Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

Device Description

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter and connected to a hardshell cardiotomy venous reservoir.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Dideco S.p.A. Synthesis Mimesys Hollow Fiber Oxygenator:

Acceptance Criteria and Device Performance

The provided document describes the SYNTHESIS MIMESYS Adult Membrane Oxygenator and its substantial equivalence to predicate devices. The acceptance criteria for this device are primarily demonstrated through in vitro testing and biocompatibility assessments, aligning with established industry standards and FDA guidance. The reported device performance indicates that the SYNTHESIS MIMESYS met these established specifications.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Acceptance Metric (Implied)	Reported Device Performance
Biocompatibility	Hemolysis	Met established specifications	Results met established specifications
	Cytotoxicity	Met established specifications	Results met established specifications
	Irritation	Met established specifications	Results met established specifications
	Acute Systemic Toxicity	Met established specifications	Results met established specifications
	Mutagenicity	Met established specifications	Results met established specifications
	Sterility	Met established specifications	Results met established specifications
	Pyrogenicity	Met established specifications	Results met established specifications
	ETO residuals	Met established specifications	Results met established specifications
	Package Integrity	Met established specifications	Results met established specifications
In Vitro Performance	Operating Blood Volume	Met established specifications	Results met established specifications
	Mechanical Integrity	Met established specifications	Results met established specifications
	Connection Testing	Met established specifications	Results met established specifications
	Pressure Drop	Met established specifications	Results met established specifications
	Arterial Filter Characterization	Met established specifications	Results met established specifications
	Hemolysis/Cell Depletion	Met established specifications	Results met established specifications
	Softshell Venous Reservoir Microembolic Activity	Met established specifications	Results met established specifications
	Filtration Efficiency	Met established specifications	Results met established specifications
	Uniformity Test	Met established specifications	Results met established specifications
	Flaking/Leaching	Met established specifications	Results met established specifications
Functional Performance	Gas Transfer Studies	Comparable to predicate device	Characteristics comparable to SYNTHESIS predicate
	Heat Exchanger Performance	Comparable to predicate device	Characteristics comparable to SYNTHESIS predicate
	Venous Cardiotomy Characterization	Comparable to predicate device	Characteristics comparable to SYNTHESIS predicate
Coating Performance	Phosphorylcholine (PC) coating Biocompatibility & Functionality	Biocompatible and functional equivalent to predicate device coating	Biocompatible and functional, equivalent to SYNTHESIS predicate device

Study Details

The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study designed to prove the device meets pre-defined acceptance criteria in the same way a clinical trial might, but rather to show it performs as safely and effectively as existing devices.

Sample sizes used for the test set and data provenance:
- Test Set (In Vitro): The document references testing performed on the "device aged up to 3 years." It does not specify the exact number of devices tested in the in vitro studies.
- Data Provenance: The studies are described as "in vitro testing" carried out in accordance with FDA guidance and ISO standards. The location of these labs is not explicitly stated, but the manufacturer is Dideco S.p.A. in Italy, suggesting the primary testing was likely conducted in Europe or by contracted labs. The data is retrospective in the sense that it refers to testing of the manufactured product.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information (expert review for ground truth) is not applicable to this submission, as it relates to a medical device's engineering and biological performance rather than diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically employed in clinical studies or imaging-based diagnostic trials where expert consensus is needed to establish ground truth for a subjective assessment. This submission relies on objective, measurable performance characteristics.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools, not for a hollow fiber oxygenator.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical device, not an algorithm. Its performance is assessed independently of human operators for its intrinsic function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the in vitro tests was established by pre-defined specifications and established scientific and engineering standards (e.g., ISO 10993-1:1995 for biocompatibility, ISO 7199 (1996) and FDA guidances for oxygenators for performance). For biocompatibility, this involves laboratory analysis against toxicity thresholds. For in vitro performance, it involves direct measurement of physical and physiological parameters against engineering targets.
The sample size for the training set:
- Not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning algorithms for this product. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.
How the ground truth for the training set was established:
- Not applicable for the reasons stated above.

Summary

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Dideco S.p.A. Synthesis Mimesys Hollow Fiber Oxygenator

Synthesis Mimesys Hollow Fiber Oxygenator	April 17, 2003
	510(k) SUMMARY
SUBMITTER:	Dideco S.p.A.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 011 39 0535 25229
DATE PREPARED:	April 17, 2003
DEVICE TRADE NAME:	SYNTHESIS MIMESYS Adult MembraneOxygenator with Integrated Arterial Filterand Hardshell Venous CardiotomyReservoir Mimesys Treated(Phosphorylcholine coating hereinaftercalled PC coating)
COMMON NAME:	Hollow Fiber MembraneOxygenator/Integrated ArterialFilter/Reservoir
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator/Cardiopulmonary Bypass HeatExchanger/ Cardiopulmonary BypassBlood Reservoir/ CardiopulmonaryBypass Defoamer/ CardiopulmonaryBypass Arterial Line Blood Filter
PREDICATE DEVICES:	SYNTHESIS Adult MembraneOxygenator with Integrated Arterial Filterand Hardshell Venous/CardiotomyReservoir Mimesys treatedMONOLYTH C 1200 Hollow FiberMembrane Lung Integrated SoftshellVenous Reservoir, CVR 600 and 1200Sotfshell Venous Reservoir (reservoironly) (K990103),D 903 AVANT 2 Ph.I.S.I.O. Hollow FiberOxygenator (K030351)

Oxygenator (K020351),

MONOLYTH MIMESYS Hollow Fiber Oxygenator (K004001).

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DEVICE DESCRIPTION:

INDICATION FOR USE:

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated (PC coating) hereinafter called the SYNTHESIS MIMESYS is a sterile, nonpyrogenic device intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40µm. SYNTHESIS MIMESYS is an adult oxygenator intended for use in operations on adult patients. SYNTHESIS MIMESYS must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

TECHNOLOGICAL CHARACTERISTICS:

The SYNTHESIS MIMESYS Adult Membrane Oxygenator with Integrated Hardshell Venous/Reservoir, Heat Exchanger and Arterial Filter Mimesys treated (PC coating), is essentially identical to the SYNTHESIS predicate device with respect to operating principles, control mechanisms and biocompatibility of the PC coating. The softshell venous reservoir present in both SYNTHESIS C MIMESYS and MONOLYTH C 1200 predicate device share the same technological characteristics, operating principles and materials. The only modification made to the SYNTHESIS MIMESYS (and other modified version) is the extension of the coating already present on the whole oxygenating module and hardshell venous reservoir (except the filtering media of the reservoir) to the integrated arterial filter and softshell venous reservoir. The coating is identical to the phosphorycholine coating used on the SYNTHESIS, D 903 AVANT 2 Ph.1.S.I.O. and MONOLYTH MIMESYS predicate devices.

The oxygenator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

BIOCOMPATIBILITY TEST RESULTS:

A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1:1995 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the SYNTHESIS (accelerated aging). The device aged up to three years was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of the testing met established specifications.

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IN VITRO TEST RESULTS:

In vitro testing were carried out in accordance with the requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff" issued on November 13, 2000 - "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" Final Guidance for Industry and FDA issued on November 29, 2000 - "Guidance for Cardiopulmonary Bypass Arterial line Blood Filter 510(k) Submission" Final Guidance for industry and FDA issued on November 29, 2000 and the ISO 7199 (1996) standard for "Cardiovascular Implants and Artificial Organs - Extra Corporeal Blood-Gas Exchangers (Oxygenator)" when applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness requirements. The device was aged up to 3 years and was tested for operating blood volume, mechanical integrity, connection testing, pressure drop, arterial filter characterization, hemolysis/cell depletion, softshell venous reservoir microembolic activity and filtration efficiency, uniformity test and flaking/leaching of the results of these tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the SYNTHESIS and SYNTHESIS C predicate device. This 510(k) crosses reference performance data previously submitted in the SYNTHESIS 510k (K022450) for the gas transfer studies, heat exchanger performance evaluation and venous cardiotomy characterization and in the MONOLYTH C1200 510(k) (K990103) for the aspects of the softshell venous reservoir characterization as the above mentioned aspects are not affected by the modification.

The results of the study showed the device characteristics between SYNTHESIS MIMESYS and SYNTHESIS were comparable.

CONCLUSIONS:

The results of in vitro studies demonstrate that the SYNTHESIS MIMESYS devices perform in a manner substantially equivalent to the predicate devices. Biocompatibility studies demonstrate that the phosphorylcholine coating is biocompatible and functional tests demonstrate that its performance are equivalent to the SYNTHESIS predicate device, according to its intended use. Additional testing has demonstrated the effectiveness of production techniques to assure that the oxygenator is sterile and non-pyrogenic.

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Image /page/3/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a central symbol. The symbol consists of a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines extending below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Dideco S.P.A. c/o Mr. Barry Sall Senior Regulatory Consultant Parexel International 195 West Street Waltham, MA 02451-1163

Re: K031223

Synthesis Mimesys Adult Membrane Oxygenator with Integrated Arterial Filter, Mimesys Treated Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: April 17, 2003 Received: April 18, 2003

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.

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Page 2 - Mr. Barry Sall

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. 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

KoleTtu

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): -

K031223

Device Name: Synthesis Mimesys Adult Membrane Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys Treated

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescritption Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Otional format 1-2-96)

V. Deletta

510(k) Numbe

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.”