(79 days)
Not Found
No
The description details a microprocessor-controlled system for temperature and oxygen regulation based on sensor inputs and operator settings, without mentioning any learning or adaptive algorithms characteristic of AI/ML.
Yes.
The device provides thermal support and controlled oxygen delivery to neonates, directly treating their inability to self-regulate temperature and providing necessary oxygenation.
No
The device description indicates that the Giraffe Incubator provides thermal support and, optionally, oxygen concentration within an enclosed environment for neonates. It focuses on maintaining physiological parameters (temperature, oxygen) rather than diagnosing conditions.
No
The device description clearly details hardware components such as an infant bed, heating elements, air circulation system, oxygen delivery system with sensors, and a microprocessor controlling these components. The software is described as controlling the hardware, not as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide thermal support and potentially controlled oxygen to neonates. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on how the device maintains temperature and oxygen levels within the incubator. It describes physical mechanisms and sensors for environmental control, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests in vitro (outside the body) on these types of samples.
The device is clearly an infant incubator, which is a medical device used for patient care, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates I he Onative incubation is an antalians on their own physiology. They achieve this by providing an who are unable to theme regarate reason ent for 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%).
Product codes (comma separated list FDA assigned to the subject device)
FMZ
Device 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 maintains the infant's temperature by anable to provided 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. the ur temperature of the patient is obtained through the side portholes or by opening one of the side doors.
The optional Giraffe Servo Controlled Oxygen System is a fully integrated option available on the Giraffe I Incubator. The Servo Controlled Oxygen 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 specific volue and compares it with the value corresponding to the concentration set by the operator. The school output and compartment compartment are opened and closed as necessary to maintain the varves that suppy only goll w set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 necessary. The produce mowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls - were satisfied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAY 09 2002
Ohmeda Medical Giraffe® Incubator 510(k) Summary
Submitter Information
Alberto F. Profumo, RAC 8880 Gorman Road Laurel, MD 21046-1801 Tel. (410) 888-5104 Summary prepared on 2/12/2002
Device Name(s)
Classification Name:
-
Neonatal Incubator .
Common Name: -
Incubator ●
Proprietary Name: -
ar > Railer
Ohmeda Medical Giraffe™ Incubator with Optional Servo Control Oxygen System .
Predicate Device Information
The Giraffe Incubator is substantially equivalent to the following Class II devices:
| Device | Last 510(k)
Number |
|---------------------------------------------|-----------------------|
| Ohmeda Medical Giraffe Incubator (original) | K010222 |
| Drager Incubator 8000 IC | K954204 |
| Isolette Infant Incubator Model C2HS | K001242 |
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 maintains the infant's temperature by anable to provided 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. the ur temperature of the patient is obtained through the side portholes or by opening one of the side doors.
1
The optional Giraffe Servo Controlled Oxygen System is a fully integrated option available on the Giraffe I Incubator. The Servo Controlled Oxygen 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 specific volue and compares it with the value corresponding to the concentration set by the operator. The school output and compartment compartment are opened and closed as necessary to maintain the varves that suppy only goll w set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.
Indications for Use
The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates The Onable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for 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%).
Assessment of Technological Characteristics
The technological characteristics of the Giraffe Incubator are similar to those of predicate devices and do not raise new safety or effectiveness issues.
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 necessary. The produce mowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls - were satisfied.
Sterilization Information
The Giraffe" Incubator is not intended to be sterilized. Cleaning and disinfection instructions can be found in the Operations and Maintenance Manual.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 9 2002
Mr. Alberto F. Profumo Director, Product Assurance Ohmeda Medical 8880 Gorman Road Laural, Maryland 20723
Re: K020547
Trade/Device Name: Giraffe™ Incubator Regulation Number: 880.5400 Regulation Name: Incubator, Neonatal Regulatory Class: II Product Code: FMZ Dated: February 18, 2002 Received: February 19, 2002
Dear Mr. Profumo:
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.
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.
3
Page 2 - Mr. Profumo
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): 《レス054 7
Device Name: Giraffe™ Incubator
Indications for Use:
The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates I he Onative incuration is an antalians on their own physiology. They achieve this by providing an who are unable to theme regarate reason ent for 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%).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CDR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________