(206 days)
No
The summary describes a physical medical device (annuloplasty ring) and its mechanical and biological testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to correct a medical condition (tricuspid valvular insufficiency) and restore or improve a bodily function, which falls under the definition of a therapeutic device.
No
This device is an annuloplasty ring intended to correct anatomical issues (annular dilatation, leaflet coaptation) related to tricuspid valvular insufficiency, not to diagnose a condition.
No
The device description clearly states it is constructed of a titanium core with a silicone sewing ring margin covered with a polyester cloth, indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that is surgically implanted to correct a structural issue with the tricuspid valve. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The description details the physical construction of an implantable medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / 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.
Product codes
KRH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tricuspid valvular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, has successfully completed design verification and validation testing. The following studies were conducted:
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Edwards MC3® Tricuspid annuloplasty ring (K020864), Cosgrove-Edwards® annuloplasty system (K923367), Carpentier-Edwards® Classic® Tricuspid annuloplasty ring (K912554)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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 Richardson |
| Regulatory Affairs Associate | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| daryl 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, model |
| 6200, is constructed of a titanium core with a silicone sewing ring | |
| margin covered with a polyester cloth. | |
| ·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. | |
| Comparative Analysis: | It has been demonstrated that the Carpentier-Edwards Physio |
| Tricuspid annuloplasty ring, model 6200, is comparable to its predicate | |
| devices in design, intended use, materials, fundamental technology | |
| and principal of operation. | |
| Functional/Safety Testing: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model |
| 6200, has successfully completed design verification and validation | |
| testing. 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.
2
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 |
|---|---|
| ISO | |
| 10993-1:2009 | Biological evaluation of medical device - |
| Part 1: Biological Testing | |
| ASTM | |
| F2182:2009 | Standard Test Method for Measurement |
| of Radio Frequency Induced Heating | |
| Near Passive Implants During Magnetic | |
| Resonance Imaging | |
| ASTM | |
| F2052:2006 | Standard Test Method for Measurement |
| of Magnetically Induced Displacement | |
| Force on Medical Devices in the | |
| Magnetic Resonance Environment | |
| ASTM | |
| F2119:2007 | Standard Test Method for Evaluation of |
| MR Image Artifacts from Passive | |
| Implants | |
| ASTM | |
| F2213:2006 | Standard Test Method for Measurement |
| of Magnetically Induced Torque on | |
| Medical Devices in the Magnetic | |
| Resonance Environment | |
| BS EN ISO | |
| 11607-1:2009 | Packaging for Terminally Sterilized |
| Medical Devices, Part 1: Requirements | |
| for Materials, Sterile Barrier Systems | |
| and Packaging Systems (ISO 11607- | |
| 1:2006) | |
| ASTM | |
| D4169:2005 | Standard Practice for Performance |
| Testing of Shipping Containers and | |
| Systems | |
| ISO | |
| 14971:2007 | Medical Devices - Application of risk |
| management to medical devices |
3
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.
4
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
5
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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