(140 days)
None
Not Found
No
The summary describes a mechanical device (membrane oxygenator) for cardiopulmonary bypass and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is described as providing oxygenation and carbon dioxide removal from venous blood, and controlling blood temperature during cardiopulmonary bypass surgery. These functions directly treat the patient's physiological state.
No
Explanation: The device is an oxygenator used during cardiopulmonary bypass surgery to provide blood oxygenation, carbon dioxide removal, and temperature control. It performs a therapeutic function rather than diagnosing a condition.
No
The device description clearly identifies it as a "Membrane Oxygenator," which is a physical medical device used in cardiopulmonary bypass surgery. It describes hardware components like a membrane, heat exchanger, and venous reservoir.
Based on the provided information, the Dideco D902 Lilliput 2 Membrane Oxygenator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Dideco D902 Lilliput 2 Membrane Oxygenator is a device used during cardiopulmonary bypass surgery to oxygenate and remove carbon dioxide from the patient's blood outside the body. It also controls blood temperature.
- Intended Use: The intended use clearly describes a device used for extracorporeal circulation during surgery, not for testing samples.
Therefore, this device falls under the category of a medical device used for treatment and support during surgery, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Dideco D902 Lilliput 2 Membrane Oxygenator is intended for use in infants less than 20 Kg (44 Lb.) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The D 902 LILLIPUT 2 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Product codes
74 DTZ
Device Description
Not Found
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
infants less than 20 Kg (44 Lb.)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
0
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black and white, and the text is also in black. The overall design is simple and iconic, representing the department's role in protecting the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 8 1997
Dideco, S.P.A. c/o Mr. Barry Sall Senior Regulatory Consultant Parexel International Corporation 1601 Trapelo Road Waltham, Massachusetts 02154
Re: K971877 Lilliput 2 Infant Hollow Fiber Oxygenator Requlatory Class: III (Three) Product Code: 74 DTZ Dated: August 25, 1997 August 26, 1997 Received:
Dear Mr. Sall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Barry Sall
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
870.4350- DTZ - DTZ - CPG Oxygenator
510(k) Number (if known): ____ 9 218 17_
Device Name: Dideco D902 Lilliput 2 Membrane Oxygenator
Indications For Use:
The Dideco D902 Lilliput 2 Membrane Oxygenator is intended for use in infants less than 20 Kg (44 Lb.) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The D 902 LILLIPUT 2 should not be used longer than 6 hours.
Contact with blood for longer periods is not advised.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beta R. Rempelee
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971877
V Prescritpion Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Otional format 1-2-96)
005A