Sorin Monolyth Venous Reservoir 1200 PC with Phosphorilcholine coating (hereafter referred to as the MVR 1200 PC) is a soft, flexible polyviny chloride plastic bag designed for use during extracorporeal bypass surgery as in-line venous bag reservoir. Blood contact surfaces of the MVR 1200 PC have been coated with phosphorylcholine (PC) coating improves blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for the "MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with phosphorylcholine coating". This is a medical device, and the information focuses on demonstrating its substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performance against those criteria in the way one might for a diagnostic AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (like expert-established ground truth, MRMC studies, sample sizes for training/test sets, adjudication methods, and effect sizes) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this traditional medical device submission, which primarily revolves around biocompatibility, functional equivalence, and safety.

Here's a breakdown of the available information structured to best answer your query given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Met Specifications
Biocompatibility	Hemolysis (ISO 10993-1995)	Met established specifications.
	Cytotoxicity (ISO 10993-1995)	Met established specifications.
	Irritation (ISO 10993-1995)	Met established specifications.
	Acute Systemic Toxicity (ISO 10993-1995)	Met established specifications.
	Sterility	Met established specifications; production techniques assure sterility.
	Pyrogenicity	Met established specifications; nonpyrogenic fluid path; production techniques assure non-pyrogenicity.
	ETO residuals	Met established specifications.
	Package integrity testing	Met established specifications.
In Vitro Functional	Minimum operating blood volume requirements ("Guidance for Blood Extracorporeal... 510(k) Submission")	Met established specifications. The device characteristics were "comparable" to the predicate device (MVR 1200).
	Burst/leak testing ("Guidance for Blood Extracorporeal... 510(k) Submission")	Met established specifications. The device characteristics were "comparable" to the predicate device (MVR 1200).
	Fill capacity ("Guidance for Blood Extracorporeal... 510(k) Submission")	Met established specifications. The device characteristics were "comparable" to the predicate device (MVR 1200).
	In vitro hemolysis/cell depletion ("Guidance for Blood Extracorporeal... 510(k) Submission")	Met established specifications. The device characteristics were "comparable" to the predicate device (MVR 1200). Phosphorylcholine coating demonstrated to be biocompatible and functional, with performance equivalent to MVR 1200. Claim of reduced platelet adhesion on coated surfaces.
	Air removal efficiency ("Guidance for Blood Extracorporeal... 510(k) Submission")	Met established specifications. The device characteristics were "comparable" to the predicate device (MVR 1200).
	Uniformity test of the PC coating ("Guidance for Blood Extracorporeal... 510(k) Submission")	Met established specifications. The device characteristics were "comparable" to the predicate device (MVR 1200). Phosphorylcholine coating demonstrated to be biocompatible and functional, with performance equivalent to MVR 1200. Comparative testing against MVR 1200 predicate device was conducted. Stability of coating evaluated using Synthesis 510(k) (K022450) and Synthesis Mimesys 510(k) (K031223) data for characterization, flaking, and leaching studies.
Material/Design Equivalence	Identical operating principles, control mechanisms, and materials to MVR 1200 predicate, except for coating extension.	Demonstrated.
	Identical coating material, biocompatibility, and manufacturing process of PC coating with Synthesis and CVR 1200 PC predicate devices.	Demonstrated.
Aging Stability	Device aged up to 3 years	All tests (biocompatibility and in vitro functional) were performed on aged devices and met established specifications.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or AI/ML datasets. The testing involved various in vitro and biocompatibility tests on the device itself.
Data Provenance: The device tested was the MVR 1200 PC, which was subjected to accelerated aging up to three years. The data provenance is from tests conducted on this manufactured device. There is no mention of "country of origin of the data" in terms of patient data, nor is it retrospective or prospective in the clinical trial sense. The studies were laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical medical device. "Ground truth" in this context refers to the defined specifications and standards (e.g., ISO 10993-1995, FDA guidance documents) against which the device's physical and biological performance is measured. It does not involve expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not Applicable. As above, the tests are laboratory-based measurements against established technical and biological specifications, not qualitative assessments requiring adjudication.

5. 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. This is not an AI/ML device involving human readers or comparative effectiveness studies of that nature.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by well-defined international standards (ISO 10993-1995) and FDA guidance documents for biocompatibility and in vitro functional testing of blood-contacting medical devices. The device's performance is assessed against these established specifications and against the performance of predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established

Not Applicable. No training set was used.

Summary

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DEC 1 1 2003

K033714
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	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:	November 26, 2003
DEVICE TRADE NAME:	MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PCwith phosphorylcholine coating (hereinafter called PCcoating)
COMMON NAME:	Softshell Venous Reservoir
CLASSIFICATION NAME:	Reservoir, Blood Cardiopulmonary Bypass
PREDICATE DEVICES:	MVR 1200 Sorin Monolyth Venous Reservoir (K933481).
	SYNTHESIS Adult Membrane Oxygenator with IntegratedArterial Filter and Hardshell Venous/Cardiotomy ReservoirMimesys treated (Phosphorilcholine coating hereinaftercalled PC coating) (K022450),
	SYNTHESIS MIMESYS Adult Membrane Oxygenator withIntegrated Arterial Filter and Hardshell venous/CardiotomyReservoir Mimesys Treated (PC coating) including the CVR1200 PC with PC coating soft shell reservoir (K031223).

DEVICE DESCRIPTION:

INDICATION FOR USE:

The MVR 1200 PC is a sterile, nonpyrogenic device intended for use as a storage reservoir for blood in an extracorporeal bypass circuit. The MVR 1200 PC must not be used for longer than 6 hours.

TECHNOLOGICAL CHARACTERISTICS:

The MVR 1200 PC is essentially identical to the MVR 1200 predicate device with respect to operating principles, control mechanisms and materials. The only modification made to the MVR 1200 PC is the extension of the coating material that bears the claim of reduced platelet adhesion on treated surfaces, to all blood contact surfaces of the softshell venous reservoir. The MVR 1200 PC shares the identical coating material, bicompatibility and manufacturing process of the PC coating with the Synthesis and the CVR 1200 PC coated (included in the Synthesis Mimesys) predicate devices.

The softshell venous reservoir is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only. The device is not intended to be used for periods greater than 6 hours.

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K033114

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BIOCOMPATIBILITY TEST RESULTS:

A complete battery of tests were carried out in accordance with the requirements of ISO 10993-11995 and / Complete Battlery of the ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the MVR 1200 PC (accelerated aging). The device aged up to three years was tested for Hemolysis, Cytotoxicity, Irritation, Acute Systemic Toxicity, Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of the testing met established specifications.

IN VITRO TEST RESULTS:

In vitro testing were carried out in accordance with the requirements of "Guidance for Blood Extracorporeal m firs to the barner 510(k) Submission" Final Guidance for Industry and FDA issued on November 29, Diood Onean Beloamor Cro(in 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 minimum operating blood volume, requirements, burstileak testing, fill capacity, in vitro hemolysis/cell depletion, air removal efficiency and uniformity test of the PC coating. The results of these tests met established specifications. For comparative unfinoning test of the F & outing. The been conducted also on the MVR 1200 predicate device. purposes, the Same tocking, mier appance data previously submitted in the Synthesis 510(k) (K022450) for This of of the characterization and in the Synthesis Mimesys 510(k) (K031223) for flaking and leaching studies in order to evaluate the stability of the coating.

The results of the study showed that the device characteristics between MVR 1200 PC and MVR 1200 were comparable.

CONCLUSIONS:

The results of in vitro studies demonstrate that the MVR 1200 PC device performs in a manner substantially r rie results of in 7 are clause demonstrate that the phosphorylcholine coating is biocompatible and functional tests demonstrate that its performance are equivalent to the MVR 1200 blocompanible and functional tools and its intended use. Additional testing has demonstrated the effectiveness of production techniques to assure that the soft shell venous reservoir is sterile and non-pyrogenic.

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2003

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

Re: K033714

MVR 1200 PC Sorin Monolyth Venous Reservoir 1200 PC with PohosphoryIcholine Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: November 26, 2003 Received: November 26, 2003

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 If your de for 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.

Sincerely yours,

Clas. Mllio

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): K033714

MVR 1200 PC Sorin Monolyth Venous Reservoir 1200 PC with Device Name: pohosphoryicholine coating

Indications For Use:

The MVR 1200 PC is intended for use as a storage reservoir for blood in an extracorporeal bypass circuit for periods up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use_

O. Malla

Division ( cular Devices

510(k) Number

(Optional format 1-2-96)

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.