NATUS BLUE LIGHT PHOTOTHERAPY UNIT

{0}------------------------------------------------ KO 22196 #### 510(k) Summary of Safety and Effectiveness 8 This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: ## 1. Submitter Natus Medical Inc. 1501 Industrial Road San Carlos, CA 94070 650) 802-0400 Phone: 650) 802-6600 Fax: Contact Date Prepared: Sheila Ramerman, Director RA/QA July 3, 2002 #### 2. Device Names Classification name Common names Trade name Unit, Neonatal Phototherapy Phototherapy Light, Bili Light Natus® Blue Light Phototherapy Unit #### 3. Predicate Device Olympic Bili-Light, Model 33, K940996 #### 4. Device Description The Natus Blue Light Phototherapy Unit is a floor-standing, mobile phototherapy device that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The device consists of a lightweight plastic light enclosure that can be tilted and adjusted both horizontally and vertically on a rollstand assembly. The light enclosure can be tilted to a maximum of approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the rollstand post, as well as horizontally out from the rollstand post (proximity adjustment) to aid in positioning the device. A red target light can be briefly illuminated by the user, using a rocker switch on the front panel, to help position the device over the infant. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. There are two intensity settings, high and low. The user selects the desired setting using a rocker switch on the front panel of the device. The light output is optimized to provide an average intensity of 35 uW/cm-/nm at the high setting and 15 uW/cm-/nm at the low setting at 30 cm (12 inches) distance from the baby. A diffuser panel provides a more uniform illumination pattern from the multiple LED Natus Blue Light Phototherapy Unit - July 3, 2002 Natus Medical Inc. 1501 Industrial Road, San Carlos, CA 94070-4111 650-802-0400 FAX 650-802-6620 {1}------------------------------------------------ light sources, and protects the user from viewing a single point source of light. The diffuser panel also protects the device from incidental debris or fluid exposure. Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin. and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, so there is no concern about IR exposure and excessive warming of the infant. As with all phototherapy devices, protective eye shades should be used to protect the infant's eyes from excessive light exposure. LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. Instructions for adjusting the output are included in the User Manual (see Appendix A). A drawing of the location of the location of the potentiometers is included in Appendix C. In normal operating conditions the device is expected to operate as specified approximately 10,000 hours at the low setting, and approximately 3,000 hours at the high setting. No pre-aging of the LEDs is required; the LEDs are 'burned in' at the factory. The Natus Blue Light device is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure. There are no single-use components or accessories for the Natus Blue Light Phototherapy device. #### 5. Intended Use The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for 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 degradation of bilirubin. #### 6. Comparison with Predicate Device The Natus Blue Light Phototherapy Unit and the Olympic Bili-Lite Model 33 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. {2}------------------------------------------------ | Natus® Blue Light vs. Olympic Bili-lite™ Model 33 | | | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Feature | Natus Blue Light | Olympic Bili-Lite (K940996) | | Intended Use | For the treatment of neonatal<br>hyperbilirubinemia | For the treatment of neonatal<br>hyperbilirubinemia | | Target population | Neonates | Neonates | | Sites of use | Nursery, doctor's office,<br>anywhere phototherapy is<br>delivered | Nursery, doctor's office,<br>anywhere phototherapy is<br>delivered | | Physical Design | | | | Type | Freestanding device | Freestanding device | | Mounting hardware | Roll Stand, 5 legs w/casters, 2<br>locking | Roll Stand, 4 legs w/casters | | Light attachment | Lights mounted in hood enclosure | Lights mounted in hood<br>enclosure | | Width, light enclosure | 20.5 in (52 cm) | 25 in (63.5 cm) | | Depth, light enclosure | 10.5 in (27cm) | 19 in (48 cm) | | Weight (light on stand) | < 35 lb. (< 16kg) | Approx. 80 lbs (36 kg) | | Height | 43-60 in, adjustable | 43.5-60 in, adjustable | | Light enclosure tilt | Standard<br>0° to ~ 40° from horizontal | Optional<br>0° to 60° from horizontal | | Accessories | None | Tilt Attachment, Bili-timer | | Performance Specifications | | | | Light source | | | | • Type | • Light Emitting Diodes (LED) | • Fluorescent | | • Number | • Approx. 750 LEDs | • 8-20 W tubes | | • Life | • 10,000 hr (low setting)<br>3,000 hr (high setting) | • 200 hours minimum<br>9000 hour maximum | | • Color | • Blue | • Blue (standard configuration)<br>• White (daylight, optional)<br>• High-intensity blue (optional) | | Wavelength | 400-550 nm<br>Peak @ 450-475 nm | 400-520 nm<br>Peak: not stated | | Intensity | Low: 15 ± 2 μW/cm²/nm<br>High: 35 ± 3.5 μW/cm²/nm | 9 μW/cm²/nm (White bulbs)<br>20 μW/cm²/nm (Blue)<br>40 μW/cm²/nm (hi intensity) | | Light intensity adjustment | High/Low switch adjusts between<br>two levels of intensity | Adjust light enclosure height<br>(distance from baby) | | Operating Voltage | 85-264VAC | 106-127 VAC, 60 Hz or<br>194-233VAC, 50 Hz | | Overload protection (fuses) | 2A @ 120V | 2A @ 120V | | Current Leakage | < 100 uA | @120 VAC: < 100 uA<br>@220VAC: <150 uA | | Fan | 24 VDC Fan | Not applicable (no fan) | | Feature | Natus Blue Light | Olympic Bili-Lite (K940996) | | Acoustic Noise | < 35 dB | Not available | | Operating temperature | 50 - 86° F (10 - 30° C) | 60 - 99° F (15.5 - 37°C) | | Storage temperature | 23 - 122° F (-5 to +50° C) | -30 - +150° F (-34 to +65.5°C) | | Operating humidity | 10 to 90% non-condensing | 0% - 95% RH | | Storage humidity | 0 to 90% non-condensing | 0% - 95% RH | | Standards and Safety | | | | Electrical safety | EN 60601-1 and 1-1-2<br>UL 2601-1<br>CSA/CAN C22.2 601.1<br>EN 60601-2-50 | UL 544<br>CSA/NRTL | | Mechanical safety | Plastic diffuser minimizes<br>accidental viewing of single point<br>light source<br>Diffuser protects baby and lights<br>from incidental debris or fluids | Transparent plastic shield<br>under bulbs prevents injury<br>from broken glass | | Thermal safety | Fan to cool circuitry, minimize<br>device heating<br>LEDs give off little heat, by<br>design | Height adjustment prevents<br>patient overheating | | Radiation safety | LED light source produces<br>minimal ultraviolet light | Transparent plastic shield<br>under bulbs filters out UV<br>radiation | | Human Factors | | | | Controls and Indicators | • On/Off power switch<br>• High/low intensity switch<br>• Positioning light | • On/Off power switch | | Compatibility with environment<br>or other devices | Can be used outside a bassinet<br>or incubator, under a radiant<br>warmer<br>Tilt adjustments standard | Can be used outside a bassinet<br>or incubator<br>Requires tilt attachment for use<br>under radiant warmer | # Comparison Table Natus Blue Light Phototherapy Unit 510(k) – July 3, 2002 {3}------------------------------------------------ ### 7. Summary of Nonclinical Testing This submission includes the results of testing prototype devices to specifications, spectral characterization of the blue LED light source, and an analysis of the potential optical radiation hazard of the blue LED light source. 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 Natus® Blue Light Phototherapy Unit is substantially equivalent to the currently legally marketed Olympic Bili-lite™ Model 33, manufactured and distributed by Olympic Medical. 8.4 {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Public Health Service SEP 1 9 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Sheila Ramerman Director, RA/OA Natus Medical, Incorporated 1501 Industrial Road San Carlos, California 94070 Re: K022196 Trade/Device Name: Natus® Blue Light Phototherapy Unit Regulation Number: 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: July 3, 2002 Received: July 5, 2002 Dear Ms. Ramerman: 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. 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. {5}------------------------------------------------ Page 2 -- Ms. Ramerman 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 (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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html Sincerely vours. Susan Runge Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Indications For Use Statement 7 1022196 510(k) Number (if known): Natus® Blue Light Phototherapy Unit Device Name: Indications for Use: The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for 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. #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) \$\surd\$ OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) Patricis Cuexite Division of Anesthesiology, General Hospital, 510(k) Number: K022196 Natus Blue Light Phototherapy Unit 510(k) - July 3, 2002