Who is the manufacturer of Infant Incubator?

Ningbo David Medical Device Co., Ltd. filed the 510(k) submission for Infant Incubator (K190494).

What is the FDA product code for Infant Incubator?

FMZ. It is classified under 21 CFR 880.5400 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Infant Incubator?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Infant Incubator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Infant Incubator

K190494 · Ningbo David Medical Device Co., Ltd. · FMZ · Nov 25, 2019 · General Hospital

Device Facts

Record ID	K190494
Device Name	Infant Incubator
Applicant	Ningbo David Medical Device Co., Ltd.
Product Code	FMZ · General Hospital
Decision Date	Nov 25, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5400
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

Device Story

The YP-3000 is a dual-function infant incubator and radiant warmer; functions are converted via a canopy lifting system. In incubator mode, it uses a convective heater and servo-control to maintain air/skin temperature and humidity. In warmer mode, it uses an infrared heating source with a parabolic reflector to provide heat to the patient, controlled via skin temperature feedback. The device includes a mattress, electronic scale, oxygen control system, observation lamp, tray, and IV pole. It is used in clinical settings for neonatal care, including resuscitation and emergency treatment. Healthcare providers monitor the device via integrated sensors and alarms; output allows for precise thermal and environmental management, supporting neonatal stability during transition or treatment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), alarm systems (IEC 60601-1-8), and performance standards for infant incubators (IEC 60601-2-19) and radiant warmers (IEC 60601-2-21). Biocompatibility testing was performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Dual-mode infant incubator/warmer; convective heater (incubator) and infrared radiant heater (warmer). Servo-controlled temperature (air/skin), humidity, and oxygen concentration. Includes electronic scale, RS232 connectivity, and multi-port transducer connectors. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-19, IEC 60601-2-21, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for neonates, including low birth weight infants and critically sick babies, who are unable to thermoregulate. Used for constant temperature incubation, body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization.

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

OmniBed (K993407)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 25, 2019 Ningbo David Medical Device Co., Ltd Lin Dingyu Vice General Manager No.2, Keyuan Road, Shipu Technology Park, Xiangshan Ningbo. 15731 China Re: K190494 Trade/Device Name: Infant Incubator Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal incubator Regulatory Class: Class II Product Code: FMZ, FMZ, FMT Dated: October 23, 2019 Received: October 25, 2019 Dear Lin Dingyu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K190494 Device Name YP-3000 Infant Incubator #### Indications for Use (Describe) The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------|--| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K190494 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (As Required by 21 CFR 807.92) ### 1. Date Prepared [21 CFR 807.92(a)(1)] November 22, 2019 ### 2. Submitter's Information [21 CFR 807.92(a)(1)] | Company Name: | Ningbo David Medical Device Co., Ltd. | |------------------|---------------------------------------------------------------------------------------------| | Company Address: | NO. 2, KEYUAN ROAD, SHIPU TECHNOLOGY PARK, XIANGSHAN, NINGBO, ZHEJIANG PROVINCE, P.R. China | | Fax: | +86-574-87800008 | **Fax:** ### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name: | | |--------------------|--| | Models: | | | Product Codes: | | | Regulation Number: | | | Regulation Name: | | | Device Class: | | Infant Incubator YP-3000 FMZ, FMT 21 CFR 880.5400 Neonatal incubator Class II ### 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[ The identification of the predicate device within this submission is as follows: Manufacturer: Trade Name: Product Codes: Regulation Name: Regulation Number: FDA 510 (k) #: OHMEDA MEDICAL. OmniBed FMZ, FMT Neonatal incubator 21 CFR 880.5400 K993407 ### 5. Description of the Device [21 CFR 807.92(a)(4)] {4}------------------------------------------------ The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole. ### 6. Indications for Use [21 CFR 807.92(a)(5)] The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment. ### 7. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)] | | YP-3000 Infant Incubator | OmniBed | Differences Discussion | |----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | State | Subject Device | Predicate Device | N/A | | | | | | | Standards | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-19 IEC 60601-2-21 ISO 10993-5 ISO 10993-10 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-19 IEC 60601-2-21 ISO 10993-5 ISO 10993-10 | Same | | Indications for Use | The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature- controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment. | The OmniBed is a combination of an infant incubator (incubator) and an infant warmer (warmer). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature- controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. | Similar - same intended use, users, and use environment; minor grammatical differences and device trade name is not mentioned. | | Electrical Description | | | | | Power supply | AC 220-230V/50Hz; AC 110-120V/60Hz | 100V, 115V, 220V, 230V, 240V, 50/60Hz | Similar-1. We performed safety tests and performance tests based on IEC 60601-1, IEC 60601-2-19 and IEC | | | | | 60601-2-21 standards to cover both voltage ranges. The test results demonstrate that the subject device YP-3000 met the standard requirements, so this difference does not raise new questions of safety and effectiveness. | | Maximum current/ power consumption | 1300VA | ≈1100VA | Similar-2. We conducted safety tests and performance tests based on the IEC 60601-1 standard. The test results demonstrate that the subject device YP-3000 met the standard requirements, so this difference does not raise new questions of safety and effectiveness. | | Electrical safety | According to IEC 60601-1 | According to IEC 60601-1 | Same | | Principles of Operation | | | | | General | Radiant Warmer and Infant Incubator | Radiant Warmer and Infant Incubator | Same | | Control Modes | Incubator mode; Warmer mode | Incubator mode; Warmer mode | Same | | Probe Type & Connectors | Air temperature sensor | Air temperature sensor | Same | | | Skin temperature sensor | Skin temperature sensor | Same | | | air flow temp. sensor | air flow temp. sensor | Same | | | O2 Sensors | O2 Sensors | Same | | | Humidity Sensor | Humidity Sensor | Same | | | Isolated air temperature sensor | Isolated air temperature sensor | Same | | | Multi-port connector connects 2 | Multi-port connector connects 2 | Same | | | transducers | transducers | | | | RS232 connector | RS232 connector | Same | | Warmer Operation | | | | | Warmer | Radiant Warmer | Radiant Warmer | Same | | Temperature Control Modes | Pre-warm mode; Manual mode; Baby mode (Baby temperature control) | Manual mode; Baby mode; (Pre-warm mode); | Same | | Temperature Control Range Under the Skin temp. Mode | 34.5°C~37.5°C in 0.1 increments | 35~37.5°C in 0.1 increments | Similar-3. Compared with the predicate device, the temperature control range of the subject device YP- 3000 is slightly wider, and under this temperature control range, the temperature control accuracy of the device, the consistency of the bed temperature and the predicate device are equivalent. This control range satisfies the requirements of 201.15.4.2.2.101 of IEC60601-2-21. This difference does not raise new questions of safety and effectiveness. | | Difference Between Skin Temperature Sensor and Control Temperature | ≤0.5°C | ≤0.5°C | Same | | Temperature Uniformity of Bed Surface | ≤2°C | ≤2°C | Same | | Incubator Operation | | | | | Heater | Convective heater | Convective heater | Same | | Modes under the incubator mode | Air mode; Baby mode | Air mode; Baby mode | Same | | Air Temperature Control range | 25~39℃ in 0.1increments | 20~39℃ in 0.1 increments | Similar-4. Neonatal patients in the ambient temperature should not be less than 25 ℃, so YP-3000 product air control temperature range is designed to 25℃~39℃. Under this temperature control range, the temperature control accuracy, temperature stability and predicate equipment of the equipment are equivalent. This control range satisfies the requirements of 201.15.4.2.2.101 in IEC60601-2-19. Therefore, this difference does not raise new questions of safety and effectiveness. | | Skin Temperature Control range | 34~38℃ in 0.1 increments | 35~37.5℃ in 0.1 increments | Similar-5. The comparison with the predicate device, YP- 3000's temperature control range is slightly wider, and under this temperature control range, the temperature control accuracy, temperature stability and predicate equipment of the device are all equivalent. This control range satisfies the requirements of 201.15.4.2.2.102 in | | | | | | | | | | IEC60601-2-19. Therefore, this difference does not raise new questions of safety and effectiveness. | | Temperature Rise Time | ≤40min | <50min | Similar-6. Compared with the predicate device, the temperature rise time of the YP-3000 is faster, and the product can be warmed up to the predetermined temperature and put into use. The performance of this article meets the requirements of 201.12.1.107 in IEC60601- 2-19, so this difference does not raise new questions of safety and effectiveness. | | Difference Between Average Incubator Temperature and Control Temperature | ≤1.0°C | ≤1.0°C | Same | | Difference Between Incubator Temperature and Average Incubator Temperature | ≤0.5°C…

Infant Incubator

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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