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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BiliCocoon™ Phototherapy System (K163526).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily proving efficacy through a clinical trial. Therefore, the information provided primarily pertains to bench testing and comparison, rather than comprehensive clinical study data as might be expected for novel devices or PMAs.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific statistical endpoint (e.g., accuracy, sensitivity, specificity) relevant to a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance of the predicate device and relevant industry standards. The "reported device performance" is largely described through a comparison against the predicate and adherence to safety and performance standards.

The closest equivalent to "acceptance criteria" for a phototherapy device would be its light output specifications and safety characteristics.

Acceptance Criteria (Implied from Predicate/Standards)	Reported Device Performance (BiliCocoon™)
Light Characteristics
Peak Emission Range	Blue LED Light with peak emission between 430 and 490 nm
Intensity (Irradiance) average	30 - 40 µW/cm²/nm
Recommended by AAP for intensive phototherapy	Meets recommendation (>30 µW/cm²/nm)
Safety and Electrical
Leakage Current	<100µA
Electrical Safety	Compliant with IEC 60601-1 (3rd edition A1:2012)
Electromagnetic Compatibility (EMI/EMC)	Compliant with IEC 60601-1-2 (4th edition)
Phototherapy Safety and Performance	Compliant with IEC 60601-2-50 (2nd edition)
Home Use Assessment	Assessed per IEC 60601-1-11 (2nd edition:2015) and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices"
Photobiological Safety	Assessed with IEC 62471
Biocompatibility
Disposable cover skin-contacting (prolonged)	Cytotoxicity (ISO 10993-5, USP 87) - Met requirements Intracutaneous Irritation (ISO 10993-10) - Met requirements Sensitization (ISO 10993-10, USP 88) - Met requirements
Other
Noise	35dB (Similar to predicate's 25dB; considered similar)
Alarms (bad optical connection, LED overheating, LED control)	Yes, for all listed.

2. Sample Size Used for the Test Set and Data Provenance

This document primarily describes bench testing for hardware and software components, as well as biocompatibility. There is no "test set" in the context of clinical data (e.g., images, patient records) or a machine learning model.

Sample Size: Not applicable in the traditional sense for a test set of clinical data. Testing involved samples of materials (e.g., disposable cover), components, and the device itself.
Data Provenance: Not applicable. The testing is based on laboratory measurements and adherence to international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no clinical "ground truth" derived from expert consensus mentioned in this 510(k) summary for the device's technical performance. Ground truth for biocompatibility is established by standardized lab tests, and for electrical/optical performance by instrumentation and adherence to published standards.

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" requiring expert adjudication in the context of this device's bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This device is a phototherapy system, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The BiliCocoon™ Phototherapy System is a medical device, not an AI algorithm. Its performance is directly tied to its physical characteristics and light output.

7. Type of Ground Truth Used

The "ground truth" for the various performance and safety tests conducted were:

Biocompatibility: Established by reference to ISO 10993 standards and USP 87/88.
Spectral Output, Light Irradiance, Effective Surface Treatment Area: Established by direct measurement using calibrated equipment.
Electrical Safety, EMC, Phototherapy Safety/Performance, Home Use, Photobiological Safety: Established by adherence to and compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50, IEC 60601-1-11, IEC 62471) and FDA guidance.

8. Sample Size for the Training Set

Not applicable. This device does not employ a machine learning algorithm; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning algorithm.

Summary regarding the nature of the study:

The provided document describes a bench testing study designed to demonstrate the substantial equivalence of the BiliCocoon™ Phototherapy System to a legally marketed predicate device (K103589, neoBLUE® blanket LED Phototherapy System). The study focuses on comparing technological characteristics and ensuring adherence to relevant safety and performance standards for neonatal phototherapy units. It is not a clinical study or an AI/software performance study in the way the input questions imply.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K163526

Device Name BiliCocoon™ Phototherapy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K163526 510(K) SUMMARY

Manufacturer's Name:	NEOMEDLIGHT89-90 Rue Frederic FAYS69100 VilleurbanneFrancePh.: +33 6 33 902 900
Corresponding Official:	Pierre SAINT-GIRONSCEO
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 Phototherapy21 CFR 880.5700LBI : unit, neonatal phototherapyPDH : blanket, neonatal phototherapy
Device Class:	Class II
Primary Predicate Device:	K103589, neoBLUE® blanket LED Phototherapy System

Device Description

The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.

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Indications for Use

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 DeviceneoBLUE blanket LED PhototherapySystem, K103589	Subject DeviceBiliCocoon™ Phototherapy SystemK163526	Comments
Indications for Use	The neoBLUE blanket LEDPhototherapy System is intended forthe treatment of neonatalhyperbilirubinemia. It can be used inthe clinical setting or in the home.	The BiliCocoon™ PhototherapySystem is intended for the treatmentof unconjugated hyperbilirubinemiain the population of neonates andinfants under 3 months old andweighing less than 10kg. It can beused in the clinical setting or in thehome.	Different – seeComment 1
Population	Neonates	Neonates and infants under 3 monthsand 10kg	Different – seecomment 1
TreatmentMethod	Underneath blue light	Nest Pad : Underneath blue lightBag Pad : Underneath and above bluelight	Different – SeeComments 2, 4
Sites of use	Clinical, Home Use	Clinical, Home Use	Same
Type of Device	Portable	Portable	Same
Technological Features
Type of Bluelight	Blue Led Light with peak emissionbetween 450 and 475 nm	Blue Led Light with peak emissionbetween 430 and 490 nm	Different – SeeComment 2
Intensity(irradiance)average	30 - 35 μW/cm²/nm	30 - 40 μW/cm²/nm	Different – SeeComment 2
Connection	1 bundle of opticalfiber (diameter 1.8 cm)	6 bundle of optical fiber (diameter0.75cm)	Different – SeeComment 3
Power Supply	12 VCC / 8.3A 100W	12 VCC / 7.5A 90W	Different – SeeComment 3
Power Security	double insulation class I	double insulation class II	Different – SeeComment 3
Leakage Current	<100μA	<100μA	Same
Light Box
Dimensions	11.4 cm x 22.9 cm x 14.0 cm	21.5 cm x 19.8 cm x 16.0 cm	Similar
Weight	1.5 kg	1.4 kg	Similar
PAD Treatment Area
light emitting area	Small Blanket : 819 cm²Large Blanket : 542 cm²	Nest Pad : 1200 cm²Bag Pad : 1200 cm²	Different - SeeComment 4
effective treatment areaaccording to IEC60601-2-50	Small Blanket : 504 cm²Large Blanket : 296 cm²	Nest Pad : 1200 cm²Bag Pad : 1200 cm²	Different - SeeComment 4
PAD Materials	Polyurethane (mattress covering thefiber optics PAD)	Polyurethane (mattress covering thefiber optics PAD)	Same
Use Intent	Multiple Patients	Multiple Patients	Same
Disposable Blanket
Use Intent	Single Patient	Single Patient	Same
patient contact	Non-woven polypropylene	Nonwoven Polypropylene/Polyester-Viscose	Different - SeeComment 5
Alarms
Bad optical connection	Yes	Yes	Same
LED overheating	Yes	Yes	Same
LED Control	Yes	Yes	Same
Noise	25dB	35dB	Similar
Timer	No	Yes	Different - SeeComment 6

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Comment 1

The predicate device is intended for the treatment of hyperbilirubinemia in the neonate population. Hyperbilirubinemia in neonates is a common pathology which is characterized by an augmentation bilirubin. Hyperbilirubinemia is commonly associated to unconjugated hyperbilirubinemia because it is the most common pathology creating an augmentation of bilirubin. Phototherapy is a method to treat unconjugated hyperbilirubinemia by transforming bilirubin into water-soluble isomers that can be eliminated without conjugation in the liver.

The subject devices restricts the intended use to unconjugated hyperbilirubinemia which is the most common form of hyperbilirubinemia. Conjugated hyperbilirubinemia is rare and not treated by phototherapy device intended to treat hyperbilirubinemia is essentially referring to unconjugated hyperbilirubinemia. Intended use of Bilicocoon™ Phototherapy System is thus equivalent to the intended use of the predicate device.

The claimed targeted population is also different but this difference does not bring any additional risk. Neonates are defined by the Agency as birth to 28 days. However, the chosen the targeted population is up to 3 months and 10kg. This will not change the risk, as an older and heavier population is less critical.

Comment 2

Both devices use the same principle - blue light, peak emission range 430-490nm and irradiance >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.

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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
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.

Regulation Number and Section

§ 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).