(30 days)
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.
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.
The provided document is a 510(k) summary for the CG Future® Annuloplasty Band, describing a device modification. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed performance data from a clinical study for acceptance criteria.
Therefore, many of the requested items (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) cannot be extracted from this document as it's not a clinical trial report.
However, based on the summary, here is the information that can be extracted or reasonably inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. It generally states that "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."
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (General Statement in the document) |
|---|---|
| (Presumably, "modifications do not affect intended use or performance") | "The modifications to the predicated device are appropriate and do not affect the intended use or performance of the device." |
| (Implicit: Maintain same safety and effectiveness as predicate) | (Implicitly achieved by demonstrating substantial equivalence to the predicate device K011395) |
2. Sample size used for the test set and the data provenance
Not explicitly stated. The "verification and validation studies" mentioned are typically engineering and bench tests for device modifications, not clinical efficacy studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a medical device modification submission, not an AI-assisted diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance is assessed against engineering specifications and the predicate device's established performance, not against a clinical ground truth like pathology for diagnosis.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established
Not applicable.
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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 ShermanRegulatory 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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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.
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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".
§ 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.”