(206 days)
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is constructed of a titanium core with a silicone sewing ring margin covered with a polyester cloth.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Carpentier-Edwards® Physio Tricuspid™ annuloplasty ring, model 6200:
Summary of Acceptance Criteria and Device Performance for K103520
This 510(k) submission describes a medical device, an annuloplasty ring, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects (training set, test set, ground truth experts, MRMC studies, standalone performance) are not applicable in this context. The acceptance criteria here refer to the successful completion of design verification and validation testing for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functional/Safety Testing | Computational stress analysis, Finite element analysis, Tensile strength, Suture retention, Flexibility, Ring / Ring holder removal force, Corrosion resistance, Magnetic resonance compatibility (RF heating, image artifact, displacement force, induced torque), Biocompatibility (percent inhibition of cell growth, medium eluate method - cytotoxicity, blood compatibility, complement activation, gene mutation assay, chromosomal aberration effect assay, agar overlay - cytotoxicity, DNA damage / effects assay, Mouse systemic injection - systemic toxicity, rabbit pyrogen - systemic toxicity, rabbit intracutaneous reactivity, guinea pig maximization, rabbit intramuscular implantation sub-chronic and chronic evaluations), Relative resistance evaluation and comparison for sterilization, Bioburden, Limulus amebocyte lysate pyrogen testing, Packaging qualification (visual inspection, sterile barrier integrity, dye leak, burst), Shelf-life assessments of packaging and product components, Design validation by surgeons in simulated use environment. | "The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, has successfully completed design verification and validation testing." (A general statement of success across all listed tests, without specific numerical results in this summary document.) The conclusion is that the device is "substantially equivalent to its predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This is a physical medical device, not an AI/ML system. There is no "test set" in the context of data for an algorithm. The testing involves physical prototypes or materials of the device. The provenance of the "data" would refer to where the biomechanical, material, and biocompatibility testing was performed. This information is not detailed in the summary, but such testing is typically done in controlled laboratory environments.
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 physical medical device. There is no "ground truth for a test set" in the sense of expert annotation for an algorithm. However, the summary mentions "Design validation by surgeons in simulated use environment." While the number of surgeons and their specific qualifications are not provided in this summary, these would be the "experts" involved in validating the device's usability and surgical handling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As this is not an AI/ML system evaluating data, there is no "adjudication method" for a test set of data. The design validation by surgeons would likely involve observation, feedback, and potentially consensus or individual assessments of the device's performance in a simulated environment.
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 medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm. Standalone performance refers to an AI system operating independently; this concept does not apply to a heart valve ring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/ML sense): For a physical medical device, "ground truth" relates to established engineering standards, material science properties, biological compatibility guidelines, and successful clinical outcomes (which are implicitly aimed for). The successful completion of the listed functional/safety tests against established benchmarks and standards (e.g., ISO 10993 for biocompatibility, ASTM standards for MR compatibility) serves as the "ground truth" that the device meets its design requirements. Surgical design validation by experts also contributes to establishing usability "ground truth."
8. The sample size for the training set
- Not Applicable: This is a physical medical device, not an AI/ML system. There is no concept of a "training set" for an annuloplasty ring. Device development involves iterative design, prototyping, and testing.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set or ground truth in the AI/ML sense. For a physical device, the "ground truth" for its development involves engineering principles, material specifications, regulatory standards, and clinical needs that guide its design and subsequent testing.
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Image /page/0/Picture/1 description: The image shows a logo with the word "Edwards" written below a square graphic. The graphic contains a large letter "E" in white, overlaid on a grid pattern. Circular designs are visible behind the letter "E" and within the grid, adding a complex, layered effect to the logo. The overall design appears to be for a company or brand named Edwards.
510(k) Summary
:
JUN 2 4 2011
| Submitter: | Edwards Lifesciences LLC |
|---|---|
| Contact Person: | Daryl RichardsonRegulatory Affairs AssociateOne Edwards WayIrvine, CA 92614daryl richardson@edwards.com(ph) 949-250-5036 / (fax) 949-250-3630 |
| Date Prepared: | June 15, 2011 |
| Trade Name: | Carpentier-Edwards® Physio Tricuspid™ annuloplasty ring,model 6200 |
| Classification Name: | Class II, CFR 870.3800 Annuloplasty Ring, KRH |
| Predicate Device(s): | Edwards MC3® Tricuspid annuloplasty ring (K020864)Cosgrove-Edwards® annuloplasty system (K923367)Carpentier-Edwards® Classic® Tricuspid annuloplasty ring (K912554) |
| Device Description: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model6200, is constructed of a titanium core with a silicone sewing ringmargin covered with a polyester cloth. |
| ·Indications for Use: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model6200, is intended for use in patients with tricuspid valvularinsufficiency. It is intended to correct annular dilatation, increaseleaflet coaptation, reinforce annular suture lines, and prevent furtherdilatation of the annulus. |
| Comparative Analysis: | It has been demonstrated that the Carpentier-Edwards PhysioTricuspid annuloplasty ring, model 6200, is comparable to its predicatedevices in design, intended use, materials, fundamental technologyand principal of operation. |
| Functional/Safety Testing: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model6200, has successfully completed design verification and validationtesting. The following studies were conducted:Computational stress analysis |
- Finite element analysis .
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Image /page/1/Picture/0 description: The image shows a logo with the letter 'E' inside a square. The letter 'E' is white and bold, and it is surrounded by a circle. The background of the square is black and white. Below the square is the word 'Edwards' in a serif font.
- Tensile strength .
- Suture retention .
- . Flexibility
- Ring / Ring holder removal force .
- Corrosion resistance .
- Magnetic resonance compatibility (RF heating, image artifact, . displacement force, induced torque)
- Biocompatibility (percent inhibition of cell growth, medium . eluate method - cytotoxicity, blood compatibility, complement activation, gene mutation assay, chromosomal aberration effect assay, agar overlay - cytotoxicity, DNA damage / effects assay, Mouse systemic injection - systemic toxicity, rabbit pvrogen - systemic toxicity, rabbit intracutaneous reactivity, guinea pig maximization, rabbit intramuscular implantation sub-chronic and chronic evaluations)
- Relative resistance evaluation and comparison for sterilization .
- . Bioburden
- Limulus amebocyte lysate pyrogen testing .
- Packaging qualification (visual inspection, sterile barrier . integrity, dye leak, burst)
- Shelf-life assessments of packaging and product components .
- Design validation by surgeons in simulated use environment .
Standards used in support of the application
See the attached table
Conclusion:
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is substantially equivalent to its predicate devices.
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Image /page/2/Picture/0 description: The image shows a logo with the word "Edwards" written below a square graphic. The graphic contains a white letter "E" superimposed over a grid pattern and circular shapes. The letter "E" is stylized and appears to be partially obscured by the circular elements within the square.
Utilization of Standards
| Standard No. | Standard Title |
|---|---|
| ISO10993-1:2009 | Biological evaluation of medical device -Part 1: Biological Testing |
| ASTMF2182:2009 | Standard Test Method for Measurementof Radio Frequency Induced HeatingNear Passive Implants During MagneticResonance Imaging |
| ASTMF2052:2006 | Standard Test Method for Measurementof Magnetically Induced DisplacementForce on Medical Devices in theMagnetic Resonance Environment |
| ASTMF2119:2007 | Standard Test Method for Evaluation ofMR Image Artifacts from PassiveImplants |
| ASTMF2213:2006 | Standard Test Method for Measurementof Magnetically Induced Torque onMedical Devices in the MagneticResonance Environment |
| BS EN ISO11607-1:2009 | Packaging for Terminally SterilizedMedical Devices, Part 1: Requirementsfor Materials, Sterile Barrier Systemsand Packaging Systems (ISO 11607-1:2006) |
| ASTMD4169:2005 | Standard Practice for PerformanceTesting of Shipping Containers andSystems |
| ISO14971:2007 | Medical Devices - Application of riskmanagement to medical devices |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top and left side of the circle. The eagle is composed of three curved lines that form the body and wings, and a smaller curved line that forms the head and beak.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edwards Lifesciences, LLC c/o Mr. Daryl Richardson Regulatory Affairs Associate One Edwards Way Irvine, CA 92614
JUN 2 4 2011
Re: K103520
Carpentier-Edwards™ Physio Tricuspid™ Annuloplasty Ring, Model 6200 Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: June 22, 2011 Received: June 23, 2011
Dear Mr. Richardson:
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.
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Page 2 - Mr. Daryl Richardson
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
R. D. Hinderaker, M.D.
Bram D. Auckerman, 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): 《103520
Device Name: Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200
Indications for Use:
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
Prescription Use: 冈 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: [] (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
yascular Devices 510(k)
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§ 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.”