(81 days)
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.
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.
Here's an analysis of the provided text regarding the Giraffe Blue Spot PT Lite's acceptance criteria and the supporting study, structured according to your request.
Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial. As such, some of your requested information (particularly around AI-specific details like MRMC studies, training set ground truth, and expert qualifications for ground truth) is not applicable or explicitly stated for this type of medical device which is a physical phototherapy light, not an AI/algorithm-based diagnostic tool. I will indicate where this is the case.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Giraffe Blue Spot PT Lite are primarily tied to demonstrating equivalent therapeutic performance and safety to its predicate device and meeting relevant international standards for medical electrical equipment.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Therapeutic Effectiveness | Spectral irradiance greater than 30.0 µW·cm⁻²·nm⁻¹ for effective therapy treatment (American Academy of Pediatrics guideline). Sufficient light output per area for treating hyperbilirubinemia. | At a distance of 38 cm, a treatment area of 990 cm² and a spectral irradiance of 45 µW·cm⁻²·nm⁻¹ +25%/-20%. This exceeds the recommended spectral irradiance, indicating effective therapy. Bench testing showed that the Giraffe Blue Spot PT Lite provides equivalent therapeutic overhead phototherapy treatment as the predicate Giraffe Spot PT Lite. This equivalence was maintained across minimum and maximum environmental conditions. |
| Safety - Electrical & EMC | Compliance with IEC 60601-1 (General Requirements for Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). | Intertek ETL certified the product to IEC 60601-1 (Ed:2, Amd. 1-1991, Amd. 2-1995) and IEC 60601-1-2 (Ed:3.0). |
| Safety - Phototherapy Specific | Compliance with IEC 60601-2-50 (Particular Requirements for the Safety of Infant Phototherapy Equipment), especially regarding UV/IR emissions and sound levels. | Intertek ETL certified the product to IEC 60601-2-50 (Ed:1, with TRFs for UV/IR Testing and Sound Testing to IEC 60601-2-50 2nd edition issue 3/9/2009). Physical testing confirmed very low levels of energy in the ultraviolet (UV) or infrared (IR) regions of the light spectrum. |
| Substantial Equivalence to Predicate Device | Demonstrated equivalence in light delivery system, adjustability, and overall functionality, despite differences in light source type and wavelength. Performance should be comparable to or better than the predicate for its intended use. | Bench testing included comparative spectral irradiance levels with temperature and humidity levels at max device environmental ratings and nominal room environments. Results showed equivalent therapeutic overhead phototherapy treatment to the predicate Giraffe Spot PT Lite. Major differences (LED vs. Metal Halide, blue vs. broad spectrum) were addressed by arguing that LED sources are found in other FDA-approved devices, and the new design eliminated the need for a quartz rod buffer. The overall conclusion was that it is "safe and effective for the treatment of hyperbilirubinemia" based on this comparison and adherence to standards. |
| Light Source Longevity | 7,000 Hours of operation while providing minimum levels of therapy as defined by the American Academy of Pediatrics guideline. | "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...'" (This is a statement of expectation rather than a direct performance measurement result from a specific test in the provided text, but it’s presented as an outcome of design and testing). |
2. Sample size used for the test set and the data provenance
The document describes bench testing and 3rd party agency approvals rather than clinical studies with human subjects.
- Sample Size for Test Set: Not applicable in the context of clinical "test sets" as understood for algorithmic performance. The testing involved samples of the device itself and its predicate, subjected to various physical and environmental conditions. No specific number of devices tested is explicitly stated, but the implication is "the Giraffe Blue Spot PT Lite" and "the predicate Giraffe Spot PT Lite."
- Data Provenance: The data comes from "in-house bench testing" by Lumitex, Inc. and certifications by "Intertek ETL," a 3rd party agency. This is retrospective in the sense that the device was developed and then tested, and the data provenance is primarily from laboratory and compliance testing within the US (given the FDA submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a physical medical device (phototherapy unit) for which performance is measured by physical parameters (light intensity, wavelength, safety standards compliance) rather than diagnostic accuracy against a ground truth established by experts. The "ground truth" for therapeutic effectiveness is based on published clinical guidelines (American Academy of Pediatrics recommendations for spectral irradiance).
4. Adjudication method for the test set
This is not applicable. There was no need for adjudication as the testing involved objective physical measurements of the device's output and compliance with engineering and safety standards, rather than subjective interpretations or clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This device is a phototherapy unit, not an AI-assisted diagnostic or treatment planning tool that involves human readers. Therefore, an MRMC study or AI-related comparative effectiveness is outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is not an algorithm; it is a physical device providing light therapy.
7. The type of ground truth used
The "ground truth" for the device's therapeutic effectiveness is based on clinical guidelines and established medical consensus: 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," which recommends a spectral irradiance greater than 30.0 µW·cm⁻²·nm⁻¹ for effective therapy.
8. The sample size for the training set
This is not applicable. The device is a physical phototherapy unit; there is no "training set" in the context of machine learning or AI. The design was likely developed through engineering principles, prior knowledge, and iterative design processes.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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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
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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 PhototherapySystem | Giraffe Spot PT Lite PhototherapySystem (Predicate) | |
| 510k Number | TBD | K011549 |
| Light DeliverySystem | Single Fiber Optic Cable | Single Fiber Optic Cablewith a quartz rod buffer between thefiber and the light source |
| Wavelength | Light output is limited to blue light,typically within 400nm - 500nm. | Light output is white light from a metalhalide bulb allowing for a very broadspectrum, 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 atreatment area of 990 cm² and aspectral irradiance of 45 µW·cm-2·nm-1+25%/-20%. | At a distance of 38 cm there is atreatment area of 315 cm² and aspectral irradiance of 57.6 µW·cm-2·nm-1±25%. |
| Light OutputAdjustment | Light output may be adjusted bychanging the distance from the lens ofthe device to the patient.As the lens is moved farther from thepatient the light output per areadecreases and the area increases. | Light output may be adjusted bychanging the distance from the lens ofthe device to the patient.As the lens is moved farther from thepatient the light output per areadecreases 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
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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
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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 Requirementsfor 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: GeneralRequirements 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: ParticularRequirements for the Safety of Infant PhototherapyEquipmentIncludes TRFs for UV/IR Testing and Sound Testing to IEC60601-2-50 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
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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.
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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.
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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
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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
§ 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).