MEDILED MINI

K103735 · Medix I.C.S.A. · LBI · Aug 15, 2011 · General Hospital

Device Facts

• Record ID: K103735
• Device Name: MEDILED MINI
• Applicant: Medix I.C.S.A.
• Product Code: LBI · General Hospital
• Decision Date: Aug 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

MediLEDmini Phototherapy Lamp treats neonatal hyperbilirubinemia; emits narrow-band blue light to degrade bilirubin. Designed for use with incubators, bassinets, or radiant warmers; compact form factor for space-constrained clinical environments. Operated by healthcare professionals. Device features three selectable light intensities (high, medium, low) to meet varying therapeutic needs. Cold LED light source avoids IR/UV radiation, preventing patient overheating. High-power output aims to reduce treatment duration and costs. Output is visual light directed at the patient; clinical decision-making based on bilirubin levels and standard neonatal care protocols.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1 and IEC 60601-1-2 standards. No clinical data provided.

Technological Characteristics

LED-based phototherapy lamp. Emits narrow-band blue light; no IR or UV radiation. Three intensity settings. Compact form factor for incubator integration. Complies with IEC 60601-1 and IEC 60601-1-2. Standalone device.

Indications for Use

Indicated for treatment of neonatal hyperbilirubinemia in infants. Used in clinical settings with infants in bassinets, incubators, open beds, or radiant warmers. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Natus Blue Light Phototherapy Unit (K022196)
• Medix MediLED Phototherapy Unit (K083179)

Submission Summary (Full Text)

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# AUG 1 5 2011

Image /page/0/Picture/1 description: The image shows the word "medix" in a stylized font. Below the word "medix" is the alphanumeric string "K103735". The word "Summary" is located below the alphanumeric string. The text is in black and the background is white.

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 MediLEDmini Phototherapy Lamp.

#### 1. Company making the submission:

| Name: | Medix I.C.S.A. |
|-------------|-------------------------------------------------------------------------------|
| Address: | Marcos Sastre 1675, El Talar,<br>Tigre<br>Buenos Aires, B1618EWC<br>Argentina |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact: | Analia Gaidimauskas |
| E-mail: | [e-mail] |
| U.S. Agent: | Natus Medical Incorporated |
| Address: | 1501 Industrial Road.<br>San Carlos, CA 94070 |
| Telephone: | 650-801-7212 |
| Fax: | 650-802-0401 |
| Contact: | Michael Bobadilla |
| E-mail: | [e-mail] |

#### 2. Device Name:

| 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 MediLEDmini Phototherapy Lamp is substantially equivalent to the Natus Blue Light Phototherapy Unit [K022196] and the Medix MediLED Phototherapy Unit [K083179].

#### Intended Use Statement: ব:

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.

> Marcos Sastre 1675 ( B 1 6 1 8 El Talar, Tigre Buenos Aires, Argentina Tel: [phone] Fax: [phone]

www.medix.com.ar

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### 5. Description of Device:

Medil EDmini is a LED Phototherapy lamp for neonatal use. It was specially crafted and designed to be used with incubators. Its small form size allows for great versatility without compromising powér, since it is one of the most powerful units in the market.

LED technology is so advanced that its cold light avoids overheating in patients since it does not emit IR or UV radiation. Its high power and therapeutic efficacy reduces treatment costs, allowing the patient to be discharged in less time than with conventional phototherapy.

lts small size and versatility is very useful in small environments and where space is a priority.

The unit has 3 light intensities to choose: high-medium-low in order to answer different treatment needs

| Treatment Light | | |
|-----------------|---------------|---------------------------------------------|
| Distance [cm] | Blue [µW/cm2] | Effective Surface<br>Length x Width<br>[cm] |
| 50cm | 50 | 20 x 30 |

### ד

### 6. Testing:

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 ●

### 7. 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.

#### 8. 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.

> Marcos Sasire 1675 (B1618EWC) El Talar, Tigre Buenos Aires, Argentina Tel: [phone] Fax: [phone]

www.medix.com.ar

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Image /page/2/Picture/0 description: The image shows the word "medix" in a stylized font. The letters are outlined in black, giving them a distinct appearance. The font is rounded and bold, making the word easily readable.

MediLED Phototherapy Lamp does not raise any new safety or effectiveness issues.

Medix, I.C.S.A.

Eng. Juan Carlos Guerra Vice President

Date: _

·

Marcos Sastre 1675 (81618EWC) El Talar, Tigre Buenos Aires, Argentina Tel: [phone] Fax: [phone]

www.medix.com.ar

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Image /page/3/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an abstract symbol, consisting of three curved lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medix I.C.S.A. C/O Mr. James H. Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071 - 3404

AUG 15 2011

Re: K103735

Trade/Device Name: MediLEDmini Phototherapy Lamp Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: July 27, 2011 Received: August 1, 2011

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. 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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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); 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/CDRHQffices/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 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 [phone] or [phone] or at its Internet address http://www.fda.gov /MedicalDevices/ResourcesforYou/Industry/default.htm.

` Sincerely yours,

. Anthony V. Anton

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 Statement

510(k) Number: K103735

Device Name: MediLEDmini Phototherapy Lamp

Indications for Use: The Medix MediLEDmini Phototherapy Lamp is intended for the treatment of neonatal hyperbilirubinemia. The device can be used with infants in a bassinet, incubator, open bed or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.

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)

Richard C. Chapman 8/15/11
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K/03735

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Indcations for use form.doc Celphi Consulting Group Houston, TX 77071

Section 4 510(k) Submission Page #