(107 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and structural integrity of the annuloplasty ring, with no mention of AI or ML capabilities.
Yes
The device is indicated for the reconstruction and/or remodeling of pathological mitral valves to correct valvular insufficiency and/or stenosis, which are therapeutic actions.
No
Explanation: The device description clearly states it is an "Annuloplasty Ring" indicated for "reconstruction and/or remodeling of pathological mitral valves." This is a therapeutic implantable device, not a diagnostic one. Its ability for "radiographic visualization" is for post-implantation verification, not for diagnosing a condition.
No
The device description clearly states the device is a physical annuloplasty ring made of titanium, silicone, and polyester fabric, which is implanted in the body. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstruction and/or remodeling of pathological mitral valves within the body. This is a surgical implant used for treatment.
- Device Description: The device is a physical ring designed to be implanted in the mitral position.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. It doesn't analyze blood, tissue, or other bodily fluids.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The Profile 3D™ Annuloplasty Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
Product codes
KRH
Device Description
The Profile 3D™ Annuloplasty Ring, Model 680R, consists of a titanium core overmolded with silicone and covered with polyester fabric. The ring must be implanted in the mitral position. The ring is marked at three points by colored sutures; two markers correspond to the trigones of the mitral valve and one identifies the midpoint of the device. The device size is identified by the inside diameter of the ring at its widest point. The titanium core enables radiographic visualization of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral position
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
The Profile 3D™ Annuloplasty Ring was subjected to verification and validation studies. These verification/validation studies demonstrate the modifications to the predicate device are appropriate and do not affect the intended use or performance of the device.
Key Metrics
Not Found
Predicate Device(s)
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
MAR 1 3 Zuuc
510(k) Summary – Medtronic Profile 3D™ Annuloplasty Ring
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 Heart Valves (Medtronic) |
---|---|
Company Address: | 8299 Central Avenue N.E. |
Minneapolis, MN 55432 | |
Company Phone: | |
Company Facsimile: | 763-514-6600 |
763-514-6775 | |
Contact Person: | Becky Hannack |
Regulatory Affairs Specialist | |
Date Summary Prepared: | November 26, 2007 |
DEVICE IDENTIFICATION ll.
Trade/Proprietary Name: | Profile 3D™ Annuloplasty Ring, Model 680R |
---|---|
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: | CG Future® Annuloplasty System, Model 638R (Ring) |
---|---|
510(k) Number: | K061127 |
510(k) Clearance Date: | May 23, 2006 |
IV. DEVICE DESCRIPTION
The Profile 3D™ Annuloplasty Ring, Model 680R, consists of a titanium core overmolded with silicone and covered with polyester fabric. The ring must be implanted in the mitral position. The ring is marked at three points by colored
1
sutures; two markers correspond to the trigones of the mitral valve and one identifies the midpoint of the device. The device size is identified by the inside diameter of the ring at its widest point. The titanium core enables radiographic visualization of the device.
V. DESCRIPTION OF INTENDED USE
The Profile 3D™ Annuloplasty Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
SUBSTANTIAL EQUIVALENCE VI.
The Profile 3D™ Annuloplasty Ring is substantially equivalent to the predicate device, the CG Future® Annuloplasty Ring. They have the same fundamental scientific technology and intended use.
VII. PERFORMANCE DATA
The Profile 3D™ Annuloplasty Ring was subjected to verification and validation studies. These verification/validation studies demonstrate the modifications to the predicate device are appropriate and do not affect the intended use or performance of the device.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Medtronic Heart Valves c/o Ms. Becky Hannack Regulatory Affairs Specialisty 8299 Central Avenue NE Minneapolis, MN 55432
Re: K073324
Medtronic Profile 3D™ Annuloplasty Ring, Model 680R Regulation Number: 870,3800 Regulation Name: Ring, Annuloplasty Regulatory Class: Class II (two) Product Code: KRH Dated: January 10, 2008 Received: January 11, 2008
Dear Ms. Hannack:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duna R. Wuchner
Image /page/3/Picture/5 description: The image shows a handwritten signature or symbol on the left side, which appears to be a stylized loop or flourish. To the right of this symbol are the letters 'B' and 'D' stacked vertically. The overall impression is that of a signature or initial, possibly from a document or piece of artwork.
Bram D. Zuckerman, 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): Ko 73 32 4
Device Name: Medtronic PROFILE 3D Annuloplasty Ring, Model 680R
Indications For Use:
The PROFILE 3D Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
ver P. leclunes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_Ko7 3324
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Profile 3D™ Annuloplasty Ring Medtronic Confidential
November 26, 2007 K07XXXXX