NOT be used in cases of:

(a) Congenital porphyria or a family history of porphyria

(b) Concomitant use of drugs or agents that are photosensitizers

A use that does not take into account these contraindications may lead to an ineffective treatment or to potential risks to the patient's health.

#### 5. Device Description:

The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia.

The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy.

The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up.

The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined

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as in the American Academy of Pediatrics (AAP) standard.

Average irradiance for:

Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%);

Single Fiber Optic Panel: 60 uW/cm2/nm (±25%).

The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation.

The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.

Environment:

Operating temperature/humidity: 59 to 95 °F (15 to 35 °C)/15 to 95 % RH, non-condensing Storage temperature/humidity: -4 to 122 °F (-20 to 50 °C) /15 to 95 %RH, non-condensing Atmospheric pressure: 700-1060 hPa

#### 6. Comparison of technological characteristics with the predicate de vice

#### Comparison Table

| Device name | Subject device<br>Neonatal Phototherapy System<br>Model: KANGALITE<br>K200031 | Predicate device<br>Bili-Tx<br>K070180 | Comparison |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Manufacturer | Avalon Biomedical (Shenzhen)<br>Limited | Respironics Inc. | N/A |
| Regulation No. | 880.5700 | 880.5700 | same |
| Product Code | LBI | LBI | same |
| Classification | II | II | same |
| Device name | Subject device<br>Neonatal Phototherapy System<br>Model: KANGALITE<br>K200031 | Predicate device<br>Bili-Tx<br>K070180 | Comparison |
| Indications for<br>use | The Neonatal Phototherapy<br>System, Model: KANGALITE is<br>intended for the treatment of<br>unconjugated hyperbilirubinemia<br>in the population of neonates:<br>gestational age ≥38 weeks and<br>weight within 2500-4500 grams. It<br>can be used in the clinical setting<br>or in the home environment. It<br>should be used for neonates whom<br>phototherapy has been prescribed.<br>Contraindication<br>The Neonatal Phototherapy<br>System, Model: KANGALITE<br>should NOT be used in cases of:<br>(a) Congenital porphyria or a<br>family history of porphyria<br>(b) Concomitant use of drugs or<br>agents that are photosensitizers<br>A use that does not take into<br>account these contraindications<br>may lead to an ineffective<br>treatment or to potential risks to<br>the patient's health. | The Bili-Tx is intended to<br>treat hyperbilirubinemia<br>through phototherapy in a<br>home<br>Or<br>hospital/institutional<br>environment. | Different<br>See comment 1 |
| Contraindications | 1. Congenital porphyria or a family<br>history of porphyria<br>2. Concomitant use of drugs or<br>agents that are<br>photosensitizers | There is no publicly-<br>available information. | Different<br>See comment 1 |
| | Subject device<br>Neonatal Phototherapy System | Predicate device | |
| Device name | Model: KANGALITE | Bili-Tx | Comparison |
| | K200031 | K070180 | |
| | KANGALITE treats neonatal<br>hyperbilirubinemia via blue light<br>phototherapy. The device delivers<br>a narrow band of high-intensity<br>blue light via a blue light<br>emitting diode (LED). Under<br>blue light irradiation,<br>subcutaneous bilirubin absorbs<br>strongly in the blue region of the<br>light spectrum and converts into<br>less lipophilic waste products<br>which can be excreted through the<br>bile or urine without the need for<br>conjugation. | The Bili-Tx phototherapy<br>systemuses blue light<br>emitting diodes (LEDs) to<br>convert bilirubin to waste<br>products that are mostly<br>excreted through urine<br>and stool, thus reducing<br>the bilirubin level in the<br>baby's blood. | |
| Principle of<br>operation | | | Same |
| | 1. Swaddle, the material in contact<br>with patient's body skin is made<br>of 100% cotton<br>2. Disposable Cover, the material<br>in contact with patient's chest and<br>back skin is made of non-woven<br>polypropylene<br>3. Dual Fiber Optic Panels, the<br>material in contact with patient's<br>chest and back skin is made of<br>TPU<br>4. Single Fiber Optic Panel, the<br>material in contact with patient's<br>back skin is made of TPU | There is no publicly-<br>available information. | |
| Patient contact<br>materials<br>(Patient is in supine<br>position) | | | Different<br>See comment 2 |
| Targeted<br>population | Neonates: gestational age ≥38 weeks<br>and weight within 2500-4500 grams. | Neonates | Different<br>See comment 3 |
| Prescription Use | Yes | Yes | Same |
| Over-The-Counter<br>Use | No | No | Same |
| Device name | Subject device<br>Neonatal Phototherapy System<br>Model: KANGALITE<br>K200031 | Predicate device<br>Bili-Tx<br>K070180 | Comparison |
| Site of use | In the clinical setting or in the<br>home | In the clinical setting or in<br>the home | Same |
| Treatment mode | Use with Fiber Optic Panel | Two different modes<br>1) Use with Fiber Optic<br>Panel<br>2) Overhead treatment | Different<br>See comment 4 |
| Device Components | 1. Light Source (with AC power<br>cord)<br>2. Dual Fiber Optic Panels<br>(Standard accessory) / Single Fiber<br>Optic Panel (optional accessory)<br>3. Swaddle (One size)<br>4. Shoulder Strap<br>5. Table Mounting Clip (optional<br>accessory)<br>6. Disposable Cover × 2 (single-<br>use) | With Fiber Optic Panel:<br>1. Illuminator device with<br>AC power cord<br>2. Fiber Optic Panel<br>3. Disposable Cover<br>4. Illuminator device<br>carrying case (optional)<br>5. System Carrying Case<br>(optional)<br>Other components from<br>overhead phototherapy<br>6. Mounting brace<br>7. Circuit support arm<br>8. Circuit support adaptor | Similar<br>See comment 5 |
| Eye protection for<br>the baby is<br>required during<br>treatment | No | No | Same |
| If Eye Shield<br>includes in the<br>accessories list | No | No | Same |
| TECHNOLOGICAL FEATURES | | | |
| Device name | Subject device<br>Neonatal Phototherapy System<br>Model: KANGALITE<br>K200031 | Predicate device<br>Bili-Tx<br>K070180 | Comparison |
| Light Source | Single blue LED | Uses blue light emitting<br>diodes (LEDs) | Similar<br>See comment 6 |
| Treatment<br>Wavelength | Blue LED: 400-500 nm<br>Peak: 455 ± 10 nm | Blue LEDs emit light in<br>the range of 400–550 nm<br>(peak wavelength 450–<br>470 nm). | Similar<br>See comment 6 |
| Light Intensity<br>(Irradiance) | Dual Fiber Optic Panel irradiance<br>level:<br>$50 \mu W/cm^2/nm(\pm 25\%)$<br>Single Fiber Optic Panel<br>irradiance level:<br>$60 \mu W/cm^2/nm(\pm 25\%)$ | Standard Panel-Light:<br>$30 \mu W/cm^2/nm$<br>Neonatal Panel-Light:<br>$55 \mu W/cm^2/nm$<br>Overhead Therapy: When<br>the illuminator is<br>positioned 30 cm (12<br>inches) above the<br>neonate: $30 \mu W/cm^2/nm$ | Similar<br>See comment 6 |
| Expected LED life | Nominal lifetime: >45000 hours | Minimum<br>lifetime<br>of<br>30,000 hours | Different<br>See comment 7 |
| Connection of the<br>Fiber optic bundle<br>to Light Source | Direct insert with a "click" sound | Insert and rotate a quarter<br>turn | Different<br>See comment 8 |
| Power Supply to<br>Light Box | AC Power: 100-240 VAC, 50/60<br>Hz, 1.0-0.5 A | AC Power:<br>100-240<br>VAC, 50/60 Hz, 1.0 A | Same |
| Timer | Yes | Yes | Same |
| LIGHT BOX/ LIGHT SOURCE | | | |
| Light box<br>dimensions | 7.5 cm × 7.7 cm × 15.9 cm (Light<br>Source) | 16.10 cm × 7.40 cm<br>(Illuminator) | Similar<br>See Comment 9 |
| Device name | Subject device<br>Neonatal Phototherapy System<br>Model: KANGALITE<br>K200031 | Predicate device<br>Bili-Tx<br>K070180 | Comparison |
| Weight | < 1.5 kg | < 2.50 lb (1. 3 kg) | |
| FIBER OPTIC PANEL AND SWADDLES | | | |
| Fiber optic panel<br>Dimensions and<br>effective treatment<br>area according to<br>IEC<br>60601-2-50 | Dual Fiber Optic Panels :<br>size of effective illuminated area:<br>16.0 cm × 12.0 cm × 2<br>= 384 cm²<br><br>Single Fiber Optic Panel:<br>size of effective illuminated area:<br>16.0 cm × 12.0 cm<br>= 192 cm² | Model: EG-2000N (Flat<br>Neonatal Panel)<br>Overall<br>Pad<br>Size-<br>Neonatal: 5.00"× 7.00"<br>(12.70 cm × 17.78 cm)<br>Illuminated<br>Area-<br>Neonatal: 4.00" × 6.00"<br>(10.16 cm×15.24 cm) =<br>155 cm²<br><br>Model: EG-2000 (Wrap<br>Around Panel)<br>Overall<br>Pad<br>Size-<br>Standard: 4.00" × 15.00"<br>(10.16 cm × 38.10 cm)<br>Illuminated<br>Area-<br>Standard: 3.00" × 14.00"<br>(7.62 cm × 35.56 cm) =<br>271 cm² | Similar<br>See Comment 10 |
| Swaddle | 100% cotton | N/A | Different<br>See comment 11 |
| PAD TREATMENT AREA | | | |
| Panel material with<br>direct contact to<br>patient | TPU | TPU | Same |
| Use Intent | Multiple patients | Multiple patients | Same |
| NOISE | | | |
| Noise | < 60 dB(A) | < 60 dB (A) | Same |
| Device name | Subject device<br>Neonatal Phototherapy System<br>Model: KANGALITE<br>K200031 | Predicate device<br>Bili-Tx<br>K070180 | Comparison |
| STANDARDS COMPILED | | | |
| Biocompatibility<br>test | Biocompatibility tests performed<br>per ISO 10993 for patient<br>contacting materials (Disposable<br>cover and Swaddle). Both the<br>Disposable cover and Swaddle are<br>considered a skin-contacting<br>device with prolonged exposure.<br>Cytotoxicity per ISO 10993-5<br>Intracutaneous irritation study per<br>ISO 10993-10<br>Sensitization per ISO 10993-10 | There is no publicly-<br>available information. | Different<br>See comment 12 |
| Electrical safety<br>tests | IEC 60601-1 Generalrequirements<br>for basic safety and essential<br>performance | IEC 60601-1 General<br>Requirements for Safety<br>of Medical Electrical<br>Equipment | Same |
| Electromagnetic<br>Compatibility tests<br>(EMI/EMC) | Electromagnetic Compatibility<br>tests (EMI/EMC) performed per<br>IEC 60601-1-2 (4th edition)…