Search Results

The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. 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.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation 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 Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) based on the user's selection. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient 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 operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

In the open bed mode, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.

The Giraffe OmniBed Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The Giraffe Incubator Carestation is an enclosed 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 closed 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 Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort.

The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

N/A

Ask a specific question about this device

The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the on user's demand. It cannot be operated in both modes at the same time. 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.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an enclosed 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 closed 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 Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.

However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.

Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:

2. Sample size used for the test set and the data provenance

The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.

• Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
• Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety outcomes.

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

• Not applicable. This submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the latch modifications, the "ground truth" is defined by:

• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
• Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
• Risk Analysis: Identification and mitigation of potential risks associated with the changes.
• Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.

Ask a specific question about this device

The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. 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.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe OmniBed Carestation is an updated version of the cleared predicate Giraffe OmniBed. The Giraffe OmniBed Carestation is a combination device that can function as an incubator (with the canopy closed) or as an infant radiant warmer (with the canopy open) based on the user's selection.

Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. With the canopy closed, the bed functions as an incubator, maintaining 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 operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

With the canopy opened, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.

The Giraffe OmniBed Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The proposed modification of the Giraffe OmniBed is referred to as the Giraffe OmniBed Carestation.

The Giraffe OmniBed Carestation updates the graphical monochrome display user interface (UI) on the predicate to a digital touchscreen UI, with the required software changes to support the new format and layout. The main system control software was not changed; however the software for the UI was updated because of the UI format change. The modified Giraffe OmniBed Carestation maintains the predicate Giraffe OmniBed functionality, performance, and clinical workflows. The changes also include a modified device visual indicator light and the capability for Hands Free Alarm Silencing (HFAS).

Other modifications being made for the Giraffe OmniBed Carestation include upgrading the power supply from 75W to 120W to support the increased power requirements of the touchscreen and associated electronics.

There is no change in the indications for use or intended use of the system. There are no changes to the patient contacting materials of the device, and they remain identical to the predicate. The changes made do not affect the function, performance, safety, or clinical use of the device.

This document is a marketing submission (510(k) summary) for a medical device, specifically a neonatal incubator/warmer, and not a study proving a device meets acceptance criteria. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it does not contain the specifics of a performance study with defined acceptance criteria and results.

The document states: "The subject of this premarket submission, Giraffe OmniBed Carestation, did not require clinical studies to support substantial equivalence." This means that the manufacturer is claiming substantial equivalence based on non-clinical tests (such as electrical safety, performance verification against standards, software testing) and the device's technological similarity to previously cleared predicate devices, rather than through a comparative clinical study.

Here's what can be inferred and what cannot, based on the provided text:

What Can Be Inferred/Extracted (to some extent):

• Device Name: Giraffe OmniBed Carestation CS1 (K152814)
• Device Type: Combination infant incubator and infant warmer.
• Indication for Use: To provide heat in a controlled manner to neonates unable to thermoregulate. Can operate as an incubator (closed canopy) or radiant warmer (open canopy). May incorporate a Servo Controlled Oxygen Delivery System for stable oxygen concentration (21-65%).
• Predicate Device(s): Giraffe OmniBed (K101788, K071175, K020543, K993407)
• Key Modification: Updates the graphical monochrome display user interface (UI) to a digital touchscreen UI, with associated software changes. Also, an upgraded power supply (75W to 120W) and updated visual indicator light and Hands Free Alarm Silencing (HFAS) capability.
• Determination of Substantial Equivalence: Based on non-clinical tests and technological similarity to predicates.
• Non-Clinical Tests Mentioned (examples of types of tests, not specific results or acceptance criteria):
  • Risk Analysis
  • Design Reviews
  • Unit level testing (Module verification)
  • Integration testing (System verification)
  • Software testing (Verification and Validation, IEC 62304:2006)
  • Performance testing (Verification of performance specifications, including IEC 60601-2-21:2009 for warmers, IEC 60601-2-19:2009 for incubators)
  • Safety and EMC testing (Verification ES 60601-1:2005+A1 2012, IEC60601-1-2:2007)
  • Usability testing (Validation IEC 62366: 2014)

What Cannot Be Extracted (because the document is not a study report):

1. A table of acceptance criteria and the reported device performance: This document lists types of tests performed (e.g., performance testing against standards), but it does not provide the specific numerical acceptance criteria (e.g., "temperature stability must be within +/- 0.5°C") nor the measured device performance against those criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable as it's not a clinical study. The non-clinical tests would have involved specific test units, but the "sample size" of patients/data as in a clinical study is not relevant here.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no clinical ground truth was established for "testing" in the sense of patient data. Usability testing might involve experts, but details are not provided.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No, the document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." An MRMC study would be a clinical study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is electro-mechanical, not AI-driven in the sense of an algorithm interpreting data to generate a finding.
7. The type of ground truth used: Not applicable. Ground truth for clinical studies would be, for example, pathology results for a lesion, or confirmed diagnosis; here, "ground truth" would be the engineering specifications and performance standards.
8. The sample size for the training set: Not applicable. This device is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence of a medical device based on non-clinical testing and comparison to predicate devices, not a report of a study designed to prove the device meets specific clinical acceptance criteria.

Ask a specific question about this device

The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. 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.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Legally Marketed Device
Giraffe OmniBed is a combination device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode), based on the user's selection. The device cannot function in both modes at the same time.

Giraffe OmniBed can be used with the Giraffe Uninterruptible Power Supply (UPS) accessory. The UPS is an accessory that mounts to the Giraffe OmniBed as well as the Giraffe Incubator and the Giraffe and Panda Warmers. Giraffe UPS provides uninterruptible power to the bed for quick trips. It also allows thermally supported, cordless mobility during periods of power uncertainty. Whether moving between bed places, or between care areas, the UPS for Giraffe and Panda offers uninterrupted power to the bed and display for continuous monitoring of the baby's situation, and bed controls.

When used with the UPS, the Giraffe OmniBed are is not intended for use as transport incubator or to be taken outside of the hospital building.

Description of Device Modification
The proposed modification of the Giraffe OmniBed is the addition of the Giraffe Shuttle accessory.

The Giraffe OmniBed can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the OmniBed. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room.

This eliminates the need to transfer the infant to and from a transport incubator for transport within the hospital building, reducing the potential for clinical problems associated with patient touch, handling and movement. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation. .

Similarly to the UPS accessory, the Shuttle facilitates the mobility of the Giraffe OmniBed within the hospital building. Giraffe OmniBed when used with the UPS or with the Shuttle is not a transport incubator and is not intended to be used outside of the hospital building.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit.

To detach the Shuttle from the bed, the locking arms are rotated back to their unlocked position by stepping on the Unlock pedal. Once unlocked, the Shuttle can be moved away from the bed.

The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module.

The provided text describes a 510(k) premarket notification for a modification to the Giraffe OmniBed, specifically the addition of the Giraffe Shuttle accessory. This is a medical device submission, and as such, it does not involve the typical "acceptance criteria" and "study" format usually associated with AI or diagnostic algorithm performance. Instead, it focuses on demonstrating "substantial equivalence" to an already legally marketed device.

Therefore, many of the requested categories for AI/diagnostic studies (like sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

However, I can extract the information relevant to the device and the nature of its evaluation as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission, "acceptance criteria" are related to compliance with voluntary standards and successful execution of quality assurance measures, rather than a specific numerical performance metric for a diagnostic algorithm. The "reported device performance" is framed as the device, with the modification, being "as safe, as effective, and performance is substantially equivalent" to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission is for a hardware modification to a medical device, not a diagnostic algorithm that processes data. The "testing" mentioned is for engineering verification and validation of the device and its accessory, not a clinical study with a "test set" of patient data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This document does not describe a study involving expert validation or ground truth establishment for a diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

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

• Not Applicable. This is a hardware modification for an infant care device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. No algorithms or standalone diagnostic performance are discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. Not a diagnostic study. The "ground truth" for this type of submission would relate to engineering specifications, safety standards, and functional performance metrics of the device itself (e.g., power delivery, locking mechanism function, thermal regulation, etc.), which are verified through the "Quality Assurance Measures" listed in point 1.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm is involved.

9. How the ground truth for the training set was established

• Not Applicable. No training set for an algorithm is involved. This K101788 submission focuses on demonstrating that the modified device, the Giraffe OmniBed with the Giraffe Shuttle accessory, is substantially equivalent in terms of safety and effectiveness to the predicate Giraffe OmniBed. The evaluation is based on engineering testing, compliance with standards, and risk analysis related to the device's physical and electrical functions, rather than clinical trial data or algorithm performance.

Ask a specific question about this device