(88 days)
Not Found
No
The summary describes a phototherapy device using LEDs and manual adjustments, with no mention of AI or ML capabilities.
Yes
The device is intended for the "treatment for neonatal hyperbilirubinemia," which indicates a therapeutic purpose.
No
The device is described as a phototherapy light intended for the treatment of neonatal hyperbilirubinemia, not for the diagnosis of the condition. It delivers blue light to degrade bilirubin.
No
The device description clearly outlines multiple hardware components including LEDs, a mattress, a power supply, and a light enclosure. It is a physical medical device that utilizes light therapy.
Based on the provided information, the neoBLUE cozy phototherapy light is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The neoBLUE cozy system is a therapeutic device that applies light directly to the infant's skin to treat a condition (neonatal hyperbilirubinemia). It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use is treatment, not diagnosis. The device is explicitly stated as being "intended for the treatment for neonatal hyperbilirubinemia." IVDs are used to diagnose or aid in the diagnosis of diseases or conditions.
The neoBLUE cozy is a medical device, but it falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.
Product codes
LBI
Device Description
The neoBLUE cozy system is a portable phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy system is designed to vrovide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinett, an open crib, a warming tat hlast or incubator.
Blue LEDs emit light in the range of 400 -- 550 nm (peak wavelength 450-470 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. As with all phototherapy lights, protective eyeshades must 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 biomedical engineer can adjust the output of the LEDs using the potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours.
The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.
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
Clinical setting, home-use
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 of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the nonclinical testing.
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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2005
Ms. Luanne Ng Regulatory/Clinical Affairs Manager Natus Medical, Incorporated 1501 Industrial Road San Carlos. California 94070
Re: K051869
Trade/Device Name: NEOBLUE COZY LED PHOTOTHERAP Y SYSTEM Regulation Number: 21 CFR 880.5700 · Regulation Name: Neonatal phototherapy unit Regulatory Class: II Product Code: LBI Dated: October 21, 2005 Received: October 24, 2005
Dear Ms. Ng:
This letter corrects our substantially equivalent letter of October 7, 2005.
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 (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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
Page 2 - Ms. Ng
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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sajette Y. Michael Omd
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: neoBLUE cozy™ LED Phototherapy System
INDICATIONS FOR USE: The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.
Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Supbart B) (21 CFR 801 Subpart C)
(PLEASE DONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anten Dm
Division of Anesthesiology, General Hospital, Infection Contion Dental Devices
3 10(k) Number ..
3
8 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 Phone: 650-802-6400 FAX: 650-802-0401
Contact: Luanne Ng Regulatory/Clinical Affairs Manager Date Prepared: July 7, 2005 Device Names Classification name Unit, Neonatal Phototherapy Common name Phototherapy Light Trade Name Natus® ncoBLUE cozy systemPhototherapy Unit
Predicate Devices
Medela Bilibed, K962612 Natus Blue Light Phototherapy Unit, K022196
Device Description
The neoBLUE cozy system is a portable phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy system is designed to vrovide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinett, an open crib, a warming tat hlast or incubator.
Blue LEDs emit light in the range of 400 -- 550 nm (peak wavelength 450-470 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. As with all phototherapy lights, protective eyeshades must 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 biomedical engineer can adjust the output of the LEDs using the
4
potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours.
The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.
Intended Use
The neoBLUE cozy system is a portable phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy system is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinett, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.
Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450-470 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. As with all phototherapy lights, protective eyeshades. must be used to protect the infant's eyes from excessive light exposure
The neoBLUE cozy system can be used in conjunction with an overhead phototherapy light for more patient surface area coverage. A simple blanket may be placed over the patient during phototherapy treatment with the neoBLUE cozy system to praced or the surroundings from stray blue light.
Comparison with Predicate Device
The neoBLUE cozy system, the Medela BiliBed and the Natus Blue Light Phototherapy Unit have the same intended use of treatment of neonatal hyperbilirubinemia and use the same operating principle of delivery of light to degrade bilirubin. See the Comparison Table below for details.
| Feature | Natus neoBLUE
cozy LED
Phototherapy
System | Medela BiliBed
(K962612) | Natus Blue Light
Phototherapy Unit
(K022196) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | For the treatment of
neonatal
hyperbilirubinemia | For the treatment of
neonatal
hyperbilirubinemia | For the treatment of
neonatal
hyperbilirubinemia |
| Treatment Method | Underbaby
phototherapy | Underbaby
phototherapy | Overhead
phototherapy |
| Targeted Population | Neonates | Neonates | Neonates |
| Sites of Use | Clinical setting,
home-use | Clinical setting,
home-use | Clinical setting |
| Feature | Natus neoBLUE
cozy LED
Phototherapy
System | Medela BiliBed
(K962612) | Natus Blue Light
Phototherapy Unit
(K022196) |
| Specifications | | | |
| Type of Device | Free standing device | Free standing device | Free standing device |
| Type of Light | Blue light (LED) | Blue light
fluorescent | Blue light (LED) |
| Intensity | 30-35 µW/cm²/nm | Approx. 40-60 µW
/cm²/nm or more | 30 – 35 µW/cm²/nm |
| Height |