(91 days)
No
The summary describes a phototherapy unit that shines blue light and does not mention any AI/ML components or image processing.
Yes
The device is intended for the treatment of neonatal hyperbilirubinemia, indicating a therapeutic purpose.
No
Explanation: The device is a phototherapy unit used for treatment, not diagnosis. It shines blue light onto a patient for hyperbilirubinemia.
No
The device description clearly states it is a "phototherapy unit" and an "overhead unit" that "shines a blue light onto the patient," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treatment of neonatal hyperbilirubinemia." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device "shines a blue light onto the patient for the treatment." This describes a physical intervention on the patient, not a test performed on a sample taken from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device directly treats the patient.
N/A
Intended Use / Indications for Use
The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
Product codes
LBI
Device Description
The BILI-THERAPY Spot Type is an overhead unit available in two versions:
. Arm
. Stand
The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.
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 institutional
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
We have performed bench tests which included the list below and found that the BILI-THERAPY Spot Type met all pass /fail criteria, cited standards requirements and were found to be equivalent in comparison to the predicate.
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988: Amendment 1, 1991-11, Amendment 2, 1995
- . IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility -Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- IEC 60601-2-50: 2009 Medical Electrical Equipment Part 2-50: Particular . requirements for the basic safety and essential performance of infant phototherapy equipment.
Key Metrics
Not Found
Predicate Device(s)
Respironics - Bili-Tx K070180
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
510(k) Summary Page 1 of 3 11-Mar-11
MAR 2 9 2011
| Atom Medical Corporation | |
|---|---|
| 3-18-15, Hongo, Bunkyo-ku | Tel - 011-81-3-3815-3632 |
| Tokyo, Japan 113-0033 | Fax - 011-81-3-3812-3199 |
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | BILI-THERAPY Spot Type |
| Common/Usual Name: | Neonatal phototherapy unit. |
| Classification Name/Code: | LBI - Neonatal phototherapy unit. |
| CFR 880.5700 | |
| Device: | BILI-THERAPY Spot |
| Predicate Device: | Respironics - Bili-Tx K070180 |
Device Description:
The BILI-THERAPY Spot Type is an overhead unit available in two versions:
- . Arm
- . Stand
The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.
Indications for Use:
The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
Environment of Use: Hospital or institutional
Summary of substantial equivalence
The Atom Phototherapy Units
The BILI-THERAPY Spot Type was compared to the predicate Respironics BiliTx (K070180).
Indications for Use - The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
The BILI-THERAPY Spot Type has the same intended use (treatment of hyperbilirubinemia) as the Respironics BiliTx (K070180).
1
510(k) Summary Page 2 of 3 l 1-Mar-1 l
Patient Population - The BILI-THERAPY Spot Type is indicated for Neonates as is the predicate.
Environment for use – The BILI-THERAPY Spot Type has the identical environments for use as the predicate (hospital/institutional)
Prescriptive - The BILI-THERAPY Spot Type is prescriptive as is the predicate.
Design and Technology - The BILI-THERAPY Spot Type has equivalent design and features as the predicate and has the identical technology to the predicate.
Performance and Specifications - The BILI-THERAPY Spot Type has equivalent specifications of performance as the predicate.
Compliance with standards -- The BILI-THERAPY Spot Type and predicate device declare compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-50.
Conclusion
The BILI-THERAPY Spot Type is substantially equivalent to the predicate Respironics BiliTx (K070180) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards
Performance Testing
We have performed bench tests which included the list below and found that the BILI-THERAPY Spot Type met all pass /fail criteria, cited standards requirements and were found to be equivalent in comparison to the predicate.
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988: Amendment 1, 1991-11, Amendment 2, 1995
- . IEC 60601-1-2: Collateral standard: Electromagnetic Compatibility -Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- IEC 60601-2-50: 2009 Medical Electrical Equipment Part 2-50: Particular . requirements for the basic safety and essential performance of infant phototherapy equipment.
2
510(k) Summary Page 3 of 3
11-Mar-1 l
Device Comparison
| | BILI-THERAPY Spot Type | Respironics
Bili-Tx (K070180) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| General Attributes | | |
| Indications for Use | The BILI-THERAPY Spot Type is a
phototherapy unit intended for the
treatment of neonatal hyperbilirubinemia. | The Bili-Tx is intended to treat
hyperbilirubinemia through phototherapy in
a home or hospital/institutional environment |
| Patient Population | Neonatal | Neonatal |
| Environment of Use | Hospital or institutional | Home or hospital/institutional |
| Prescriptive | Yes | Yes |
| Patient Connection | No | No with Bili-Tx overhead
Yes with Bili-Tx Fiber optic light panel |
| Technology | Blue light-emitting diodes (LEDs) | Blue light-emitting diodes (LEDs) |
| Technical specifications | | |
| Dimensions | Arm Type: 1000W x 130D x 450H
(mm)
Stand Type: 450W x 710D x 1900H
(mm) | Illuminator
16.10 cm x 7.40 cm (6.34 in x 2.92 in) |
| Weight | Arm Type: approximately 2.2 kg
Stand Type: approximately 12 kg | 1.3 Kg (2.86 lb) |
| Irradiation Intensity | 30-40 $μW/cm^2/nm$
(measurement obtained by BiliBlanket®
meter at irradiation distance of 30 cm) | Spectral Irradiance Level |
| | | Distance Irradiance ( $µW/cm^2/nm$ ) |
| | | 15 cm (6 in) 75 $µW/cm^2/nm$ |
| | | 30 cm (12 in) 32 $µWcm^2/nm$ |
| | | 45 cm (18 in) 10 $µWcm^2/nm$ |
| | | 60 cm (24 in) 9 $µWcm^2/nm$ |
| | Change in irradiance after 6 hours +/-
10% (in effective area)
Effective irradiated area 20 x 30 cm | |
| Wavelength | Peak 450 to 475 nm | Peak between 450 nm and 485 nm |
| Sound level | 60 dB or less | 52 dB |
| Power Supply | Rated, Voltage 120VAC
Power consumption 30VA, frequency
50/60 Hz
Working voltage range 120VAC +/-10% | (Input) 100 - 240 VAC, 50/60 Hz, 1.0 A |
| Operating
Temperature | Ambient: 10-30°C
Relative Humidity 30-85% (non-
condensing) | 15°C to 35°C |
| Storage Temperature | Ambient 0-45°C
Relative Humidity 0-90% (non-
condensing) | -20 °C to 55 °C |
| Mounting Options | Arm or Stand | Overhead mounting option (standard IV
pole and bracket) |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Atom Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K103828
MAR 2 9 2011
Trade/Device Name: BILI-THERAPY Spot Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: March 11, 2011 Received: March 14, 2011
Dear Mr. Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2 Mr. Dryden
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration 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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Page 1 of 1
510(k) Number:
K/Q3828 (To be assigned)
Device Name:
BILI-THERAPY Spot
Indications for Use:
The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of · neonatal hyperbilirubinemia.
or
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Richard C. Chapman 3/29/11
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103828