(99 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the annuloplasty ring, with no mention of AI or ML technologies.
Yes
The device is indicated for the "reconstruction and/or remodeling of pathological tricuspid valves," which describes a therapeutic intervention.
No
This device is an annuloplasty ring intended for the reconstruction and/or remodeling of pathological tricuspid valves, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical annuloplasty ring made of titanium, silicone, and polyester fabric, which is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the Contour 3D™ Ring is a physical implantable device used for the "reconstruction and/or remodeling of pathological tricuspid valves." This is a surgical procedure performed in vivo (within the living body), not a test performed in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the Contour 3D™ Ring is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Contour 3D™ Ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
The Contour 3D™ Annuloplasty Ring, Model 690R, consists of a titanium core encapsulated with silicone and covered with polyester fabric. The titanium core enables radiographic visualization of the device. The Contour 3D™ Ring is for single-use only. It is available in six sizes for the tricuspid position: 26, 28, 30, 32, 34, and 36 mm. The device size is identified by the inside diameter of the ring at its widest point. The ring is marked at three (3) points by colored sutures. The three (3) markers correspond to the commissures of the tricuspid valve. The ring is packaged with a single annuloplasty ring assembled on a disposable holder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tricuspid valves
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 Contour 3D™ Annuloplasty Ring was subjected to verification and validation studies. This testing was conducted in accordance with the FDA Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and Staff issued January 31, 2001. The results of the testing demonstrate the Contour 3D™ Ring is safe and effective for its use in the reconstruction and/or remodeling of pathological tricuspid valves. Testing included: biocompatibility, computational structural analysis, tensile strength, suture pull out, fatigue, MRI, radiopacity, sterilization validation, bioburden, pyrogen, and shelf life validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
. K101212
AUG - 7 2010
5. 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CRF 807.92.
SUBMITTER INFORMATION I.
| Company Name: | Medtronic CardioVascular - Structural Heart
(Medtronic) |
|--------------------------------------|------------------------------------------------------------|
| Company Address: | 8200 Coral Sea Street N.E.
Mounds View, MN 55112 |
| Company Phone:
Company Facsimile: | 763-514-9840
763-367-8147 |
| Contact Person: | Becky Hannack
Senior Regulatory Affairs Specialist |
| Date Summary Prepared: | April 29, 2010 |
II. DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Contour 3D™ Annuloplasty Ring, Model 690R |
|---|---|
| 21 CFR Reference: | 870.3800 |
| 21 CFR Common Name: | Ring, Annuloplasty |
| Classification: | Class II |
| Panel: | CV (74) KRH |
III. IDENTIFICATION OF PREDICATE DEVICE
| Trade/Proprietary Name: | MC 3 Tricuspid Annuloplasty System |
|---|---|
| 510(k) Number: | K020864 |
| 510(k) Clearance Date: | April 17, 2002 |
IV. DEVICE DESCRIPTION
The Contour 3D™ Annuloplasty Ring, Model 690R, consists of a titanium core encapsulated with silicone and covered with polyester fabric. The titanium core enables radiographic visualization of the device.
1
The Contour 3D™ Ring is for single-use only. It is available in six sizes for the tricuspid position: 26, 28, 30, 32, 34, and 36 mm. The device size is identified by the inside diameter of the ring at its widest point. The ring is marked at three (3) points by colored sutures. The three (3) markers correspond to the commissures of the tricuspid valve. The ring is packaged with a single annuloplasty ring assembled on a disposable holder.
V. DESCRIPTION OF INTENDED USE
The Contour 3DTM Annuloplasty Ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves.
VI. SUBSTANTIAL EQUIVALENCE
The Contour 3D™ Annuloplasty Ring is substantially equivalent to the predicate device, the MC3 Tricuspid Annuloplasty System. Both devices are indicated for and intended to be used with tricuspid annuloplasty procedures for reconstructive treatment of valvular insufficiency. The two devices have the same technological characteristics as they are both rigid remodeling rings designed for use in the tricuspid valve. They both consist of a titanium core encapsulated with silicone and covered with polyester fabric. Both rings are provided sterile, mounted on a holder, and come in varying sizes. Substantial equivalence has also been determined by comparing results of tensile strength and suture pull-out performance testing of the two devices.
VII. PERFORMANCE DATA
The Contour 3D™ Annuloplasty Ring was subjected to verification and validation studies. This testing was conducted in accordance with the FDA Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and Staff issued January 31, 2001. The results of the testing demonstrate the Contour 3D™ Ring is safe and effective for its use in the reconstruction and/or remodeling of pathological tricuspid valves.
Testing included: biocompatibility, computational structural analysis, tensile strength, suture pull out, fatigue, MRI, radiopacity, sterilization validation, bioburden, pyrogen, and shelf life validation.
The following page contains a table of the standards applicable to this device.
2
·
.
.
| Standard Number | Standard Title |
|---|---|
| EN ISO 13485:2003 | Medical devices - Quality management systems - requirements for |
| regulatory purposes | |
| EN ISO 14971:2007 | Application of risk management to medical devices |
| EN ISO 10993-1:2003 | Biological evaluation of medical devices - Part 1: Evaluation and testing |
| EN ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements |
| for materials, sterile barrier systems and packaging systems | |
| EN ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation |
| requirements for forming, sealing and assembly processes | |
| EN ISO 17665-1:2006 | Sterilization of health care products Moist heat Part 1: Requirements for |
| the development, validation and routine control of a sterilization process | |
| for medical devices | |
| EN 556-1:2001 | Sterilization of Medical Devices - Requirements for medical devices to be |
| designated "sterile" - Part 1: Requirements for terminally sterilized | |
| medical devices | |
| EN 980:2008 | Graphical symbols for use in the labeling of medical devices |
| EN 1041:1998 | Information supplied by the manufacturer with medical devices |
.
.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG - 7 2010
Medtronic Inc c/o Ms. Becky Hannack Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE MoundsView, MN 55112
Re: K101212
Medtronic Contour 3D Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: July 29, 2010 Received: July 30, 2010
Dear Ms. Hannack:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegans the Medical Device Amendments, or to commerce print to rize, 2011-12-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, manot at the Act include requirements for annual registration, listing of general controls of the Frective, labeling, and prohibitions against misbranding and devices, good manufacturing praction, lace information related to contract liability adulteration. Trease note: ODFET active 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 If your device is classified (see above) institions affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. ' In addition, FDA may found in the Oode of Peacharts concerning your device in the Federal Register.
4
Page 2 - Ms. Becky Hannack
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/CDRH/CDRHOffices/ucm115809.html fast 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K10/2/2
AUG - 7 2010
510(k) Number (if known): |