(77 days)
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.
The Physio Flex annuloplasty ring is a semi-rigid, open, mitral annuloplasty ring with an asymmetrical open anterior segment. The ring has an asymmetrical open anterior segment corresponding to the mitral annulus below the aorto-mitral curtain. The complete portion of the ring begins at the anterolateral commissure and extends beyond the posteromedial commissure and the posteromedial trigone into the anterior annulus. The ring design has a rectangular Nitinol core which enables different flexibilities in-plane and out-of-plane. The ring flexibility progressively increases in-plane from size 24 mm to 30 mm. It remains relatively constant from size 30 mm to 40 mm. For each ring size, the out-of-plane flexibility is greater than the in-plane flexibility. The ring also has a progressive saddle height with a complete posterior saddle and an open anterior saddle. The ratio of the saddle height to the A-P (antero-lateral to postero-medial) dimension progressively increases from size 24 mm to size 36 mm. It remains constant from size 36 mm to 40 mm. The Nitinol core is covered with a silicone sleeve and an external, knitted, polyester cloth. The sewing cuff is designed for ease of needle penetration and suture placement. A green circumferential suture line placed between the outer perimeter of the ring and the outer perimeter of the Nitinol core identifies the suture placement area. The ring has two commissure markers and a mid-posterior marker to facilitate orientation during implantation. The ring incorporates a holder with a proximal arm for connection to handle models 1150 and 1151. The holder arm is designed with a section made of stainless steel that can be bent to facilitate access and positioning of the ring on the valve annulus. The Physio Flex annuloplasty ring is available in sizes 24, 26, 28, 30, 32, 34, 36, 38 and 40 mm. The Physio Flex annuloplasty ring is designed to be used with sizer model 1252.
The provided text describes a 510(k) premarket notification for the "PHYSIO FLEX Annuloplasty Ring, model 5300". This document reports on the substantial equivalence of the new device to a predicate device, K083470 Carpentier-Edwards Physio II annuloplasty ring, model 5200.
The document discusses functional/safety testing performed to support substantial equivalence, but it does not provide specific acceptance criteria or an analytical study involving human readers or AI-assistance. The tests mentioned are device-specific and relate to its physical properties and biocompatibility.
Therefore, most of the requested information cannot be extracted from the provided text as it is focused on a medical device (annuloplasty ring) and its physical performance, not on a diagnostic algorithm or image analysis tool.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists "Ring parachuting, Holder removal, Fatigue Life Analysis, Magnetic Resonance, Corrosion Resistance, Biocompatibility" as performance testing areas. However, it does not provide specific numerical acceptance criteria or the reported device performance for these tests. It only states that these data "demonstrate the device is substantially equivalent to the predicate."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "representative samples of the devices underwent testing," but does not specify the sample size or data provenance.
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)
This is not applicable and not provided. The device is a physical annuloplasty ring, not a diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. As above, the testing described is for physical device performance, not for diagnostic accuracy 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
This is not applicable and not provided. The document describes a physical medical device (annuloplasty ring), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. The document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for this device would be its physical and biocompatible properties meeting engineering specifications, rather than a clinical diagnosis.
8. The sample size for the training set
This is not applicable and not provided. As this is a physical device and not an AI algorithm, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable and not provided.
In summary, the provided text primarily focuses on establishing substantial equivalence for a physical medical device. It does not contain the detailed information about acceptance criteria or specific study methodologies that would be relevant for a diagnostic or AI-powered medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Image /page/3/Picture/0 description: The image shows the word "Edwards" in a serif font, with the first letter "E" being larger than the rest of the word. The "E" is stylized with a geometric design, including squares and circles, overlaid on top of it. The background behind the "E" is a solid gray color, while the rest of the word "Edwards" is in black.
510(k) Summary
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Milinda Mawley, Senior Specialist, Regulatory AffairsOne Edwards WayIrvine, CA 92614(949) 250-5847 |
| Date Prepared: | September 27, 2019 |
| Trade Name: | PHYSIO FLEX Annuloplasty Ring, model 5300 |
| Classification Name: | Annuloplasty ring21 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, mitralannuloplasty ring with an asymmetrical open anterior segment.The ring has an asymmetrical open anterior segment corresponding tothe mitral annulus below the aorto-mitral curtain. The complete portion ofthe ring begins at the anterolateral commissure and extends beyond theposteromedial commissure and the posteromedial trigone into theanterior annulus.The ring design has a rectangular Nitinol core which enables differentflexibilities in-plane and out-of-plane.The ring flexibility progressively increases in-plane from size 24 mm to 30mm. It remains relatively constant from size 30 mm to 40 mm. For eachring size, the out-of-plane flexibility is greater than the in-plane flexibility.The ring also has a progressive saddle height with a complete posteriorsaddle and an open anterior saddle. The ratio of the saddle height to theA-P (antero-lateral to postero-medial) dimension progressively increasesfrom size 24 mm to size 36 mm. It remains constant from size 36 mm to40 mm.The Nitinol core is covered with a silicone sleeve and an external, knitted,polyester cloth. The sewing cuff is designed for ease of needlepenetration and suture placement. A green circumferential suture lineplaced between the outer perimeter of the ring and the outer perimeter ofthe Nitinol core identifies the suture placement area.The ring has two commissure markers and a mid-posterior marker tofacilitate orientation during implantation. |
| The ring incorporates a holder with a proximal arm for connection tohandle models 1150 and 1151. The holder arm is designed with a sectionmade of stainless steel that can be bent to facilitate access andpositioning of the ring on the valve annulus. | |
| The Physio Flex annuloplasty ring is available in sizes 24, 26, 28, 30, 32,34, 36, 38 and 40 mm. | |
| The Physio Flex annuloplasty ring is designed to be used with sizermodel 1252. | |
| Indications For Use: | The Physio Flex Annuloplasty Ring, model 5300, is indicated for thecorrection of mitral valve insufficiency, or mixed mitral insufficiency, wheretreatment does not necessitate replacement of the natural mitral valve. |
| A comparison of the characteristics of the proposed device and thepredicate devices shows the Physio Flex Annuloplasty Ring to have thesame fundamental technological characteristics as the predicate devicethat has received 510(k) clearance. | |
| Comparative Analysis: | Equivalence is based upon intended use, indications for use, principles ofoperation, and fundamental scientific technology. Both devices areintended to repair a malfunctioning heart valve. |
| Both rings have similar or identical structure, materials of composition,sterilization method, size range, sizing accessories, packaging, and site ofapplication in the body. The subject device differs from the predicate in itsopen design and core material. | |
| To verify that device design meets functional and performancerequirements, representative samples of the devices underwent testing inaccordance with applicable standards and guidance. These datademonstrate the device is substantially equivalent to the predicate. | |
| Functional/SafetyTesting: | Performance testing was performed to support substantial equivalence,including: |
| Ring parachuting Holder removal Fatigue Life Analysis Magnetic Resonance Corrosion Resistance Biocompatibility | |
| Conclusion: | The Physio Flex Annuloplasty Ring is substantially equivalent to thenamed predicate device based on technological comparison, principle ofoperation, indications for use, and intended use. There are no newquestions of safety and effectiveness. |
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Image /page/4/Picture/0 description: The image shows a logo for a company named Edwards. The logo features a large, stylized letter "E" in white, set against a square background with a grid pattern. The word "Edwards" is written in a serif font below the logo.
§ 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.”