(81 days)
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Not Found
No
The summary describes a phototherapy unit and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device provides "light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice," which are therapeutic interventions.
No
Explanation: The device provides light therapy for treatment, indicating a therapeutic function rather than a diagnostic one.
No
The device is described as a "Neonatal Phototherapy Unit CFL 101," which is a physical piece of equipment used for light therapy. This description clearly indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy. This is a treatment applied externally to the body, not a test performed on a sample.
- Intended Use: The intended use is to treat hyperbilirubinemia and jaundice, not to diagnose or monitor a condition through analysis of a biological sample.
Therefore, based on the provided information, the device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly called jaundice, during the newborn period in the hospital.
Product codes
LBI
Device Description
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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
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Indicated Patient Age Range
newborn period
Intended User / Care Setting
hospital
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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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 is a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized lines that resemble a person with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
International Hospital Supply Company C/O Ms. Angelika Scherp Submission Correspondent Business Support International Amstel 320-1 Amsterdam, NETHERLANDS, 1017AP
Re: K040853
Trade/Device Name: PHOENIX Neonatal Phototherapy Unit CFL 101 Regulation Number: 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: March 30, 2004 Received: April 12, 2004
Dear Ms. Scherp:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your betermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichuments, or to do rosses Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 Mrs), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oo found to found announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Scherp
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DT 3 issualles of that your device complies with other requirements mean that 1127 has mace a actes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and reguirements, including, but not limited to: registration You must comply with and are reseling (21 CFR Part 801); good manufacturing practice a and listing (21 CFR Part 607), laceling (21 CFR Parts (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality is a 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) This letter will anow yourse overnment of substantial equivalence of your device to a premaired notification. THC I Drillaning on 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 regulation (21 CFR Part 801), IT you desire specific au roo for your we at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of 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,
Shiu-Ling Lin, Ph.D.
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
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INDICATIONS FOR USE
510(k) Number (if known): K040853
Device Name: PHOENIX Neonatal Phototherapy Unit CFL 101
Indications for Use:
The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice, during the newborn period in the hospital.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antin V my
Division Sian-Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _