BABYTHERM 8004 BABYTHERM 8010

{0} 001 - 3 1997 00011 K971198 Drager Datei: Summary.RTF Date: Jan.08, 1997 Author: Frank Clanzett # 510(k) SUMMARY ## Summary of Safety and Effectiveness ### APPLICANTS NAME AND ADDRESS: Drager Inc. Critical Care Systems 4101-100 Pleasant Valley Road Chantilly, VA 20151 ### APPLICANTS TELEPHONE NUMBER: (703)-817-0100 ### APPLICANTS FACSIMILE NUMBER: (703)-817-0101 ### APPLICANTS CONTACT PERSON: Harald Kneuer Regulatory Affairs Manager ### DATE THE SUMMARY WAS PREPARED: January 08, 1997 ### DEVICE NAME: Trade Name: Babytherm 8004 / 8010 Common Name: Babytherm 8004 / 8010 Classification Name: System, Thermal Regulating ### LEGALLY MARKETED DEVICE TO WHICH DRAGER INC. IS CLAIMING SUBSTANTIAL EQUIVALENCE: Babytherm 8000 WB - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc. RH 600 (Radiant Heater) - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc. PT 4000 (Phototherapy) - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc. Microlite™ (Phototherapy) - Manufactured by Air Shields, USA Page 1 of 10 {1} Dräger Table of Comparison | | Dräger Babytherm 8000 WB | Dräger Radiant Heater RH 600 | Dräger PT4000 | AirShields Microlite™ | Dräger Babytherm 8004 / 8010 | | --- | --- | --- | --- | --- | --- | | 510(k) Number | K 94 5467 | K 95 3489 | K 95 4611 | K 91 2908 | | | Intended Use | Heated bassinet intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. | Radiant warmer system to compensate for heat lost by infants during medical examinations or therapy. | PT 4000 is used to decrease blood bilirubin levels via phototherapy in premature and full term infants who are treated in incubators or on radiant warmer beds. | Phototherapy for treatment of Hyperbilirubinemia | Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia. | | Physical Size (mm) | | | | | | | Height (mm) | 1220 to 1515 with height adjustment | --- | --- | --- | 1820 to 2385 with height adjustment | | Length (mm) | 1070 | --- | --- | --- | 1315 | | Width (mm) | 750 | --- | --- | --- | like Babytherm 8000 WB | | Weight | 85 kg max | --- | --- | --- | 135 kg max | | Mattress Size (mm) | 750 x 490 | --- | --- | --- | like Babytherm 8000 WB | | Bassinet Tilt | ± 10° from horizontal | --- | --- | --- | like Babytherm 8000 WB | | Case Material | PS-TSG | --- | --- | --- | like Babytherm 8000 WB | | Case Color | blue | --- | --- | --- | like Babytherm 8000 WB | | Power Input | | | | | | | Voltage | 120 VAC, 60 Hz | 110 / 127 VAC, 60 Hz | 110 / 127V | 110 / 120 VAC | like Babytherm 8000 WB | | Total | 135 W + 560 W for height adjustment | 735 W | 120 W | 300 W | 670 W for Babytherm 8004 790 W for Babytherm 8010 +120 W for variable height adjust + 440 W for Phototherapy | | Fuses | 2 x 1.6 A / 2 x 6.3 A | 2 x 6.3 A | 2 x 1.6 A | 2 x 4 A | 2 x 15 A | | Leakage Current | < 0.2 mA | < 0.1 mA | < 0.2 mA | < 0.1 mA | < 0.5 mA | see explanation of differences {2} Dräger | | Dräger Babytherm 8000 WB | Dräger Radiant Heater RH 600 | Dräger PT4000 | AirShields Microlite™ | Dräger Babytherm 8004 / 8010 | | --- | --- | --- | --- | --- | --- | | Design | Heated Mattress Control and heater unit and the mattress are together in one housing which is mounted on a trolley with optional height adjustment and four casters | Radiant Warmer Control and heater unit are together in one housing which is mounted on mobile stand or on a wall. | Phototherapy The Photo-therapy is a separate device with an examination light included. | Phototherapy The Photo-therapy is a separate device | The Babytherm 8004 / 8010 is developed to combine the two products Dräger Babytherm 8000 WB and Dräger Radiant warmer RH600. Components of the Heated Mattress (Babytherm 8010 only) are the same as for Babytherm 8000 WB. The ThermoMonitoring is included in the Babytherm 8004 and 8010. The Radiant Warmer of the Babytherm 8004/8010 is a further development of the RH 600. The Heater unit, the examination light and the optional Phototherapy unit are together in one housing which is located in a distance of 80 cm over the mattress, mounted on two columns at the head end of the bed. The Control Unit is located below the end of the radiant warmer between the two columns at the head end of the bed. | | | | | | | | | Energy used | Electric: A 120 W, 24 VAC heater heats up an aluminium plate and the patient is heated up by conductive warm through the Gel mattress. The lower heater voltage of 24 VAC insures maximum safety for the patient. | Electric: Four 150 W, 120 VAC ceramic heater are used to provide radiative heat in direction of the bed. | Electric: Flourescent bulbs for the phototherapy | Electric: Halogen bulbs for the phototherapy | Electric. For the heated mattress the same as Babytherm 8000 WB. For the radiant warmer two ceramic heater of 300 W are used to provide radiative heat in the direction to the bed. For the phototherapy halogen bulbs are used | | Heated Mattress | | | | | | | Type | 4 mm Aluminium plate with heating foil | --- | --- | --- | like Babytherm 8000 WB | | Power | 24 VAC / 120 W | --- | --- | --- | like Babytherm 8000 WB | see explanation of differences {3} Dräger | | Dräger Babytherm 8000 WB | Dräger Radiant Heater RH 600 | Dräger PT4000 | AirShields Microlite™ | Dräger Babytherm 8004 / 8010 | | --- | --- | --- | --- | --- | --- | | | | | | | | | Heated Mattress (Continue) | | | | | | | Setting Temp. Range | 30.0°C - 38.0°C | --- | --- | --- | like Babytherm 8000 WB | | Measurement Range | 5.0°C - 45.0°C | --- | --- | --- | like Babytherm 8000 WB | | Accuracy | ± 0.5 °C | --- | --- | --- | like Babytherm 8000 WB | | Applied Part | BF | --- | --- | --- | like Babytherm 8000 WB | | | | | | | | | Radiant Heater | | | | | | | Type | --- | ceramic | --- | --- | like RH 600 | | Power | --- | 600 W | --- | --- | like RH 600 | | Control | --- | manual or servo | --- | --- | like RH 600 | | Distance heater - mattress | --- | 70 cm default, possible 60cm to 80 cm | --- | --- | 80 cm | | Exam light | --- | 1 x 35 W | --- | --- | 1 x 11 W, 1 x 19 W | | Manual setting | --- | Level 0 to 10, 23 mW/cm² max. at 70 cm distance | --- | --- | Level 0 to 10, 30 mW/cm² max. at 80 cm³ | | Setting Temp. Range | --- | 35°C - 37°C | --- | --- | 35°C - 37.5 °C⁴ | | Measurement Range | --- | 33°C - 38°C | --- | --- | 15°C to 42 °C⁵ | | Accuracy | --- | ± 0.3 °C | --- | --- | like RH 600 | | Applied Part | --- | B | --- | --- | BF⁶ | | Power Fail | Actuates if there is a loss of supply voltage | Actuates if there is a loss of supply voltage | --- | --- | Actuates if there is a loss of supply voltage | ⁴ see explanation of differences {4} Dräger | | Dräger Babytherm 8000 WB | Dräger Radiant Heater RH 600 | Dräger PT4000 | AirShields Microlite™ | Dräger Babytherm 8004 / 8010 | | --- | --- | --- | --- | --- | --- | | Phototherapy Option | | | | | | | Type | --- | --- | Phototherapy system mounted on a mobile stand for use in combination with radiant warmers or incubators | Phototherapy system mounted on a mobile stand for use in combination with radiant warmers or incubators | Phototherapy system integrated in radiant warmer housing for use in combination with radiant warmer, mounted on two columns at the head end of the bed, with a fixed distance to the patient | | Light source | --- | --- | flourescent bulbs | 3 halogen bulbs | 6 halogen bulbs^{7} | | Power input | --- | --- | 120 W | 300 W | 440 W^{8} | | Distance to mattress | --- | --- | variable, 30 cm minimum | variable | 80 cm | | On/Off switch | --- | --- | yes | yes | yes | | effective Irradiance within Wave length range | --- | --- | 13 μW/cm²/nm at 40 cm distance 400..500 nm | 17 μW/cm²/nm at 43 cm distance 400..500 nm | 12 μW/cm²/nm at 80 cm distance 425..475 nm | | Bulb life | --- | --- | 1000 hours | 1000 hours | 1000 hours | | Hour meter | --- | --- | dual timing system for patient exposure time and bulb life | dual timing system for patient exposure time and bulb life | dual timing system for patient exposure time and bulb life. | | Control System | | | | | | | Type | Microprocessor based, digital | Microprocessor based, digital | --- | --- | Microprocessor based, digital | | Self-Calibrating | Yes | Yes | --- | --- | Yes | | Setpoint-Readout | Digital, 3 digit | Digital, 3 digit | --- | --- | Digital, 3 digit | | Power On | Red LED | Red LED | --- | --- | Green LED^{9} | | Power Fail | Actuates if there is a loss of supply voltage | Actuates if there is a loss of supply voltage | --- | --- | Actuates if there is a loss of supply voltage | see explanation of differences {5} Dräger | | Dräger Babytherm 8000 WB | Dräger Radiant Heater RH 600 | Dräger PT4000 | AirShields Microlite™ | Dräger Babytherm 8004 / 8010 | | --- | --- | --- | --- | --- | --- | | Safety System | | | | | | | Overtemperature | 40.0°C | --- | --- | --- | For mattress: like Babytherm 8000 WB. For skin temp. 39.0°C in skin mode or in manual mode, if sensor is connected. 10 | | Overheat Protection | Yes. | Yes. | --- | --- | Yes | | Probe Fail | Actuates if mattress temp. sensors (2 pairs) are open, shorted or unplugged, or if temp. difference between mattress sensors is too large | Actuates during skin temp. control if skin temp. probe has been disconnected or is faulty | --- | --- | For mattress: Like Babytherm 8000 WB. For radiant heater: like RH 600 | | Set point deviation | Mattress Set temp. ± 1°C | Skin Set temp. ± 0.5°C | --- | --- | For mattress, same as Babytherm 8000 WB. For skin temp., like RH 600 11 | | Shut off temperature | 42.0°C | --- | --- | --- | like Babytherm 8000 WB. | | 15 Minute Alarm | --- | Actuates after 15 minutes in manual mode with level > 5 | --- | --- | Actuates after 15 minutes in manual mode with level > 3, and heater output is reduced to level 2 12 | | Visuable Alarm | Yes | Yes | --- | --- | Yes. | | Audible Alarm | Yes | Yes | --- | --- | Yes. | {6} Dräger # Explanation of Differences related to the Table of Comparison: 1. The ThermoMonitoring function uses two sensors for temperature measurement: One for the peripherally and one for the core sensor. 2. For the Babytherm 8004 / 8010 other types of ceramic heaters are used. The geometry of the reflectors was improved. The performance still meets the requirements of IEC 601-2-21. 3. The maximum irradiance was improved because of better reflector geometry. The device still meets the requirements of IEC 601-2-21. 4. This is an improved performance. The device still meets the requirements of IEC 601-2-21. 5. Two temperature channels for core and peripheral temperature with a range from 15°C to 42°C. 6. This is an improved safety requirement of IEC 601-2-21. 7. By this modification an even distribution of the irradiance over an area of 20 x 40 cm is achieved. 8. see explanation number 7. 9. Change in LED Colour to fullfill exactly this requirement of IEC 601. 10. This is an improved safety feature for the radiant heater. 11. The allowable deviation may be changed by the user in a range from 0.3°C to 1.0°C 12. For the Babytherm 8004/8010 at level 3 the heater output is approximately 9 mW/cm², level 2 corresponds to heater output of 6 mW/cm². According to 601-2-21 the 15 Minutes-Alarm has to be activated at a heater output of more than 10 mW/cm². 7 of 10 {7} Dräger # DESCRIPTION OF THE DEVICE: Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater. Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth. 00013 {8} Dräger # SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES: The Babytherm 8004 / 8010 are substantially equivalent to the predicate devices Babytherm 8000 WB, Radiant Heater RH 600, Phototherapy PT 4000 and Phototherapy Microlite™. The function of the Babytherm 8004 / 8010 including the optional Phototherapy is also covered by the predicate devices and the equivalent intended use is covered by these devices, too. The Babytherm 8004 / 8010 fulfil at least the same international standards as the predicate devices of Dräger and has been tested according to these standards. Therefore the Babytherm 8004 / 8010 are as safe and effective as the predicate devices. Frank Clanzett Regulatory Affairs Specialist (Dragerwerk AG, Germany) Jan. 08.1997 00020 {9} DEPARTMENT OF HEALTH &amp; HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Mr. Harald Kneuer Regulatory Affairs Manager Drager Incorporated 4101 Pleasant Valley Road, Suite 100 Chantilly, VA 20151 OCT - 3 1997 Re: K971198 Trade Name: Babytherm 8004 Babytherm 8010 Regulatory Class: II Product Code: FMT Dated: July 7, 1997 Received: July 9, 1997 Dear Mr. Kneuer: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {10} Page 2 - Mr. Kneuer through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health -Enclosure {11} Dräger # INTENDED USE OF THE DEVICE: Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia. Frank Clanzett Regulatory Affairs Specialist (Dragerwerk AG, Germany) Jan. 08.1997 Davison Sign-Off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K971198 Prescription Use ☑ (Per 21 CFR 801.109) 00019 Page 9 of 10