OLYMPIC BILI-BASSINET

K971601 · Olympic Medical Corp. · LBI · Sep 24, 1997 · General Hospital

Device Facts

• Record ID: K971601
• Device Name: OLYMPIC BILI-BASSINET
• Applicant: Olympic Medical Corp.
• Product Code: LBI · General Hospital
• Decision Date: Sep 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5700
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

For the treatment of Neonatal Hyperbilirubinemia.

Device Story

Olympic Bili-Bassinet provides phototherapy for neonatal hyperbilirubinemia; integrates three phototherapy fixtures into a bassinet. Two overhead fixtures mount on counter-balanced arms; recessed storage position. Phototherapy pad/mattress is transparent to light; light box located below pad shines upward. Uses conventional blue (type B), daylight, or high-intensity (type BB) fluorescent lamps. Overhead lamps air-cooled; light pad fan-cooled. Operated by clinicians in clinical settings. Provides therapeutic light exposure to infants to reduce bilirubin levels. Safety features include tip-over stability, fluid spill resistance, and over-temperature thermostat.

Clinical Evidence

No clinical data. Bench testing only, including light output measurements, electrical safety (ground impedance, leakage current), tip-over stability, biocompatibility, temperature testing, side latch strength, weight capacity, and fluid spill testing.

Technological Characteristics

Fluorescent lamp phototherapy system. Materials: transparent pad/mattress. Energy: 115/120 Vac, 360 W total. Dimensions: 53.5" x 39.5" x 32.0". Standards: UL-544, CSA/NRTL, IEC 601-1. Cooling: air-cooled overhead, fan-cooled pad. Irradiance: 9-50 µw/cm²/nm depending on bulb type and pad setting. Non-software based.

Indications for Use

Indicated for the treatment of Neonatal Hyperbilirubinemia in infants.

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

• Olympic Bili-Lite Model 33
• Ohmeda Bili-Blanket (6600-0104-960)

Submission Summary (Full Text)

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K971601

SEP 2 4 1997

Attachment C

# SAFETY AND EFFECTIVENESS SUMMARY

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# SAFETY AND EFFECTIVENESS SUMMARY

*This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Contact Person: Joseph Stefanile Olympic Medical 5900 First Ave. S. Seattle, WA 98108 206-767-3500 Common or usual name of device -----------------------------------------------------------------------------------------------------------------------------------------------Trade or proprietary name ----------------------------------------------------------------------------------------------------------------------------------------------------Classification name (if known)------------------------------------------------------------------------------------------------------------------------------------------------Predicate device(s) to which substantial equivalence is being claimed -------------------------------------------------------------------------------------------------------------------------------------------------

### Device Description

- 1. Brief explanation of how the device functions.
The Olympic Bili-Bassinet has three phototherapy fixtures built into a bassinet.

The two identical overhead fixtures swing and lock in their up position. They are mounted on counter-balanced arms. Thier storage position is recessed into the sides of the bassinet.

The phototherapy pad is a pad/mattress, which is transparent to light. Unlike a fiberoptic pad, which used plastic optical fibers within the pad to transmit the light from the remote light box, the Bili-Bassinet light box is below the pad/mattress and shines through the pad.

All fixtures use conventional blue (type "B") fluorescent phototherapy lamps. "Daylight" and high-intensity (type BB) fluorescent lights are available for use in the overhead fixtures.

- 2. Basic scientific concepts that form the basis for the device.
The Bili-Bassinet is a very simple device utilizing conventional fluorescent lamp technology. The overhead lamps are conventional air cooled and the light pad is fan cooled.

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- Significant physical and performance characteristics of the device. 3. (Eg. device design and physical properties.
## Physical:

| Height | 53.5" |
|--------|---------|
| Length | 39.5" |
| Width | 32.0" |
| Weight | 220 lbs |

## Electrical:

3A at 115/120 Vac Total wattage = 360 W

#### Lamp Type:

Fluorescent

| Maximum Irradiance: | μw/cm²/nm | |
|---------------------|-----------|------------------------|
| Overhead | 9 | using "Daylight" bulbs |
| Overhead | 18 | using "B" bulbs |
| Overhead | 18 | using "BB" bulbs |
| Pad | 30 | on Low setting |
| Pad | 50 | on HI setting |

- Intended Use of the device 4.
- The diseases or conditions the device will diagnose, treat, prevent, cure, or A. mitigate.

Neonatal Hyperbilirubinemia

- B. The patient population for which the device is intended.
Infants

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- Does the indication statement (4) differ from those of the predicate device? ട.
Differs (complete section 6) Check one: Does not differ (skip to section 7) ×

- Explanation of why the differences are not critical to the intended use of the device 6. and why the differences do not affect the safety or effectiveness of the device.
N/A

- 7. The technological characteristics of the device to the predicate product.
(See comparison chart next page)

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# Comparison Chart

| | New Device | Predicate Devices | |
|--------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------|
| Manufacturer | Olympic | Olympic | Ohmeda |
| Model | Bili-Bassinet<br>581 | Bili-Lite<br>Model 33 | Bili-Blanket<br>6600-0104-960 |
| Physical:<br>Height<br>Length<br>Width<br>Weight | 53.5"<br>39.5"<br>32.0"<br>220 lbs | 62.5"<br>25.0"<br>24.5"<br>67 lbs | 10.5"<br>11.0"<br>4.5"<br>14 lbs |
| Electrical Req.<br>Lamp Wattage<br>Total Wattage | 3A at 115/120 Vac<br>2 x 80 W overhead<br>120 W P.T. Pad<br>360 W | 2A at 115/120 Vac<br>270 W | 2A at 100/120 Vac<br>140 W<br>250 W |
| Lamp Type | Fluorescent | Fluorescent | Quartz Halogen |
| Lamp Life | 9000 Hours | 9000 Hours | 300 Hours |
| Leakage current | Less than 100<br>Microamperes | Less than 100<br>Microamperes | Less than 100<br>Microamperes |
| Ground Impedance | Less than 0.1 ohm | Less than 0.1 ohm | Less than 0.1 ohm |
| Max. Irradiance<br>(µw/cm²/nm) | 9 "Daylight" Bulbs<br>18 "B" Bulbs<br>40 "BB" Bulbs<br>P.T. Pad<br>30 Low<br>50 Hi | 9 "Daylight" Bulbs<br>20 "B" Bulbs<br>40 "BB" Bulbs | P.T. Pad<br>18 - Low<br>30 - Med<br>42 - Hi |
| Controls &<br>Indicators | • On/Off Switches<br>(1 ea. for overhead)<br>• HI/OFF/LOW for<br>P.T. Pad | • On/Off Power<br>Switch | • On/Off Power<br>Switch<br>• Illuminated Power<br>Indicator |
| Standards | UL-544<br>CSA/NRTL<br>IEC 601-1 | UL-544<br>CSA/NRTL<br>IEC 601-1 | |
| Accessories | P.T. Pad Cover<br>(disposable) | Tilt Accessory<br>Bili-Timer | P.T. Pad Cover<br>(2 types-disposable) |
| Intended Use | For the treatment<br>of Neonatal<br>Hyperbilirubinemia | For the treatment<br>of Neonatal<br>Hyperbilirubinemia | For the treatment<br>of Neonatal<br>Hyperbilirubinemia |

ө At 15 inches

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- A brief description of nonclinical tests and their results. 8.

| Test | Result |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Light Output (μw/cm²/nm) | See Comparison Chart for light output |
| Electrical Safety Tests | Meets applicable standards including<br>ground impedance of less than 0.1 ohm<br>and leakage current of less than 100<br>microamperes. |
| Tip-over Safety Test | Meets or exceeds 10° stability<br>(CSA Standard) |
| Tripartite Biocompatibility | Meets guidance document requirements. |
| Temperature Tests | Meets applicable standards. |
| Safety Side Latch Strength<br>Test | Meets 25kg inward and outward force<br>test requirement. |
| Weight Capacity Test | Passes 4 times capacity tests |
| Fluid Spill Test | Passed. |
| Over Temperature Thermostat<br>Safety Test | Thermostat performance verified. |

- A brief description of clinical tests submitted, referenced or relied on for 510(k) 9. clearance.
#### N/A

- 10. Conclusions drawn from nonclinical and clinical tests that demonstrate the device is safe, effective, and performs as well as or better than the legally marketed device.
- Performance is equal to predicate devices. 1.
- 2. Device safety is verified.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HI. AN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1997

Mr. Joseph P. Stefanile Product Development Manager Olympic Medical Corporation 5900 First Avenue, South Seattle, Washington 98108

Re: K971601 Trade Name: Olympic Bili-Bassinet Requlatory Class: II LBI Product Code: Dated: June 24, 1997 Received: June 27, 1997

Dear Mr. Stefanile:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Stefanile

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Olin S. L/tr
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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K971601 510(k) Number (if known):

Device Name:

Olympic Bili-Bassinet

Indications For Use:

For the treatment of Neonatal Hyperbilirubinemia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vira Nolemana G. Pxc

(Division Sign-Off Division of Dental, Infection Co and General Hospital Devi 510(k) Number

Prescription Use (Per 21 CFR 801.109)

ﺮ

OR

Over-The-Counter Use _____________