(272 days)
Not Found
No
The device description focuses on the hardware components and the mechanism of phototherapy using LED light. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The device provides a fixed light output level and does not appear to adapt or learn based on patient data.
Yes
The device is intended for the treatment of unconjugated hyperbilirubinemia in neonates, which is a therapeutic purpose. It directly delivers blue light to convert bilirubin into an excretable form.
No
Explanation: The device is intended for the treatment of hyperbilirubinemia by delivering light therapy, not for diagnosing the condition.
No
The device description explicitly lists multiple hardware components including a Light Source, Fiber Optic Panels, Swaddle, Strap, Disposable Covers, and Table Mounting Clip. It describes the physical mechanism of delivering light therapy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Neonatal Phototherapy System, Model: KANGALITE is a therapeutic device that delivers light to the skin of a neonate to treat hyperbilirubinemia. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for the "treatment of unconjugated hyperbilirubinemia," which is a therapeutic application, not a diagnostic one.
The device description and performance studies also focus on the physical characteristics of the device, its light output, and its safety and performance in delivering phototherapy, not on analyzing biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LBI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Neonates: gestational age ≥38 weeks
Intended User / Care Setting
Clinical setting or in the home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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)
- Skin Irritation (ISO 10993-10:2010)
- 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" and IEC 62366.
Risk Analysis: ISO 14971:2019 Medical Devices-Application of risk management to medical devices
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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)
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
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.
4
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
5
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 device
Neonatal Phototherapy System
Model: KANGALITE
K200031 | Predicate device
Bili-Tx
K070180 | 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 device
Neonatal Phototherapy System
Model: KANGALITE
K200031 | Predicate device
Bili-Tx
K070180 | Comparison |
| 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. | The Bili-Tx is intended to
treat hyperbilirubinemia
through phototherapy in a
home
Or
hospital/institutional
environment. | Different
See comment 1 |
| Contraindications | 1. Congenital porphyria or a family
history of porphyria
2. Concomitant use of drugs or
agents that are
photosensitizers | There is no publicly-
available information. | Different
See comment 1 |
| | Subject device
Neonatal Phototherapy System | Predicate device | |
| Device name | Model: KANGALITE | Bili-Tx | Comparison |
| | K200031 | K070180 | |
| | KANGALITE treats neonatal
hyperbilirubinemia via blue light
phototherapy. The device delivers
a narrow band of high-intensity
blue light via a blue light
emitting diode (LED). 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 Bili-Tx phototherapy
systemuses blue light
emitting diodes (LEDs) to
convert bilirubin to waste
products that are mostly
excreted through urine
and stool, thus reducing
the bilirubin level in the
baby's blood. | |
| Principle of
operation | | | Same |
| | 1. Swaddle, the material in contact
with patient's body skin is made
of 100% cotton
2. Disposable Cover, the material
in contact with patient's chest and
back skin is made of non-woven
polypropylene
3. Dual Fiber Optic Panels, the
material in contact with patient's
chest and back skin is made of
TPU
4. Single Fiber Optic Panel, the
material in contact with patient's
back skin is made of TPU | There is no publicly-
available information. | |
| Patient contact
materials
(Patient is in supine
position) | | | Different
See comment 2 |
| Targeted
population | Neonates: gestational age ≥38 weeks
and weight within 2500-4500 grams. | Neonates | Different
See comment 3 |
| Prescription Use | Yes | Yes | Same |
| Over-The-Counter
Use | No | No | Same |
| Device name | Subject device
Neonatal Phototherapy System
Model: KANGALITE
K200031 | Predicate device
Bili-Tx
K070180 | Comparison |
| Site of use | In the clinical setting or in the
home | In the clinical setting or in
the home | Same |
| Treatment mode | Use with Fiber Optic Panel | Two different modes
- Use with Fiber Optic
Panel - Overhead treatment | Different
See comment 4 |
| Device Components | 1. Light Source (with AC power
cord)
- Dual Fiber Optic Panels
(Standard accessory) / Single Fiber
Optic Panel (optional accessory) - Swaddle (One size)
- Shoulder Strap
- Table Mounting Clip (optional
accessory) - Disposable Cover × 2 (single-
use) | With Fiber Optic Panel: - Illuminator device with
AC power cord - Fiber Optic Panel
- Disposable Cover
- Illuminator device
carrying case (optional) - System Carrying Case
(optional)
Other components from
overhead phototherapy - Mounting brace
- Circuit support arm
- Circuit support adaptor | Similar
See comment 5 |
| Eye protection for
the baby is
required during
treatment | No | No | Same |
| If Eye Shield
includes in the
accessories list | No | No | Same |
| TECHNOLOGICAL FEATURES | | | |
| Device name | Subject device
Neonatal Phototherapy System
Model: KANGALITE
K200031 | Predicate device
Bili-Tx
K070180 | Comparison |
| Light Source | Single blue LED | Uses blue light emitting
diodes (LEDs) | Similar
See comment 6 |
| Treatment
Wavelength | Blue LED: 400-500 nm
Peak: 455 ± 10 nm | Blue LEDs emit light in
the range of 400–550 nm
(peak wavelength 450–
470 nm). | Similar
See comment 6 |
| Light Intensity
(Irradiance) | Dual Fiber Optic Panel irradiance
level:
$50 \mu W/cm^2/nm(\pm 25%)$
Single Fiber Optic Panel
irradiance 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: When
the illuminator is
positioned 30 cm (12
inches) above the
neonate: $30 \mu W/cm^2/nm$ | Similar
See comment 6 |
| Expected LED life | Nominal lifetime: >45000 hours | Minimum
lifetime
of
30,000 hours | Different
See comment 7 |
| Connection of the
Fiber optic bundle
to Light Source | Direct insert with a "click" sound | Insert and rotate a quarter
turn | Different
See comment 8 |
| Power Supply to
Light Box | AC Power: 100-240 VAC, 50/60
Hz, 1.0-0.5 A | AC Power:
100-240
VAC, 50/60 Hz, 1.0 A | Same |
| Timer | Yes | Yes | Same |
| LIGHT BOX/ LIGHT SOURCE | | | |
| Light box
dimensions | 7.5 cm × 7.7 cm × 15.9 cm (Light
Source) | 16.10 cm × 7.40 cm
(Illuminator) | Similar
See Comment 9 |
| Device name | Subject device
Neonatal Phototherapy System
Model: KANGALITE
K200031 | Predicate device
Bili-Tx
K070180 | Comparison |
| Weight | 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
14
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.
15
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"
16
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.