(27 days)
The Giraffe Incubator is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%)
The Ohmeda Medical Giraffe Incubator is an infant bed which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the enclosed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The optional Giraffe Servo Control Oxygen Delivery System is a fully integrated option available on the Giraffe Incubator. The Giraffe Servo Control Oxygen Delivery System is capable of oxygenating the entire infant compartment at oxygen concentrations of 21%-65% by volume. The device uses fuel cell type sensors that generate specific voltages depending on the oxygen concentrations they contact. The microprocessor stores the sensor output and compares it with the value corresponding to the concentration set by the operator. The valves that supply oxygen to the infant compartment are opened and closed as necessary to maintain the oxygen concentration at the set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.
The Giraffe and Panda Uninterruptible Power Supply (UPS) provides a short term source of electrical power Giraffe Incubator, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Incubator.
The UPS serves as an extension to the Giraffe Incubator by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.
The provided text is a 510(k) summary for the Ohmeda Medical Giraffe Incubator, which is an infant incubator designed to provide thermal support for neonates. The document describes the device, its intended use, and the studies performed to demonstrate its safety and effectiveness.
Here’s a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on the safety and performance of the Giraffe Incubator, particularly with the addition of the Uninterruptible Power Supply (UPS) option. The acceptance criteria and performance are outlined for the UPS battery life.
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| UPS battery life in nominal operating conditions (37°C, 70% RH) | 15 minutes |
| UPS battery life at worst-case operation condition (39°C, 95% RH) | 10 minutes |
| UPS battery life at worst-case operation condition with phototherapy accessory and all available lights on (39°C, 95% RH) | 7 minutes |
| UPS battery recharge time | 6 hours |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical "sample size" in terms of a number of units tested for a specific performance metric. Instead, it states that the product was subjected to "extensive bench testing."
- Data Provenance: The testing was conducted in-house by GE Healthcare (Ohmeda Medical), a US-based company. The data is from retrospective bench testing. The document states, "The product was subject to extensive bench testing, the software was validated and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C-Design Controls were satisfied."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. The "ground truth" for the performance specifications, specifically for the UPS battery life, was established through direct measurement during bench testing against predefined product specifications and consensus standards, not through expert consensus or clinical judgment.
- Qualifications of Experts: Not applicable for establishing ground truth as described above.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance was measured directly against engineering specifications and consensus standards rather than requiring adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is an infant incubator, a life-support system where direct performance metrics (like temperature control, oxygen delivery, battery life) are assessed, not diagnostic interpretations by human readers. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant to this device's evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Yes, in a sense, the primary evaluation was a standalone performance assessment of the device (including its optional Servo Control Oxygen Delivery System and UPS) based on its engineering design and mechanical/electrical functionality. The incubator's ability to maintain temperature and oxygen levels (algorithm-driven controls in the case of servo systems) and the UPS's battery life were evaluated directly and independently of human operational input for the performance metrics specified. The document states, "Performance of the Giraffe Incubator with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards."
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance was based on product specifications and recognized consensus standards. This is an engineering and regulatory approach, where the device must meet quantifiable, pre-defined operational parameters. For example, battery life was measured to meet specific duration targets under various operational conditions.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. The device is a physical medical device (infant incubator) with electro-mechanical systems. It does not employ machine learning or artificial intelligence in a way that requires a "training set" of data for an algorithm to learn from. Its control systems are based on established engineering principles and pre-programmed parameters, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the device's design and control algorithms would be established through engineering design specifications, scientific principles, and regulatory requirements for medical device functionality and safety.
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K0725/2 p. lot=2
510(k) Summary
Submitter Information and Date Prepared
Agata Smieja GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA
Phone: 410 888 5218 Mobile: 410 456 0329
Prepared: September 4, 2007
Device Identification
Proprietary Name: Common Name:
Ohmeda Medical Giraffe Incubator Giraffe Incubator
Predicate Device Information
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Intended Use Statement
The Giraffe Incubator is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%)
B 001
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K622572 p. dof 3
Product Description
The Ohmeda Medical Giraffe Incubator is an infant bed which provides thermal support for infants who are unable to provide for their own heat requirements. The device manintains the infant's temperature by circulating heated air within the enclosed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The optional Giraffe Servo Control Oxygen Delivery System is a fully integrated option available on the Giraffe Incubator. The Giraffe Servo Control Oxygen Delivery System is capable of oxygenating the entire infant compartment at oxygen concentrations of 21%-65% by volume. The device uses fuel cell type sensors that generate specific voltages depending on the oxygen concentrations they contact. The microprocessor stores the sensor output and compares it with the value corresponding to the concentration set by the operator. The valves that supply oxygen to the infant compartment are opened and closed as necessary to maintain the oxygen concentration at the set value. Fluctuations in fuel cell performance due to temperature and humidity are are compensated for by the microprocessor.
The Giraffe and Panda Uninterruptible Power Supply (UPS) provides a short term source of electrical power Giraffe Incubator, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Incubator.
The UPS serves as an extension to the Giraffe Incubator by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.
Performance Data
Since care of newborns in incubators, with or without supplemental oxygen, is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, the software was validated and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C-Design Controls were satisfied.
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KC7-2572 p. 3 of 3
The UPS battery has a life of 15 minutes in nominal operating conditions (37C, 70% RH), 10 minutes at the worst case operation condition (39C, 95% RH) and 7 minutes at the worst case operating condition with the addition of the phototherapy accessory and with all available lights on (39C, 95% RH) . The recharge time is 6 hours.
Performance of the Giraffe Incubator with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards.
Prepared by: AGATA SMIEYA
Date 09/04/07
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Agata Smieja Global Compliance Leader Datex-Ohmeda, Incorporated A Division of Datex Ohmeda, A GE Healthcare Company 8880 Gorman Road Laurel, Maryland 20723
2007
Re: K072512
Trade/Device Name: Ohmeda Medical Giraffe Incubator Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: September 4, 2007 Received: September 6, 2007
Dear Ms. Smieja:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Smieja
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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):_K 072512
Device Name: Ohmeda Medical Giraffe Incubator
Indications For Use:
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X Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chuton vem
(Division Sign-Off) Division of Anesthesiology, General Hospital Page 1 of 1 Infection Control, Dental Devices
2072512 510(k) Number:
A 001
§ 880.5400 Neonatal incubator.
(a)
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.(b)
Classification. Class II (performance standards).