(108 days)
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. Additionally, this product can be used with an underbaby phototherapy light to increase patient coverage.
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.
The provided text is a 510(k) summary for the Dräger NanoBlu™ 500 Phototherapy Light, which is a device intended to treat neonatal hyperbilirubinemia.
Here's an analysis of the acceptance criteria and the study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly present a table of "acceptance criteria" in the way a clinical study might define primary and secondary endpoints. Instead, the "acceptance criteria" are implied by the performance characteristics compared to the predicate device and compliance with relevant standards. The "reported device performance" refers to the NanoBlu 500's specifications as stated in the submission.
| Feature | Acceptance Criteria (Implied by Predicate/Standards) | NanoBlu™ 500 Reported Performance |
|---|---|---|
| Intended Use | Treat neonatal hyperbilirubinemia | Treat neonatal hyperbilirubinemia |
| Target Population | Neonates | Neonates |
| Light Source | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Wavelength | 400-550 nm | 400-550 nm |
| Intensity | Similar to predicate (35 ± 3.5 μW/cm²·nm @ High) | Minimum 40 μW/cm²·nm |
| Electrical Safety | IEC 60601-1, UL 60601-1, CSA/CAN C22.2 601.1 | Compliant with these standards |
| EMC | IEC 60601-1-2 | Compliant with this standard |
| Infant Phototherapy Specific Safety | IEC 60601-2-50 | Compliant with this standard |
2. Sample size used for the test set and the data provenance
The document describes nonclinical testing of "prototype devices" and does not refer to a "test set" in the context of patient data or clinical samples. It focuses on engineering and performance testing. Therefore, there is no patient-based sample size mentioned, nor is there data provenance in terms of country of origin or retrospective/prospective status for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission describes nonclinical testing, not a clinical study involving ground truth established by experts.
4. Adjudication method for the test set
This information is not applicable as the submission describes nonclinical testing, not a clinical study requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a phototherapy light, not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The NanoBlu 500 is a hardware device for phototherapy, not an algorithm, and the testing described is of its physical and performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing described, the "ground truth" would be established by reference standards, engineering specifications, and the specified requirements of the medical device standards (e.g., IEC, UL). There is no clinical ground truth (like expert consensus, pathology, or outcomes data) mentioned as this was a nonclinical submission.
8. The sample size for the training set
This information is not applicable as no "training set" in the context of machine learning or clinical data is mentioned. The testing involved prototype devices and compliance checks.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as above. There was no training set.
Summary of the Study:
The study described in this 510(k) summary is a nonclinical performance and safety evaluation of the NanoBlu™ 500 Phototherapy Light. The "study" involved:
- Testing prototype devices to specifications: This likely involved verifying manufacturing tolerances, functionality, and specific performance metrics.
- Spectral characterization of the LED light source: Measuring the actual light output spectrum (wavelengths) to ensure it falls within the therapeutic range (400-550 nm).
- Analysis of the potential optical radiation hazard: Assessing the safety of the light output to ensure it does not pose undue risks to patients or users.
- Compliance testing against international and national standards:
- IEC 60601-1 (General Safety for Medical Electrical Equipment)
- UL 60601-1 (General Safety for Medical Electrical Equipment, US specific)
- IEC 60601-1-2 (Electromagnetic Compatibility - EMC)
- IEC 60601-2-50 (Particular Safety Requirements for Infant Phototherapy Equipment)
The purpose of these tests was to demonstrate substantial equivalence to a predicate device (Natus® Blue Light Phototherapy) by showing similar intended use, operating principles, hardware configuration, and comparable performance and safety characteristics. The conclusion was that the device meets expectations and raises no new safety or effectiveness issues based on this nonclinical testing. No clinical studies were conducted or deemed necessary for this 510(k) submission.
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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
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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 neonatalhyperbilirubinemia | 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,3locking | Roll Stand, 5 legsw/casters, 2locking |
| 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 -2UL 60601-1CSA/CAN C22.2 601.1IEC 60601-2-50 | EN 60601 -1 and 1-1 -2UL 2601-1CSA/CAN C22.2 601.1EN 60601 -2-50 |
Summary Comparison Table NanoBlu 500 vs. Natus® Blue Light
· Summary of Nonclinical Testing
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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:
Page of
§ 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).