LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR by DIDECO S.P.A.

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.

Device Description

Dideco Lilliput Ph.I.S.I.O. Hollow Fiber Membrane Oxygenator

AI/ML Overview

The provided text is a U.S. FDA 510(k) clearance letter for the "Dideco Lilliput Ph.I.S.I.O. Membrane Oxygenator." This document grants market clearance based on substantial equivalence to a predicate device, rather than requiring a detailed study demonstrating device performance against specific acceptance criteria in the format typically used for AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies is not present in the provided text, as these are generally not required for 510(k) applications for a device of this nature cleared in 2000.

The 510(k) process for this type of device primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing and comparison of specifications, rather than large-scale clinical trials with specific performance metrics against a defined ground truth.

However, based on the Indications For Use section, we can infer some implied performance criteria:

The device is intended to:

Provide oxygenation and carbon dioxide removal from venous blood.
Control blood temperature (using the integrated heat exchanger).
Collect blood during normal operation to assure proper oxygenation capability.

The primary "proof" for this device's acceptance would have come from:

Bench testing: Demonstrating the oxygenator's ability to transfer gases (O2 and CO2) at specified flow rates and partial pressures, and the heat exchanger's ability to control blood temperature.
Biocompatibility testing: Ensuring the materials are safe for contact with blood, especially given the "not advised longer than 6 hours" caution.
Comparison to a predicate device: Showing that its design, materials, and performance characteristics (e.g., oxygen transfer rate, heat exchange efficiency) are substantially equivalent to a device previously cleared by the FDA for the same intended use.

Therefore, I cannot populate the requested table or answer the specific questions because the provided document does not contain that level of detail regarding acceptance criteria or a formal study as would be described for an AI/ML device.

Summary

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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.

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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,

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

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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:

(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

Over-The-Counter Use

(Otional format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number 491737

CONFIDENTIAL

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Regulation Number and Section

§ 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.”