(29 days)
Not Found
No
The device description focuses on the physical components and mechanical function of an annuloplasty ring and its associated holder. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
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
This device is an annuloplasty ring intended for the reconstruction and/or remodeling of pathological mitral valves, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly details physical components like a metal stiffener, silicone, fabric, a disposable holder, and packaging, indicating it is a physical medical 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 the "reconstruction and/or remodeling of pathological mitral valves." This is a surgical procedure performed in vivo (within the body) to repair a heart valve.
- Device Description: The device is a physical implant (annuloplasty ring) designed to be surgically placed within the body. It also includes a holder for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo to treat a condition.
N/A
Intended Use / Indications for Use
The CG 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 (comma separated list FDA assigned to the subject device)
KRH
Device Description
The Model 638R CG Ring is based on the marketed released Model 638B CG Band and Model 620R/620B Duran Product Family. The CG Ring is a semi-rigid annuloplasty ring intended for remodeling and/or reconstruction of pathological mitral valves. Similar to the CG Ring is composed of a C-shaped metal stiffener that is covered with silicone and fabric. Unlike the CG Future Band but similar to the Duran Product Family, the CG Ring is a fully closed ring, formed by joining the ends of the stiffener with suture and fabric, resulting in a D-shaped device. In addition, a similar radiopaque strip that is used in the Duran Product Family is placed between the stiffener ends for identification of the device on X-ray.
The disposable CG Ring Holder provides for attachment of the ring, guides the implantation of the ring, and interfaces with the Model 7615 Annuloplasty Handle. There are eight (8) sizes for the holder (24, 26, 28, 30, 32, 34, 36, and 38 mm), and a single holder is provided with each packaged ring assembly. The CG Ring packaging consists of double-aseptic pouches (containing the ring attached to its holder). The pouch assembly is placed in a shelf carton box along with instructions for use and product traceability labels for shipping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral 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 CG Ring was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device.
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
MAY 2 3 2006
510(k) Summary - CG Future® Annuloplasty Ring
Applicant (Sponsor) Name and Address
Medtronic Heart Valves (Medtronic) 8299 Central Avenue N.E. - M.S. 108 Minneapolis, MN 55432 Establishment Reg. No .: 2127690
Contact Name and Phone
Phil Neururer Regulatory Affairs Specialist Company Phone: (763) 514-6600 Company Fax: (763) 514-6775
Device Trade/Proprietary Name
CG Future® Annuloplasty Ring (CG Ring)
Device Classification/Common Name/Panel
21 CFR Reference: 870.3800 21 CFR Common Name: Ring, Annuloplasty Classification: Class II Panel: CV (74) KRH
Identification of Predicate Device
Medtronic believes the CG Ring is substantially equivalent to the CG Future® Annuloplasty Band (CG Band) previously cleared to market in the U.S. by FDA on November 10, 2005 (K052860) and also the Duran AnCore® Ring and Band (Duran Product Family) previously cleared to market in the U.S. by FDA on December 5, 2003 (K032810) and may market our device under these equivalencies.
Substantial Equivalence
The CG Ring has the same fundamental scientific technology and intended use as the predicate devices.
1
Description of Intended Use
The CG 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.
Device Description
The Model 638R CG Ring is based on the marketed released Model 638B CG Band and Model 620R/620B Duran Product Family. The CG Ring is a semi-rigid annuloplasty ring intended for remodeling and/or reconstruction of pathological mitral valves. Similar to the CG Ring is composed of a C-shaped metal stiffener that is covered with silicone and fabric. Unlike the CG Future Band but similar to the Duran Product Family, the CG Ring is a fully closed ring, formed by joining the ends of the stiffener with suture and fabric, resulting in a D-shaped device. In addition, a similar radiopaque strip that is used in the Duran Product Family is placed between the stiffener ends for identification of the device on X-ray.
The disposable CG Ring Holder provides for attachment of the ring, guides the implantation of the ring, and interfaces with the Model 7615 Annuloplasty Handle. There are eight (8) sizes for the holder (24, 26, 28, 30, 32, 34, 36, and 38 mm), and a single holder is provided with each packaged ring assembly. The CG Ring packaging consists of double-aseptic pouches (containing the ring attached to its holder). The pouch assembly is placed in a shelf carton box along with instructions for use and product traceability labels for shipping.
Performance Data
The CG Ring was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
Mr. Phil Neururer Regulatory Affairs Specialist Medtronic, Incorporated 8299 Central Avenue N.E. Minneapolis, MN 55432
Re: K061127
Trade/Device Name: CG Future® Annuloplasty Ring (CG Ring) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: April 21, 2006 Received: April 24, 2006
Dear Mr. Neururer:
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. Iisting 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.
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
3
Page 2 – Mr. Phil Neururer
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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510(k) Number (if known): K06
Device Name: CG Future® Annuloplasty Ring and Band
Indications for Use:
The CG Future® Annuloplasty Ring and Band 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
OR
Over-The-Counter Use
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