(87 days)
Not Found
Not Found
No
The device description and performance studies focus solely on the physical and spectral characteristics of fluorescent lamps for phototherapy, with no mention of AI or ML.
Yes
The device is used in the treatment of Hyperbilirubinemia in newborn infants, directly indicating a therapeutic purpose.
No
The device, Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps, is explicitly stated for "treatment of Hyperbilirubinemia in newborn infants," indicating a therapeutic rather than diagnostic purpose.
No
The device is described as standard fluorescent lamps, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "treatment of Hyperbilirubinemia in newborn infants." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a fluorescent lamp that emits blue light. This is a physical device used for light therapy, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Examining biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for a therapeutic application (phototherapy for hyperbilirubinemia) and not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.
Product codes
LBI
Device Description
The Interlectric Bili Blue F20T12/BBY and F40T12/BBY devices are standard 2-foot and 4-foot T-12 fluorescent lamps that contain a phosphor composition that emits blue light energy in the range between 400 - 500 nanometers and produces no energy in the ultraviolet region of the spectrum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
newborn 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)
Comparison testing between the New Device and the Predicate Device demonstrates that the New Device lamps are substantially equivalent to the Predicate Device lamps with respect to:
- -Intended Use (Treatment of Hyperbilirubinemia)
- Spectral output in the effective range (400 500 nanometers)
- Ultraviolet Radiation Safety
- -Conformity to ANSI Specifications for Dimensional and Electrical Characteristics for fluorescent lamps (ANSI C78.2-1978 and ANSI C78.1-1991)
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
Image /page/0/Picture/1 description: The image shows a logo with the letters 'I' and 'C' on either side of a stylized image of a writing utensil. The 'I' is on the left and the 'C' is on the right. The writing utensil is oriented diagonally from the upper left to the lower right, bisecting the space between the two letters. The logo is black and white.
1401 Lexington Ave Warren, PA. 16365
fax 814-723-6069
510(k) Summary as required by section 807.92(c)
Submitter Information
Interlectric Corporation 1401 Lexington Ave. Warren, PA. 16365 814-723-6061 fax 814-723-1074 Contact: Ken C Frazier
APR 2 4 2009
Reason for Submission: New Device
Summary prepared on December 28, 2008
Device Name
Trade Name: Bili Blue F20T12/BBY and F40T12/BBY Common Name: 2-foot and 4-foot T12 Blue fluorescent lamps Classification Name: Unit, Neonatal Phototherapy (21 CFR 880.5700, product code LBI)
Predicate Device
F40 and F20; Philips Special Blue; Philips Lighting Co., Division of Philips Electronics
Product Description
The Interlectric Bili Blue F20T12/BBY and F40T12/BBY devices are standard 2-foot and 4-foot T-12 fluorescent lamps that contain a phosphor composition that emits blue light energy in the range between 400 - 500 nanometers and produces no energy in the ultraviolet region of the spectrum.
1
KOSO192
Indications for Use
Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.
Technological Characteristics
Phototherapy for treating Hyperbilirubinemia in newborn infants is a well-established clinical practice. Exposure to light from blue fluorescent lamps for such treatment was adopted in the United States back in the 1970's. Comparison testing between the New Device and the Predicate Device demonstrates that the New Device lamps are substantially equivalent to the Predicate Device lamps with respect to:
- -Intended Use (Treatment of Hyperbilirubinemia)
- Spectral output in the effective range (400 500 nanometers)
- Ultraviolet Radiation Safety
- -Conformity to ANSI Specifications for Dimensional and Electrical Characteristics for fluorescent lamps (ANSI C78.2-1978 and ANSI C78.1-1991)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and human needs. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ken C. Frazier Engineering Manager Interlectric Corporation 1401 Lexington Avenue Warren, Pennsylvania 16365
APR 2 4 2009
Re: K090192
Trade/Device Name: 2-Foot and 4-Foot T12 Blue Flourescent Lamps Trade Name: "Bili Blue F20T12/BBY and F40T12/BBY" Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: December 28, 2008 Received: January 27, 2009
Dear Mr. Frazier:
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 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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Page 2- Mr. Frazier
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. finiter
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 2-foot and 4-foot T12 Blue fluorescent lamps Trade Name: "Bili Blue F20T12/BBY and F40T12/BBY"
Indications for Use:
Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KOSO 197
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dentai Devices
510(k) Number:
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