(76 days)
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.
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 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.
The Natus® Blue Light Phototherapy Unit is a medical device intended for the treatment of neonatal hyperbilirubinemia. The 510(k) summary provides details on the device's acceptance criteria and the non-clinical study conducted to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the device's performance specifications in comparison to a predicate device, the Olympic Bili-Lite™ Model 33. The acceptance criteria are implicitly derived from these performance specifications and safety standards.
| Feature | Acceptance Criteria (Natus Blue Light Phototherapy Unit) | Reported Device Performance (Natus Blue Light Phototherapy Unit) |
|---|---|---|
| Intended Use | For the treatment of neonatal hyperbilirubinemia | Meets intended use |
| Target Population | Neonates | Neonates |
| Sites of Use | Nursery, doctor's office, anywhere phototherapy is delivered | Nursery, doctor's office, anywhere phototherapy is delivered |
| Light Source Type | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Light Source Number | Approx. 750 LEDs | Approx. 750 LEDs |
| Light Source Life | 10,000 hr (low setting); 3,000 hr (high setting) | Meets specification |
| Light Source Color | Blue | Blue |
| Wavelength | 400-550 nm, Peak @ 450-475 nm | Meets specification |
| Intensity (at 30 cm distance) | Low: 15 ± 2 μW/cm²/nm; High: 35 ± 3.5 μW/cm²/nm | Low: 15 μW/cm²/nm; High: 35 μW/cm²/nm (within tolerance) |
| Light Intensity Adjustment | High/Low switch adjusts between two levels of intensity | High/Low switch present |
| Operating Voltage | 85-264VAC | 85-264VAC |
| Overload Protection (fuses) | 2A @ 120V | 2A @ 120V |
| Current Leakage | < 100 uA | < 100 uA |
| Fan | 24 VDC Fan | 24 VDC Fan |
| Acoustic Noise | < 35 dB | < 35 dB |
| Operating Temperature | 50 - 86° F (10 - 30° C) | Meets specification |
| Storage Temperature | 23 - 122° F (-5 to +50° C) | Meets specification |
| Operating Humidity | 10 to 90% non-condensing | Meets specification |
| Storage Humidity | 0 to 90% non-condensing | Meets specification |
| Electrical Safety | EN 60601-1 and 1-1-2, UL 2601-1, CSA/CAN C22.2 601.1, EN 60601-2-50 | Complies with specified standards |
| Mechanical Safety | Plastic diffuser minimizes accidental viewing, protects baby and lights from incidental debris | Plastic diffuser present and functions as described |
| Thermal Safety | Fan to cool circuitry, minimize device heating; LEDs give off little heat by design | Fan present, LEDs confirmed to give off little heat |
| Radiation Safety | LED light source produces minimal ultraviolet light | Confirmed minimal UV light production |
| Controls and Indicators | On/Off power switch, High/low intensity switch, Positioning light | Controls and indicators present as described |
| Compatibility | Can be used outside a bassinet or incubator, under a radiant warmer; Tilt adjustments standard | Meets compatibility requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that the submission includes "the results of testing prototype devices to specifications." However, it does not specify the exact sample size (i.e., how many prototype devices were tested) or the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). This information is not detailed in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The testing described is non-clinical and focuses on device specifications and safety standards, rather than clinical efficacy studies involving expert evaluation of patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. The testing described is non-clinical and focuses on device specifications and compliance with standards. There is no mention of a human-based adjudication process for a test set in the context of clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states that it 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." This is a non-clinical evaluation focused on substantial equivalence to a predicate device, not a comparative clinical effectiveness study involving human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device described is a phototherapy unit, a physical medical device, not an AI-powered algorithm. The testing described is purely engineering and performance-based to ensure the device meets its specifications and safety standards.
7. The Type of Ground Truth Used:
The "ground truth" used for this device's evaluation is primarily based on engineering specifications, physical measurements, and compliance with established safety and performance standards. This includes:
- Spectral characterization of the blue LED light source.
- Measurements of light intensity, wavelength, operating voltage, current leakage, acoustic noise, temperature, and humidity.
- Verification of compliance with electrical, mechanical, thermal, and radiation safety standards (e.g., EN 60601-1, UL 2601-1).
- Assessment of physical design features and controls against the described specifications.
There is no mention of a clinical "ground truth" such as pathology, expert consensus on patient outcomes, or other clinical efficacy data because this was a non-clinical submission.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The Natus Blue Light Phototherapy Unit is a hardware device, not an algorithm that requires a training set. The "prototype devices" mentioned in the non-clinical testing are the subject of evaluation, not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, this device is not an AI/algorithm that requires a training set. The "ground truth" for the device's performance relies on engineering principles, recognized standards, and direct physical measurements.
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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
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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.
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| Natus® Blue Light vs. Olympic Bili-lite™ Model 33 | ||
|---|---|---|
| Feature | Natus Blue Light | Olympic Bili-Lite (K940996) |
| Intended Use | For the treatment of neonatalhyperbilirubinemia | For the treatment of neonatalhyperbilirubinemia |
| Target population | Neonates | Neonates |
| Sites of use | Nursery, doctor's office,anywhere phototherapy isdelivered | Nursery, doctor's office,anywhere phototherapy isdelivered |
| Physical Design | ||
| Type | Freestanding device | Freestanding device |
| Mounting hardware | Roll Stand, 5 legs w/casters, 2locking | Roll Stand, 4 legs w/casters |
| Light attachment | Lights mounted in hood enclosure | Lights mounted in hoodenclosure |
| 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 | Standard0° to ~ 40° from horizontal | Optional0° 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)3,000 hr (high setting) | • 200 hours minimum9000 hour maximum |
| • Color | • Blue | • Blue (standard configuration)• White (daylight, optional)• High-intensity blue (optional) |
| Wavelength | 400-550 nmPeak @ 450-475 nm | 400-520 nmPeak: not stated |
| Intensity | Low: 15 ± 2 μW/cm²/nmHigh: 35 ± 3.5 μW/cm²/nm | 9 μW/cm²/nm (White bulbs)20 μW/cm²/nm (Blue)40 μW/cm²/nm (hi intensity) |
| Light intensity adjustment | High/Low switch adjusts betweentwo levels of intensity | Adjust light enclosure height(distance from baby) |
| Operating Voltage | 85-264VAC | 106-127 VAC, 60 Hz or194-233VAC, 50 Hz |
| Overload protection (fuses) | 2A @ 120V | 2A @ 120V |
| Current Leakage | < 100 uA | @120 VAC: < 100 uA@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 1-1-2UL 2601-1CSA/CAN C22.2 601.1EN 60601-2-50 | UL 544CSA/NRTL |
| Mechanical safety | Plastic diffuser minimizesaccidental viewing of single pointlight sourceDiffuser protects baby and lightsfrom incidental debris or fluids | Transparent plastic shieldunder bulbs prevents injuryfrom broken glass |
| Thermal safety | Fan to cool circuitry, minimizedevice heatingLEDs give off little heat, bydesign | Height adjustment preventspatient overheating |
| Radiation safety | LED light source producesminimal ultraviolet light | Transparent plastic shieldunder bulbs filters out UVradiation |
| Human Factors | ||
| Controls and Indicators | • On/Off power switch• High/low intensity switch• Positioning light | • On/Off power switch |
| Compatibility with environmentor other devices | Can be used outside a bassinetor incubator, under a radiantwarmerTilt adjustments standard | Can be used outside a bassinetor incubatorRequires tilt attachment for useunder radiant warmer |
Comparison Table
Natus Blue Light Phototherapy Unit 510(k) – July 3, 2002
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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
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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.
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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
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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
§ 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).