(236 days)
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.
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
The MediLEDmini Phototherapy Lamp is designed for treating neonatal hyperbilirubinemia.
1. Acceptance Criteria and Reported Device Performance:
The document states that the MediLEDmini Phototherapy Lamp has been tested and meets the requirements of the following standards:
| Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| IEC 60601-1-2 | Compliance with Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. | Met the requirements of this standard. |
| IEC 60601-1 | Compliance with Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | Met the requirements of this standard. |
| EN 60606-1-2-50 | (Likely a typo or mislabeling) Should be IEC 60601-2-50 for Phototherapy equipment for newborns. Acceptance criteria would involve specific performance parameters for phototherapy devices. | Met the requirements of this standard (assuming it refers to the relevant phototherapy standard). |
Specifically for the phototherapy capabilities, the document provides the following performance data:
| Treatment Light | Parameter | Value |
|---|---|---|
| Distance | Blue [µW/cm²] | 50 |
| 50cm | Effective Surface Length x Width [cm] | 20 x 30 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding the specific sample size used for any clinical test set or the provenance of any data (e.g., country of origin, retrospective/prospective). The testing described appears to be related to engineering compliance with standards, not clinical performance studies involving a patient cohort.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
This information is not provided in the document. The document describes engineering testing against established standards, not a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the document does not describe a clinical study requiring adjudication of a test set. The reported testing is against established engineering safety and performance standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done according to the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable. The MediLEDmini Phototherapy Lamp is a physical medical device, not an algorithm or AI system for diagnostic or assistive purposes.
7. Type of Ground Truth Used:
The "ground truth" for the reported testing is the requirements and specifications outlined in the referenced international electrical and medical device standards (IEC 60601-1-2, IEC 60601-1, and likely IEC 60601-2-50). These standards define the acceptable safety and performance characteristics for such devices.
8. Sample Size for the Training Set:
This information is not applicable. The MediLEDmini Phototherapy Lamp is a hardware device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
{0}------------------------------------------------
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,TigreBuenos Aires, B1618EWCArgentina |
| Telephone: | +54-11 5354 3700 |
| Fax: | +54-11 5354 3721 |
| Contact: | Analia Gaidimauskas |
| E-mail: | agaidimauskas@medix.com.ar |
| U.S. Agent: | Natus Medical Incorporated |
| Address: | 1501 Industrial Road.San Carlos, CA 94070 |
| Telephone: | 650-801-7212 |
| Fax: | 650-802-0401 |
| Contact: | Michael Bobadilla |
| E-mail: | mobobadilla@natus.com |
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: +54-11-5354-3700 Fax: +54-11-5354-3721
{1}------------------------------------------------
Image /page/1/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 choice and the outlining contribute to the overall visual style of the word.
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 SurfaceLength x Width[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: +54-11-5354-3700 Fax: +54-11-5354-3721
{2}------------------------------------------------
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: +54-11-5354-3700 Fax: +54-11-5354-3721
{3}------------------------------------------------
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.
{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); 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 (800) 638-2041 or (301) 796-7100 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
{5}------------------------------------------------
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
Page 1 of 1
Indcations for use form.doc Celphi Consulting Group Houston, TX 77071
Section 4 510(k) Submission Page #
§ 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).