(238 days)
Not Found
No
The summary describes a standard LED phototherapy device with intensity settings and a timer. There is no mention of AI, ML, or any features that would suggest the use of such technologies for diagnosis, treatment planning, or device control beyond basic user input.
Yes
The device is designed to reduce serum bilirubin concentration, which is a medical treatment.
No
The device is described as a phototherapy light designed to reduce serum bilirubin concentration, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines hardware components such as LED lights, a display screen, keys, and the physical housing of the phototherapy light, indicating it is a physical medical device with integrated software, not a software-only device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- BiliLux Function: The BiliLux phototherapy light is a therapeutic device. It uses light radiation to treat a condition (hyperbilirubinemia) directly on the patient's body. It does not analyze samples taken from the patient.
The description clearly states its purpose is to "reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation." This is a direct treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
Product codes
LBI
Device Description
The device BiliLux is a configurable LED phototherapy light designed to reduce serum bilirubin concentration in premature babies and neonates with unconjuqated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation. The blue light of the phototherapy light lies within the wavelength range of 460 nm to 490 nm. The front panel has a display screen and keys to control functions and change settings. There are five intensity settings (20%, 60% 80% and 100% of nominal intensity). On the user interface, the user can see session time and any software errors that may occur.
The BiliLux phototherapy light can be placed directly on an incubator hood or be combined with a spring arm and trolley. An optional radiometer is also available to measure the phototherapeutic effective irradiance produced by the phototherapy light
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
up to 3 months of age
Intended User / Care Setting
The BiliLux phototherapy light can be used in hospital departments that provide neonatal and infant care, including nurseries and Neonatal Intensive Care Unit (NICU) levels I-IV.
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 BiliLux was tested in accordance with applicable standards, guidance and internal design control procedures including performance testing, functional/operation testing, verification and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/0 description: The image shows 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 consists of 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.
May 1, 2018
Draeger Medical Systems, Inc. Gale Winarsky Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969
Re: K172656
Trade/Device Name: BiliLux® Phototherapy Light Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: March 26, 2018 Received: March 27, 2018
Dear Gale Winarsky:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172656
Device Name BiliLux® Phototherapy Light
Indications for Use (Describe)
The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitter's Name and Address: | Draeger Medical Systems Inc.
3135 Quarry Road
Telford, PA 18969 |
|-------------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Gale Winarsky
Manager, Regulatory Affairs
Phone: 215-660-2239
Fax: 215-721-5424 |
| Date prepared: | April 24, 2018 |
| Device Name: | |
| | Trade Name: BiliLux® Phototherapy Light |
| | Common Name: Phototherapy light or unit
Classification Name: Neonatal phototherapy unit |
| | Regulation Number: |
Requlation Number:
Product Code:
Class:
Legally Marketed Device Identification: Substantial equivalence is claimed to the predicate device, NanoBlu™ 500, K113206, Draeger Medical Systems Inc.
880.5700
LBI
=
Device Description:
The device BiliLux is a configurable LED phototherapy light designed to reduce serum bilirubin concentration in premature babies and neonates with unconjuqated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation. The blue light of the phototherapy light lies within the wavelength range of 460 nm to 490 nm. The front panel has a display screen and keys to control functions and change settings. There are five intensity settings (20%, 60% 80% and 100% of nominal intensity). On the user interface, the user can see session time and any software errors that may occur.
The BiliLux phototherapy light can be placed directly on an incubator hood or be combined with a spring arm and trolley. An optional radiometer is also available to measure the phototherapeutic effective irradiance produced by the phototherapy light
Intended Use:
The BiliLux is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb.)
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| Device Name | Device Under Review
BiliLux (PT-LED) | Predicate Device
NanoBlu™ 500 | Comments |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image | Image: BiliLux (PT-LED) | Image: NanoBlu™ 500 | |
| Manufacturer | Draeger Medical Systems, Inc. | Draeger Medical Systems, Inc. | N/A |
| 510(k) | K172656 | K113206 | N/A |
| Regulation # | 880.5700 | Same | N/A |
| Product Code | LBI | Same | N/A |
| Classification | II | Same | N/A |
| Indications for Use | The BiliLux phototherapy light is
designed to reduce the serum bilirubin
concentration in premature babies and
neonates with hyperbilirubinemia by
means of phototherapeutic radiation. It is
intended for use with patients up to 3
months of age who weigh less than 10
kg (22 lb). | The Draeger NanoBlu 500 LED
Phototherapy Light is intended to treat
neonatal hyperbilirubinemia by providing
phototherapeutic light to the body of the
patient. It is intended for use on the
recommendation and under the
supervision of healthcare professionals.
The Draeger NanoBlu 500 can be used
in a hospital. Additionally, this product
can be used with an under-baby
phototherapy light to increase patient
coverage. | The indications for use of the BiliLux and the
predicate and reference devices are substantial
equivalent. The differences do not raise
questions about the safety or effectiveness for
the subject device. |
| Environment of Use | The BiliLux phototherapy light can be
used in hospital departments that
provide
neonatal and infant care, including
nurseries and Neonatal Intensive Care
Unit (NICU) levels I-IV. | It is intended for use on the
recommendation and under the
supervision of healthcare professionals.
The Draeger NanoBlu 500 can be used
in a hospital. | Differences in environment of use are not
clinically relevant. All three devices are for use
on Neonates under the supervision of healthcare
professional within a hospital environment. |
| Safety Standards | · IEC 60601-1
· IEC 60601-1-2
· IEC 60601-2-50 | Same | Same |
| Physical Description | | | |
| Light - Length | ≤39 cm (15.4 in) | 23.0 cm (9.06 in) | Differences in light length, width, height and |
| Light - Width | ≤19 cm (7.5 in) | 11.6 cm (4.57 in) | weight are not clinically relevant. |
| Light - Height | ≤8 cm (3.1 in) | 100.0 cm to 140.0 cm
(39.37 in to 55.12 in) | |
| Light - Weight (without options/acces≥ 1.2 kg (2.7 lb) | ≥ 1.2 kg (2.7 lb) | | |
| Optional Trolley - weight | ≤14.9 kg (32.8 lb) | 9.0 kg (19.8 lb) | Differences in accessory weights are not |
| Arm - weight | ≤1.5 kg (3.3 lb) | | clinically relevant. |
| Technology | | | |
| Expected service life of device | 8 years | UNK | N/A |
| Light source lifetime | 50,000 hours | 20,000 hr | Light source lifetime is not clinically relevant. |
| Light bulb type | LED | Same | Same |
| Counter for running time of lights | Yes | Same | Same |
| Integrated white exam light | Yes | No | Same |
| Irradiance | 100% irradiance setting, 460-490nm
at 30cm: >85.5 µW/cm2/nm
at 40cm: >50.1 µW/cm2/nm
at 50cm: >33.4 µW/cm2/nm | 100% irradiance setting, 400-550nm
at 30cm: 45 to 65 µW/cm2/nm
at 40cm: 30 to 45 µW/cm2/nm
at 50cm: 20 to 30 µW/cm2/nm | The American Academy of Pediatrics (AAP)
recommend optimal irradiance not less than 30
µW/cm 2/nm 1.1 All devices meet this
recommendation. |
| Wavelength | 460 to 490 nm | 400 to 550 nm | The AAP recommends the light source
wavelength be in the blue-green spectrum (~460-
490 nm).1 The device under review and
predicate device cover this range. |
| Intensity Settings | 5 settings (20%, 40%, 60% 80% and
100% of nominal intensity) | 10 settings (10-100% in 10% increments) | Differences in Intensity Settings do not raise any
new questions of safety or effectiveness. |
| Effective surface area | at 40cm distance | UNK | AAP recommends maximal skin area exposure. |
| Width | 30cm | UNK | Effective surface areas are similar and do not |
| Length | 50cm | UNK | raise any new questions on safety or
effectiveness. |
| Audible noise | ≤20 dB |