(147 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and intended use are purely focused on phototherapy for neonatal hyperbilirubinemia.
Yes
The intended use explicitly states the device is for "treatment for Neonatal Hyperbilirubinemia," which qualifies it as a therapeutic device.
No
Explanation: The device is intended for treatment (phototherapy for neonatal hyperbilirubinemia), not for diagnosis.
No
The device description explicitly states "Ultra Bili Light model 2000" and its intended use is "Home Phototherapy treatment," which strongly suggests a physical light-emitting device, not software. There is no mention of software as the primary component or function.
Based on the provided information, the Ultra Bili Light model 2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide phototherapy treatment for neonatal hyperbilirubinemia. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description simply states "Ultra Bili Light," which is consistent with a phototherapy device.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The Ultra Bili Light is used to treat a condition, not diagnose it.
N/A
Intended Use / Indications for Use
The intended use of the portable Ultra Bili Light model 2000 is to provide Home Phototherapy treaturent for Neonatal Hyperbilirubinemia.
Product codes
LBI
Device Description
Ultra Bili Light
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
Neonatal
Intended User / Care Setting
Home Phototherapy
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of several curved lines that create a sense of movement and flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Robert J. Rose, M.D. ·President Physician Engineered Products, Incorporated 420 West Second Street Park Rapids, Minnesota 56470
Re : K974830 Ultra Bili Liqht Trade Name: Regulatory Class: II Product Code: LBI Dated: February 10, 1998 Received: March 4, 1998
Dear Dr. Rose:
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 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Rose
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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 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/dsma/dsmamajn.html".
Sincerely yours,
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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·
・
.
S 10(k) Number (if known): K974830
1 1 1 1 1 4 1 1 1 1 1 1 1 1 1
Device Name: Ultra Bili Light
Date: May 8-1998
Indications for use:
. . . ... . . . . .
The intended use of the portable Ultra Bili Light model 2000 is to provide Home Phototherapy treaturent for Neonatal Hyperbilirubinemia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
| Concurrence of CDRH, Office of Device evaluation (ODE) | |
|---|---|
| Patricia Cucenta | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K 974830 |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | ---------------------------------------------------- |
OR
| Over-The Counter Use | _________________________ |
|---|---|
| (Optional Format 1-2-96) |