The Dideco D920, Lilliput I twin reservoir is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuumassisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as the venous reservoir, as a filtered reservoir for cardiac suction blood in a bypass extracorporeal circuit, but does not have a venous return. Following intraoperative use, the reservoirs are used for the collection and autotransfusion of shed blood.

Device Description

The D 920 serves as a collection reservoir for venous blood recovered by intracardiac sucker and ventricular vent devices. The D 920 device can also be attached to an oxygenator, previously cleared by the Agency for the same patient population, in order to collect blood during normal operations, assuring the proper oxygenation capability of the device is currently being developed in an open system configuration which includes the Dideco D901 Lilliput oxygenator, cleared by the Agency on March 15th 1996 (K953835).

The hard-shell cardiotomy/venous reservoirs are comprised of a rigid polycarbonate housing with an internal support; in which a filtering system is placed around the support. The D 920 has two distinct (upper and lower) sections connected by an overflow system. The upper section contains a defoamer sponge and screen filter which are designed to remove microaggregates and microemboli from cardiotomy suction and vent blood. The devices are available with a 30 micron filter. The venous return blood enters the lower section and passes through a defoamer sponge. Only the lower section is contained within a polyester outer screen.

The D 920 has four cardiotomy suction/vent inlet ports which accommodate both 1/4 and 3/16" inner diameter tubing. Three priming ports are positioned on the top of the reservoir: 3 x luer lock (filtered), 1 x luer lock (unfiltered) and 1 x 1/4-3/16". Fluid added through the one outer priming port bypasses the integral cardiotomy section. Fluids added through the three inner luer and 1/4-3/16" ports flow through the defoamer and filter elements in the cardiotomy section. Venous blood enters through the 1/4-3/16" inlet port at the bottom of the unit. The D 920 has a 1/4-3/16" blood outlet port at the bottom of the unit. The 1/4" gas outlet port is located at the top of the unit. Both devices are supported by a holder.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dideco D920, Lilliput 1 twin reservoir, a medical device for infant cardiopulmonary bypass surgery. However, the document does not present a formal study with acceptance criteria and device performance metrics in the way that would typically be seen for a new, substantially different device.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (VENOMIDICARD/MIDICARD and MICRO SAFE). This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use, along with standard biocompatibility and in vitro performance testing.

Therefore, many of the specific questions about sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of regulatory submission focusing on substantial equivalence based on predicate devices.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this 510(k) is primarily centered on demonstrating similar safety and effectiveness to the predicate devices. The "performance" is shown through direct comparisons of technical specifications and an assertion of similar operating principles.

Parameter	Predicate Device (VENOMIDICARD/MIDICARD)	Predicate Device (MICRO-SAFE)	Dideco D920 (New Device)	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as presented for D920)
Maximum Blood Flow Rate	4 LPM	0.8 LPM	1.5 LPM	Within acceptable range compared to predicates	1.5 LPM
Recommended Operating Blood Flow Rate	4000 ml/min	800 ml/min	800 ml/min	Within acceptable range compared to predicates	800 ml/min
Filtering Pore Size (Cardiotomy filter)	20 micron	40 micron	30 micron	Within acceptable range compared to predicates	30 micron
Material (Housing)	Polycarbonate	Polycarbonate	Polycarbonate	Same or equivalent to predicates	Polycarbonate
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Same as predicates	Ethylene Oxide
Intended Use	Infant population, cardiopulmonary bypass	Infant population, cardiopulmonary bypass	Infant population, cardiopulmonary bypass	Same as predicates	Same as predicates
Biocompatibility	(Assumed to be compliant)	(Assumed to be compliant)	Successfully completed	Compliant with ISO 10993-1:1992 and FDA Memorandum	Successfully completed full range of testing
In vitro Performance	(Assumed to be compliant)	(Assumed to be compliant)	Successfully completed	Compliant with ISO 7199 international standard	Successfully performed testing

Note: The "acceptance criteria" in the table are inferred from the 510(k) process for substantial equivalence. The goal is to demonstrate that the new device is as safe and effective as the predicate, not necessarily to meet specific numerical targets beyond what the predicates achieve.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. For a 510(k) based on substantial equivalence, specific "test sets" with clinical outcome data in the sense of a new clinical trial are typically not required unless there are significant technological differences or new indications. The performance data mentioned (biocompatibility, in vitro performance) would be conducted on device samples, but the number of samples is not specified, nor is the "data provenance" in terms of patient cohorts. These are laboratory/bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as there is no mention of a clinical "test set" requiring expert ground truth establishment for diagnostic or prognostic accuracy. The testing performed (biocompatibility, in vitro performance) relies on standardized laboratory procedures.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study focuses on human reader performance, often with and without AI assistance, which is typically for diagnostic imaging devices. The Dideco D920 is a physical medical device (venous cardiotomy reservoir), not a diagnostic or AI-powered system, so an MRMC study would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. The Dideco D920 is a physical medical device, not an algorithm or AI system, so the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the biocompatibility testing, the "ground truth" would be the established safety profiles outlined in ISO 10993-1:1992 and FDA guidance, ensuring the device materials are not toxic or harmful.
For the in vitro performance testing (based on ISO 7199), the "ground truth" would be the predefined performance specifications and test methods in the standard, demonstrating the device's functional integrity (e.g., flow rates, filtration efficiency under simulated conditions).

8. The Sample Size for the Training Set

Not Applicable. As the Dideco D920 is a physical medical device and not an AI/machine learning system, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable (as there is no training set).

Summary

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510(k) Safety and Effectiveness Summary

1. Submitted by:

Barry Sall Senior Regulatory Consultant PAREXEL International Corporation Waltham, MA, USA

2. Contact Person:

Luigi Vecchi Regulatory Affairs Manager Dideco, S.p.A. via Statale 12 Nord, 86 P.O. Box 87 41037 Mirandola (MODENA) Italy

Telephone number: 01139 0535 29811

3 Date of Preparation:

December 2, 1998

Name and Address of Owner/Operator and Manufacturer 4

Dideco, S.p.A. via Statale 12 Nord, 86 P.O. Box 87 41037 Mirandola (MODENA) Italy

5 Product Name

Trade Name: D 920, Lilliput 1 twin reservoir

Common Name: Infant-newborn Venous Cardiotomy Reservoir

6. Predicate Devices

1) VENOMIDICARD/MIDICARD D752/D762 manufactured by:

Dideco S.p.A.. Via Statale 12 Nord, 86 41037 Mirandola (MO) ITALY

K941215, cleared on May 5, 1995

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MICRO SAFE manufactured by:

Polystan AJS Walgerholm 8 3500 Vaerlose DENMARK

K953976, cleared on February 4, 1997

7. Claim of Substantial Equivalence

The D 920 is an infant/newborn hard-shell venous reservoir, like the predicate devices. The basic function of all hardshell reservoirs is the same. They store the blood coming from the surgical theater, draw it from the venous reservoir and push it through an oxygenator via an external pump. The operating principles and control mechanisms are exactly the same for the D 920 and the predicate devices.

As both the Venomidicard and the D 920 are manufactured by Dideco, they share the same incoming raw materials inspections, manufacturing in process controls; in addition the D 920 utilizes the same material type and a similar blood flow path as the Venomidicard and the filtration sequence is the same for D 920 and Venomidicard.

The indications for use are the same for both D 920, Micro safe and Venomidicard: all devices are intended for the infant population who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation.

All predicate devices have a bayonet/YSI 400 compatible temperature probe.

Parameters	VENOMIDICARD/MIDICARD	MICRO-SAFE	D 920
Manufacturer	Dideco S.p.A.	Polystan A/V.	Dideco S.p.A.
Method of sterilization	Ethylene Oxyde	Ethylene Oxyde	Ethylene oxide
Maximum blood flow rate	4 LPM	0.8 LPM	1.5 LPM
Recommended operatingblood flow rate	4000 ml/min	800 ml/min	800 ml/min
Filtering pore size	20 micron	40 micron	30 micron

Substantial Equivalence Comparison Chart: Performance Characteristics

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Substantial Equivalence Comparison Chart: General features

Parameters	VENOMIDICARD/MIDICARD	MICRO-SAFE	D 920
Connections:
Venous return	3/16"	3/16" - 1/4"	3/16" - 1/4"
Venous outlet	3/8"	3/16" - 1/4"	3/16" - 1/4"
Cardiotomy inlet	3/16" - 1/4"	3/16" - 1/4"	3/16" - 1/4"
Reservoir venous inlet	3/8"	1/4"	1/4"
Filter materials:
Cardiotomy filter	polyester 20 microns	polyester 40 microns	polyester 30 microns
Reservoir filter	polyurethane	polyurethane	polyurethane
Screen filter	polyester 120 microns	polyester 175 microns	polyester 120 microns
Availableconfiguration	Card. /venousreservoir	Venous reservoir	Card. /venousreservoir
Housing:
type	rigid hardshell	rigid hardshell	rigid hardshell
material	polycarbonate	polycarbonate	polycarbonate
max. volume	2000 ml	400 ml	700 ml
Packaging:
type	Single/multi unit box	single/multi unit box	single/multi unit box
material	Tyvek pouch/cartonbox	Tyvek pouch/cartonbox	Tyvek pouch/cartonbox
Patient population	Children	Infants	Infants

8. Device Description

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9. Intended Use

The Dideco D 920 is intended for use in infants who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation (ECC) for whom a low circuit priming volume is required. The venous reservoir with cardiotomy filter is intended for use as a storage reservoir (gravity or vacuumassisted) for venous return blood and as a filtered reservoir for cardiac suction during ECC. The cardiotomy reservoir has the same intended use as the venous reservoir above mentioned as a filtered reservoir for cardiac suction blood in a bypass extracorporeal circuit, but does not have a venous return.

Following intraoperative use, the reservoirs are used for the collection and autotransfusion of shed blood.

10. Summary of Nonclinical Data

The Dideco D 920 has successfully completed the full range of biocompatability testing as specified in ISO 10993-1:1992 and FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for Biocompatibility Testing. Dideco has also successfully performed in vitro performance testing on the D 920 based on the ISO 7199 international standard.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 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" around the top half of the circle. Inside the circle is a stylized image of an eagle with three heads.

MAR - 2 1999

Dideco, S.P.A. c/o Mr. Barry Sall Senior Regulatory Consultant Parexel International Corporation 1601 Trapelo Road Waltham, MA 02154

Re : K984322 Dideco D920, Lilliput 1 Twin Reservoir Regulatory Class: II (Two) and III (Three) Product Code: DTN and DTP Dated: December 2, 1998 Received: December 3, 1998

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 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). 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 regulation (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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callaman, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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k 984322 510(k) Number (if known):

Device Name: Dideco D920, Lilliput 1 twin reservoir

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Satie & Compule

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K984322

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)

Regulation Number and Section

§ 870.4230 Cardiopulmonary bypass defoamer.

(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”