The use of the MEMO 3D ReChord 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.

Device Description

Like its predicate device (the MEMO 3D Semirigid Annuloplasty Ring, K071327), the MEMO 3D ReChord 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.

The MEMO 3D ReChord features a fully removable system (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 the replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring.

Both ReChord System threads end with a knot protruding from the ring surface, which is pulled at the end of the implant procedure to remove the threads from the ring. The annuloplasty ring is attached to a disposable holder (i.e., the two-piece holder) composed of a polysulfone disk and a polyetherimide template.

The disk attaches to a handle accessory and allows device handling, whilst the template keeps the device sufficiently stiff during suturing.

The MEMO 3D ReChord Semirigid Annuloplasty Ring is available in sizes 24 mm through 38 mm, in 2 mm increments. The number of the ReChord System thread loops varies based on the size of the annuloplasty ring: six (6) loops for ring sizes 24-30, eight (8) loops for ring sizes 32-38.

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

AI/ML Overview

This document is a 510(k) Summary for the MEMO 3D ReChord Semirigid Annuloplasty Ring. It does not describe a study to prove acceptance criteria for a new device's performance but rather demonstrates substantial equivalence to a predicate device. Therefore, many of the requested categories related to clinical performance data, expert review, training sets, and sample sizes for a new device's performance metrics are not applicable to this submission.

However, I can extract the information provided regarding the non-clinical performance data used to support substantial equivalence.

Here's a breakdown based on your request, highlighting what is available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria (e.g., specific quantitative thresholds for performance) for the MEMO 3D ReChord device itself, nor does it list specific reported numerical performance results against such criteria. Instead, it states that non-clinical testing was conducted based on risk analysis and lists the types of tests performed. The basis for acceptance is demonstrating that these tests support substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size: Not explicitly stated for any of the non-clinical tests.
Data provenance: Not explicitly stated, but the submission is from Sorin Group Italia S.r.l. in Italy, suggesting the tests might have been conducted there or by affiliated entities. The study is non-clinical (bench testing, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a non-clinical evaluation of a physical medical device, not an AI/diagnostic device requiring expert consensus for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This pertains to expert review of diagnostic findings, which is not relevant for this device submission.

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

Not applicable. This is a physical annuloplasty ring, not an AI-assisted diagnostic or decision support system.

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

Not applicable. This is a physical medical device.

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

For the non-clinical tests, the "ground truth" would be established by validated test methodologies and engineering specifications for aspects like:

Physical integrity (tensile strength, rigidity)
Biocompatibility
Sterility
Functionality (e.g., ReChord System thread removal)
These are assessed against established standards and internal specifications, not expert consensus or pathology in a biological sense.

8. The sample size for the training set

Not applicable. This product does not involve machine learning algorithms with training sets.

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

Not applicable. This product does not involve machine learning algorithms with training sets.

Summary of Reported Non-Clinical Performance Data & Study:

The primary study type mentioned is non-clinical verification and validation testing.

Description of Non-Clinical Testing Performed for MEMO 3D ReChord:

Tests conducted specifically for MEMO 3D ReChord:
- Extraction tests for the ReChord System threads and disposable holder.
- Biocompatibility testing for the ReChord System thread and disposable holder components.
- Simulated distribution testing (likely testing packaging integrity under shipping conditions).
- Simulated use testing (wet lab on isolated porcine hearts) – this tested the functionality of the ReChord System in a simulated surgical environment.
Tests not repeated for MEMO 3D ReChord (as the implantable part is identical to the predicate):
- Ultimate tensile strength
- Suture pull-out
- Rigidity determination
- Computational stress analysis
- Fatigue and durability testing
- Corrosion resistance
- Biocompatibility on the implanted materials
- Shelf life testing

Acceptance Criteria for Non-Clinical Testing:

The document states: "Sorin Group Italia S.r.l. has conducted verification and validation testing of the MEMO 3D ReChord based on the risk analysis for the device." This implies that the acceptance criteria for these non-clinical tests were derived from the device's risk analysis and were deemed sufficient to demonstrate the safety and effectiveness of the new features and components, and to uphold the substantial equivalence claim. Specific numerical acceptance values are not provided in this summary.

Conclusion:

The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (MEMO 3D Semirigid Annuloplasty Ring, K071327) by showing that the changes (introduction of the ReChord System and new holder) do not alter the fundamental safety, effectiveness, or indications for use of the implantable ring. Therefore, the "study" is a series of non-clinical bench tests and biocompatibility assessments targeting the new components, rather than a clinical trial with performance metrics typically found for new diagnostic or therapeutic devices. No clinical testing was conducted.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

Sorin Group Italia S.r.l % Mr. Fabio De Pasquale Acting Director, Regulatory Affairs 5005 North Fraser Wav Burnaby, V5J 5M1 CA

Re: K142221

Trade/Device Name: MEMO 3D ReChord Semirigid Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: August 6, 2014 Received: August 12, 2014

Dear Mr. De Pasquale,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillemann

for

for 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) K142221

Device Name MEMO 3D ReChord Semirigid Annuloplasty Ring

Indications for Use (Describe) MEMO 3D ReChord device is intended for correction of mitral insufficiencies or steno-insufficiences.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K_________________

l. Submitter Information

Submitter:	Sorin Group Italia S.r.l.Via Crescentino, sn13040 Saluggia (VC)ITALY
Contact Person:	Fabio De PasqualeActing Director, Regulatory Affairs, Sorin Group Canada Inc.Tel: +1 (250) 920 6501Fax: +1 (604) 412 5690e-mail: fabio.depasquale@sorin.com
Date Prepared:	August 6th, 2014

Device Name and Classification II.

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

III. Predicate Device

The MEMO 3D ReChord 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:	K071327
Proprietary Name:	MEMO 3D 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 disk attaches to a handle accessory and allows device handling, whilst the template keeps the device sufficiently stiff during suturing.

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

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V. Indications for Use

MEMO 3D ReChord device is intended for correction of mitral insufficiencies or steno-insufficiences.

VI. Substantial Equivalence Discussion

Table 1 presented in the following page compares the characteristics and features of the MEMO 3D ReChord to its predicate device.

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510(k) Summary (continued)

Table 1 - Comparison with the predicate device
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MEMO 3D ReChordcharacteristic / feature	PredicateDevice510(k) #	PredicateDeviceProprietaryName	Device Equivalence
- Intended Use /Indications for use- Anatomical site forimplantation- Target population			The intended use and indications for use reportedin the device labeling are the same between theMEMO 3D ReChord and the predicate device.The anatomical site for implantation and surgicalaccess of the MEMO 3D ReChord annuloplastyring are the same with respect to the predicatedevice.The replacement of mitral chordae tendineae is acommon procedure which is routinely performedin concomitance with annuloplasty ring implant.The addition of the ReChord System is onlyintended to provide a reference point to facilitatesurgeons in performing a concomitant procedurewhich is already carried out when implanting thepredicate device; therefore, the proposedchanges do not affect the patient population.
- Physicalcharacteristics- Device designand materials- Safety andperformance	K071327	MEMO 3DSemirigidAnnuloplastyRing	The MEMO 3D ReChord annuloplasty ring, in itsfinal implant configuration, is identical to thepredicate device; thus, the safety andperformances of the implantable device areunaffected by the proposed changes.The additional components introduced on the ring(i.e. the ReChord System threads) are made ofstandard surgical sutures which are removed inthe course of the implant procedure.The introduction of the disposable two-pieceholder and handle accessory does not affect thedevice function (i.e. it only ensures correct ringposition during storage / transport and allowdevice handling).
- Product packagingand sterilization			The MEMO 3D ReChord utilizes the same sterilebarrier (double polysulfone container) currentlyqualified and in use for the predicate device.The MEMO 3D ReChord is steam-sterilized usingthe same process in the same facility with respectto 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 3D ReChord based on the risk analysis for the device.

Non-clinical testing included:

extraction tests for the ReChord System threads and disposable holder;
biocompatibility testing for the ReChord System thread and disposable holder components;
simulated distribution testing; and
simulated use testing (wet lab on isolated porcine hearts).

Ultimate tensile strenght, suture pull-out, rigidity determination, computational stress analysis, fatigue and durability testing, corrosion resistance, biocompatibility on the implanted materials and shelf life testing were previously conducted on the predicate device MEMO 3D and, since the implanted annuloplasty rings are identical, were not repeated for the MEMO 3D ReChord.

VIII. Clinical Performance Data

No clinical testing was conducted in support of the MEMO 3D ReChord Semirigid Annuloplasty Ring, as the indications for use are equivalent to those of its predicate device MEMO 3D.

These types of devices have been on the market for many years with proven safety and efficacy of use. The non-clinical testing referred to in this submission supports the substantial equivalence of this device.

IX. Statement of Substantial Equivalence

MEMO 3D ReChord Semirigid Annuloplasty Ring has been The 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 3D ReChord Semirigid Annuloplasty Ring 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.”