(272 days)
Not Found
Not Found
No
The summary describes a physical medical device (membrane oxygenator) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for cardiopulmonary bypass surgery, providing oxygenation, carbon dioxide removal, and temperature control, all of which are therapeutic interventions.
No
Explanation: The device, a membrane oxygenator, is described as providing oxygenation and carbon dioxide removal, and controlling blood temperature during cardiopulmonary bypass surgery. These are therapeutic functions, not diagnostic ones.
No
The device description clearly identifies it as a "Hollow Fiber Membrane Oxygenator," which is a physical medical device used in cardiopulmonary bypass surgery. It also mentions components like a heat exchanger and venous reservoir, all of which are hardware.
Based on the provided information, the Dideco Lilliput Ph.I.S.I.O. 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a membrane oxygenator used during cardiopulmonary bypass surgery. Its function is to oxygenate and remove carbon dioxide from venous blood outside the body and control blood temperature.
- Intended Use: The intended use is for infants undergoing cardiopulmonary bypass surgery, which is a surgical procedure, not a diagnostic test performed on a sample.
The device is a therapeutic device used to support a patient's physiological function during surgery, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Dideco Lilliput Ph.I.S.I.O.Membrane Oxygenator is intended for use in infants weighing not more than 8 Ky (17.6 lb.) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanqer 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 Lilliput Ph.I.S.I.O. should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Product codes
DTZ
Device Description
Dideco Lilliput Ph.I.S.I.O. Membrane Oxyqenator
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 weighing not more than 8 Ky (17.6 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): 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.
Not Found
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing right, and the text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2000
Mr. Barry Sall Dideco S.P.A. c/o Parexel International Corporation 1601 Trapelo Road Waltham, MA 02154
K991737 Re: R991Ppit Phospholypidic Inert Surface In Oxygenation Regulatory Class: III (three) DTZ Product Code: Dated: November 22, 1999 Received: November 23, 1999
Dear Mr. Sall:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boose and we have determined the device is ent aartially equivalent (for the indications for use stated in the subbeancrairy ogally marketed predicate devices marketed in enciosure) co regarif maries of program programment date of the Interstate Commerce prior of the devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In actordance with the primay, therefore, market the device, subject to the general controls provisions of the Act. The general controls che general conclude requirements for annual registration, provise of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device to sIII (Premarket Approval), it may be subject to such controls) of class - Existing major regulations affecting your device audicional concroll Code of Fedoral Regulations, Title 21, Parts 800 can be round in the ally equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regulated. The Food and Drug Administration (FDA) will verify such rnspections, Ene rood and Eroly with the GMP regulation may result in assumptions. I railition, FDA may publish further announcements reguratory acorely as the Federal Register. Please note: this response to your premarket notification submission does not affect any response co your pat have under sections 531 through 542 of the Act obligation you might have and of the 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 This letter will allow you to begin marketing your mand in your 510(k) premarket notification. marketed predicate device equivalence of your device to a regarly marroos f
results in a classification for your device and thus, permits your resures i proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for your additionally 809.10 for in vitro
regulation (21 CFR Part 801 and additionally 809.10 for pliance at regulation (21 CFR Part 801 and address over Compliance at
diagnostic devices), please contact the office of the promotion a diagnostic devices), prease concace che promotion and (301) 594–4648. Additionally, Lor questions on this peopliance at
advertising of your device, please contact the office of the advertising of your device, prease won regulation entitled, (301) 594-4639. Also, please note the regarication"(21 CFR 807.97).
"Misbranding by reference to promorsacibilities under the Act may "Misbranding by reference to premarket noterities under the Act may
Other general information on your responsibilities under at i Other general information of Small Manufacturers Assistance at its be obtained from the Division of Silari Manufaceau220 car
toll-free number (800) 638-2041 or (301) 443-6597, or at its internet toll-free number (800) 836-2011 025ma/dsmamain.html".
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sincerely yours,
Carl Beta k. Ruyseerle
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Dovices and Radiological Health
Enclosure
2
D901 Lilliput Ph.I.S.I.O. Hollow Fiber Membrane Oxygenator Dideco S.p.A.
510(k) Notification
510(k) Number (if known):
K991137/5001
Device Name: Dideco Lilliput Ph.I.S.I.O. Membrane Oxyqenator
Indications For Use:
The Dideco Lilliput Ph.I.S.I.O.Membrane Oxygenator is intended for use in infants weighing not more than 8 Ky (17.6 lb.) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanqer 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 Lilliput Ph.I.S.I.O. 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)
Prescritpion Use (Pcr 21 CFR 801.109
OR
Over-The-Counter Use
(Otional format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number 491737
CONFIDENTIAL
0 0 4