(146 days)
Not Found
Not Found
No
The device description and performance studies focus on conventional phototherapy technology and electrical/mechanical safety, with no mention of AI or ML.
Yes.
The device is used for the "treatment of Neonatal Hyperbilirubinemia," which indicates a therapeutic purpose.
No
The device is described as being for "treatment of Neonatal Hyperbilirubinemia" and for phototherapy, which indicates a therapeutic rather than diagnostic purpose. There is no mention of analysis, measurement, or imaging for diagnostic purposes.
No
The device description clearly outlines physical hardware components including a bassinet, phototherapy fixtures, lamps, and a phototherapy pad/mattress. The performance studies also focus on hardware-related testing (electrical safety, tip-over safety, temperature, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the treatment of Neonatal Hyperbilirubinemia." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bassinet with built-in phototherapy fixtures. This is a physical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing blood, urine, tissue, or other biological samples, which are the hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a therapeutic device used to treat a condition.
N/A
Intended Use / Indications for Use
For the treatment of Neonatal Hyperbilirubinemia.
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infants
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
- Light Output (μw/cm²/nm): See Comparison Chart for light output.
- Electrical Safety Tests: Meets applicable standards including ground impedance of less than 0.1 ohm and leakage current of less than 100 microamperes.
- Tip-over Safety Test: Meets or exceeds 10° stability (CSA Standard).
- Tripartite Biocompatibility: Meets guidance document requirements.
- Temperature Tests: Meets applicable standards.
- Safety Side Latch Strength Test: Meets 25kg inward and outward force test requirement.
- Weight Capacity Test: Passes 4 times capacity tests
- Fluid Spill Test: Passed.
- Over Temperature Thermostat Safety Test: Thermostat performance verified.
Clinical tests: N/A
Conclusions: Performance is equal to predicate devices. Device safety is verified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
SEP 2 4 1997
Attachment C
SAFETY AND EFFECTIVENESS SUMMARY
1
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
-
- Brief explanation of how the device functions.
The Olympic Bili-Bassinet has three phototherapy fixtures built into a bassinet.
- Brief explanation of how the device functions.
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.
-
- 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.
- Basic scientific concepts that form the basis for the device.
2
- 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
3
-
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 -
- The technological characteristics of the device to the predicate product.
(See comparison chart next page)
- The technological characteristics of the device to the predicate product.
4
Comparison Chart
| New Device | Predicate Devices | ||
|---|---|---|---|
| Manufacturer | Olympic | Olympic | Ohmeda |
| Model | Bili-Bassinet | ||
| 581 | Bili-Lite | ||
| Model 33 | Bili-Blanket | ||
| 6600-0104-960 | |||
| Physical: | |||
| Height | |||
| Length | |||
| Width | |||
| Weight | 53.5" | ||
| 39.5" | |||
| 32.0" | |||
| 220 lbs | 62.5" | ||
| 25.0" | |||
| 24.5" | |||
| 67 lbs | 10.5" | ||
| 11.0" | |||
| 4.5" | |||
| 14 lbs | |||
| Electrical Req. | |||
| Lamp Wattage | |||
| Total Wattage | 3A at 115/120 Vac | ||
| 2 x 80 W overhead | |||
| 120 W P.T. Pad | |||
| 360 W | 2A at 115/120 Vac | ||
| 270 W | 2A at 100/120 Vac | ||
| 140 W | |||
| 250 W | |||
| Lamp Type | Fluorescent | Fluorescent | Quartz Halogen |
| Lamp Life | 9000 Hours | 9000 Hours | 300 Hours |
| Leakage current | Less than 100 | ||
| Microamperes | Less than 100 | ||
| Microamperes | Less than 100 | ||
| Microamperes | |||
| Ground Impedance | Less than 0.1 ohm | Less than 0.1 ohm | Less than 0.1 ohm |
| Max. Irradiance | |||
| (µw/cm²/nm) | 9 "Daylight" Bulbs | ||
| 18 "B" Bulbs | |||
| 40 "BB" Bulbs | |||
| P.T. Pad | |||
| 30 Low | |||
| 50 Hi | 9 "Daylight" Bulbs | ||
| 20 "B" Bulbs | |||
| 40 "BB" Bulbs | P.T. Pad | ||
| 18 - Low | |||
| 30 - Med | |||
| 42 - Hi | |||
| Controls & | |||
| Indicators | • On/Off Switches | ||
| (1 ea. for overhead) | |||
| • HI/OFF/LOW for | |||
| P.T. Pad | • On/Off Power | ||
| Switch | • On/Off Power | ||
| Switch | |||
| • Illuminated Power | |||
| Indicator | |||
| Standards | UL-544 | ||
| CSA/NRTL | |||
| IEC 601-1 | UL-544 | ||
| CSA/NRTL | |||
| IEC 601-1 | |||
| Accessories | P.T. Pad Cover | ||
| (disposable) | Tilt Accessory | ||
| Bili-Timer | P.T. Pad Cover | ||
| (2 types-disposable) | |||
| Intended Use | For the treatment | ||
| of Neonatal | |||
| Hyperbilirubinemia | For the treatment | ||
| of Neonatal | |||
| Hyperbilirubinemia | For the treatment | ||
| of Neonatal | |||
| Hyperbilirubinemia |
ө At 15 inches
5
- 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 |
| ground impedance of less than 0.1 ohm | |
| and leakage current of less than 100 | |
| microamperes. | |
| Tip-over Safety Test | Meets or exceeds 10° stability |
| (CSA Standard) | |
| Tripartite Biocompatibility | Meets guidance document requirements. |
| Temperature Tests | Meets applicable standards. |
| Safety Side Latch Strength | |
| Test | Meets 25kg inward and outward force |
| test requirement. | |
| Weight Capacity Test | Passes 4 times capacity tests |
| Fluid Spill Test | Passed. |
| Over Temperature Thermostat | |
| Safety Test | Thermostat performance verified. |
- A brief description of clinical tests submitted, referenced or relied on for 510(k) 9. clearance.
N/A
-
- 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.
-
- Device safety is verified.
6
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
7
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 (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" (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 (800) 638-2041 or (301) 443-6597 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
8
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 _____________