(93 days)
Not Found
No
The device description focuses on light therapy and transillumination using fiber optics, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as providing "light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice". The term "treatment" indicates a therapeutic purpose.
No
The device is described as a phototherapy system and an illumination device used for treatment and visualizing internal structures, not for diagnosing conditions.
No
The device description clearly outlines hardware components including an illuminator box, fiberoptic cable, and blanket, which are essential for its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The BiliBlanket Plus High Output Phototherapy System is a therapeutic device. It uses light therapy applied externally to the patient's skin to treat a condition (hyperbilirubinemia). It also has a transillumination function, which is also an external examination technique.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, based on the provided information, the BiliBlanket Plus High Output Phototherapy System is a therapeutic device and an external examination 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, 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, HJM
Device Description
The BiliBlankel 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 b) 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 (42.5 - 475 nm), is transmitted from the illuminator to 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 tip 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.
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
hospital or home setting
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
Since treatment of neonatal hyperbilirulinemia 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Ko40068
APR 1 6 2004
Ohmeda Medical BiliBlanket Plus High Output (67,5 yW/cm2/nm max) Phototherapy System (modified)
510(k) Summary
Submitter Information
Alberto F. Profumo, RAC (also contact person) 8880 Gorman Road Laurel, MD 20723 Tcl. 410-888-5204
Summary prepared on December 29, 2003
Device Name(s)
Classification Names:
- Neonatal Phototherapy Unit .
- AC powered Transilluminator .
Common Names:
- Phototherapy Lamp .
- t Transilluminator
Proprietary Name:
- BiliBlanket Plus High Output Phototherapy System .
Predicate Device Information
The BiliBlacker Plus High Outpur Phototherapy System is substantially equivalent to the following, legally marketed product:
Ohrneda - BiliBlanket Plus High Ourput (original) 510(k) No. K993712
Indications for Use
The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.
BiliBlanket Plus High Output 510(k) Summary Page 1
1
Product Description
The BiliBlankel 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 b) 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 (42.5 - 475 nm), is transmitted from the illuminator to 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 tip 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.
Description of Modification
Light output level increased from 18-45 ± 25% µW/cm²/nm to 21-50 +35% -25% µW/cm²/nm
Performance Data
Since treatment of neonatal hyperbilirulinemia 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 BillBlanket 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 should not be sterilized. Cleaning and disinfecting instructions can be found in the Operation and Maintenance Manual. Disposable covers for the light cmitting pad are available and instructions for their use are provided in the manual.
BiliBlanket Plus High Output 510(k) Summary Page 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
Dr. Alberto F. Profumo, R.A.C. Director, Quality and Regulatory Systems Ohmeda, Medical 8880 Gorman Road Laurel, Maryland 20723
Re: K040068
Trade/Device Name: Biliblanket Plus High Output Phototherapy System Regulation Number: 880.5400, 886.1945 Regulation Name: Neonatal Incubator, Transilluminator Regulatory Class: II Product Code: FMZ, HJM Dated: January 12, 2004 Received: January 20, 2004
Dear Dr. Profumo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Dr. Profumo
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be actived that 12 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rice of any I with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n from at the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral information on your responsibilities under the Act from the micr Sound Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qur
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of I
510(k) Number (if known):
K 04/0068
Device Name: BiliBlankst Plus High Output Phototherapy System
Indications For Use:
The BiliBlanket Plus High Output (67.5 µW/cm²/nm maximum )Phototherapy System provides I he BillBlaiket I lust Ingh Output (01:5 | in binemia, commonly know as neonatal jaundice, 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)
William M. Burden Rha. Chris. Lerr
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040068
Prescription Use (Per 21 CFR 801.109)
OR
Over- The Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)