(6 days)
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No
The document describes a phototherapy system and a transillumination system, both based on light transmission through fiber optics. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies section also focuses on bench testing and established clinical practice, not on algorithmic performance.
Yes
The device is described as providing "light therapy for the treatment of hyperbilirubinemia," which indicates a therapeutic purpose.
No
The device is primarily for treatment (phototherapy for hyperbilirubinemia) and for aiding procedures (transillumination for locating sites or detecting conditions), not for making a diagnosis itself. While transillumination can help in detecting pneumothoraces, it's a visualization aid rather than a definitive diagnostic tool on its own.
No
The device description clearly outlines hardware components including an illuminator box, fiberoptic cable, and blanket, which are integral to the device's function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The BiliBlanket Plus High Output Phototherapy System directly treats a condition (hyperbilirubinemia) by applying light therapy to the patient's skin. It also uses light for transillumination, which is a visual aid for procedures performed on the patient's body.
- No Specimen Analysis: The device does not collect, prepare, or analyze any specimens from the patient's body.
Therefore, based on the provided information, the BiliBlanket Plus High Output Phototherapy System is a therapeutic and diagnostic aid device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.
Product codes
FMZ
Device Description
The BiliBlanket Plus High Output Phototherapy System has two modes of operation: phototherapy, used for the treatment of hyperbilirubinemia; and transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting pneumothoraces or hydrocephalus.
In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (400 - 550 nm), is transmitted from the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket.
The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the end of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
newborn period
Intended User / Care Setting
hospital or home setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Since treatment of neonatal hyperbilirubinemia with phototherapy is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Ohmeda - BiliBlanket Plus (original), PEP - Ultra BiliLight, Medela - BiliBed
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).
0
X993712
Ohmeda Medical BiliBlanket Plus High Output
510(k) Summary
Submitter Information
Alberto F. Profumo, RAC (also contact person) 9065 Guilford Road Columbia, MD 21046-1801 Tel. (410) 381- 4004 Summary prepared on November 2, 1999
Device Name(s)
Classification Names:
- . Neonatal Phototherapy Unit
- AC- powered Transilluminator ●
Common Names:
- Phototherapy Lamp .
- . Transilluminator
Proprietary Name:
- BiliBlanket Plus High Output Phototherapy System .
Predicate Device Information
The BiliBlanket Plus High Output Phototherapy System is substantially equivalent to the following, legally marketed products:
- . Ohmeda - BiliBlanket Plus (original)
- . PEP - Ultra BiliLight
- . Medela - BiliBed
Indications for Use
The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.
Product Description
The BiliBlanket Plus High Output Phototherapy System has two modes of operation:
- phototherapy, used for the treatment of hyperbilirubinemia; and a)
- transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting b) pneumothoraces or hydrocephalus.
In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (400 - 550 nm), is transmitted from the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket.
1
The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces. Transilluminators have been used, and are being used, in NICUs and nurseries all over the world. Their intended use and user familiarity are well established.
Performance Data
Since treatment of neonatal hyperbilirubinemia with phototherapy is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied.
Assessment of Technological Characteristics
The technological characteristics of the BiliBlanket Plus High Output Phototherapy System are similar to those of the predicate devices and do not raise new safety or effectiveness issues.
Sterilization Information
The BiliBlanket Plus High output Phototherapy System is not intended to be sterilized. Cleaning and disinfecting instructions can be found in the Operation and Maintenance Manual.
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 9 1999
Alberto F. Profumo, R.A.C. Director, Product Assurance Ohmeda Medical 9065 Guilford Road 21046-1801 Columbia, MD
Re : K993712 Ohmeda Medical-BiliBlanket Plus High Output Trade Name: Phototherapy System Regulatory Class: II Product Code: FMZ November 2, 1999 Dated: November 3, 1999 Received:
Dear Mr. Profumo:
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 The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Mr. Profumo
obligation you might have under sections 531 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 asbeing 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 diaqnostic 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" (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
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
K9937/2
Device Name: BiliBlanket Plus High Output Phototherapy System
Indications For Use:
The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly knowas neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | ----------------- |
OR
| Over- The Counter Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K993712 |
|---|---|
| --------------- | --------- |