(108 days)
Not Found
No
The device description details a microprocessor controller for programming functions, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on safety and spectral characteristics, not algorithmic performance.
Yes
The device is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light, which is a therapeutic intervention.
No
Explanation: The device is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components such as an LED module, fan, microprocessor controller, display, keyboard, and physical mounting mechanisms (suction cups, trolley, arm). This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Drager NanoBlu 500 LED Phototherapy Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the patient's body. This is a therapeutic intervention applied directly to the patient, not a diagnostic test performed on samples taken from the patient.
- Device Description: The description details a light source and its mechanical components for positioning. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
Therefore, the Drager NanoBlu 500 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dräger NanoBlu 500 LED Phototherapy Light is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals. Additionally, this product can be used with an underbaby phototherapy light to increase patient coverage.
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
The Dräger NanoBlu 500 is an LED phototherapy light. It consists of an LED module with 5 LEDs and a fan, a microprocessor controller, and an alphanumeric display and keyboard. The display and keyboard are used to program the functions of the light.
The Dräger NanoBlu 500 is available in two versions, the hood mount and the trolley mount. The hood mount version has suction cups on the bottom that are used when placed on the top of an incubator.
The trolley mount version is mounted on a rolling trolley to allow use above an incubator or radiant warmer. The trolley consists of a base supported by three 2 in (5.08 cm) castors. A column, with an adjustable and articulating arm, connects them. Both of these features allow the light to be positioned for optimum light over the patient.
There are no single-use components or accessories for the NanoBlu™ 500.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body of the patient
Indicated Patient Age Range
neonatal
Intended User / Care Setting
healthcare professionals
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)
This submission includes the results of testing prototype devices to specifications, spectral characterization of the LED light source, and an analysis of the potential optical radiation hazard of the blue LED light source.
Testing was also performed to assess compliance to the following standards:
- IEC60601-1, Medical Electrical Equipment, Part 1: General Requirements . for Safety
- UL60601-1, Medical Electrical Equipment, Part 1: General Requirements . for Safety
- IEC60601-1-2, Medical Electrical Equipment, Part 1-2: General Require-. ments for Safety Collateral Standard: Electromagnetic Compatibility
- IEC60601-2-50, Medical Electrical Equipment, Part 2: Particular require-. ments for the Safety of Infant Phototherapy Equipment
The results were as expected and no new issues of safety or effectiveness were raised as a result of the nonclinical testing.
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
510(k) Summarv NanoBluTM 500
Dräger K1132.06
FEB 1 7 2012
510(k) Summary
acc. to 807.92
Draeger Medical Systems, Inc Submitter's Name and Address: 3135 Quarry Road Telford, PA 18969 USA
Contact Person:
Bryan Overton Phone: 215.660.2135 Fax: 215.721.5424
Date submission was prepared:
2011-10-31
Device Name:
Proprietary Name: Common Name: Classification Name: Regulation Number: Product Code: Class:
NanoBlu™ 500 Phototherapy Light, Bili Light Neonatal Phototherapy Unit 21 CRF 880.5700 LBI 2
Legally Marketed Device Identification: Natus® Blue Light Phototherapy, K022196
Device Description:
The Dräger NanoBlu 500 is an LED phototherapy light. It consists of an LED module with 5 LEDs and a fan, a microprocessor controller, and an alphanumeric display and keyboard. The display and keyboard are used to program the functions of the light.
The Dräger NanoBlu 500 is available in two versions, the hood mount and the trolley mount. The hood mount version has suction cups on the bottom that are used when placed on the top of an incubator.
The trolley mount version is mounted on a rolling trolley to allow use above an incubator or radiant warmer. The trolley consists of a base supported by three 2 in (5.08 cm) castors. A column, with an adjustable and articulating arm, connects them. Both of these features allow the light to be positioned for optimum light over the patient.
There are no single-use components or accessories for the NanoBlu™ 500.
Intended Use:
The Dräger NanoBlu 500 LED Phototherapy Light is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of
1
Image /page/1/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The letters are black and have a slightly pixelated appearance. The two dots above the "a" are also black and bold.
healthcare professionals. Additionally, this product can be used with an underbaby phototherapy light to increase patient coverage.
Predicate Devices:
510(k) Number K022196
Device Name Natus Blue Light Phototherapy Unit
Substantial Equivalence:
The NanoBlu™ 500 and the Natus® Blue Light Phototherapy Unit have the same intended use (treatment of hyperbilirubinemia), use the same operating principle (delivery of light to degrade bilirubin), and are similar in their hardware configuration. See the Comparison Table below for details.
| Feature | NanoBlu 500 | Natus® Blue Light
(K022196) |
|------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use | For the treatment of neonatal
hyperbilirubinemia | For the treatment of neo-
natal hyperbilirubinemia |
| Target population | Neonates | Neonates |
| Physical Design | | |
| Type | Freestanding device | Freestanding device |
| Mounting hardware | Roll Stand, 3 legs w/casters,
3
locking | Roll Stand, 5 legs
w/casters, 2
locking |
| Light attachment | Lights mounted in enclosure | Lights mounted in enclo-
sure |
| Performance | | |
| Light source | Light Emitting Diodes (LED) | Light Emitting Diodes
(LED) |
| Wavelength | 400-550.nm | 400-550 nm |
| Intensity | Minimum 40 μW/cm2·nm | 35 ± 3.5 pW/cm2/nm @
High setting |
| Electrical Require-
ments | | |
| Operating Voltage | 90 VAC to 240 VAC | 85 VAC to 264 VAC |
| Standards and Safety | | |
| Electrical Safety | IEC 60601 -1 and 1-1 -2
UL 60601-1
CSA/CAN C22.2 601.1
IEC 60601-2-50 | EN 60601 -1 and 1-1 -2
UL 2601-1
CSA/CAN C22.2 601.1
EN 60601 -2-50 |
Summary Comparison Table NanoBlu 500 vs. Natus® Blue Light
· Summary of Nonclinical Testing
2
Image /page/2/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The text is black and the background is white.
This submission includes the results of testing prototype devices to specifications, spectral characterization of the LED light source, and an analysis of the potential optical radiation hazard of the blue LED light source.
Testing was also performed to assess compliance to the following standards:
- IEC60601-1, Medical Electrical Equipment, Part 1: General Requirements . for Safety
- UL60601-1, Medical Electrical Equipment, Part 1: General Requirements . for Safety
- IEC60601-1-2, Medical Electrical Equipment, Part 1-2: General Require-. ments for Safety Collateral Standard: Electromagnetic Compatibility
- IEC60601-2-50, Medical Electrical Equipment, Part 2: Particular require-. ments for the Safety of Infant Phototherapy Equipment
Clinical Tests - Not Applicable
The results were as expected and no new issues of safety or effectiveness were raised as a result of the nonclinical testing.
Conclusions
Based on the data and information presented in this submission, the NanoBlu™ 500 Phototherapy Light is substantially equivalent to the currently legally marketed Natus® Blue Light Phototherapy Unit manufactured and distributed by Natus Medical, Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Bryan Overton Director, Quality Assurance & Compliance Draeger Medical Systems, Inc. 3135 Quarry Road Telford, Pennsylvania 18969
·FEB 1 7 2012
Re: K113206
Trade/Device Name: NanoBlu™ 500 Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: January 26, 2012 Received: January 27, 2012
Dear Mr. Overton:
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 Amendinents, or to ac rices that in tio Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 wire), it may of basyon . Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Overton
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. or the For of any voth 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 (reporting of increats 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 /ucm115809.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 Compilance: "Theo, provins 201CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to ad verse evelife ander and mo Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may obtain other geturers, International and Consumer Assistance at its toll-free Diviser (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
el
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
5
Indications for Use Form
Indications for Use
510(k) Number (if known): ____
Device Name: NanoBlu™ 500_
Indications for Use:
The Drager NanoBlu 500 LED Phototherapy Light is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
RSC Chape 2/15/12
(Division Sign-Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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