(30 days)
Not Found
No
The device description focuses on the physical components and materials of an implantable annuloplasty band and its accessories. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is indicated for the reconstruction and/or remodeling of pathological mitral valves, which corrects valvular insufficiency and/or stenosis, thus providing a therapeutic effect.
No
The device is described as an "implantable device intended for the repair of a patient's mitral valve," not for diagnosis. It is a surgical implant designed to reconstruct and remodel the mitral valve.
No
The device description clearly describes a physical, implantable medical device made of polyester fabric, metallic wire, and silicone, along with associated physical accessories (holder, sizers, handle). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "reconstruction and/or remodeling of pathological mitral valves." This is a surgical procedure performed in vivo (within the body) to repair a physical structure.
- Device Description: The device is described as a "single use, permanent, semi-rigid, implantable device" consisting of fabric, wire, and silicone. This is a physical implant designed to be placed inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. The description of the CG Future Annuloplasty Band does not involve any such testing of specimens.
Therefore, the CG Future Annuloplasty Band is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CG Future Annuloplasty 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.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
The CG FUTURE Band is a single use, permanent, semi-rigid, implantable device intended for the repair of a patient's mitral valve. The CG FUTURE Band consists of a partial band of polyester fabric covering a formed, metallic (MP35N) wire stiffener material with eyelets formed at both ends. The stiffener element is over-molded with LSR silicone. The band is marked at three locations (the two trigone locations and the center) with green-colored suture. Two trigone markers identify the eyelets in the stiffener to facilitate anchoring of the stiffener into the trigones by the surgeon with sutures. The individual band size (26, 28, 30, 32, 34, 36, and 38mm) represents the widest, straight-line distance as measured at the inside of the fabric-covered band. The band is designed for implantation in the mitral position only.
The CG FUTURE Band is used with associated accessories that include a holder, sizers and a handle. Implantation of the band is aided with the disposable band holder. The band is released from the holder by cutting suture at two points. The CG FUTURE Band sizer set is used to assess appropriate band size. The sizers cover all seven sizes of the CG FUTURE Band and are marked with the band size and the trigone locations. The sizers are reusable and are provided non-sterile. The reuseable annuloplasty handle, which is available in two lengths, interfaces with both the holder and the sizers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral valve
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 FUTURE Band 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.
No changes have been made to the manufacturing or sterilization of this device to warrant new or additional biocompatibility testing of the device components.
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
K 052 860
CG FUTURE™ Annuloplasty Band
Special 510(k): Device Modification
NOV 1 0 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
CG Future® Annuloplasty Band
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and CFR 807.92.
I SUBMITTER INFORMATION
Company Name: | Medtronic Heart Valves (Medtronic |
---|---|
Company Address: | 8299 Central Avenue N.E. |
Minneapolis, MN 55432 | |
Company Phone: | (763) 514-6600 |
Company Facsimile: | (763) 514-6775 |
Contact Person: | Julie Sherman |
Regulatory Affairs Manager | |
Date Summary Prepared: | October 10, 2005 |
II DEVICE IDENTIFICATION
| Trade/Proprietary Name: | CG Future® Annuloplasty Band
[Model 638B] |
|-------------------------|----------------------------------------------|
| 21 CFR Reference: | 870.3800 |
| 21 CFR Common Name: | Ring, Annuloplasty |
| Classification: | Class II |
| Panel: | CV (74) KRH |
III IDENTIFICATION OF PREDICATE DEVICE
Device | Model # | FDA Clearance |
---|---|---|
CG Future® Annuloplasty Band | 638B | K011395, July 12, 2001 |
IV DEVICE DESCRIPTION
The CG FUTURE Band is a single use, permanent, semi-rigid, implantable device intended for the repair of a patient's mitral valve. The CG FUTURE Band consists of a partial band of polyester fabric covering a formed, metallic (MP35N) wire stiffener material with eyelets formed at both ends. The stiffener element is over-molded with LSR silicone. The band is marked at three locations (the two trigone locations and the center) with green-colored suture.
Image /page/0/Picture/13 description: The image shows the Medtronic logo and the word "Confidential" underneath it. The Medtronic logo is a stylized image of a person with outstretched arms. The text is in a bold, sans-serif font. The image is likely from a document or presentation that is confidential and intended for internal use only.
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1
Two trigone markers identify the eyelets in the stiffener to facilitate anchoring of the stiffener into the trigones by the surgeon with sutures. The individual band size (26, 28, 30, 32, 34, 36, and 38mm) represents the widest, straight-line distance as measured at the inside of the fabric-covered band. The band is designed for implantation in the mitral position only.
The CG FUTURE Band is used with associated accessories that include a holder, sizers and a handle. Implantation of the band is aided with the disposable band holder. The band is released from the holder by cutting suture at two points. The CG FUTURE Band sizer set is used to assess appropriate band size. The sizers cover all seven sizes of the CG FUTURE Band and are marked with the band size and the trigone locations. The sizers are reusable and are provided non-sterile. The reuseable annuloplasty handle, which is available in two lengths, interfaces with both the holder and the sizers.
V DESCRIPTION OF INTENDED USE
The CG Future® Annuloplasty 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.
SUBSTANTIAL EQUIVALENCE VI
The CG FUTURE Band and the modified CG FUTURE Band are manufactured using the same raw materials, manufacturing, packaging and sterilization processes. Both products have the same indications for use.
VII PERFORMANCE DATA
.
The CG FUTURE Band 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.
No changes have been made to the manufacturing or sterilization of this device to warrant new or additional biocompatibility testing of the device components.
Image /page/1/Picture/10 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. Below the logo, the word "Confidential" is written in a smaller, black font. The Medtronic logo is a circular design with abstract shapes inside.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2005
Medtronic Cardiac Surgery c/o Ms. Julie Sherman Regulatory Affairs Manager 8299 Central Avenue NE Minneapolis, MN 55432-3576
Re: K052860 CG Future® Annuloplasty Band Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (Two) Product Code: KRH Dated: October 10, 2005 Received: October 11, 2005
Dear Ms. Sherman:
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. Julie Sherman
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dmna R. Vachner
Image /page/3/Picture/5 description: The image shows a signature. The signature is composed of a few curved lines and a horizontal line. The signature is in black ink and is on a white background.
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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Page 1 of 1
510(k) Number (if known): K05 ھے ھاے ے کے ے
Device Name: CG Future Annuloplasty Band [Model 638B]
Indications for Use:
The CG Future Annuloplasty 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 _ X Per 21 CFR 801.109
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Dr. Anna R. Lochner
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_k 0.5 28 0
Image /page/4/Picture/14 description: The image shows the Medtronic logo and the word "Confidential" in bold black font. The Medtronic logo is on the left side of the image and consists of a circle with a stylized design inside. The word "Medtronic" is on the right side of the logo, and the word "Confidential" is below the word "Medtronic".