(272 days)
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.
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 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.
The provided text describes a 510(k) premarket notification for a medical device, the Neonatal Phototherapy System, Model: KANGALITE. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/device.
Therefore, many of the requested details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI models or new clinical devices, are not explicitly provided in this 510(k) submission.
Here's a breakdown of what can be inferred or stated based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit acceptance criteria with numerical performance targets typical for clinical efficacy studies (e.g., sensitivity, specificity, or improvement in bilirubin levels). Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to a previously cleared predicate device (Bili-Tx, K070180) through various non-clinical tests and comparisons of technological characteristics.
The "reported device performance" is largely qualitative, asserting that the device meets relevant safety and performance standards established for such phototherapy systems.
Here's what can be extracted regarding performance and comparison:
| Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance (KANGALITE) |
|---|---|---|
| Intended Use | Treatment of hyperbilirubinemia in neonates (Bili-Tx) | Treatment of unconjugated hyperbilirubinemia in neonates: gestational age ≥38 weeks and weight within 2500-4500 grams |
| Principle of Operation | Blue light phototherapy converting bilirubin to excretable products (Bili-Tx) | KANGALITE uses blue light LEDs (400-500 nm, peak 455±10 nm) for bilirubin conversion |
| Light Intensity (Irradiance) | Standard Panel-Light: 30 µW/cm²/nm; Neonatal Panel-Light: 55 µW/cm²/nm; Overhead Therapy: 30 µW/cm²/nm (Bili-Tx) | Dual Fiber Optic Panels: 50 µW/cm²/nm (±25%); Single Fiber Optic Panel: 60 µW/cm²/nm (±25%). Meets AAP intensive phototherapy standard (>30 µW/cm²/nm). |
| Wavelength | Blue LEDs: 400–550 nm (peak 450–470 nm) (Bili-Tx) | Blue LED: 400-500 nm (peak: 455 ± 10 nm) |
| LED Lifetime | Minimum lifetime of 30,000 hours (Bili-Tx) | Nominal lifetime: >45,000 hours |
| Biocompatibility | Not publicly available for predicate (Bili-Tx) | Passed ISO 10993 for Cytotoxicity, Sensitization, Skin Irritation for patient-contact materials (disposable covers, Swaddle). |
| Electrical Safety | Conforms to IEC 60601-1 (Bili-Tx) | Conforms to ES60601-1 and related amendments. |
| Electromagnetic Compatibility (EMC) | Conforms to EN 60601-1-2 (2nd edition) (Bili-Tx) | Conforms to IEC 60601-1-2 (4th edition) |
| Phototherapy Safety/Performance | Conforms to IEC 60601-2-50 (Bili-Tx) | Conforms to IEC 60601-2-50. |
| Home Use Safety | Intended for home/hospital use (Bili-Tx) | Conforms to IEC 60601-1-11 for home healthcare environment. |
| Water Ingress Protection (Light Source) | IPX0 (Bili-Tx) | IP22 (KANGALITE), fulfills IEC 60601-1-11 requirement for home use. |
| Noise | < 60 dB(A) (Bili-Tx) | < 60 dB(A) |
The acceptance criteria are implicitly met if the KANGALITE device demonstrates equivalent or superior performance based on these technical specifications and safety standards, and if any differences do not raise new questions of safety or effectiveness.
2. Sample Sizes Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical data used for performance claims typical for AI-based devices or new therapeutic modalities. The testing described is primarily non-clinical bench testing (e.g., electrical safety, EMC, biocompatibility, light performance).
- Test Set Sample Size: N/A (no clinical test set)
- Data Provenance: Not applicable for clinical study data. The non-clinical tests were performed to established medical device standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: N/A (no clinical test set requiring expert ground truth)
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A (no clinical test set with human adjudication)
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:
- MRMC Study: No. This device is a phototherapy system, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The device's performance is "standalone" in the sense that it delivers phototherapy directly, and its performance is validated through bench testing against established standards for its physical and functional characteristics.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by adherence to recognized international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and phototherapy equipment), and the device's measured performance against the specifications deemed safe and effective for its intended use and equivalent to the predicate.
8. The Sample Size for the Training Set:
- Training Set Sample Size: N/A (no clinical data training for an AI model as this is not an AI device).
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: N/A (Not an AI device using a training set).
Summary of the Study:
The "study" presented in this 510(k) notification is primarily a bench testing and comparative analysis rather than a clinical trial or AI model validation study. Its purpose is to demonstrate that the Neonatal Phototherapy System, Model: KANGALITE, is substantially equivalent in terms of safety and effectiveness to a legally marketed predicate device (Bili-Tx, K070180). This is achieved by showing that:
- The new device has the same intended use as the predicate device (though with a slightly more specific target population and additional contraindications explicitly stated, which are considered to not raise new safety concerns).
- The technological characteristics are sufficiently similar. Where differences exist, the submission explains why these differences do not raise new questions of safety or effectiveness (e.g., longer LED lifetime, different connection mechanism, higher IP rating for home use, larger illuminated area).
- The device conforms to relevant electrical safety, EMC, biocompatibility, and phototherapy equipment standards through detailed non-clinical bench testing.
Conclusion from the document: "Based on the performance testing, comparison, and risk analysis in this submission, the subject device Neonatal Phototherapy System, Model: KANGALITE is substantially equivalent to the predicate device K070180."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and 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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Image /page/3/Picture/1 description: The image shows the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, followed by the word "AVALON" in a larger, bold, blue font. Below "AVALON" is the word "BIOMEDICAL" in a smaller, lighter blue font. The logo is simple and modern, and the use of blue suggests a sense of trust and reliability.
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: +86 755 2107 0534 Email: zhul@avalonbiomedical.com
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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Image /page/5/Picture/1 description: The image contains the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, followed by the word "AVALON" in large, bold, blue letters. Below "AVALON" is the word "BIOMEDICAL" in smaller, lighter blue letters.
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 deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
|---|---|---|---|
| Manufacturer | Avalon Biomedical (Shenzhen)Limited | Respironics Inc. | N/A |
| Regulation No. | 880.5700 | 880.5700 | same |
| Product Code | LBI | LBI | same |
| Classification | II | II | same |
| Device name | Subject deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
| Indications foruse | The Neonatal PhototherapySystem, Model: KANGALITE isintended for the treatment ofunconjugated hyperbilirubinemiain the population of neonates:gestational age ≥38 weeks andweight within 2500-4500 grams. Itcan be used in the clinical settingor in the home environment. Itshould be used for neonates whomphototherapy has been prescribed.ContraindicationThe Neonatal PhototherapySystem, Model: KANGALITEshould NOT be used in cases of:(a) Congenital porphyria or afamily history of porphyria(b) Concomitant use of drugs oragents that are photosensitizersA use that does not take intoaccount these contraindicationsmay lead to an ineffectivetreatment or to potential risks tothe patient's health. | The Bili-Tx is intended totreat hyperbilirubinemiathrough phototherapy in ahomeOrhospital/institutionalenvironment. | DifferentSee comment 1 |
| Contraindications | 1. Congenital porphyria or a familyhistory of porphyria2. Concomitant use of drugs oragents that arephotosensitizers | There is no publicly-available information. | DifferentSee comment 1 |
| Subject deviceNeonatal Phototherapy System | Predicate device | ||
| Device name | Model: KANGALITE | Bili-Tx | Comparison |
| K200031 | K070180 | ||
| KANGALITE treats neonatalhyperbilirubinemia via blue lightphototherapy. The device deliversa narrow band of high-intensityblue light via a blue lightemitting diode (LED). Underblue light irradiation,subcutaneous bilirubin absorbsstrongly in the blue region of thelight spectrum and converts intoless lipophilic waste productswhich can be excreted through thebile or urine without the need forconjugation. | The Bili-Tx phototherapysystemuses blue lightemitting diodes (LEDs) toconvert bilirubin to wasteproducts that are mostlyexcreted through urineand stool, thus reducingthe bilirubin level in thebaby's blood. | ||
| Principle ofoperation | Same | ||
| 1. Swaddle, the material in contactwith patient's body skin is madeof 100% cotton2. Disposable Cover, the materialin contact with patient's chest andback skin is made of non-wovenpolypropylene3. Dual Fiber Optic Panels, thematerial in contact with patient'schest and back skin is made ofTPU4. Single Fiber Optic Panel, thematerial in contact with patient'sback skin is made of TPU | There is no publicly-available information. | ||
| Patient contactmaterials(Patient is in supineposition) | DifferentSee comment 2 | ||
| Targetedpopulation | Neonates: gestational age ≥38 weeksand weight within 2500-4500 grams. | Neonates | DifferentSee comment 3 |
| Prescription Use | Yes | Yes | Same |
| Over-The-CounterUse | No | No | Same |
| Device name | Subject deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
| Site of use | In the clinical setting or in thehome | In the clinical setting or inthe home | Same |
| Treatment mode | Use with Fiber Optic Panel | Two different modes1) Use with Fiber OpticPanel2) Overhead treatment | DifferentSee comment 4 |
| Device Components | 1. Light Source (with AC powercord)2. Dual Fiber Optic Panels(Standard accessory) / Single FiberOptic Panel (optional accessory)3. Swaddle (One size)4. Shoulder Strap5. Table Mounting Clip (optionalaccessory)6. Disposable Cover × 2 (single-use) | With Fiber Optic Panel:1. Illuminator device withAC power cord2. Fiber Optic Panel3. Disposable Cover4. Illuminator devicecarrying case (optional)5. System Carrying Case(optional)Other components fromoverhead phototherapy6. Mounting brace7. Circuit support arm8. Circuit support adaptor | SimilarSee comment 5 |
| Eye protection forthe baby isrequired duringtreatment | No | No | Same |
| If Eye Shieldincludes in theaccessories list | No | No | Same |
| TECHNOLOGICAL FEATURES | |||
| Device name | Subject deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
| Light Source | Single blue LED | Uses blue light emittingdiodes (LEDs) | SimilarSee comment 6 |
| TreatmentWavelength | Blue LED: 400-500 nmPeak: 455 ± 10 nm | Blue LEDs emit light inthe range of 400–550 nm(peak wavelength 450–470 nm). | SimilarSee comment 6 |
| Light Intensity(Irradiance) | Dual Fiber Optic Panel irradiancelevel:$50 \mu W/cm^2/nm(\pm 25%)$Single Fiber Optic Panelirradiance level:$60 \mu W/cm^2/nm(\pm 25%)$ | Standard Panel-Light:$30 \mu W/cm^2/nm$Neonatal Panel-Light:$55 \mu W/cm^2/nm$Overhead Therapy: Whenthe illuminator ispositioned 30 cm (12inches) above theneonate: $30 \mu W/cm^2/nm$ | SimilarSee comment 6 |
| Expected LED life | Nominal lifetime: >45000 hours | Minimumlifetimeof30,000 hours | DifferentSee comment 7 |
| Connection of theFiber optic bundleto Light Source | Direct insert with a "click" sound | Insert and rotate a quarterturn | DifferentSee comment 8 |
| Power Supply toLight Box | AC Power: 100-240 VAC, 50/60Hz, 1.0-0.5 A | AC Power:100-240VAC, 50/60 Hz, 1.0 A | Same |
| Timer | Yes | Yes | Same |
| LIGHT BOX/ LIGHT SOURCE | |||
| Light boxdimensions | 7.5 cm × 7.7 cm × 15.9 cm (LightSource) | 16.10 cm × 7.40 cm(Illuminator) | SimilarSee Comment 9 |
| Device name | Subject deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
| Weight | < 1.5 kg | < 2.50 lb (1. 3 kg) | |
| FIBER OPTIC PANEL AND SWADDLES | |||
| Fiber optic panelDimensions andeffective treatmentarea according toIEC60601-2-50 | Dual Fiber Optic Panels :size of effective illuminated area:16.0 cm × 12.0 cm × 2= 384 cm²Single Fiber Optic Panel:size of effective illuminated area:16.0 cm × 12.0 cm= 192 cm² | Model: EG-2000N (FlatNeonatal Panel)OverallPadSize-Neonatal: 5.00"× 7.00"(12.70 cm × 17.78 cm)IlluminatedArea-Neonatal: 4.00" × 6.00"(10.16 cm×15.24 cm) =155 cm²Model: EG-2000 (WrapAround Panel)OverallPadSize-Standard: 4.00" × 15.00"(10.16 cm × 38.10 cm)IlluminatedArea-Standard: 3.00" × 14.00"(7.62 cm × 35.56 cm) =271 cm² | SimilarSee Comment 10 |
| Swaddle | 100% cotton | N/A | DifferentSee comment 11 |
| PAD TREATMENT AREA | |||
| Panel material withdirect contact topatient | TPU | TPU | Same |
| Use Intent | Multiple patients | Multiple patients | Same |
| NOISE | |||
| Noise | < 60 dB(A) | < 60 dB (A) | Same |
| Device name | Subject deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
| STANDARDS COMPILED | |||
| Biocompatibilitytest | Biocompatibility tests performedper ISO 10993 for patientcontacting materials (Disposablecover and Swaddle). Both theDisposable cover and Swaddle areconsidered a skin-contactingdevice with prolonged exposure.Cytotoxicity per ISO 10993-5Intracutaneous irritation study perISO 10993-10Sensitization per ISO 10993-10 | There is no publicly-available information. | DifferentSee comment 12 |
| Electrical safetytests | IEC 60601-1 Generalrequirementsfor basic safety and essentialperformance | IEC 60601-1 GeneralRequirements for Safetyof Medical ElectricalEquipment | Same |
| ElectromagneticCompatibility tests(EMI/EMC) | Electromagnetic Compatibilitytests (EMI/EMC) performed perIEC 60601-1-2 (4th edition) | ElectromagneticCompatibility tests(EMI/EMC) performedper EN 60601-1-2 (2ndedition) | Same |
| Phototherapysafety andperformance tests | IEC 60601-2-50 Particularrequirements for the basic safetyand essential performance of infantphototherapy equipment | IEC 60601-2-50 Particularrequirements for the basicsafety and essentialperformance of infantphototherapy equipment | Same |
| Device name | Subject deviceNeonatal Phototherapy SystemModel: KANGALITEK200031 | Predicate deviceBili-TxK070180 | Comparison |
| Home Use | Intended for home and hospitaluse:IEC 60601-1-11 Generalrequirements for basic safety andessential performance - CollateralStandard: Requirements formedical electrical equipment andmedical electrical systems used inthe home healthcare environment | The Bili-Tx is intendedto treathyperbilirubinemiathrough phototherapy in ahome orhospital/institutionalenvironment. | SameSee comment 13 |
| Ingression of waterfor Light Source | IP22 | IPX0 | DifferentSee comment 14 |
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Image /page/6/Picture/1 description: The image contains the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, and the text "AVALON BIOMEDICAL" on the right. The word "AVALON" is in a larger, bolder font than the word "BIOMEDICAL", which is placed below it.
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Image /page/7/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 text "AVALON BIOMEDICAL" on the right. The word "AVALON" is in a larger, bolder font than the word "BIOMEDICAL."
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Image /page/8/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 word "AVALON" in blue on the right. Below the word "AVALON" is the word "BIOMEDICAL" in a smaller, lighter blue font. The logo is clean and modern, and the use of blue suggests a connection to science or technology.
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Image /page/9/Picture/1 description: The image shows the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, followed by the word "AVALON" in blue, and the word "BIOMEDICAL" in a smaller font size below it. The dots are arranged in a grid-like pattern, with varying shades of blue.
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Image /page/10/Picture/1 description: The image contains the logo for Avalon Biomedical. On the left side of the logo is a graphic of a circle made up of smaller circles in varying shades of blue. To the right of the graphic is the company name, "AVALON", in a bold, blue sans-serif font. Below the company name is the word "BIOMEDICAL" in a smaller, lighter blue sans-serif font.
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Image /page/11/Picture/1 description: The image contains the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, followed by the word "AVALON" in a bold, blue sans-serif font. Below "AVALON" is the word "BIOMEDICAL" in a smaller, lighter blue font. The overall design is clean and modern.
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Image /page/12/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 text "AVALON BIOMEDICAL" on the right. The word "AVALON" is in a larger, bolder font than the word "BIOMEDICAL".
7. Discussion:
Comment 1
The subject device. Neonatal Phototherapy System. Model: KANGALITE, restricts the intended use to a specific weight of neonates and unconjugated hyperbilirubinemia which is the most common form of hyperbilirubinemia.
Two contraindications published in American Academy of Pediatrics (AAP) Guidelines were added to the Indications for Use of the subject device. Neither of these raise any new safety of effectiveness questions.
Comment 2
All the materials used for patient contact which includes Swaddle, Disposable Cover, Dual Fiber Optic Panels, and Single Fiber Optic Panel have been passed the biocompatibility test (ISO 10993 1). There is no publicly-available information of predicate device.
Comment 3
The targeted population of predicate device is neonates which includes pre-term neonates and term neonates. The Neonatal Phototherapy System, Model: KANGALITE is more specific to describe the targeted population with gestational age and weight limit which is Neonates: gestational age ≥ 38 weeks and weigh within 2500-4500 grams, that is excluded pre-term neonates. The risk of the targeted population of subject device is a subset of the predicate, and it does not raise new safety and effectiveness questions.
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Image /page/13/Picture/1 description: The image shows the logo for Avalon Biomedical. The logo consists of a circular pattern of blue dots on the left, with the word "AVALON" in large, bold blue letters to the right. Below "AVALON" is the word "BIOMEDICAL" in smaller, lighter blue letters. The logo is clean and modern, with a focus on the company name.
Comment 4
Neonatal Phototherapy System, Model: KANGALITE does not include the design of overhead phototherapy treatment. Comparison to be made only with the Fiber Optic Panel treatment mode for Neonatal Phototherapy System, Model: KANGALITE to that of the predicate product. The difference does not raise any new safety and effectiveness questions as the predicate also includes the mode of fiber optic panel.
Comment 5
The predicate device uses disposable cover onto the panel to wrap-around the baby. It does not include the swaddle component. The Swaddle in the subject device, Neonatal Phototherapy System, Model: KANGALITE, is used to enclose the Fiber Optic Panel and block the treatment blue light from leakage. The Table Mounting Clip. Shoulder Strap do not impact the performance of the device. These difference does not raise any new or different questions of safety or effectiveness for the subject device, Neonatal Phototherapy System, Model: KANGALITE.
Comment 6
Both devices use the same principle - blue light, peak emission in the wavelength range 430-490 nm and irradiance >30 µW/cm²/nm - recommended by the AAP for intensive phototherapy treatment. The subject device, Neonatal Phototherapy System, Model: KANGALITE, meets the recommend range and has performed and passed the bench test for the light peak emission, irradiance. The test demonstrates that the Neonatal Phototherapy System, Model: KANGALITE is as safe and effective as the predicate device.
Comment 7
KANGLITE has a longer expected LED lifetime than the predicate device. The performance test has conducted which can demonstrate the specification of KANGALITE LED lifetime. The different does not raise any new safety and effectiveness questions.
Comment 8
The connection mechanism of the subject device and predicate device is different. A "click" sound will appear when the subject device bundle end direct insert to the Light Source, operator can ensure the bundle has been inserted properly by the "click" sound. This difference does not raise new or different questions of safety or effectiveness for the subject device.
Comment 9
The dimensions and weight of the Light box are similar between the subject device and the predicate device. This difference does not raise new or different questions of safety or effectiveness for the subject device.
Comment 10
There are no relevant differences in the therapy, except that the subject device, Neonatal Phototherapy System, Model: KANGALITE, enables to cover a larger portion of the body surface of the infant. The APP recommends covering as much as possible the body surface of 2-11 the infant for
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Image /page/14/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 word "AVALON" in blue on the right. Below "AVALON" is the word "BIOMEDICAL" in a smaller font size and a lighter shade of blue.
phototherapy treatment. Therefore, the difference does not raise new or different questions of safety or effectiveness.
Comment 11
The Swaddle of the subject device is made by 100% cotton, it complies with the ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993- 10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The materials tested were found to be non-cytotoxic, non-sensitizers, and nonirritants. This difference does not raise any new or different questions of safety or effectiveness for the subject device.
Comment 12
The Neonatal Phototherapy System, Model: KANGALITE has undergone biocompatibility testing for the patient contact components (Swaddle, Disposable Cover and Fiber Optic Panel) in compliance with the ISO 10993 standards. The bench tests for the subject device has performed and the test results demonstrate that the design of subject device meet the specification which showing on the labeling and verified the safety and/or effectiveness for the subject device.
Comment 13
The subject and predicate device are intended for home and hospital use. The Neonatal Phototherapy System, Model: KANGALITE is fulfilled the requirement of IEC 60601-1-11:2015 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment, which is verified the safety and/or effectiveness for home use.
Comment 14
Consider the Neonatal Phototherapy System, Model: KANGALITE can be used in the home environment, the design of the Light Source is fulfilled IP22 requirement. The test conducted against falling water when tilted up to 15 degrees and against solid foreign objects of 50 mm diameter and greater which is fulfilled the requirement in according with IEC 60601-1-11 for home use. While the waterproof level of the Light box of predicate device is IPX0 which is no special protection from water. It does not raise new safety and effectiveness questions.
8. Non-clinical Tests
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device, Neonatal Phototherapy System, Model: KANGALITE, results of testing were acceptable.
- The expected duration of treatment with the KANGALITE is 48-72 hours. Using ISO 1.
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Image /page/15/Picture/1 description: The image shows the logo for Avalon Biomedical. The logo consists of a grid of blue circles on the left and the word "AVALON" in blue on the right. Below the word "AVALON" is the word "BIOMEDICAL" in a smaller font and a lighter shade of blue.
10993-1:2009, this Nature of Body Contact is categorized as "Surface Device / Skin" with a "B - Prolonged (> 24 h to 30 days)" Contact Duration for all patient-contact materials. Therefore, the following biocompatibility tests were conducted on the disposable covers and Swaddle; the KANGALITE disposable covers and Swaddle passed all of these tests:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Sensitization (ISO 10993-10:2010)
- Skin Irritation (ISO 10993-10:2010)
- Skin Irritation (ISO 10993-10:2010)
- ଧ Electrical safety and EMC testing were conducted to establish conformance with the following voluntary, FDA-recognized standards:
- ES60601-1:2005/(R)2012 - and - A1:2012 -ANSI/AAMI C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-50 Edition 2.1 2016-04 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)]
- IEC 60601-1-11 Edition 2.0 2015-01 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
Reprocessing and Cleaning/Disinfection
The subject device and accessories were assessed in accordance with the FDA guidance as applicable: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff, 2015.
Human Factors Study:
The human factors/usability test protocol and report inclusive of human factors validation data was performed in accordance with the FDA guidance "Applying human factors and usability engineering to medical devices"
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Image /page/16/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 word "AVALON" in blue on the right. Below "AVALON" is the word "BIOMEDICAL" in a smaller, lighter blue font. The logo is simple and modern, and the use of blue suggests a connection to science or technology.
and IEC 62366.
Risk Analysis:
Risk Analysis: ISO 14971:2019 Medical Devices-Application of risk management to medical devices
Clinical study 9.
No clinical study is included in this submission
10. Conclusions:
Based on the performance testing, comparison, and risk analysis in this submission, the subject device Neonatal Phototherapy System, Model: KANGALITE is substantially equivalent to the predicate device K070180.
§ 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).