(107 days)
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.
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.
The provided document describes a 510(k) premarket notification for the Medtronic Profile 3D™ Annuloplasty Ring, Model 680R. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) would.
Therefore, many of the requested data points related to clinical studies, acceptance criteria, and specific performance metrics are not applicable or not available in this type of submission. The document explicitly states:
"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."
This indicates that the focus of the performance data was on engineering verification and validation (e.g., material testing, mechanical properties, biocompatibility) to ensure the new device performs similarly to the predicate, not on clinical performance against specific acceptance criteria for a diagnostic or treatment outcome.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document for clinical performance. The 510(k) submission focuses on substantial equivalence to a predicate device. | Not explicitly stated in the provided document for clinical performance against specific metrics. The document states: "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." This implies performance was demonstrated to be comparable/equivalent to the predicate. |
Self-correction: For 510(k) submissions, acceptance criteria are generally focused on demonstrating that the new device is as safe and effective as the predicate, often through non-clinical testing (e.g., mechanical, biocompatibility) or comparison of design features. Specific clinical performance metrics with pre-defined acceptance criteria (like sensitivity, specificity, accuracy for a diagnostic device, or efficacy endpoints for a therapeutic device) are typically not included unless the device has significant technological differences or new indications for use that warrant clinical data. This document does not provide such details.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. The submission focuses on verification/validation studies, likely engineering tests, rather than a clinical test set with human subjects for performance evaluation against specific metrics.
- Data Provenance: Not applicable / Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable / Not provided.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / Not provided.
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
- MRMC Comparative Effectiveness Study: Not applicable. This is a medical device (annuloplasty ring), not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This is an implantable medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable / Not provided. For this type of device, "ground truth" typically refers to engineering specifications, material properties, and functionality consistent with the predicate device, demonstrated through non-clinical testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable / Not provided. This is not an AI/machine learning device.
Summary of Device and Performance Information from the Document:
- Device Name: Medtronic Profile 3D™ Annuloplasty Ring, Model 680R
- Intended Use: Reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.
- Predicate Device: CG Future® Annuloplasty System, Model 638R (K061127)
- Performance Data: The device was subjected to verification and validation studies to demonstrate that modifications to the predicate device are appropriate and do not affect the intended use or performance. These are likely engineering and biocompatibility tests rather than clinical outcome studies against specific performance metrics.
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to the predicate device, allowing it to be marketed. This decision is based on a comparison of the new device to a legally marketed predicate, rather than an independent demonstration of safety and effectiveness through a new clinical trial with pre-defined acceptance criteria for performance.
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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: | 763-514-6600763-514-6775 |
| Contact Person: | Becky HannackRegulatory 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
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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.
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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
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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
§ 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.”