(100 days)
The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.
The Sunflower Warmer is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Sunflower Warmer has the capability to control the infant's skin temperature as well as the CPR timer. It is provided in eight mechanical variants, the canopy (heat source) is identical in all variants.
Acceptance Criteria and Device Performance Study for the Sunflower Radiant Warmer
The provided document describes the substantial equivalence of the Sunflower Radiant Warmer to its predicate device, the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335. The device's performance was evaluated through bench testing against established standards and internal criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Sunflower Radiant Warmer are primarily demonstrated through compliance with international standards and equivalent performance specifications compared to the predicate device. Specific quantitative acceptance criteria are given for skin temperature accuracy.
| Feature / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Compliance with Standards | Adherence to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21. | Met all cited standards requirements. |
| Alarm Testing | All specified alarms (Baby Check, Set temperature, High Temperature, Probe Short/Open circuit/No probe, Power failure, System failure) must function correctly. | Met all pass/fail criteria. |
| Skin Temperature Accuracy | Skin Temperature Display: ±0.3°C | Achieved accuracy within ±0.3°C (as per specifications). |
| Temperature Control Testing | Effective thermoregulation within specified ranges and modes. | Met all pass/fail criteria. |
| Mattress Temperature Distribution Testing | Uniformity in mattress temperature; specific criteria not detailed but assumed to be within acceptable physiological limits. | Met all pass/fail criteria. |
| Pre-warming Mode | Functionality as designed. | Met all pass/fail criteria. |
| Power Switch Malfunction under Heat Stress | Power switch must not malfunction under heat stress. | Tested and found to not malfunction. |
| Heater Capacity | 500W | 500W |
| Set Temperature Range | 34.0~38.0°C (in 0.1°C increments) | 34.0~38.0°C (in 0.1°C increments) |
| Skin Temperature Display Range | 30.0~42.0°C | 30.0~42.0°C |
| Heater Output Setting Range | 0~100% (in 5% increments) | 0~100% (in 5% increments) |
| Modes | Manual, Servo (automatic based on skin temperature probe) | Manual, Servo (automatic based on skin temperature probe) |
| Operating Environmental Conditions | 18 to 30°C, RH 30 to 75% (non-condensing) | Operates within 18 to 30°C, RH 30 to 75%. |
| Storage Environmental Conditions | 0°C to 50°C, RH 30-75% (non-condensing) | Stores within 0°C to 50°C, RH 30-75%. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "bench tests" were performed. However, it does not specify the sample size used for these tests. The data provenance is implied to be from internal laboratory testing conducted by Atom Medical Corporation, Japan, making it retrospective in the sense that the testing was completed prior to submission. The country of origin for the testing is Japan, where Atom Medical Corporation is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The device is an infant radiant warmer, and its performance testing focuses on technical specifications, safety standards, and functional benchmarks rather than subjective interpretations by human experts. The "ground truth" for these tests would be defined by the technical specifications, standard requirements (e.g., IEC 60601-1), and accurate measurements from calibrated equipment.
4. Adjudication Method for the Test Set
This information is not applicable. As the testing involves objective measurements and compliance with technical standards for a medical device, an adjudication method for reconciling expert opinions is not relevant. Pass/fail criteria are determined by pre-defined technical thresholds and compliance with regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices where human performance (with and without aid) is a primary outcome. For an infant radiant warmer, the focus is on the device's physical performance, safety, and functional equivalence to a predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire "Performance Testing" section describes bench tests of the device itself (the "algorithm only" in a functional sense, as there's no diagnostic algorithm) without human operators as part of the primary performance metric. The tests evaluate the warner's ability to maintain temperature, manage alarms, and comply with safety standards independently.
7. The Type of Ground Truth Used
The ground truth for the performance testing was based on:
- International Standards: Primarily IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-21.
- Manufacturer's Specifications: The design specifications for the device, such as set temperature range, skin temperature display accuracy, and heater capacity.
- Predicate Device Performance: The functional and performance characteristics of the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 served as a benchmark for equivalence.
- Bench Test Pass/Fail Criteria: Specific objective criteria established for each internal test (e.g., alarm activation at correct thresholds, stable temperature control).
8. The Sample Size for the Training Set
Not applicable. The Sunflower Radiant Warmer is a hardware device with embedded control systems, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Its internal control logic is designed and validated, not trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" for this type of medical device. The "ground truth" for its design and performance validation relies on engineering principles, recognized safety standards, and performance specifications derived from the intended use and predicate device.
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6 2012 JUL
| Atom Medical Corporation3-18-15, Hongo, Bunkyo-kuTokyo, Japan 113-0033 | Tel - 011-81-3-3815-3632Fax - 011-81-3-3812-3199 |
|---|---|
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Sunflower Radiant Warmer |
| Common/Usual Name: | Infant Radiant Warmer |
| Classification Name/Code: | Product Code: FMT, Regulation: 880.5130 Name: warmer,infant radiant |
| Device: | Sunflower Radiant Warmer |
| Predicate Device: | Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant WarmerK003335 |
Device Description:
The Sunflower Warmer is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Sunflower Warmer has the capability to control the infant's skin temperature as well as the CPR timer. It is provided in eight mechanical variants, the canopy (heat source) is identical in all variants.
Indications for Use:
The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.
Environment of Use: Hospital or institutional
Summary of Substantial Equivalence
The Sunflower Radiant Warmer was compared to the predicate Hill-Rom Air-Shields (Draeger) -Resuscitaire Radiant Warmer K003335
Indications for Use - The Sunflower Radiant Warmer is intended for thermoregulation and skin temperature monitoring of newborn infants. The sunflower Radiant Warmer has the same intended use as the Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 except it does not provide resuscitation functions.
Patient Population - The Sunflower Radiant Warmer is indicated for newborns and premature neonates as is the predicate.
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510(k) Summary Page 2 of 3 7/3/2012
Environment for use – The Sunflower Radiant Warmer has the identical environments for use as the predicate (hospital/institutional)
Prescriptive - The Sunflower Radiant Warmer is prescriptive as is the predicate.
Design and Technology - The Sunflower Radiant Warmer has equivalent design and features as the predicate and has the identical technology to the predicate with regard to radiant heating.
Performance and Specifications - The Sunflower Radiant Warmer has equivalent specifications of performance as the predicate with regard to radiant heating.
Compliance with standards - The Sunflower Radiant Warmer and predicate device declare compliance with IEC 60601-1, IEC 60601-1-2. Additionally the Sunflower Radiant Warmer complies with IEC 60601-2-21.
| Sunflower Radiant Warmer | Hill-Rom Air-Shields (Draeger)-Resuscitaire Radiant Warmer K003335 | |
|---|---|---|
| General Attributes | ||
| Indications for Use | The Sunflower Warmer is intendedfor thermoregulation, skintemperature monitoring, and Apgartiming of newborn infants. | The Resuscitaire® Radiant Warmer isintended for thermoregulation, skintemperature monitoring, Apgar timing, andresuscitation of newborn infants. |
| Patient Population | Newborn and Premature Neonates | Newborn Infants |
| Environment of Use | Hospital or institutional | Hospital or institutional |
| Prescriptive | Yes | Yes |
| Patient Connection | Yes via temperature probe | Yes via temperature probe |
| Technology | Electric heater | Electric heater |
| Technical specifications | ||
| Dimensions | Equivalent, see Section 11 for detaileddimensions for the various configurations | Equivalent |
| Weight | 20-89 kg depending on variant | 100-127 kg depending on variant |
| Power | 120V±10%, 60Hz, 700VA | 120V, 50-60Hz, 750 W |
| Performance | ||
| Heater Capacity | 500W | Similar based on power consumption |
| Alarms | Baby Check | Check patient |
| Set temperature | Baby temperature | |
| High Temperature | High temperature | |
| Probe Short or open circuit / No probe | Probe Short or open circuit / No probe | |
| Power failure | Power failure | |
| System failure | ||
| Set TemperatureRange | 34.0~38.0°C (in 0.1°C increments) | 34-38° C |
| Skin TemperatureDisplay | 30.0~42.0°C Accuracy: ±0.3°C | 18-43° C +/- 0.2° C |
Device Comparison
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510(k) Summary Page 3 of 3 7/3/2012
| Sunflower Radiant Warmer | Hill-Rom Air-Shields (Draeger)-Resuscitaire Radiant Warmer K003335 | |
|---|---|---|
| Technical specifications | ||
| Skin Temperaturesensing | Thermistor | Thermistor |
| Heater output settingrange | 0~100% (in 5% increments) | 0-100%, 10% increments |
| Modes | Manual, Servo (automatic based on skintemperature probe) | Manual, Servo (automatic based on skintemperature probe) |
| Environmental | ||
| Operating | 18 to 30°CRH 30 to 75% (non-condensing) | 15°C to 35°C |
| Storage | 0°C to 50°CRH 30-75% (non-condensing) | -20°C to 55°C |
Conclusion
The Atom Sunflower Warmer is substantially equivalent to the predicate Hill-Rom Air-Shields (Draeger) - Resuscitaire Radiant Warmer K003335 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 Sunflower warmer met all pass /fail criteria, cited standards requirements and was 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 60601-2-21: 2009 Medical Electrical Equipment Part 2-21: Particular requirements . for the basic safety and essential performance of infant radiant warmers
- . Alarm testing
- . Skin Temperature Accuracy testing
- Temperature Control Testing .
- . Mattress temperature Distribution Testing
- . Pre-warming mode
- Testing has been performed to insure power switch does not malfunction under heat . stress.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
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: K120937
Trade/Device Name: Sunflower Radiant Warmer Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: June 11, 2012 Received: June 13, 2012
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.
6 2012 JUL
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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.
For
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 Statement
Page 1 of 1
510(k) Number: K120937
Sunflower Radiant Warmer Device Name:
Indications for Use:
The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Ril
(Division Sign-Off)
7/6/2012
Division of Anesthesiology General Hospital Infection Control, Dental Dental Dental De neess
510(k) Number: K120937
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.