(79 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 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%).
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.
The provided document is a 510(k) summary for the Ohmeda Medical Giraffe® Incubator. It states that "clinical or animal testing to demonstrate safety and effectiveness is not necessary" because "care of newborns in incubators, with or without supplemental oxygen, is a well established clinical practice."
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML device evaluations (e.g., performance metrics, ground truth, expert adjudication).
Instead, the submission relies on:
- Substantial equivalence to previously cleared predicate devices (Ohmeda Medical Giraffe Incubator (original), Drager Incubator 8000 IC, and Isolette Infant Incubator Model C2HS).
- Bench testing: "The product was subject to extensive bench testing." No specific details about the nature of this testing, acceptance criteria, or results are provided.
- Software validation: "the software was validated." No details about the validation methodology, criteria, or results are provided.
- Compliance with design controls: "the requirements of 21 CFR 820, Subpart C -- Design Controls - were satisfied." This refers to general quality system regulations, not specific performance criteria.
Given the nature of the device (an incubator) and the submission type (510(k) for a non-AI/ML device from 2002), the requested information categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test/training sets, training set size, ground truth establishment for training set) are not applicable or not provided in this regulatory document.
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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.
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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.
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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.
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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
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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 ________________________________________________________________________________________________________________________________________________________________
§ 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).