(241 days)
Not Found
No
The description focuses on the light source (LEDs), intensity, wavelength, and physical components. There is no mention of any computational analysis, algorithms, or learning processes that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" section states that "Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia," indicating a therapeutic purpose.
No
Explanation: The device is described as providing phototherapy treatment for neonatal unconjugated hyperbilirubinemia, which is a therapeutic function rather than a diagnostic one. It treats a condition, it does not detect or diagnose it.
No
The device description explicitly lists hardware components such as "Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and power supply."
Based on the provided information, the Skylife™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of neonatal unconjugated hyperbilirubinemia through phototherapy. IVDs are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body.
- Device Description: The device description details a phototherapy light system that delivers light to the baby's skin to break down bilirubin. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens (like blood, urine, etc.), which are fundamental to IVDs.
Therefore, Skylife™ is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
Skylife™ is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. Skylife™ is designed to provide phototherapy treatment from underneath the baby. The system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator.
Skylife™ utilizes blue LEDs to achieve intensities from 25 uW/cm²/nm to >55 uW/cm²/nm, emitting light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin. Skylife™ utilizes blue LEDs in this range to achieve peak intensities between 25 to 35, and over 55 uw/cm²/nm at low, high settings. Skylife™ at the Very High setting provides an average intensity of 56.3 uw/cm/nm over the treatment area with peak at 72.4 uw /cm-/nm.
Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using Skylife™ can be applied at home or in a hospital.
Skylife™ consists of the following components: Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and 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 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 performance tests were performed. These included:
- Electrical safety and electromagnetic compatibility.
- Biocompatibility of patient contacting materials
- Human Factors Usability
Key results:
Biocompatibility of Materials: The materials tested were found to be non-cytotoxic, non-sensitizers, and non-irritants.
Human Factors and Usability: The human factors and usability study was conducted with 2 user groups to validate the usability of Skylife™ in a healthcare and home environment. The results of the study support the instructions for successfully using the device as intended. The results of human factors and usability study substantiates the acceptability of the risks identified during the risk assessment activities.
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
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 is 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.
October 27, 2017
NeoLight. LLC % Paul E. Dryden Regulatory Consultant ProMedic, LLC 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K170585
Trade/Device Name: Skylife™ Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal phototherapy unit Regulatory Class: Class II Product Code: LBI Dated: September 23, 2017 Received: September 26, 2017
Dear Paul E. Dryden:
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 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.
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
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)
K170585
Device Name
Skylife™
Indications for Use (Describe)
Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. Skylife™ can be used in a clinical setting or in the home.
Type of Use (Select one or both, as applicable)
| XX Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary NeoLight, LLC - Skylife™ Page 1 of 7
| Date Prepared | October 25, 2017 |
|---|---|
| 1 – SUBMITTER | NeoLight, LLC. |
| 1475 N Scottsdale Rd, Suite 200 | |
| Scottsdale AZ 85257 | |
| Telephone (480) 754-9681 | |
| 2 – CONTACT PERSON | Sivakumar Palaniswamy |
| Chief Technology Officer |
3 - DEVICE CLASSIFICATION
| Trade/Proprietary Name: | Skylife™ |
|---|---|
| Common Name: | Neonatal phototherapy device unit |
| Classification Name: | Neonatal phototherapy |
| Regulation: | (21 CFR 880.5700) |
| Product Code: | LBI |
| Regulatory Class: | II |
Telephone (480) 754-9681
4 - PREDICATE DEVICES
| Primary Predicate: | K051869 – neoBLUE cozy LED Phototherapy System, Natus Medical, Inc |
|---|---|
| Secondary Predicate: | K011549 – Ohmeda Medical Spot PT Lite Phototherapy System, Ohmeda |
| Medical |
5 - DEVICE DESCRIPTION
Skylife™ is a portable phototherapy light system that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal unconjugated hyperbilirubinemia. Skylife™ is designed to provide phototherapy treatment from underneath the baby. The system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator.
Skylife™ utilizes blue LEDs to achieve intensities from 25 uW/cm²/nm to >55 uW/cm²/nm, emitting light in a narrow bandwidth between 430-475 nm. This light bandwidth corresponds to the spectral absorption of light by bilirubin. Skylife™ utilizes blue LEDs in this range to achieve peak intensities between 25 to 35, and over 55 uw/cm²/nm at low, high settings. Skylife™ at the Very High setting provides an average intensity of 56.3 uw/cm/nm over the treatment area with peak at 72.4 uw /cm-/nm.
Treatment is intended to be applied until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Phototherapy treatment of neonatal jaundice using Skylife™ can be applied at home or in a hospital.
Skylife™ consists of the following components: Light bed and light modules, GelMat, disposable mattress cover (Cloud Swaddle), controller, and power supply.
6 - INDICATIONS FOR USE
Skylife™ is intended for the treatment of neonatal unconjugated hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. Skylife™ must be used within a patient enclosure, such as a bassinet, an open crib, a warming table, or an incubator. Skylife™ can be used in a clinical setting or in the home.
4
510(k) Summary NeoLight, LLC - Skylife™ Page 2 of 7
7 - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The intended use, design, materials, and functional characteristics of Skylife™ and the predicate device are substantially equivalent. The subject device and predicate device provide phototherapy for treatment of neonatal unconjugated hyperbilirubinemia (jaundice), are portable, and intended for home and healthcare environment use. Both devices use the same operating principle to deliver light to degrade bilirubin. In both devices, the user (caregiver) selects the desired treatment intensity as prescribed by a physician.
The following table summarizes the technological characteristics of the subject device and predicate devices.:
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510(k) Summary NeoLight, LLC - Skylife™ Page 3 of 7
| Features | Subject Device-
Skylife™ | Primary Predicate Device-
neoBLUE cozy LED Phototherapy
System - K051869 | Secondary Predicate Device-
Ohmeda Medical Spot PT Lite
Phototherapy System - K011549 | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of neonatal
hyperbilirubinemia | Similar to the subject
device | Similar to the subject
device | |
| Indications for use | Skylife™ is intended for the treatment of
neonatal unconjugated hyperbilirubinemia. It is
designed to provide phototherapy treatment
from underneath the baby. Skylife™ must be
used within a patient enclosure, such as
bassinet, an open crib, a warming table or an
incubator. Skylife™ can be used in a clinical
setting or in the home. | 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 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. | The Spot PT Lite Phototherapy System provides
light therapy for the treatment of
hyperbilirubinemia, commonly known as neonatal
jaundice, during the newborn period in the
hospital. | |
| Treatment modes | Under-baby phototherapy | Under-baby phototherapy | Overhead neonatal, phototherapy device | |
| Targeted
population | Neonates | Neonates | Neonates | |
| Sites of use | Clinical setting and home use | Clinical setting and home use | Clinical setting | |
| | Specifications | | | |
| Type of device | Free standing device | Free standing device | Overhanging device | |
| Type of light | Blue light LED | Blue light LED | White metal halide Bulb | |
| Intensity | 25-35 $μW/cm^2/nm$ , Low setting
35-55 $μW/cm^2/nm$ , High setting
55 $μW/cm^2/nm$ , Very high setting | 30 – 35 $μW/ cm^2/nm$ | 57.6 $μW/cm^2/nm$ ± 25% | |
| Height | 4.86 cm (1.913 in) | ≤ 12.7 cm (5.0 in) | Variable | |
| Width and length | 60.80 cm x 31.12 cm (23.94 in x 12.25 in) | 30.5 cm x 64.8 cm (12 in x 25.5 in) | 20 cm x 30 cm (7.9 in x 11.8 in) | |
| Weight | 55 μw/
cm²/nm (avg 56.3 μw/
cm²/nm, max 72.4 μw/
cm²/nm) | 30 – 35 μW/cm²/nm | 57.6 μW/cm²/nm ± 25%
(43.2 – 72 μW/cm²/nm) | Differences between the subject and predicates:
The subject device has an intensity range 25-55 and
55 μw/cm²/nm. This range is higher than the range
of the predicates, and i which have an upper
intensity range of 72 μw/cm²/nm, based upon their
specification.
This difference does not raise new questions of
safety or effectiveness for the subject device. |
| ---------------- | ----------- | ------------------------------------------------------------------------------ | ------------------- | ----------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The differences in the technological characteristics™ and the predicate device do not raise of safety or effectiveness.
9 - PERFORMANCE DATA
The following performance tests were performed. These included:
- Electrical safety and electromagnetic compatibility .
- Biocompatibility of patient contacting materials ●
- Human Factors Usability
Skylife™ was tested per the following standards:
- IEC 60601-1: 2005, 3rd Edition, Medical Electrical Equipments for basic safety and essential performance .
- IEC 60601-1-2: 2014, 4th Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance -Collateral . standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-50: 2009, 2nd Edition, Medical Electrical Equipment Part 2-50: Medical electrical equipment Part 2-50: Particular requirements . for the safety of infant phototherapy equipment
- . IEC 60601-1-11: 2015, 2nd Edition, Medical Electrical Equipments for basic safety and essential performance-Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-6: 2010, 3rd Edition, General requirements for basic safety and essential performance Collateral standard: Usability .
- IEC 62366:2007, 1st Edition, Medical devices -- Application of usability engineering to medical devices ●
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510(k) Summary NeoLight, LLC - Skylife™ Page 7 of 7
- IEC 60601-1-8: 2006, Medical electrical equipment -- Part 1-8: General requirements for basic . safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Biocompatibility of Materials -
ISO 10993-1 specifies the patient contacting materials as Surface Contact, Skin, Prolonged Contact (> 24 hours,