The SimuPlus flexible annuloplasty ring and band are in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimulPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.

The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.

Device Description

The SimuPlus flexible annuloplasty ring (Model 7700FR) and band (Model 7700FB) consist of a flexible braided polyester fabric with a 3 mm cross-section. The ring or band may be implanted in the mitral annulus to stabilize the annulus following valve repair. The band may be implanted in the tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the centerline of the ring or band. The individual ring or band size (26 mm to 42 mm increments) refers to the circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation.

The SimuPlus annuloplasty ring and band holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the holder opening above the typical area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chord knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.

The SimuForm semi-rigid annuloplasty ring (Model 7800RR) consists of a MP35N wire stiffener in the posterior segment, running from trigone to trigone. The ring stiffener is enclosed within a close-coiled MP35N spring that passes around the circumference of the annuloplasty ring. The spring is covered by a thin silicone sheath. Braided polyester fabric is used to cover and form the body of the ring. The ring has two green markers to indicate the anterior and posterior trigones. A green demarcation suture runs around the upper face of the ring. The individual ring size (24 mm to 40 mm in 2 mm increments) refers to the inner circumference between the green trigone markers on the ring. The internal spring and stiffener provide radiographic visualization around the circumference of the ring.

The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for annuloplasty rings and bands, arguing their substantial equivalence to previously marketed predicate devices.

The key points from the document are:

Device: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring.
Purpose: To gain clearance for these devices by demonstrating they are "substantially equivalent" to predicate devices (Simulus Flexible Annuloplasty Ring and Band, Simulus Semi-Rigid Annuloplasty Ring).
Changes:
- SimuPlus (Flexible): Updates to product name, indications (minor phrasing changes), labeled size range (to align with industry sizing, no change to implant construction or dimensions), handle compatibility, and language for instructions for use (eIFU/paper IFU).
- SimuForm (Semi-Rigid): Updates to product name, handle compatibility, and language for instructions for use (eIFU/paper IFU). No change to the implantable ring, its intended use, principles of operation, or size range.
Conclusion: "The modifications to the Simulus devices do not impact the intended use or alter the fundamental scientific technology of the devices. There is no change to the implantable rings and bands. The SimuPlus and SimuForm rings and bands are therefore substantially equivalent to the currently marketed predicate devices."
Performance Data: "Performance testing was not required to support labeling changes made to align with standard industry sizing." This explicitly states that performance testing was not done for this submission, as the changes were deemed not to affect fundamental performance.

Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document. This document focuses solely on demonstrating substantial equivalence based on the nature of the changes made and comparison to predicate devices, rather than presenting new performance data against specific acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 1, 2020

Medtronic, Inc. Lisa Corbin Sr. Regulatory Affairs Specialist 1851 E. Deere Ave. Santa Ana, California 92705

Re: K201449

Trade/Device Name: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: May 29, 2020 Received: June 1, 2020

Dear Lisa Corbin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm_identifies_combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jaime Raben Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201449

Device Name SimuPlus™ Flexible Annuloplasty Ring SimuPlus™ Flexible Annuloplasty Band SimuForm™ Semi-Rigid Annuloplasty Ring

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1.0 510(k) Summary

1.1 Applicant Information

Date Prepared:	May 29, 2020
Applicant:	Medtronic, Inc.Medtronic Heart Valves Division1851 E. Deere Ave.Santa Ana, CA 92705
Contact Person:	Lisa CorbinSr. Regulatory Affairs SpecialistPhone: (949) 399-1670Email: lisa.corbin@medtronic.com
Alternate Contact:	Zach LarsenSr. Regulatory Affairs SupervisorPhone: (949) 382-1034Email: zach.s.larsen@medtronic.com

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1.2 Device Name and Classification

Trade Name	Predicate Device	CommonName	ClassificationName	RegulationNumber	ProductClassification	ProductCode	ClassificationPanel	SpecialControls
SimuPlus™FlexibleAnnuloplasty Ring,Model 7700FR	Simulus™ FlexibleAnnuloplasty Ring,Model 700FF(K052565)
SimuPlus™FlexibleAnnuloplasty Band,Model 7700FB	Simulus™ FlexibleAnnuloplasty Band,Model 700FC(K052899)	AnnuloplastyRing	Ring,Annuloplasty	21 CFR870.3800	Class II	KRH	CardiovascularDevices Panel	Yes
SimuForm™ Semi-Rigid AnnuloplastyRing, Model7800RR	Simulus™ Semi-Rigid AnnuloplastyRing, Model 800SR(K072655)

Table 1-1: Device Name and Classification for Rebranded Simulus Devices

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1.3 Design and Manufacturing Facility Addresses

Design Site:	Medtronic Heart Valves Division1851 E. Deere Ave.Santa Ana, CA 92705Establishment Registration Number: 2025587
Manufacturing Site:	Medtronic Mexico S. de R.L. de CVAv. Paseo Cucapah 10510 El LagoTijuana, Baja California Mexico C.P. 22210Establishment Registration Number: 9617601

Device Description 1.4

SimuPlus Flexible Annuloplasty Ring and Band 1.4.1

1.4.2 SimuForm Semi-Rigid Annuloplasty Ring

The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring

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holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.

1.5 Indications for Use

Table 1-2: Indications for Use for SimuPlus, SimuForm Rings and Bands

Device Name	Indications for Use
SimuPlus FlexibleAnnuloplasty Ring,Model 7700FR	The SimuPlus flexible annuloplasty ring and band are indicated for use in patientsundergoing surgery for diseased or damaged mitral valves. The band is indicated for thesame use for tricuspid valves. The SimuPlus flexible annuloplasty ring and bandprovide support for the mitral annulus or tricuspid annulus (band only) and restrictexpansion of the annulus.
SimuPlus FlexibleAnnuloplasty Band,Model 7700FB
SimuForm Semi-RigidAnnuloplasty Ring,Model 7800RR	The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgeryfor diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ringprovides support for the mitral annulus and restricts expansion of the annulus.

1.6 Comparison to Predicate Devices

SimuPlus Flexible Annuloplasty Ring and Band 1.6.1

The following characteristics of the SimuPlus flexible annuloplasty ring and band are identical to the Simulus flexible annuloplasty ring and band: implantable ring/band, intended use, principles of operation, sterilization, shelf life, and packaging. The SimuPlus flexible annuloplasty ring and band are substantially equivalent to the Simulus flexible annuloplasty ring and band as summarized in Table 1-3.

Characteristic	SimuPlus FlexibleAnnuloplasty Ring and Band(Subject)	Simulus FlexibleAnnuloplasty Ring and Band(Predicate)	Equivalence
Indications for Use	The SimuPlus flexibleannuloplasty ring and band areindicated for use in patientsundergoing surgery for diseased ordamaged mitral valves. The bandis indicated for the same use fortricuspid valves. The SimuPlusflexible annuloplasty ring andband provide support for themitral annulus or tricuspid annulus(band only) and restrict expansionof the annulus.	The ATS SIMULUSAnnuloplasty Rings are for use inthose patients undergoing surgeryof diseased or damaged mitral ortricuspid valves in whom thesurgeon determines that the valvecan be preserved by employingthe appropriate surgical repair.The annuloplasty rings providesupport for the mitral or tricuspidannulus and restrict expansion ofthe annulus.	SubstantiallyEquivalent

Table 1-3: Flexible Rinq and Band Substantial Equivalence Comparison

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Characteristic	SimuPlus FlexibleAnnuloplasty Ring and Band(Subject)	Simulus FlexibleAnnuloplasty Ring and Band(Predicate)	Equivalence
		The ATS SIMULUS FCAnnuloplasty Bands are for use inthose patients undergoing surgeryof diseased or damaged mitral ortricuspid valves in whom thesurgeon determines that the valvecan be preserved by employingthe appropriate surgical repair.The annuloplasty bands providesupport for the mitral or tricuspidannulus and restrict expansion ofthe annulus
Labeled Size Range*	26 mm, 28 mm, 30 mm, 32 mm,34 mm, 36 mm, 38 mm, 40 mm,42 mm	23 mm, 25 mm, 27 mm, 29 mm,31 mm, 33 mm, 35 mm, 37 mm,39 mm	SubstantiallyEquivalent
Product Labeling	Update to product name,indications, labeled size range Update handle compatibilityto Model 7686 annuloplastyhandle Update to 29-language eIFU,6-language paper IFU	Compatible with Model 752annuloplasty handle 16-language eIFU, 16-language paper IFU	SubstantiallyEquivalent
*Note that there is no change to the construction or dimensions of the implantable ring/band. Modifications to thelabeled size range reflect dimensional changes to the sizer accessory to align with standard industry sizing.

Table 1-3: Flexible Ring and Band Substantial Equivalence Comparison

1.6.2 SimuForm Semi-Rigid Annuloplasty Ring

The following characteristics of the SimuForm semi-rigid annuloplasty ring are identical to the Simulus semi-rigid ring: implantable ring, intended use, principles of operation, size range, sterilization, shelf life, and packaging. The SimuForm semi-rigid ring is substantially equivalent to the Simulus semi-rigid ring as summarized in Table 1-4.

Table 1-4: Semi-rigid Ring Substantial Equivalence Comparison

Characteristic	SimuForm Semi-rigidAnnuloplasty Ring (Subject)	Simulus Semi-rigidAnnuloplasty Ring(Predicate)	Equivalence
Indications for Use	The SimuForm semi-rigidannuloplasty rings are for use inpatients undergoing surgery fordiseased or damaged mitralvalves. The SimuForm semi-rigid	The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ringsare for use in those patientsundergoing surgery of diseased ordamaged mitral valves in whom	SubstantiallyEquivalent

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Characteristic	SimuForm Semi-rigidAnnuloplasty Ring (Subject)	Simulus Semi-rigidAnnuloplasty Ring(Predicate)	Equivalence
	annuloplasty ring provides supportfor the mitral annulus and restrictsexpansion of the annulus.	the surgeon determines that thevalve can be preserved byemploying the appropriatesurgical repair. The annuloplastyrings provide support for thenatural annulus and restrictexpansion of the annulus.
Product Labeling	Update to product name Update handle compatibilityto Model 7686 annuloplastyhandle Update to include 29-language eIFU, 6-languagepaper IFU	Compatible with Model 752annuloplasty handle 16-language eIFU, 16-language paper IFU	SubstantiallyEquivalent

1.7 Summary of Performance Data

Performance testing was not required to support labeling changes made to align with standard industry sizing.

1.8 Conclusion

The modifications to the Simulus devices do not impact the intended use or alter the fundamental scientific technology of the devices. There is no change to the implantable rings and bands. The SimuPlus and SimuForm rings and bands are therefore substantially equivalent to the currently marketed predicate devices.

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.”