Physio Flex Annuloplasty Ring

K192762 · Edwards Lifesciences, LLC · KRH · Dec 16, 2019 · Cardiovascular

Device Facts

• Record ID: K192762
• Device Name: Physio Flex Annuloplasty Ring
• Applicant: Edwards Lifesciences, LLC
• Product Code: KRH · Cardiovascular
• Decision Date: Dec 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Physio Flex Annuloplasty Ring, model 5300, is indicated for the correction of mitral valve insufficiency, or mixed mitral insufficiency, where treatment does not necessitate replacement of the natural mitral valve.

Device Story

Physio Flex Annuloplasty Ring (model 5300) is a semi-rigid, open mitral annuloplasty ring; used for mitral valve repair. Device features asymmetrical open anterior segment; rectangular Nitinol core provides variable in-plane and out-of-plane flexibility; progressive saddle height design. Core covered by silicone sleeve and knitted polyester cloth; includes green circumferential suture line for placement guidance; commissure and mid-posterior markers for orientation. Implanted by surgeons during cardiac procedures; used with sizer model 1252 and handle models 1150/1151. Holder includes bendable stainless steel arm for positioning. Device supports mitral annulus; restores valve function; avoids need for valve replacement.

Clinical Evidence

Bench testing only. Performance testing included ring parachuting, holder removal, fatigue life analysis, magnetic resonance imaging compatibility, corrosion resistance, and biocompatibility testing.

Technological Characteristics

Semi-rigid, open mitral annuloplasty ring. Materials: Nitinol core, silicone sleeve, knitted polyester cloth. Sizes: 24-40 mm. Features: Asymmetrical open anterior segment, progressive saddle height, variable flexibility. Accessories: Sizer model 1252, handle models 1150/1151. Sterilization method not specified.

Indications for Use

Indicated for patients requiring correction of mitral valve insufficiency or mixed mitral insufficiency where natural valve replacement is not required.

Regulatory Classification

Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”

Predicate Devices

• Carpentier-Edwards Physio II annuloplasty ring, model 5200 (K083470)

Submission Summary (Full Text)

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December 16, 2019

Edwards Lifesciences LLC Milinda Mawley Senior Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K192762

Trade/Device Name: Physio Flex Annuloplasty Ring, model 5300 Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: October 17, 2019 Received: October 18, 2019

Dear Ms. Mawley:

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/cfpmn/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 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

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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Nicole G. Ibrahim, Ph.D. 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) K192762

Device Name PHYSIO FLEX Annuloplasty Ring, Model 5300

Indications for Use (Describe)

The Physio Flex Annuloplasty Ring, model 5300, is indicated for the correction of mitral valve insufficiency, or mixed mitral insufficiency, where treatment does not necessitate replacement of the natural mitral valve.

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

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

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## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Milinda Mawley, Senior Specialist, Regulatory Affairs<br>One Edwards Way<br>Irvine, CA 92614<br>[phone] |
| Date Prepared: | September 27, 2019 |
| Trade Name: | PHYSIO FLEX Annuloplasty Ring, model 5300 |
| Classification Name: | Annuloplasty ring<br>21 CFR Part 870.3800, Product Code KRH, Class II (Special Controls) |
| Predicate Device: | K083470 Carpentier-Edwards Physio II annuloplasty ring, model 5200 |
| Device Description: | The Physio Flex annuloplasty ring is a semi-rigid, open, mitral<br>annuloplasty ring with an asymmetrical open anterior segment.<br>The ring has an asymmetrical open anterior segment corresponding to<br>the mitral annulus below the aorto-mitral curtain. The complete portion of<br>the ring begins at the anterolateral commissure and extends beyond the<br>posteromedial commissure and the posteromedial trigone into the<br>anterior annulus.<br>The ring design has a rectangular Nitinol core which enables different<br>flexibilities in-plane and out-of-plane.<br>The ring flexibility progressively increases in-plane from size 24 mm to 30<br>mm. It remains relatively constant from size 30 mm to 40 mm. For each<br>ring size, the out-of-plane flexibility is greater than the in-plane flexibility.<br>The ring also has a progressive saddle height with a complete posterior<br>saddle and an open anterior saddle. The ratio of the saddle height to the<br>A-P (antero-lateral to postero-medial) dimension progressively increases<br>from size 24 mm to size 36 mm. It remains constant from size 36 mm to<br>40 mm.<br>The Nitinol core is covered with a silicone sleeve and an external, knitted,<br>polyester cloth. The sewing cuff is designed for ease of needle<br>penetration and suture placement. A green circumferential suture lineplaced between the outer perimeter of the ring and the outer perimeter of<br>the Nitinol core identifies the suture placement area.<br>The ring has two commissure markers and a mid-posterior marker to<br>facilitate orientation during implantation. |
| The ring incorporates a holder with a proximal arm for connection to<br>handle models 1150 and 1151. The holder arm is designed with a section<br>made of stainless steel that can be bent to facilitate access and<br>positioning of the ring on the valve annulus. | |
| The Physio Flex annuloplasty ring is available in sizes 24, 26, 28, 30, 32,<br>34, 36, 38 and 40 mm. | |
| The Physio Flex annuloplasty ring is designed to be used with sizer<br>model 1252. | |
| Indications For Use: | The Physio Flex Annuloplasty Ring, model 5300, is indicated for the<br>correction of mitral valve insufficiency, or mixed mitral insufficiency, where<br>treatment does not necessitate replacement of the natural mitral valve. |
| A comparison of the characteristics of the proposed device and the<br>predicate devices shows the Physio Flex Annuloplasty Ring to have the<br>same fundamental technological characteristics as the predicate device<br>that has received 510(k) clearance. | |
| Comparative Analysis: | Equivalence is based upon intended use, indications for use, principles of<br>operation, and fundamental scientific technology. Both devices are<br>intended to repair a malfunctioning heart valve. |
| Both rings have similar or identical structure, materials of composition,<br>sterilization method, size range, sizing accessories, packaging, and site of<br>application in the body. The subject device differs from the predicate in its<br>open design and core material. | |
| To verify that device design meets functional and performance<br>requirements, representative samples of the devices underwent testing in<br>accordance with applicable standards and guidance. These data<br>demonstrate the device is substantially equivalent to the predicate. | |
| Functional/Safety<br>Testing: | Performance testing was performed to support substantial equivalence,<br>including: |
| | Ring parachuting Holder removal Fatigue Life Analysis Magnetic Resonance Corrosion Resistance Biocompatibility |
| Conclusion: | The Physio Flex Annuloplasty Ring is substantially equivalent to the<br>named predicate device based on technological comparison, principle of<br>operation, indications for use, and intended use. There are no new<br>questions of safety and effectiveness. |

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