(115 days)
Not Found
No
The description focuses on the hardware (LEDs, control box, pad) and the physical mechanism of phototherapy (delivering blue light). There is no mention of any computational analysis, algorithms, or data processing that would suggest AI/ML.
Yes
The device is described as "Infant phototherapy equipment" that provides "treatment for neonatal unconjugated hyperbilirubinemia," indicating its direct involvement in managing a medical condition.
No
The device is designed for the treatment of hyperbilirubinemia by delivering blue light, not for diagnosing the condition. Its intended use is to lower bilirubin levels, not to measure or assess them.
No
The device description explicitly states it is comprised of a control box, pad with disposable cover, rechargeable battery, and AC/DC power supply, indicating it includes hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device, the BiliTouch™, is a therapeutic device. Its purpose is to treat a condition (neonatal hyperbilirubinemia) by applying light to the infant's skin. It does not analyze any bodily specimens.
The description clearly states its intended use is for the "treatment of infants diagnosed with hyperbilirubinemia" and that it "provides phototherapy treatment." This is a direct therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Product codes
LBI
Device Description
Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby.
Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used).
Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.
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
up to 3 months
Intended User / Care Setting
hospital or at home.
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
Bench performance tests including testing for battery-powered operating test, light intensity test and testing for temperature on the pad of the device and high temperature alarm were completed to verify that the infant phototherapy equipment demonstrate the specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 28, 2021
Bistos Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114
Re: K210289
Trade/Device Name: Infant Phototherapy Equipment Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal phototherapy unit Regulatory Class: Class II Product Code: LBI Dated: April 9, 2021 Received: April 29, 2021
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 (QS) 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
BiliTouch™ (model name: Motif Phototherapy Blanket); and Infant Phototherapy Equipment (model name: BT-450)
Indications for Use (Describe)
The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
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
Traditional 510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
April 9, 2021 Date 510k summary prepared:
I. SUBMITTER
| Submitter's Name | Bistos Co., Ltd. |
|---|---|
| Submitter's Address | 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, |
| Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, | |
| Korea (Zip. 13201) | |
| Submitter's Telephone | +82 (31) 7500340 |
| Contact person | Daeeun Kim (dekim@bistos.co.kr) / RA |
II. DEVICE
| Common Name | Neonatal phototherapy unit |
|---|---|
| Trade/proprietary Name | Infant phototherapy equipment, model BT-450 |
| BiliTouch™, model Motif Phototherapy Blanket | |
| Regulation Name | Unit, Neonatal Phototherapy |
| Regulation Number | 21 CFR 880.5700 |
| Product Code | LBI |
| Regulatory Class | Class II |
| Regulation Medical Specialty/510(k) review Panel | General Hospital |
III. PREDICATE DEVICE
| Primary Predicate device | BiliBee |
|---|---|
| K072097 | |
| Illumination Technologies, LLC |
4
IV. DEVICE DESCRIPTION
Infant phototherapy equipment is a portable phototherapy light system delivers a narrow band of high-intensity blue light via blue light-emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. The device is comprised of a control box and pad including a disposable pad cover, rechargeable battery and AC/DC power supply. The pad is designed to provide phototherapy treatment from underneath the baby.
Infant phototherapy equipment provides blue LEDs to achieve intensities by two-level with emitting light from blue LEDs (bandwidth 400 - 550 nm used).
Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using the device can be applied at home or in a hospital.
V. INDICATIONS FOR USE:
The BiliTouch™, model Motif Phototherapy Blanket and Infant Phototherapy Equipment, model BT-450 are indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The intended use, design and functional characteristics between the Infant phototherapy equipment and the predicate device are substantially equivalent. The subject device and predicate device is intended to be used for the treatment of infants diagnosed with hyperbilirubinemia by delivering light to degrade bilirubin on the same operating principle.
Summary table of technological characteristics of the device compared to the predicate device:
| Device | K210289 | K072097 |
|---|---|---|
| Trade name | Infant phototherapy equipment, | |
| BiliTouch™ | BiliBee | |
| Model | BT-450, | |
| Motif Phototherapy Blanket | ||
| Manufacturer | Bistos Co., Ltd. | Illumination Technologies, LLC |
| Intended Use | ||
| /Indications for Use | The BiliTouchTM, model Motif | |
| Phototherapy Blanket and Infant | ||
| Phototherapy Equipment, model | ||
| BT-450 are indicated for use to | ||
| treatment of infants diagnosed with | ||
| hyperbilirubinemia, commonly | ||
| known as neonatal jaundice, which | ||
| can cause a yellow discoloration of | ||
| the skin and the whites of the eyes. | ||
| The devices can be used in a | ||
| hospital or at home. | ||
| The device is designed to use for | ||
| patient population described in the | ||
| infant, who is age up to 3 months | ||
| and weight less than 10 kg | The intended use of the BiliBee | |
| LED Phototherapy System is the | ||
| treatment of infants diagnosed | ||
| with hyperbilirubinemia, | ||
| commonly known as neonatal | ||
| jaundice, which can cause a | ||
| yellow discoloration of the skin | ||
| and the whites of the eyes. | ||
| Targeted population | Infant diagnosed with | |
| hyperbilirubinemia | Infant diagnosed with | |
| hyperbilirubinemia | ||
| Use environment | Home, Hospital | Home, Hospital |
| Type of device | blanket type device | |
| wrapping the patient | Free standing device | |
| underneath the patient | ||
| Visual Indicator | LCD | LCD |
| User control | 1. Power on/off |
- Intensity level up and down
- Run time setting
- 30minutes increase
- 30minutes decrease | Power on/off |
| Configuration | 1. Control box which contains LCD
display and Battery
- Pad which consists of LEDs to
emit light and is able to wrap
around a patient - Pad cover
- Adapter | 1. AA battery pack
- LED illuminator panel
- Sheath
- Adapter |
| Power | 1. AC adapter:
100-240 Vac, 50/60Hz, 2.0A - Battery:
11.1V Li-ion Polymer 4000mA
Charging time: | 1. AC adapter: - Battery:
Removable rechargeable
6 V battery(off-the-shelf
AA battery) |
| Cover | Disposable pad cover,
Which is made of white
nonwoven spunbond | The disposable sheath consists
of two pieces of synthetic woven
fabric sewn together on 3 of 4
sides. |
| Use duration | Not limited,
but the pad cover is intended to be
replaced every 24 hours | Treatment is intended to be applied
for 24 hours a day, and treatment
time is expected to range from 3
days to 3 weeks. |
| Eye shield | Using is recommended. | None |
| Weight | 1. Pad: 340 g - Control box: 370 g | 1. Light panel