(79 days)
No
The device description and summary of performance studies focus on the physical characteristics and mechanical function of an implantable annuloplasty band and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves to correct valvular insufficiency and stenosis, which are therapeutic actions.
No
The device is an implantable annuloplasty system used for the reconstruction and remodeling of heart valves. It is a treatment device, not a diagnostic device used for identifying a medical condition.
No
The device description clearly states it is a "single use, permanent, flexible, implantable device" constructed from physical materials like polyester fabric and silicone, and includes a disposable band holder. This indicates a physical medical device, not a software-only one.
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 and tricuspid valves." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "single use, permanent, flexible, implantable device intended for the repair of a patient's mitral and tricuspid valves." This is a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. The description of the Simplici-T™ Annuloplasty System does not involve any such testing of specimens.
Therefore, the Simplici-T™ Annuloplasty System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Simplici-T™ Annuloplasty System, Model 670 is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
Product codes
KRH
Device Description
The Simplici-TTM Annuloplasty System is a single use, permanent, flexible, implantable device intended for the repair of a patient's mitral and tricuspid valves.
The Simplici-T™ Annuloplasty Band is a 100 mm long band, constructed from a double velour polyester fabric wrapped around a small radiopaque silicone marker strip. Two locking running stitches run the entire 100mm band length creating a flat, low profile. A whipstitch on the side closes the band together. Implantation of the band is aided with the disposable band holder. The band is released from the holder by depressing the thumb trigger found on the handle of the holder. By depressing the thumb trigger, the holder bottom fingers push the band off of pins attached to the holder top. The device is sterilized by Steam Sterilization and has a One-year shelf life. The device is packaged on a holder in double aseptic pouches and shipped within a shelf-carton that includes instructions for use and product traceability labels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral and tricuspid 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
The Simplici-TTM Annuloplasty System 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
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.”
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K052970 pg 1 of 2
JAN 1 1 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
Simplici-T™ Annuloplasty System
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and CFR 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: | Phil Neururer |
| Regulatory Affairs Specialist | |
| Date Summary Prepared: | October 21, 2005 |
DEVICE IDENTIFICATION II
| Trade/Proprietary Name: | Simplici-T™ Annuloplasty System |
|---|---|
| [Model 670] | |
| 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 |
|---|---|---|
| Duran Band | H607H | K032810 |
| Duran Ring/Band | 610R & 610B | same |
| Duran AnCore Ring/Band | 620R & 620B | same |
| Duran AnCore Ring/Band with Chordal Guide | 620R & 620B | Same |
Cleared:
December 5, 2003
IV DEVICE DESCRIPTION
The Simplici-TTM Annuloplasty System is a single use, permanent, flexible, implantable device intended for the repair of a patient's mitral and tricuspid valves.
Image /page/0/Picture/16 description: The image contains the word "Confidential" in bold font at the top. Below that is the Medtronic logo, which includes a stylized human figure and the word "Medtronic" in bold font. The logo is black and white.
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KOS 2970 8 20F 2
The Simplici-T™ Annuloplasty Band is a 100 mm long band, constructed from a double velour polyester fabric wrapped around a small radiopaque silicone marker strip. Two locking running stitches run the entire 100mm band length creating a flat, low profile. A whipstitch on the side closes the band together. Implantation of the band is aided with the disposable band holder. The band is released from the holder by depressing the thumb trigger found on the handle of the holder. By depressing the thumb trigger, the holder bottom fingers push the band off of pins attached to the holder top. The device is sterilized by Steam Sterilization and has a One-year shelf life. The device is packaged on a holder in double aseptic pouches and shipped within a shelf-carton that includes instructions for use and product traceability labels.
V DESCRIPTION OF INTENDED USE
The Simplici-TTM Annuloplasty System, Model 670 is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
SUBSTANTIAL EQUIVALENCE VI
The Duran Product Family and the modified Simplici-T™ Annuloplasty System have the same fundamental scientific technology and intended use as the predicate device.
VII PERFORMANCE DATA
The Simplici-TTM Annuloplasty System 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.
Image /page/1/Picture/9 description: The image shows the word "Confidential" in bold, black letters at the top. Below that is the Medtronic logo, which includes a symbol of a person in motion on the left and the word "Medtronic" in bold, black letters on the right. The logo is simple and professional.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle symbol.
JAN 1 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic, Inc. c/o Mr. Phil Neururer Regulatory Affairs Specialist 8299 Central Avenue NE Minneapolsi, MN 55432-3576
Re: K052970
Simplici-TTM Annuloplasty System (Model 670) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (Two) Product Code: KRH Dated: December 13, 2005 Received: December 14, 2005
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, l'isting 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, UDA max publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Phil Neururer
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/cdrl/industry/support/index.html.
Sincerely yours,
Duna R. Vochner
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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K052970
Page 1 of 1
510(k) Number (if known): K05 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: Simplici-TTM Annuloplasty System [Model 670]
Indications for Use:
The Simplici-T™ Annuloplasty System is indicated for the reconstruction and/or remodeling The bimplier is = " = " minutes. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
(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 _________________________________________________________________________________________________________________________________________________________
Duing R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K052970
Image /page/4/Picture/14 description: The image shows the Medtronic logo, which includes a circular graphic with a figure inside. To the right of the graphic is the word "Medtronic" in a bold, sans-serif font. Below the word "Medtronic" is the word "Confidential" in a smaller, sans-serif font.
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