(81 days)
No
The device description and performance studies do not mention any AI or ML components. The device is a simple phototherapy system with manual controls.
Yes
The device is described as providing "light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice". The term "therapy" indicates a medical treatment intended to alleviate or cure a disease or condition.
No
The device is a phototherapy system used for treating hyperbilirubinemia, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical hardware components including a light box, light pipe, LED light source, cooling fan, power supply, and various physical controls and indicators. It is a hardware device with some embedded software for control and indication.
Based on the provided text, the Giraffe Blue Spot PT Lite phototherapy system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "light therapy for the treatment of hyperbilirubinemia... during the newborn period in the hospital." This describes a therapeutic intervention applied directly to the patient, not a test performed on a sample taken from the body.
- Device Description: The description details a system that generates and delivers light to the patient. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing information for diagnosis, monitoring, or screening based on the analysis of these samples.
- Reagents, calibrators, or controls used in laboratory testing.
The device is clearly described as a therapeutic device for treating a medical condition directly on the patient.
N/A
Intended Use / Indications for Use
The Giraffe Blue Spot PT Lite phototherapy system provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital.
Product codes
LBI
Device Description
The Giraffe Blue Spot PT consists of two main sub-assemblies the same as the predicate devices; a sub-assembly that generates the phototherapy light and a sub-assembly that transfers the light to the patient. For the Giraffe Blue Spot PT Lite the two halves are generically known as the Light Pipe and the Light Box.
The Light Pipe is a flexible arm that consists of a single optical fiber passing through a set of springs to a shade assembly that will focus the output light to the desired spot size from a given distance. The spring portion of the assembly provides the ability to quickly position the light pipe without the need for tools, while also providing sufficient rigidity to keep light pipe from drooping or rising out of position.
The phototherapy light provided to the patient is controlled by the operator by adjusting the positioning of the output shade above the patient. The therapy delivered to the patient varies directly with the distance of the light shade from the patient being treated. The operator changes the intensity and spot size by manually adjusting this distance.
The Light Box contains a single blue light LED providing the phototherapy light source that is then transmitted utilizing the Light Pipe. The Light Pipe is used to position and direct the therapy light onto the patient from above. There is no direct contact with the patient. The light source operates at a single light intensity and is not adjustable by the operator or patient.
The phototherapy LED emits light in a narrow bandwidth; 400nm - 500nm with a 450nm -475nm peak. As such, and confirmed by physical testing to IEC60601-2-50, there are very low levels of energy in the ultraviolet (UV) or infrared (IR) regions of the light spectrum.
The Light Box also contains an internal cooling fan to cool the internal circuitry and the phototherapy LED in order to extend product lifetime. The device is ready for use once connected to an AC power source. The device is equipped with an internal switching power supply that accepts 100-240VAC 50/60Hz power. Power connection is made through supplied power cord connected to an IEC appliance inlet with built-in fuses protection.
The front cover of the unit provides numerous operating features including an ON/OFF pushbutton to turn the phototherapy LED on and off, LED indicators for Standby/Ready, phototherapy ON and over/under temperature; and an hour meter that tracks accumulated phototherapy hours on the device. The over/under temperature indicator provides feedback to the operator that the phototherapy LED is currently too hot, or too cold, to allow it to be turned on and that the fan is actively cooling, or warming, the unit until appropriate temperatures are reached. Once the unit is at the appropriate temperature range, the Standby/Ready indicator illuminates.
On the bottom of the unit are the IEC power inlet and associated fuses, a potential equalization ground stud and the air intake filter. A mounting bracket on the back of the unit allows the unit to be positioned and secured in the dovetail slot of an accessory rail. Tightening three socket head mounting screws holds the unit in position.
LEDs have very little degradation over their lifetime with proper use and care. During normal operating conditions the device is expected to last for over 7,000 hours and provide the minimum levels of therapy as defined by the "American Academy of Pediatrics, clinical practice guideline, subcommittee on hyperbilirubinemia: Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation, 2004; 297-316".
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
newborn period
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)
Since the treatment of neonatal hyperbilirubinemia with phototherapy is a well-established clinical practice, clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product has been designed following Lumitex design controls as required by 21 CFR 820, Subpart C and subjected to extensive 30 party apency approvals and in-house bench testing.
Testing:
The Giraffe Blue Spot PT Lite is currently undergoing extensive 3 degree party testing to numerous global standards.
Intertek ETL has certified the product to numerous standards. This effort includes, but is not limited to, the following:
Standards:
IEC 60601-1 Issued:1988/12/01 Ed:2 - Medical Electrical Equipment Part 1: General Requirements for Safety; (Amd. 1-1991) (CENELEC EN 60601-1: 1990) (Amd. 2-1995) (Corrigendum-1995)
IEC 60601-1-2 Issued:2007/03/01 Ed:3.0 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-2-50 Issue:2000/07/01 Ed:1 - Medical Electrical Equipment - Part 2-50: Particular Requirements for the Safety of Infant Phototherapy Equipment Includes TRFs for UV/IR Testing and Sound Testing to IEC 60601-2-50 2nd edition issue 3/9/2009
In addition to the above 30 party certifications, Lumitex has performed substantial verification and equivalence bench testing for the Giraffe Blue Spot PT Lite and the predicate device described earlier. The tests are included with this submission and include phototherapy comparative spectral irradiance levels with temperature and humidity levels at the maximum device environmental ratings as well as nominal room environments.
The results of the bench testing show that the Giraffe Blue Spot PT Lite provides equivalent therapeutic overhead phototherapy treatment as the predicate Giraffe Spot PT Lite by Ohmeda Medical. Both devices were tested in their minimum and maximum environmental conditions. Both devices are comprised of a box containing a light source and both utilize a flexible light pipe to position and direct the light onto a patient from above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Rev B Revised May 2012
510(k) Summary
JUN - 8 2012
Giraffe Blue Spot PT Lite
Submitter Information:
Lumitex, Inc. 8443 Dow Circle Strongsville, OH 44136 Phone: 440-243-8401 Fax: 440-243-8402 Contact Person: David G. Felty P.E., Director of Engineering Email: dfelty@lumitex.com Date Prepared: March 14, 2012
Device Names:
Classification Name: Neonatal Phototherapy Unit Common Name: Phototherapy Light, Spot PT Trade Name: Giraffe Blue Spot PT Lite Product Code: LBI Classification Number: 21 CFR 880.5700 Class Type: (Class II)
Indications for Use:
The Giraffe Blue Spot PT Lite phototherapy system provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital.
Predicate Device Information:
The Giraffe Blue Spot Phototherapy Lite is substantially equivalent to the following legally marketed product:
Ohmeda Medical Giraffe Spot PT Lite Phototherapy System (K011549)
Giraffe Blue Spot PT Lite 510k Submission Section 5 - 510(k) Summary
Section 5 Page 1
1
Substantial Equivalence Comparison:
The following matrix provides a comparison of the basic key equivalence metrics between the Giraffe Blue Spot PT Lite and its predicates. A more extensive table is provided in the Substantial Equivalence section.
| Substantial Equivalence Comparison | ||
|---|---|---|
| Giraffe Blue Spot Lite Phototherapy | ||
| System | Giraffe Spot PT Lite Phototherapy | |
| System (Predicate) | ||
| 510k Number | TBD | K011549 |
| Light Delivery | ||
| System | Single Fiber Optic Cable | Single Fiber Optic Cable |
| with a quartz rod buffer between the | ||
| fiber and the light source | ||
| Wavelength | Light output is limited to blue light, | |
| typically within 400nm - 500nm. | Light output is white light from a metal | |
| halide bulb allowing for a very broad | ||
| spectrum, typically between 350nm - | ||
| 700nm. | ||
| Bulb Life | 7,000 Hours | 2,500 Hours |
| Peak Wavelength | 450nm - 475nm | 570nm - 590nm (typical peak) |
| Light Intensity(1) | At a distance of 38 cm there is a | |
| treatment area of 990 cm² and a | ||
| spectral irradiance of 45 µW·cm-2·nm-1 | ||
| +25%/-20%. | At a distance of 38 cm there is a | |
| treatment area of 315 cm² and a | ||
| spectral irradiance of 57.6 µW·cm-2·nm-1 | ||
| ±25%. | ||
| Light Output | ||
| Adjustment | Light output may be adjusted by | |
| changing the distance from the lens of | ||
| the device to the patient. | ||
| As the lens is moved farther from the | ||
| patient the light output per area | ||
| decreases and the area increases. | Light output may be adjusted by | |
| changing the distance from the lens of | ||
| the device to the patient. | ||
| As the lens is moved farther from the | ||
| patient the light output per area | ||
| decreases and the area increases. | ||
| Light Source Type | Single Light Emitting Diode | Single Metal Halide Bulb |
[1] American Academy of Pediatrics, clinical practice guideline, subcommittee on hyperbillrubinemia: Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation, 2004; 297-316 recommends spectral irradiance greater than 30.0 µW-cm 2-nm 3 for effective therapy treatment.
Product Description:
The Giraffe Blue Spot PT consists of two main sub-assemblies the same as the predicate devices; a sub-assembly that generates the phototherapy light and a sub-assembly that transfers the
Giraffe Blue Spot PT Lite 510k Submission Section 5 - 510(k) Summary
2
light to the patient. For the Giraffe Blue Spot PT Lite the two halves are generically known as the Light Pipe and the Light Box.
The Light Pipe is a flexible arm that consists of a single optical fiber passing through a set of springs to a shade assembly that will focus the output light to the desired spot size from a given distance. The spring portion of the assembly provides the ability to quickly position the light pipe without the need for tools, while also providing sufficient rigidity to keep light pipe from drooping or rising out of position.
The phototherapy light provided to the patient is controlled by the operator by adjusting the positioning of the output shade above the patient. The therapy delivered to the patient varies directly with the distance of the light shade from the patient being treated. The operator changes the intensity and spot size by manually adjusting this distance.
The Light Box contains a single blue light LED providing the phototherapy light source that is then transmitted utilizing the Light Pipe. The Light Pipe is used to position and direct the therapy light onto the patient from above. There is no direct contact with the patient. The light source operates at a single light intensity and is not adjustable by the operator or patient.
The phototherapy LED emits light in a narrow bandwidth; 400nm - 500nm with a 450nm -475nm peak. As such, and confirmed by physical testing to IEC60601-2-50, there are very low levels of energy in the ultraviolet (UV) or infrared (IR) regions of the light spectrum.
The Light Box also contains an internal cooling fan to cool the internal circuitry and the phototherapy LED in order to extend product lifetime. The device is ready for use once connected to an AC power source. The device is equipped with an internal switching power supply that accepts 100-240VAC 50/60Hz power. Power connection is made through supplied power cord connected to an IEC appliance inlet with built-in fuses protection.
The front cover of the unit provides numerous operating features including an ON/OFF pushbutton to turn the phototherapy LED on and off, LED indicators for Standby/Ready, phototherapy ON and over/under temperature; and an hour meter that tracks accumulated phototherapy hours on the device. The over/under temperature indicator provides feedback to the operator that the phototherapy LED is currently too hot, or too cold, to allow it to be turned on and that the fan is actively cooling, or warming, the unit until appropriate temperatures are reached. Once the unit is at the appropriate temperature range, the Standby/Ready indicator illuminates.
On the bottom of the unit are the IEC power inlet and associated fuses, a potential equalization ground stud and the air intake filter. A mounting bracket on the back of the unit allows the unit
Giraffe Blue Spot PT Lite 510k Submission Section 5 - 510(k) Summary
Section 5 Page 3
3
to be positioned and secured in the dovetail slot of an accessory rail. Tightening three socket head mounting screws holds the unit in position.
LEDs have very little degradation over their lifetime with proper use and care. During normal operating conditions the device is expected to last for over 7,000 hours and provide the minimum levels of therapy as defined by the "American Academy of Pediatrics, clinical practice guideline, subcommittee on hyperbilirubinemia: Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation, 2004; 297-316".
Performance Data:
Since the treatment of neonatal hyperbilirubinemia with phototherapy is a well-established clinical practice, clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product has been designed following Lumitex design controls as required by 21 CFR 820, Subpart C and subjected to extensive 30 party apency approvals and in-house bench testing.
Testing:
The Giraffe Blue Spot PT Lite is currently undergoing extensive 3° party testing to numerous global standards.
Intertek ETL has certified the product to numerous standards. This effort includes, but is not limited to, the following:
| Standards | Title |
|---|---|
| IEC 60601-1 Issued:1988/12/01 Ed:2 | Medical Electrical Equipment Part 1: General Requirements |
| for Safety; (Amd. 1-1991) (CENELEC EN 60601-1: 1990) | |
| (Amd. 2-1995) (Corrigendum-1995) | |
| IEC 60601-1-2 Issued:2007/03/01 Ed:3.0 | Medical Electrical Equipment - Part 1-2: General |
| Requirements for Basic Safety and Essential Performance – | |
| Collateral Standard: Electromagnetic Compatibility - | |
| Requirements and Tests | |
| IEC 60601-2-50 Issue:2000/07/01 Ed:1 | Medical Electrical Equipment - Part 2-50: Particular |
| Requirements for the Safety of Infant Phototherapy | |
| Equipment | |
| Includes TRFs for UV/IR Testing and Sound Testing to IEC | |
| 60601-2-50 2nd edition issue 3/9/2009 |
In addition to the above 30 party certifications, Lumitex has performed substantial verification and equivalence bench testing for the Giraffe Blue Spot PT Lite and the predicate device described earlier. The tests are included with this submission and include phototherapy
4
comparative spectral irradiance levels with temperature and humidity levels at the maximum device environmental ratings as well as nominal room environments.
The results of the bench testing show that the Giraffe Blue Spot PT Lite provides equivalent therapeutic overhead phototherapy treatment as the predicate Giraffe Spot PT Lite by Ohmeda Medical. Both devices were tested in their minimum and maximum environmental conditions. Both devices are comprised of a box containing a light source and both utilize a flexible light pipe to position and direct the light onto a patient from above.
The major difference between the two Giraffe designs is that the Giraffe Blue Spot PT Lite utilizes a narrow bandwidth LED that emits light in the desired "blue" spectrum versus the use of a broad spectrum "white" light metal-halide bulb in the predicate Giraffe Spot PT Lite. LED light sources can be found in similar FDA approved devices such as the Bilisoft Phototherapy System (K053568).
Another notable difference is that the Giraffe Blue Spot PT Lite does not require a quartz rod to buffer the optical transmission fiber from the heat developed by the light source as is the case in the predicate Giraffe Spot PT Lite.
Based on the direct comparative testing with predicate devices and the extensive 30 party testing to international standards, the Giraffe Blue Spot PT Lite is believed to be safe and effective for the treatment of hyperbilirubinemia.
Sterilization Information
The Giraffe Blue Spot PT Lite is not intended to be supplied sterile. Cleaning and disinfecting instructions can be found in the Operation, Maintenance, and Service Manual.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. David Felty, P.E. Director of Engineering Lumitex, Incorporated 8443 Dow Circle Strongsville, Ohio 44136
JUN - 8 2012
Re: K120820
Trade/Device Name: Giraffe Blue Spot PT Lite Regulation Number: 21 CFR 880.5700 Regulation Name: Neonatal Phototherapy Unit Regulatory Class: II Product Code: LBI Dated: May 15, 2012 Received: May 17, 2012
Dear Mr. Felty:
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.
6
Page 2- Mr. Felty
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/ucm 115809.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,
Tresson D.m
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
7
Indications for Use
510(k) Number (if known):
Device Name: Giraffe Blue Spot PT Lite
Indications For Use:
The Giraffe Blue Spot PT Lite phototherapy system provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Rul C. Chym 6/6/12
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K120820