(294 days)
Not Found
No
The description focuses on the physical components and light emission properties of the device, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control. The user interface is described as basic, for setting session time and indicating errors.
Yes
The device is intended for the treatment of unconjugated hyperbilirubinemia, which is a medical condition, making it a therapeutic device.
No
The device is described as a phototherapy system intended for the treatment of unconjugated hyperbilirubinemia, not for diagnosis.
No
The device description clearly outlines hardware components including a "blue light electronic generator - the Light Box" and a "light emitting fabric – the Pad". The performance studies also include testing related to hardware, such as electrical safety, EMC, and phototherapy safety and performance.
Based on the provided information, the BiliCocoon™ Phototherapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- BiliCocoon™ Function: The BiliCocoon™ Phototherapy System is a therapeutic device. It directly treats a condition (unconjugated hyperbilirubinemia) by applying light to the patient's skin. It does not analyze any biological samples.
The description clearly states its purpose is to treat a condition, not to diagnose or analyze samples.
N/A
Intended Use / Indications for Use
The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.
Product codes
LBI, PDH
Device Description
The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed.
The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin.
The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.
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 and infants under 3 months old
Intended User / Care Setting
clinical setting or in the 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 (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:
- Biocompatibility tests performed per ISO 10993 for patient contacting materials (disposable cover).
- The disposable cover is considered a skin-contacting device with prolonged exposure
- Cytotoxicity per ISO 10993-5, USP 87
- . Intracutaneous irritation Study per ISO 10993-10
- . Sensitization per ISO 10993-10, USP 88
- The disposable cover is considered a skin-contacting device with prolonged exposure
- Bench tests performed to measure spectral output. light irradiance and effective surface treatment area.
- Electrical safety tests performed per IEC 60601-1 (3rd edition A1:2012)
- Electromagnetic Compatibility tests (EMI/EMC) performed per IEC 60601-1-2 (4th edition).
- Phototherapy safety and performance tests performed per IEC 60601-2-50 (2nd edition).
- Home Use has been assessed per IEC 60601-1-11 (2nd edition:2015) and the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices"
- . Photobiological safety assessed with IEC 62471.
- Cleaning Validation 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle-like design with three stylized human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2017
Neomedlight Pierre Girons CEO 89-90 Rue Frederic Fays Villeurbanne, 69100 FRANCE
Re: K163526
Trade/Device Name: Bilicocoon™ Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: Class II Product Code: LBI Dated: August 29, 2017 Received: September 1, 2017
Dear Pierre Girons:
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, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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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) K163526
Device Name BiliCocoon™ Phototherapy System
Indications for Use (Describe)
The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home
| 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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3
K163526 510(K) SUMMARY
| Manufacturer's Name: | NEOMEDLIGHT
89-90 Rue Frederic FAYS
69100 Villeurbanne
France
Ph.: +33 6 33 902 900 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Pierre SAINT-GIRONS
CEO |
| Telephone Number: | +33 6 33 902 900 |
| E-mail: | pierre.saintgirons@neomedlight.com |
| Preparation Date: | October 3, 2017 |
| Trade Name: | BiliCocoon™ Phototherapy System |
| Common or Usual Name: | Neonatal phototherapy unit |
| Regulation Name:
Regulation Number:
Product Code: | Unit, Neonatal Phototherapy
21 CFR 880.5700
LBI : unit, neonatal phototherapy
PDH : blanket, neonatal phototherapy |
| Device Class: | Class II |
| Primary Predicate Device: | K103589, neoBLUE® blanket LED Phototherapy System |
Device Description
The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed.
The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin.
The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.
4
Indications for Use
The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.
The device is prescription only.
Substantial Equivalence Discussion
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| Characteristic | Predicate Device
neoBLUE blanket LED Phototherapy
System, K103589 | Subject Device
BiliCocoon™ Phototherapy System
K163526 | Comments |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Indications for Use | The neoBLUE blanket LED
Phototherapy System is intended for
the treatment of neonatal
hyperbilirubinemia. It can be used in
the clinical setting or in the home. | The BiliCocoon™ Phototherapy
System is intended for the treatment
of unconjugated hyperbilirubinemia
in the population of neonates and
infants under 3 months old and
weighing less than 10kg. It can be
used in the clinical setting or in the
home. | Different – see
Comment 1 |
| Population | Neonates | Neonates and infants under 3 months
and 10kg | Different – see
comment 1 |
| Treatment
Method | Underneath blue light | Nest Pad : Underneath blue light
Bag Pad : Underneath and above blue
light | Different – See
Comments 2, 4 |
| Sites of use | Clinical, Home Use | Clinical, Home Use | Same |
| Type of Device | Portable | Portable | Same |
| Technological Features | | | |
| Type of Blue
light | Blue Led Light with peak emission
between 450 and 475 nm | Blue Led Light with peak emission
between 430 and 490 nm | Different – See
Comment 2 |
| Intensity
(irradiance)
average | 30 - 35 μW/cm²/nm | 30 - 40 μW/cm²/nm | Different – See
Comment 2 |
| Connection | 1 bundle of optical
fiber (diameter 1.8 cm) | 6 bundle of optical fiber (diameter
0.75cm) | Different – See
Comment 3 |
| Power Supply | 12 VCC / 8.3A 100W | 12 VCC / 7.5A 90W | Different – See
Comment 3 |
| Power Security | double insulation class I | double insulation class II | Different – See
Comment 3 |
| Leakage Current | 30uW/cm²/nm - recommended by the American Academy of Pediatrics for intensive phototherapy treatment. The difference in the light peak emission, irradiance and surface area for treatment does not raise new or different questions of safety or effectiveness.
6
Comment 3
The connector of the BiliCocoon™ Phototherapy System is based on the same technologies than the predicate, except that the subject device employs solutions to prevent overheating and fiber degradation due to heat. The same electrical safety and performance testing was performed for both the subject and predicate device.
Comment 4
There are no relevant differences in the therapy, except that the subject device enables to cover a larger portion of the body surface of the infant, by providing larger fiber optic pads and the possibility of illuminating from underneath and above the patient. The American Academy of Pediatrics recommends covering as much as possible the body surface of the infant for phototherapy treatment. Therefore the differences in treatment area do not raise new or different questions of safety or effectiveness.
Comment 5
The predicate device disposable component material is non-woven polypropylene. The BiliCocoon™ Phototherapy System disposable is non-woven polyester viscose. Both devices underwent the same biocompatbility tests per ISO 10993 for the patient contacting materials and met the same requirements; thereby these are substantially equivalent.
Comment 6
●
The predicate software and the BiliCocon™ Phototherapy System software remain linked to the microcontroller, without any communication, interpretation or data exchange feature. The BiliCocoon™ Phototherapy System adds a screen and navigation button to set up a timer, but is not adding any risks as both the predicate device and the subject device can be switched off manually and safely at any time.
Performance Testing
The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:
- Biocompatibility tests performed per ISO 10993 for patient contacting materials (disposable cover).
- O The disposable cover is considered a skin-contacting device with prolonged exposure
- Cytotoxicity per ISO 10993-5, USP 87
- . Intracutaneous irritation Study per ISO 10993-10
- . Sensitization per ISO 10993-10, USP 88
- O The disposable cover is considered a skin-contacting device with prolonged exposure
- Bench tests performed to measure spectral output. light irradiance and effective surface treatment area. ●
- Electrical safety tests performed per IEC 60601-1 (3ra edition A1:2012) ●
- Electromagnetic Compatibility tests (EMI/EMC) performed per IEC 60601-1-2 (4th edition). ●
- Phototherapy safety and performance tests performed per IEC 60601-2-50 (2na edition). ●
- Home Use has been assessed per IEC 60601-1-11 (2w edition:2015) and the FDA Guidance, "Applying Human ● Factors and Usability Engineering to Medical Devices"
- . Photobiological safety assessed with IEC 62471.
- Cleaning Validation Testing .
There is no difference of non-clinical testing performed between the device under submission and the predicate device.
Clinical Tests
Not Applicable
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The BiliCocoon™ Phototherapy System is substantially equivalent to the NeoBLUE blanket LED Phototherapy System cleared under K103589 with respect to the indications for use, target populations, treatment method, and technological characteristics.