(157 days)
Not Found
No
The summary describes a phototherapy system based on LED and fiberoptic technology, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended for the "treatment of neonatal hyperbilirubinemia," which indicates a therapeutic purpose.
No
The device is described as a "phototherapy system" intended for "treatment of neonatal hyperbilirubinemia," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is composed of a "mobile light box coupled to a fiberoptic blanket," which are physical hardware components. The performance studies also detail testing related to biocompatibility, electrical safety, and light output, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the treatment of neonatal hyperbilirubinemia." This is a therapeutic treatment applied directly to the patient, not a test performed on a sample taken from the body to provide information about a physiological state or disease.
- Device Description: The device is a "neonatal phototherapy system composed of a mobile light box coupled to a fiberoptic blanket." This describes a physical device that delivers light therapy.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
A neonatal phototherapy system composed of a mobile light box coupled to a fiberoptic blanket. The re-usable fiberoptic blanket is covered with a mattress and a disposable cover.
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
It can be used in the 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)
Non-clinical Testing Performed: Biocompatibility tests performed per ISO 10993 for patient contacting materials (mattress and disposable cover). Bench tests performed to measure spectral output, light irradiance and effective surface treatment area. Electrical safety tests performed per IEC 60601-1 (2nd edition) and 60601-1-2 (EMI/EMC). Phototherapy safety and performance tests performed per IEC 60601-2-50 (1st edition).
Clinical Tests Performed: Not Applicable
Testing Summary: The mattress and disposable cover passed Cytotoxicity, Sensitization and Skin Irritation tests. The neoBLUE blanket LED Phototherapy System has been tested to ensure compliance with all appropriate sections of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-50. Using the method described in IEC 60601-2-50, the effective surface treatment area was measured to be 504 cm2 for the large blanket and 296 cm2 for the small blanket. In conclusion, data from the non-clinical tests and a comparison of the technology, device specifications, intended use, target population and other device features demonstrates that the neoBLUE blanket LED Phototherapy System is substantially equivalent to the predicate devices listed in Section 3.
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.
Olympic Bili-Lite Pad (K901987), Natus neoBLUE cozy LED Phototherapy System (K051869), BiliSoft Phototherapy System (K053568)
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
MAY 1 3 2011
5 – Summary of Safety and Effectiveness
As required by 21 CFR, part 807.92
| a) | 1. | Submitted By: | Natus Medical Incorporated
Olympic Medical Division
5900 First Avenue South
Seattle, WA 98108 |
|----|----|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Contact: | Julie Freed, Ph.D.
Senior Regulatory Affairs Specialist
P (206) 268-5170
F (206) 268-5104 |
| | | Date Summary
Prepared: | May 10, 2011 |
| | 2. | Proprietary Name: | neoBLUE® blanket LED Phototherapy System |
| | | Common/Usual
Name: | Neonatal phototherapy unit |
| | | Classification: | Class 2, Product Code LBI, 21CFR Part 880.5700 |
| | 3. | Predicate Device(s): | Olympic Bili-Lite Pad (K901987)
Natus neoBLUE cozy LED Phototherapy System (K051869)
BiliSoft Phototherapy System (K053568) |
| | 4. | Device Description: | A neonatal phototherapy system composed of a mobile light
box coupled to a fiberoptic blanket. The re-usable fiberoptic
blanket is covered with a mattress and a disposable cover. |
| | 5. | Intended 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. |
| | 6. | Technological
Characteristics: | The mobile light box is composed of a single "Large Format"
LED (light-emitting diode) with a peak wavelength of 460 nm.
A custom optic directs light from the LED into the fiberoptic
blanket. The power supply for the light box is exterior to the
light box and is connected by a cable.
The fiberoptic blanket is composed of high performance plastic
optical fibers enclosed in a vinyl material. A polyurethane
mattress is placed on top of the fiberoptic blanket. A
disposable cover made of non-woven polypropylene is placed
on top of the mattress. The fiberoptic blanket generates
sufficient light output to provide intensive phototherapy
(>30μW/cm²/nm). This light output is achieved for both the
large blanket and the small blanket.
Accessories sold with the neoBLUE blanket include the
mattress, the disposable covers, and a pole mounting clamp. |
| b) | 1. | Non-clinical Testing
Performed: | Biocompatibility tests performed per ISO 10993 for patient
contacting materials (mattress and disposable cover).
Bench tests performed to measure spectral output, light
irradiance and effective surface treatment area.
Electrical safety tests performed per IEC 60601-1 (2nd edition)
and 60601-1-2 (EMI/EMC).
Phototherapy safety and performance tests performed per IEC
60601-2-50 (1st edition). |
| | 2. | Clinical Tests
Performed: | Not Applicable |
| | 3. | Testing Summary: | The mattress and disposable cover passed Cytotoxicity,
Sensitization and Skin Irritation tests.
The neoBLUE blanket LED Phototherapy System has been
tested to ensure compliance with all appropriate sections of
IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-50.
Using the method described in IEC 60601-2-50, the effective
surface treatment area was measured to be 504 cm2 for the
large blanket and 296 cm2 for the small blanket.
In conclusion, data from the non-clinical tests and a
comparison of the technology, device specifications, intended
use, target population and other device features demonstrates
that the neoBLUE blanket LED Phototherapy System is
substantially equivalent to the predicate devices listed in
Section 3. |
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Dr. Julie Freed Senior Regulatory Affairs Specialist Natus Medical Incorporated Olympic Medical Division 5900 First Avenue South Seattle, Washington 98108
Re: K103589
Trade/Device Name: NeoBLUE Blanket LED Phototherapy System Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: LBI Product Code: II Dated: May 4, 2011 Received: May 5, 2011
Dear Dr. Freed:
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.
3
Page 2- Dr. Freed
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely · yours,
ho for
Anthony D. Watson, B.S., M.S., M.B.A. . Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: neoBLUE blanket LED Phototherapy System
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.
Prescription Use x Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rdlc Ch 5/1/1
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103589
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