The use of the Memo 4D device is indicated for correction of congenital insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Device Description

Like its predicate device (the MEMO 3D ReChord Semirigid Annuloplasty Ring, K142221), the MEMO 4D Semirigid Annuloplasty Ring is supplied as a sterile, non-pyrogenic ring pre-mounted on a disposable holder.

Both the predicate and subject device are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone.

The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread.

Both the predicate and subject device feature a fully removable system (i.e., the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread.

The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring.

The following changes were implemented:

The MEMO 4D is available in two new sizes: 40mm and 42mm.

The MEMO 4D features a larger silicone filler layer in the outer portion of the ring, intended to further facilitate ring suturing to the annulus.

A re-shaping of the MEMO 4D annuloplasty ring was implemented for sizes 34 to 42 mm. These sizes maintain the same core cross-sectional diameter and commissure-to-commissure dimension as the predicate MEMO 3D ReChord, but feature a gradual increase of the ring antero-posterior dimension and an out-of-plane "saddle" shape in the anterior ring portion. The ring re-shaping creates a differentiated design for the MEMO 4D with respect to the MEMO 3D ReChord. The design includes a rounder shaped implant to accommodate cases of excess leaflet tissue which may be indicative of degenerative mitral disease.

Minor design changes to the disposable holder to adapt to the modified ring shape and a new injection molding supplier for the holder were also introduced. The MEMO 4D packaging system was redesigned, introducing a double nested blister to replace the polysulfone containers used for the predicate MEMO 3D ReChord.

A complete set of accessories is available separately to properly size the annulus and implant the MEMO 4D annuloplasty ring.

AI/ML Overview

The provided text is a 510(k) Summary for the MEMO 4D Semirigid Annuloplasty Ring, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already on the market. In this context, "acceptance criteria" and "device performance" don't refer to typical clinical performance metrics for a diagnostic AI device, but rather to the engineering and design characteristics that demonstrate equivalence to the predicate device and ensure safety and efficacy.

Therefore, the requested information elements (1-9) need to be interpreted in the context of a medical device submission based on substantial equivalence, rather than a study validating an AI diagnostic algorithm.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "device performance" results in the manner one might expect for a diagnostic AI study. Instead, it details the verification and validation (V&V) testing performed to demonstrate that the MEMO 4D device maintains the safety and effectiveness profile of its predicate device, the MEMO 3D ReChord Semirigid Annuloplasty Ring (K142221).

The "acceptance criteria" are implied to be that the MEMO 4D performs comparably to the predicate or meets established engineering standards for such devices. The "reported device performance" is the successful completion of the non-clinical tests, indicating that the design changes did not negatively impact safety or efficacy.

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Test Findings)
Maintain structural integrity and mechanical properties under stress.	Computational stress analysis (FEA) and tensile strength testing completed successfully.
Maintain durability and resist fatigue.	Fatigue and durability testing completed successfully.
Ensure secure attachment and removal of the ReChord System.	Extraction tests for the ReChord System threads and disposable holder completed successfully.
Demonstrate biocompatibility.	Biocompatibility testing completed successfully.
Be compatible with MRI.	MRI compatibility testing completed successfully.
Maintain packaging integrity during distribution and over shelf-life.	Simulated distribution testing and package integrity and microbial barrier test after accelerated aging completed successfully.
Function as intended during surgical use.	Simulated use testing completed successfully.
Maintain the same material and operating principles as the predicate device.	The MEMO 4D annuloplasty ring is identical to the predicate MEMO 3D ReChord device in implanted materials, device operating principle, and mechanism of action.
Sterilization process is effective and maintained.	The MEMO 4D is steam-sterilized using the same process in the same facility with respect to the predicate device.
Packaging materials are suitable for maintaining sterility.	Materials used for MEMO 4D packaging are widely used for similar applications, and the sterile barrier has been qualified to maintain device sterility over its stated shelf-life.

Previous testing on the predicate device for suture pull-out, corrosion resistance, and long-term biocompatibility remains valid for MEMO 4D due to similar materials, design, and manufacturing technologies.

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

The document does not specify a "test set sample size" in terms of clinical cases or patient data, as this was a non-clinical submission. The "test set" refers to the physical devices and materials used in the various non-clinical engineering and biological tests (e.g., computational models for FEA, physical rings for tensile strength, fatigue, and extraction tests, materials for biocompatibility, etc.).

Sample Size: Not explicitly stated for each test, but typically, these tests involve a sufficient number of samples as per recognized engineering standards (e.g., ISO, ASTM) to provide statistical confidence.
Data Provenance: The testing was conducted by Sorin Group Italia S.r.l. and appears to be internal validation data. The country of origin for the testing would be Italy, where Sorin Group Italia S.r.l. is located. The nature of the data is retrospective in the sense that it's laboratory-generated data for product validation, not prospective clinical trial data.

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

This is not applicable as there was no clinical "test set" requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical performance relies on established engineering principles, materials science, and regulatory standards. The experts involved would be engineers, material scientists, and regulatory specialists within Sorin Group Italia S.r.l., along with those at the FDA reviewing the submission. Their qualifications are inherent in their professional roles, but not detailed here.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic accuracy, where multiple readers interpret cases and a consensus is reached. The performance data presented here is from non-clinical engineering and material property tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was conducted in support of the MEMO 4D Semirigid Annuloplasty Ring, as the indications for use are equivalent to those of its predicate device MEMO 3D ReChord." Therefore, there is no effect size for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to a physical medical device like an annuloplasty ring. This question is relevant for AI algorithms. The MEMO 4D is an implantable device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering Standards and Specifications: For mechanical properties, durability, material compatibility, and packaging integrity.
Biocompatibility Standards: In vitro and potentially in vivo (from predicate) tests to ensure the materials are safe for implantation.
Regulatory Precedent: The predicate device (MEMO 3D ReChord) having a proven safety and efficacy record on the market established the "ground truth" for the device type, allowing for substantial equivalence without new clinical data.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an AI algorithm or a machine learning model for this medical device submission. The device is a physical product designed and manufactured based on established engineering principles, not trained on data.

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

This is not applicable as there is no training set for an AI algorithm. The device's design and manufacturing rely on established medical device development processes and regulatory compliance rather than machine learning "ground truth" establishment.

Summary

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March 16, 2018

Sorin Group Italia S.r.1. Mr. Mauro Ercolani Director, Regulatory Affairs Via Crescentino sn 13040 Saluggia, VC, Italy

Re: K180411

Trade/Device Name: MEMO 4D Semirigid Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: February 13, 2018 Received: February 15, 2018

Dear Mr. Ercolani:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

for 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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Indications for Use

510(k) Number (if known) K180411

Device Name MEMO 4D Semirigid Annuloplasty Ring

Indications for Use (Describe)

Memo 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K180411

l. Submitter Information

Submitter:	Sorin Group Italia S.r.l.Via Crescentino, sn13040 Saluggia (VC)ITALY
Contact Person:	Mauro ErcolaniDirector, Regulatory AffairsTel: +39 0161 487 412Fax: +39 0161 487 048e-mail: mauro.ercolani@livanova.com
Date Prepared:	February 12, 2018

II. Device Name and Classification

Proprietary Name:	MEMO 4D Semirigid Annuloplasty Ring
Common/Usual Name:	Ring, Annuloplasty
Classification Name:	Annuloplasty Ring
Regulation Number:	21 CFR 870.3800
Product Code:	KRH
Classification:	Class II
Classification Panel:	Cardiovascular

III. Predicate Device

The MEMO 4D Semirigid Annuloplasty Ring is substantially equivalent to its cleared predicate device identified below. Both devices have the same fundamental scientific technology and intended use:

510(k) Number:	K142221
Proprietary Name:	MEMO 3D ReChord Semirigid Annuloplasty Ring
Common/Usual Name:	Ring, Annuloplasty
Classification Name:	Annuloplasty Ring
Regulation Number:	21 CFR 870.3800
Product Code:	KRH
Classification:	Class II
Classification Panel:	Cardiovascular

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IV. Device Description

Both the predicate and subject device are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone.

The following changes were implemented:

The MEMO 4D is available in two new sizes: 40mm and 42mm.

The MEMO 4D features a larger silicone filler layer in the outer portion of the ring, intended to further facilitate ring suturing to the annulus.

A complete set of accessories is available separately to properly size the annulus and implant the MEMO 4D annuloplasty ring.

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V. Indications for Use

MEMO 4D device is intended for correction of mitral insufficiencies or stenoinsufficiencies.

The use of the MEMO 4D device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

VI. Substantial Equivalence Discussion

Table 1 presented in the following page compares the characteristics and features of the MEMO 4D to its predicate device.

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510(k) Summary (continued)

MEMO 4Dcharacteristic /feature	PredicateDevice510(k) #	PredicateDeviceProprietaryName	Device Equivalence
- Intended Use / Indications for use			The intended use and indications for use reportedin the device labeling are the same between theMEMO 4D and the predicate device.
- Anatomical site for implantation			The anatomical site for implantation and surgicalaccess of the MEMO 4D are the same withrespect to the predicate device.
- Target population			The differences between the predicate and thesubject devices do not affect the disease /condition that the device is intended to treat ormitigate (i.e., mitral insufficiencies or steno-insufficiencies, with or without repair/replacementof chordae tendineae) or the target patientpopulation (i.e., patients with repairable mitralvalve via surgical approaches).
- Physical characteristics- Device design and materials	K142221	MEMO 3DReChordSemirigidAnnuloplastyRing	Both the MEMO 3D ReChord and the MEMO 4Dare closed semirigid rings with variable flexibility(maximum flexibility in the posterior portion,gradually decreasing towards the anterior ringportion) used to restore proper leaflet coaptationand valve function by mechanically reshaping themitral heart valve annulus.The MEMO 4D annuloplasty ring is identical tothe predicate MEMO 3D ReChord device both interms of implanted materials, device operatingprinciple and mechanism of action.
- Product packaging and sterilization			The MEMO 4D sterile barrier consists of doublenested polycarbonate blisters, whereas the sterilebarrier of the predicate device consists of doublenested polysulfone containers.The materials used for the MEMO 4D packagingare widely used for similar applications, and thesterile barrier has been qualified to maintain thedevice sterile over its stated shelf-life.The MEMO 4D is steam-sterilized using thesame process in the same facility with respectto the predicate device.

Table 1 – Comparison with the predicate device

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VII. Non-Clinical Performance Data

Sorin Group Italia S.r.l. has conducted verification and validation testing of the MEMO 4D based on the risk analysis for the device.

Non-clinical testing included:

computational stress analysis (FEA) and tensile strength testing;
fatique and durability testing;
extraction tests for the ReChord System threads and disposable holder; ।
biocompatibility testing;
MRI compatibility testing;
simulated distribution testing;
package integrity and microbial barrier test after accelerated ageing; ।
simulated use testing.

Suture pull-out, corrosion resistance, and long-term biocompatibility testing were previously conducted on the predicate device MEMO 3D ReChord and remain valid for the MEMO 4D due to similar materials, design and manufacturing technologies.

Clinical Performance Data VIII.

No clinical testing was conducted in support of the MEMO 4D Semirigid Annuloplasty Ring, as the indications for use are equivalent to those of its predicate device MEMO 3D ReChord. These types of devices have been on the market for many years with proven safety and efficacy of use. The nonclinical testing referred to in this submission supports the substantial equivalence of this device.

IX. Statement of Substantial Equivalence

The MEMO 4D Semirigid Annuloplasty Ring has been demonstrated as safe and effective for its intended use as the legally marketed predicate device. With respect to intended use and technological characteristics, the MEMO 4D is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.3800 Annuloplasty ring.

(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”