(122 days)
Not Found
No
The description details a standard phototherapy lamp with LED technology and basic controls (timers, indicators). There is no mention of AI, ML, image processing, or any features that would suggest adaptive learning or complex algorithmic decision-making based on patient data. The "Microprocessor" likely refers to basic control logic, not AI/ML.
Yes
The device is described as "intended for the treatment for neonatal hyperbilirubinemia," which is a therapeutic purpose.
No
The device is a phototherapy lamp intended for treatment, not for diagnosing a condition.
No
The device description clearly outlines physical hardware components such as LEDs, a rolling base, column, mobile head, and controls, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the MediLED Phototherapy Lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The MediLED Phototherapy Lamp is used to treat neonatal hyperbilirubinemia by applying light directly to the patient's skin. It does not involve the analysis of blood, urine, tissue, or any other biological sample.
- The intended use is treatment, not diagnosis. The device is explicitly indicated for the "treatment for neonatal hyperbilirubinemia." IVD devices are used to diagnose or aid in the diagnosis of conditions.
- The device description focuses on light emission and physical features. The description details the LEDs, adjustments, and controls related to delivering phototherapy, not analyzing biological samples.
Therefore, the MediLED Phototherapy Lamp falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.
Product codes
LBI
Device Description
The Medix MediLED is neonatal phototherapy equipment with blue and white LEDs, incorporating height and angle adjustments. The device is labeled and indicated for: treatment for neonatal hyperbilirubinemia. The device is intended for use in healthcare professionals in a clinical setting.
Fitted with a rolling base with brakes, column, and mobile head containing the equipment's electronics. The design allows the equipment to be used with incubators, infant warmers or cradles of all type and brand.
Features:
- Microprocessor mobile phototherapy equipment. (mobile stand with brakes) .
- Ideal for use in incubators, cribs and infant warmers .
- High brightness LED technology: led quantity 492 Blues ,108 whites. .
- Total Hour meter (LED useful life) and partial time (treatment). .
- Technical Service Indicator. .
- Examination light. .
- It is possible to maneuver with all LEDs on. .
- Continuous height shift by means of an actuator .
- Headlight positioning without the use of a tool .
Commands are found on the front of the equipment's head, consisting of three keys, two of which allow to operate separately blue from white LEDs, making it possible to check the patient's real skin color or perform interventions under white light. By turning on the blue LEDs, total and treatment counters are enabled. These indicate the total and treatment time of the phototherapy unit. The third key (reset) is used to restore the treatment counter. It also has two indicators; a green one showing the equipment is connected to the power supply and ready to be used, and a yellow one indicating the need of technical service assistance.
Blue LEDs do not emit significant ultraviolet (UV) neither infrared (IR) energy, resulting in no risk of UV, IR exposure nor excessive warming up for the patient.
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
healthcare professionals in a clinical setting.
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 MediLED Phototherapy Lamp has been tested and meets the requirements of the following Standards:
- IEC 60601-1-2 .
- IEC 60601-1 .
- EN 60606-1-2-50 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
C083179
Summary
EB 2 7 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the MediLED Phototherapy Lamp.
1. Company making the submission:
| Name: | Medix I.C.S.A. |
|---|---|
| Address: | Jose Arias 293, Villa Lynch, San |
| Martin | |
| Buenos Aires, 1672 Argentina | |
| Telephone: | +54-11 4754 5555 |
| Fax: | +54-11 4754 1713 |
| Contact: | Analia Gaidimauskas |
| E-mail: | agaidimauskas@medix.com.ar |
| U.S. Agent: | Delphi Consulting Group |
| Address: | 11874 South Evelyn Circle |
| Houston, Texas 77071-3404 | |
| Telephone: | 713-723-4080 |
| Fax: | 713-723-0786 |
| Contact: | J. Harvey Knauss |
| E-mail: | harvey.knauss@gmail.com |
Device Name: 2.
| Trade/Proprietary Name: | Unit, Neonatal Phototherapy |
|---|---|
| Common/Usual Name: | Neonatal Phototherapy Lamp |
| Proprietary Name: | MediLED Phototherapy Lamp |
| Regulation Number: | 880.5700, Class II |
| Product Code: | LBI |
3. Predicate Devices:
The MediLED Phototherapy Lamp is substantially equivalent to the Natus Blue Light Phototherapy Unit [K022196].
Intended Use Statement: 4.
INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.
1
5. Description of Device:
The Medix MediLED is neonatal phototherapy equipment with blue and white LEDs, incorporating height and angle adjustments. The device is labeled and indicated for: treatment for neonatal hyperbilirubinemia. The device is intended for use in healthcare professionals in a clinical setting.
Fitted with a rolling base with brakes, column, and mobile head containing the equipment's electronics. The design allows the equipment to be used with incubators, infant warmers or cradles of all type and brand.
Features:
- Microprocessor mobile phototherapy equipment. (mobile stand with brakes) .
- Ideal for use in incubators, cribs and infant warmers .
- High brightness LED technology: led quantity 492 Blues ,108 whites. .
- Total Hour meter (LED useful life) and partial time (treatment). .
- Technical Service Indicator. .
- Examination light. .
- It is possible to maneuver with all LEDs on. .
- Continuous height shift by means of an actuator .
- Headlight positioning without the use of a tool .
Commands are found on the front of the equipment's head, consisting of three keys, two of which allow to operate separately blue from white LEDs, making it possible to check the patient's real skin color or perform interventions under white light. By turning on the blue LEDs, total and treatment counters are enabled. These indicate the total and treatment time of the phototherapy unit. The third key (reset) is used to restore the treatment counter. It also has two indicators; a green one showing the equipment is connected to the power supply and ready to be used, and a yellow one indicating the need of technical service assistance.
Blue LEDs do not emit significant ultraviolet (UV) neither infrared (IR) energy, resulting in no risk of UV, IR exposure nor excessive warming up for the patient.
| Treatment Light | ||||
|---|---|---|---|---|
| Distance [cm] | White + Blue | |||
| [uW/cm2/nm] | Blue [uW/cm2/nm] | White [uW/cm2/nm] | Effective Surface | |
| Length x Width [cm] | ||||
| 30cm | 49 | 44 | 5 | 37x19 |
| 40cm | 40 | 36 | 4 | 40x21 |
| 50cm | 33 | 30 | 3 | 46x24 |
Examination light
| Distance [cm] | Illuminance [Lux] | Light area
Length x Width [cm] |
|---------------|-------------------|-----------------------------------|
| 30 | 3600 | 32x21 |
| 40 | 2600 | |
| 50 | 2000 | |
2
Summary of the technological characteristics of the device compared to 6. predicate devices:
The difference from the predicate device is the method of application, the predicate device is under baby phototherapy. The MediLED Phototherapy Lamp is overhead phototherapy.
The predicate device is labeled for Home use, the MediLED Phototherapy Lamp is not.
The basic method of construction and materials is very similar. The methods of operation and indications for use are the same.
Testing: 7.
The MediLED Phototherapy Lamp has been tested and meets the requirements of the following Standards:
- IEC 60601-1-2 .
- IEC 60601-1 .
- EN 60606-1-2-50 .
8. Rx or OTC
The MediLED Phototherapy Lamp is an Rx prescription device per 21 CFR Subpart D. The indication for use is for clinical setting only.
9. Conclusions:
The MediLED Phototherapy Lamp is substantially equivalent to the predicate device in the scope of practical application, effectiveness at this application, and ensuring the safety of its subject.
MediLED Phototherapy Lamp does not raise any new safety or effectiveness issues.
Medix, I.C.S.A.
Enq. Juan Carlos Guerra Vice President & CEO
Date:
Section 5 510(k) Submission Page #
Summary doc Belphi Consulting Group
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 features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medix I.C.S.A. C/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071
FEB 2 7 2009
K083179 Re:
Trade/Device, Name: MediLED Phototherapy Lamp Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: February 11, 2009 Received: February 13, 2009
Dear Mr. Knauss:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Knauss
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony, D. Ausatz, Jr.
Ginette Y. Michaud, M.D. Acting 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 Statement
510(k) Number___
Device Name: MediLED Phototherapy Lamp
INDICATIONS FOR USE: The MediLED Phototherapy Lamp is intended for the treatment for neonatal hyperbilirubinemia. The device is intended for use by healthcare professionals in a clinical setting.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sle lelk
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K093179 510(k) Number:
02_Indications_for_Use.doc