(241 days)
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.
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.
The NeoLight Skylife™ phototherapy unit for neonatal unconjugated hyperbilirubinemia underwent performance testing to demonstrate its substantial equivalence to predicate devices. The studies focused on electrical safety, electromagnetic compatibility, biocompatibility, and human factors usability.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1: 2005, 3rd Edition (Medical Electrical Equipments for basic safety and essential performance) | Device met the standard. |
| IEC 60601-1-2: 2014, 4th Edition (Electromagnetic compatibility - Requirements and tests) | Device met the standard. | |
| IEC 60601-2-50: 2009, 2nd Edition (Particular requirements for the safety of infant phototherapy equipment) | Device met the standard. | |
| IEC 60601-1-11: 2015, 2nd Edition (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | Device met the standard. | |
| IEC 60601-1-8: 2006 (General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) | Device met the standard. | |
| Biocompatibility | ISO 10993-1 (Surface Contact, Skin, Prolonged Contact (> 24 hours, < 30 days)) | Materials were found to be non-cytotoxic, non-sensitizers, and non-irritants. |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Materials were found to be non-cytotoxic. | |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Materials were found to be non-sensitizers and non-irritants. | |
| Human Factors Usability | IEC 60601-1-6: 2010, 3rd Edition (General requirements for basic safety and essential performance Collateral standard: Usability) | The study supported the instructions for successfully using the device as intended. |
| IEC 62366:2007, 1st Edition (Medical devices -- Application of usability engineering to medical devices) | The study supported the instructions for successfully using the device as intended and substantiated the acceptability of identified risks. | |
| Light Range Intensity (Device Specification) | 25-55 μW/cm²/nm (Low and High settings); >55 μW/cm²/nm (Very High setting, avg 56.3 μW/cm²/nm, max 72.4 μW/cm²/nm) | This is a specification, not an acceptance criterion from a performance test against a standard in this section. However, the document states this range is comparable or higher than predicates and does not raise new questions of safety or effectiveness. |
| Wavelength (Device Specification) | 430 – 475 nm (453 - 460 nm typical peak) | This is a specification. Wavelength range and peak wavelengths overlap with predicate devices, thus not raising new safety/efficacy questions. |
2. Sample Sizes Used for the Test Set and Data Provenance
The provided document refers to various performance tests against international standards (IEC and ISO). These types of tests typically involve specific sample sizes prescribed by the standards for evaluating materials, electrical components, and hardware. However, the exact numerical sample sizes for each specific test (e.g., number of units tested for electrical safety, number of material samples for biocompatibility) are not explicitly stated in this summary.
For the Human Factors Usability study:
- Number of participants: 2 user groups
- Data provenance: Not explicitly stated, but based on the nature of human factors usability, it would be prospective data collection (users interacting with the device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the technical performance tests (electrical safety, EMC, biocompatibility), the "ground truth" is established by adherence to the specified international standards. The evaluation is typically performed by trained engineers and technicians in accredited testing facilities. The document does not specify the number or qualifications of experts explicitly.
For the Human Factors Usability study:
- The document implies that the study was conducted by human factors experts. However, the number of experts used to establish "ground truth" (e.g., identifying usability issues or defining successful use) and their specific qualifications are not provided. The "ground truth" for usability is generally derived from user performance and expert observation against established usability principles.
4. Adjudication Method for the Test Set
The document does not describe specific adjudication methods for the performance tests in the context of clinical endpoints or expert review. For objective technical tests, the results either meet the standard's criteria or they don't, often without a need for "adjudication" in the sense of resolving inter-rater disagreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
No, the provided document does not describe an MRMC comparative effectiveness study, nor does it mention AI in any context. This device is a phototherapy unit, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, as mentioned, this device is a phototherapy unit and does not involve an algorithm or AI for standalone performance evaluation in that manner.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For Electrical Safety, EMC, and Safety of Infant Phototherapy Equipment: The ground truth is established by the requirements and methodologies defined within the respective IEC standards. Compliance with these standards indicates safety and essential performance.
- For Biocompatibility: The ground truth is established by the requirements and testing protocols defined within the ISO 10993 series of standards. Non-cytotoxicity, non-sensitization, and non-irritation are the "ground truth" criteria.
- For Human Factors Usability: The ground truth is established by the requirements of IEC 60601-1-6 and IEC 62366, which focus on preventing use errors and ensuring that the device can be used safely and effectively as intended. User performance during the study, observed errors, and successful task completion against defined criteria form the basis of the ground truth.
8. The Sample Size for the Training Set
This information is not applicable as the device is a phototherapy unit and does not rely on a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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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.
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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 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
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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 200Scottsdale AZ 85257Telephone (480) 754-9681 |
| 2 – CONTACT PERSON | Sivakumar PalaniswamyChief 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, OhmedaMedical |
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.
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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 PhototherapySystem - K051869 | Secondary Predicate Device-Ohmeda Medical Spot PT LitePhototherapy System - K011549 | |
|---|---|---|---|---|
| Intended Use | Treatment of neonatalhyperbilirubinemia | Similar to the subjectdevice | Similar to the subjectdevice | |
| Indications for use | Skylife™ is intended for the treatment ofneonatal unconjugated hyperbilirubinemia. It isdesigned to provide phototherapy treatmentfrom underneath the baby. Skylife™ must beused within a patient enclosure, such asbassinet, an open crib, a warming table or anincubator. Skylife™ can be used in a clinicalsetting or in the home. | The neoBLUE cozy phototherapy light is intendedfor the treatment for neonatal hyperbilirubinemia.It is designed to provide phototherapy treatmentfrom underneath the baby. The neoBLUE cozysystem must be used within a patient enclosure,such as bassinet, an open crib, a warming table oran incubator. The neoBLUE cozy system can beused in a clinical setting or in the home. | The Spot PT Lite Phototherapy System provideslight therapy for the treatment ofhyperbilirubinemia, commonly known as neonataljaundice, during the newborn period in thehospital. | |
| Treatment modes | Under-baby phototherapy | Under-baby phototherapy | Overhead neonatal, phototherapy device | |
| Targetedpopulation | 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 setting35-55 $μW/cm^2/nm$ , 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 | <4.99 kg (<11 lbs) | < 4.3 kg (9.5 lbs) | 4.2 kg (9.26 lbs) | |
| Treatment area | 769 $cm^2$ (119.2 $in^2$ ) | Minimum 613 $cm^2$ (95 $in^2$ ) | 315 $cm^2$ (48.8 $in^2$ ) | |
| Materials | ||||
| Device/ bed | ABS bed casing with acrylic sheet | Polycarbonate cover and polyurethane base | Not Applicable | |
| Mattress (gel mat) | Polyurethane cover filled with polyurethane gel | Polyurethane cover with polyolefin bubblecushioning | Not Applicable | |
| Mattress cover | Polypropylene fabric - disposable | Nonwoven spunlaced polyester - disposable | Not Applicable | |
| Patient sidecushioning | Polyester fiber cushion with polypropylenefabric foot bumper and restrainers | Foam bumper encasedby 100% cotton fabric | Not Applicable | |
| Features | Subject Device-Skylife™ | Primary Predicate Device -neoBLUE cozy LED PhototherapySystem - K051869 | Secondary Predicate Device -Ohmeda Medical Spot PT LitePhototherapy System - K011549 | |
| Miscellaneous | ||||
| Shape | Rectangular | Oval with flat end at foot area | Rectangular with Goose neck for overhead treatment | |
| Portable | Portable | Portable | Requires a structure for installation | |
| Patient side | Polyester fiber cushion with polypropylenefabric foot bumper and restrainers | Foam bumper encased by 100% cotton fabric | Overhead Device; no patient contact | |
| Applicable standards and Safety Features | ||||
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC 60601-2-50 | EN 60606-1 UL 2601-1EaveN 60606-1CSA C22.2 601.1EN 60601-2-50 | IEC 60601-1-2:2004;UL 60601-1:2003: IEC 60601-1:1998:CAN/CSA 601-1M90Self-certified to IEC 60601-2-50, 2000 | |
| Mechanical safety | Disposable coverMattress acts as diffuser to minimizeaccidental viewing of single point light source.Disposable cover has restrainers to restrictpatient's movement | Disposable coverPlastic diffuser acts as a diffuser to minimizeaccidental viewing of single point light source | Overhead device; Nopatient contact and always to be used with eyemask | |
| Thermal safety | Fan to cool circuitry, minimize device heating.Thermal protection circuit - turns off LEDs ifthe device gets too warm. | Fan to cool circuitry, minimize device heating.Thermal protection circuit - turns off LEDs if thedevice gets too warm. | Has fan at bottom of the device for coolingcircuitry; Continuous monitoring required whenused with warming tables, incubator and radiantwarmers | |
| Radiation safety | LED light source emits no significantultraviolet light | LED light source emits no significant ultravioletlight | Light source does not emit any significantultraviolet light | |
| Ingress of liquids | IP23 | IPX4 | Not Applicable | |
| Human Factors | ||||
| Controls andIndicators | On/Off switch.Indicators OverheatHigh/Low intensity light | On/Off switch.Indicators OverheatHigh/Low intensity light | On/Off switch.Indicators Overheat | |
| Compatibility withenvironmentand otherdevices | Used inside bassinet, opencrib, warmer table, incubator | Used inside bassinet, opencrib, warmer table, incubator | Used along with bassinet, open crib, warmer tableincubator: Requires a support structure to mount | |
| Subject device, Skylife™ System | Primary Predicate Device -neoBLUE cozy LED | Secondary Predicate Device -Ohmeda Medical Spot | Discussion | |
| Phototherapy System -K051869 | PT Lite Phototherapy System - K011549 | |||
| Total number of LEDs/light | 14 | 480 | No LEDs, a metal halide bulb | Differences between the subject and the predicate devices: The construction of the device does not raise any questions related to safety and efficacy, since both the subject and predicates deliver light intensities in the similar ranges, at the patient's skin, to treat neonatal unconjugated |
| LED/light location | Two modules placed on the bed sides | Placed on one single panel | Above the bed on an adjustable gooseneck | efficacy, since both the subject and predicates deliver light intensities in the similar ranges, at the patient's skin, to treat neonatal unconjugated |
| Light orientation | Emitted upwards from sides of light bed | Emitted upwards from center of the bed | Emitted downwards from above towards the patient | hyperbilirubinemia. |
| Light intensity level | Three levels; Low, High, and Very High | One level | One level | |
| Wavelength | 430 – 475 nm453 - 460 nm (typical peak) | 400 – 500 nm450 - 475 nm (typical peak) | 350 – 700 nm570 - 590 (typical peak) | Differences between the subject and the predicate devices: Wavelength range and peak wavelengths overlap. Hence this does not raise any questions for safety and efficacy. |
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510(k) Summary NeoLight, LLC - Skylife™ Page 4 of 7
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510(k) Summary NeoLight, LLC - Skylife™ Page 5 of 7
8 - DISCUSSION OF DIFFERENCES
Skylife™ specifically differs from the neoBLUE cozy Phototherapy System and Spot PT Lite Phototherapy System in the following areas:
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510(k) Summary NeoLight, LLC - Skylife™ Page 6 of 7
| Lightrange | intensity | 25-55 and >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 rangeof the predicates, and i which have an upperintensity range of 72 μw/cm²/nm, based upon theirspecification.This difference does not raise new questions ofsafety 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, < 30 days)
Testing included:
- . ISO 10993-5:2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices- Part 10: Tests for irritation and skin ● sensitization
Discussion - 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.
10 - SUBSTANTIAL EQUIVALENCE CONCLUSION
Based on the performance testing and the supporting documentation, it can be concluded that Skylife™ is substantially equivalent to the predicate devices.
§ 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).