(146 days)
For the treatment of Neonatal Hyperbilirubinemia.
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.
The provided document describes the Olympic Bili-Bassinet, a device intended for the treatment of Neonatal Hyperbilirubinemia using phototherapy. The submission aims to establish substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "acceptance criteria" discussed here relate to safety and performance specifications relative to established standards and the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate/standards) | Reported Device Performance (Olympic Bili-Bassinet) | Study/Section Proving Criterion Met |
|---|---|---|
| Electrical Safety | ||
| Ground Impedance < 0.1 ohm | Less than 0.1 ohm | Electrical Safety Tests (Section 8) |
| Leakage Current < 100 microamperes | Less than 100 microamperes | Electrical Safety Tests (Section 8) |
| Applicable electrical standards met (UL-544, CSA/NRTL, IEC 601-1) | Meets applicable standards | Comparison Chart (Section 7), Electrical Safety Tests (Section 8) |
| Stability | ||
| Meets or exceeds 10° stability (CSA Standard) | Meets or exceeds 10° stability | Tip-over Safety Test (Section 8) |
| Biocompatibility | ||
| Meets guidance document requirements | Meets guidance document requirements | Tripartite Biocompatibility Test (Section 8) |
| Temperature | ||
| Meets applicable standards | Meets applicable standards | Temperature Tests (Section 8) |
| Thermostat performance verified (for over-temperature safety) | Thermostat performance verified | Over Temperature Thermostat Safety Test (Section 8) |
| Mechanical Strength | ||
| Safety Side Latch Strength: Meets 25kg inward and outward force | Meets 25kg inward and outward force test requirement | Safety Side Latch Strength Test (Section 8) |
| Weight Capacity: Passes 4 times capacity | Passes 4 times capacity tests | Weight Capacity Test (Section 8) |
| Fluid Resistance | ||
| Resistant to fluid spills | Passed | Fluid Spill Test (Section 8) |
| Phototherapy Efficacy (Implicit comparator) | ||
| Comparable irradiance to predicate devices | Overhead: 9 "Daylight", 18 "B", 40 "BB" µw/cm²/nmP.T. Pad: 30 Low, 50 Hi µw/cm²/nm | Comparison Chart (Section 7), Light Output (Section 8) |
| Intended Use | ||
| For the treatment of Neonatal Hyperbilirubinemia | For the treatment of Neonatal Hyperbilirubinemia | Intended Use (Section 4), Comparison Chart (Section 7), Indications For Use (Section 8) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission is for a phototherapy device and primarily relies on non-clinical engineering and safety tests, and a comparison to predicate devices, rather than a clinical "test set" with patient data.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is internal testing performed by the manufacturer (Olympic Medical) based on engineering standards and comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This device's evaluation is based on engineering specifications and adherence to recognized standards, not on expert consensus for a clinical "ground truth."
- Qualifications of Experts: Not applicable for establishing clinical ground truth. The "experts" would be the engineers and technicians performing the physical, electrical, and performance tests against established standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set or subjective assessment requiring adjudication in this submission. The reported performance is based on objective measurements and compliance with standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- MRMC Comparative Effectiveness Study: No. This is not an AI-assisted diagnostic device, nor a device that involves "human readers" in its direct function, so an MRMC study is not relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device, not an algorithm. Its performance is measured directly by its physical, electrical, and optical properties, and its intended effect is through physical light therapy, not by an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is based on:
- Established engineering standards: e.g., UL-544, CSA/NRTL, IEC 601-1 for electrical safety, CSA Standard for stability.
- Guidance documents for biocompatibility.
- Performance specifications of legally marketed predicate devices for comparison, particularly regarding irradiance levels.
- Objective physical measurements: of weight, dimensions, irradiance, electrical characteristics, and mechanical strength.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an algorithm or AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth establishment for it.
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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
-
- 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.
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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 -
- 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.
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Comparison Chart
| New Device | Predicate Devices | ||
|---|---|---|---|
| Manufacturer | Olympic | Olympic | Ohmeda |
| Model | Bili-Bassinet581 | Bili-LiteModel 33 | Bili-Blanket6600-0104-960 |
| Physical:HeightLengthWidthWeight | 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 WattageTotal Wattage | 3A at 115/120 Vac2 x 80 W overhead120 W P.T. Pad360 W | 2A at 115/120 Vac270 W | 2A at 100/120 Vac140 W250 W |
| Lamp Type | Fluorescent | Fluorescent | Quartz Halogen |
| Lamp Life | 9000 Hours | 9000 Hours | 300 Hours |
| Leakage current | Less than 100Microamperes | Less than 100Microamperes | Less than 100Microamperes |
| Ground Impedance | Less than 0.1 ohm | Less than 0.1 ohm | Less than 0.1 ohm |
| Max. Irradiance(µw/cm²/nm) | 9 "Daylight" Bulbs18 "B" Bulbs40 "BB" BulbsP.T. Pad30 Low50 Hi | 9 "Daylight" Bulbs20 "B" Bulbs40 "BB" Bulbs | P.T. Pad18 - Low30 - Med42 - Hi |
| Controls &Indicators | • On/Off Switches(1 ea. for overhead)• HI/OFF/LOW forP.T. Pad | • On/Off PowerSwitch | • On/Off PowerSwitch• Illuminated PowerIndicator |
| Standards | UL-544CSA/NRTLIEC 601-1 | UL-544CSA/NRTLIEC 601-1 | |
| Accessories | P.T. Pad Cover(disposable) | Tilt AccessoryBili-Timer | P.T. Pad Cover(2 types-disposable) |
| Intended Use | For the treatmentof NeonatalHyperbilirubinemia | For the treatmentof NeonatalHyperbilirubinemia | For the treatmentof NeonatalHyperbilirubinemia |
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 includingground impedance of less than 0.1 ohmand leakage current of less than 100microamperes. |
| 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 StrengthTest | Meets 25kg inward and outward forcetest requirement. |
| Weight Capacity Test | Passes 4 times capacity tests |
| Fluid Spill Test | Passed. |
| Over Temperature ThermostatSafety 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.
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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 (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
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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 _____________
§ 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).