(76 days)
Not Found
No
The description focuses on the physical components, light output, and manual controls of the phototherapy unit. There is no mention of any computational analysis, learning algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is intended for the treatment of neonatal hyperbilirubinemia, which is a medical condition, making it a therapeutic device.
No
The device is described as a "phototherapy light intended for the treatment of neonatal hyperbilirubinemia." It emits light to degrade bilirubin, which is a treatment, not a diagnostic function.
No
The device description clearly outlines a physical hardware device including a floor-stand, light enclosure, LEDs, rollstand assembly, switches, potentiometers, and a power cord. It is not solely software.
Based on the provided text, the Natus® Blue Light Phototherapy Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Natus Blue Light Phototherapy Unit is a therapeutic device that applies light directly to the infant's skin for treatment. It does not analyze any biological samples.
- The intended use is for treatment of neonatal hyperbilirubinemia. This is a therapeutic indication, not a diagnostic one.
- The device description focuses on light delivery and positioning. This aligns with a therapeutic device, not a device for analyzing samples.
Therefore, the Natus Blue Light Phototherapy Unit is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
The Natus Blue Light Phototherapy Unit is a floor-standing, mobile phototherapy device that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.
The device consists of a lightweight plastic light enclosure that can be tilted and adjusted both horizontally and vertically on a rollstand assembly. The light enclosure can be tilted to a maximum of approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the rollstand post, as well as horizontally out from the rollstand post (proximity adjustment) to aid in positioning the device. A red target light can be briefly illuminated by the user, using a rocker switch on the front panel, to help position the device over the infant. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
There are two intensity settings, high and low. The user selects the desired setting using a rocker switch on the front panel of the device. The light output is optimized to provide an average intensity of 35 uW/cm-/nm at the high setting and 15 uW/cm-/nm at the low setting at 30 cm (12 inches) distance from the baby. A diffuser panel provides a more uniform illumination pattern from the multiple LED light sources, and protects the user from viewing a single point source of light. The diffuser panel also protects the device from incidental debris or fluid exposure.
Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin. and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, so there is no concern about IR exposure and excessive warming of the infant. As with all phototherapy devices, protective eye shades should be used to protect the infant's eyes from excessive light exposure.
LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. Instructions for adjusting the output are included in the User Manual (see Appendix A). A drawing of the location of the location of the potentiometers is included in Appendix C. In normal operating conditions the device is expected to operate as specified approximately 10,000 hours at the low setting, and approximately 3,000 hours at the high setting. No pre-aging of the LEDs is required; the LEDs are 'burned in' at the factory.
The Natus Blue Light device is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure.
There are no single-use components or accessories for the Natus Blue Light Phototherapy device.
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
Neonatal
Intended User / Care Setting
Nursery, doctor's office, anywhere phototherapy is delivered
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)
This submission includes the results of testing prototype devices to specifications, spectral characterization of the blue LED light source, and an analysis of the potential optical radiation hazard of the blue LED light source. The results were as expected and no new issues of safety or effectiveness were raised as a result of the nonclinical testing.
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
KO 22196
510(k) Summary of Safety and Effectiveness 8
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1. Submitter
Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 650) 802-0400 Phone: 650) 802-6600 Fax:
Contact Date Prepared: Sheila Ramerman, Director RA/QA July 3, 2002
2. Device Names
Classification name Common names Trade name
Unit, Neonatal Phototherapy Phototherapy Light, Bili Light Natus® Blue Light Phototherapy Unit
3. Predicate Device
Olympic Bili-Light, Model 33, K940996
4. Device Description
The Natus Blue Light Phototherapy Unit is a floor-standing, mobile phototherapy device that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.
The device consists of a lightweight plastic light enclosure that can be tilted and adjusted both horizontally and vertically on a rollstand assembly. The light enclosure can be tilted to a maximum of approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the rollstand post, as well as horizontally out from the rollstand post (proximity adjustment) to aid in positioning the device. A red target light can be briefly illuminated by the user, using a rocker switch on the front panel, to help position the device over the infant. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
There are two intensity settings, high and low. The user selects the desired setting using a rocker switch on the front panel of the device. The light output is optimized to provide an average intensity of 35 uW/cm-/nm at the high setting and 15 uW/cm-/nm at the low setting at 30 cm (12 inches) distance from the baby. A diffuser panel provides a more uniform illumination pattern from the multiple LED
Natus Blue Light Phototherapy Unit - July 3, 2002
Natus Medical Inc. 1501 Industrial Road, San Carlos, CA 94070-4111 650-802-0400 FAX 650-802-6620
1
light sources, and protects the user from viewing a single point source of light. The diffuser panel also protects the device from incidental debris or fluid exposure.
Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin. and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, so there is no concern about IR exposure and excessive warming of the infant. As with all phototherapy devices, protective eye shades should be used to protect the infant's eyes from excessive light exposure.
LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. Instructions for adjusting the output are included in the User Manual (see Appendix A). A drawing of the location of the location of the potentiometers is included in Appendix C. In normal operating conditions the device is expected to operate as specified approximately 10,000 hours at the low setting, and approximately 3,000 hours at the high setting. No pre-aging of the LEDs is required; the LEDs are 'burned in' at the factory.
The Natus Blue Light device is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure.
There are no single-use components or accessories for the Natus Blue Light Phototherapy device.
5. Intended Use
The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. It emits a narrow band of blue light considered to be the most effective in degradation of bilirubin.
6. Comparison with Predicate Device
The Natus Blue Light Phototherapy Unit and the Olympic Bili-Lite Model 33 have the same intended use (treatment of hyperbilirubinemia), use the same operating principle (delivery of light to degrade bilirubin), and are similar in their hardware configuration. See the Comparison Table below for details.
2
| Natus® Blue Light vs. Olympic Bili-lite™ Model 33 | ||
|---|---|---|
| Feature | Natus Blue Light | Olympic Bili-Lite (K940996) |
| Intended Use | For the treatment of neonatal | |
| hyperbilirubinemia | For the treatment of neonatal | |
| hyperbilirubinemia | ||
| Target population | Neonates | Neonates |
| Sites of use | Nursery, doctor's office, | |
| anywhere phototherapy is | ||
| delivered | Nursery, doctor's office, | |
| anywhere phototherapy is | ||
| delivered | ||
| Physical Design | ||
| Type | Freestanding device | Freestanding device |
| Mounting hardware | Roll Stand, 5 legs w/casters, 2 | |
| locking | Roll Stand, 4 legs w/casters | |
| Light attachment | Lights mounted in hood enclosure | Lights mounted in hood |
| enclosure | ||
| Width, light enclosure | 20.5 in (52 cm) | 25 in (63.5 cm) |
| Depth, light enclosure | 10.5 in (27cm) | 19 in (48 cm) |
| Weight (light on stand) |