(27 days)
No
The device description and performance studies focus on the mechanical and material properties of the annuloplasty band, with no mention of AI or ML capabilities.
Yes
The device is described as an implantable annuloplasty band used to support and restrict dilatation of the posterior mitral valve annulus in patients undergoing surgery for diseased or damaged mitral valves, which directly addresses a medical condition.
No
This device is an implantable annuloplasty band designed to support and restrict dilatation of the posterior mitral valve annulus during mitral valve repair surgery. It is a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical, implantable annuloplasty band made of braided polyester with drawstrings, a radiopaque marker, and a holder. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Medtronic KHONSARI Annuloplasty Band is an implantable device used during surgery to support and restrict the mitral valve annulus. It is a physical device that is placed inside the body.
- Lack of Diagnostic Testing: The device does not perform any tests on biological samples to diagnose a condition or provide diagnostic information. Its function is purely mechanical and structural.
Therefore, based on the provided information, the Medtronic KHONSARI Annuloplasty Band is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.
Product codes
KRH
Device Description
The Medtronic KHONSARI Annuloplasty Band [Model H609M] is an implantable, flexible, adjustable band. The band reduces and stabilizes the mitral valve annulus in patients undergoing mitral valve repair. The body of the band is made of braided polyester and has drawstrings that permit segments of the annulus to be independently shortened.
The band contains a flexible (non-metallic) radiopaque marker that enables radiographic visualization of its entire length. Eight radially spaced surgeon's flags indicate recommended locations for implantation sutures. Each annuloplasty band is attached to a holder. A circumferential groove in the holder protects the drawstrings from entrapment by the implanting sutures. The stem of the handle is malleable to facilitate seating of the band during placement.
The four adjustable drawstrings are coiled within cylindrical canisters on the holder. A retaining suture secures each end of the band to the holder. The drawstrings will automatically release from the holder as it is removed from the band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral valve annulus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, surgery
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 KHONSARI Annuloplasty Band was subjected to verification and validation studies to demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device.
Manufacturing process validation was performed. The modified manufacturing processes meet all procedure requirements. Physical performance studies were conducted to verify that the device performs as intended after routine sterilization and accelerated aging cycles. Sterilization validation of the device was also completed. Based on the results of the study, the sterility assurance level (SAL) of the sterlization process was qualified at 10 ° sterilization level at a minimum sterilization dose of 25kGy. The verification/validation studies demonstrate that the modifications to the manufacturing process are appropriate and do not affect the intended use of the product.
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
Not Found
Predicate Device(s)
Reference Device(s)
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.”
0
KG84435
SUMMARY OF SAFETY AND EFFECTIVENESS
MEDTRONIC KHONSARI™ 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.
SUBMITTER INFORMATION I
| Company Name: | Medtronic Heart Valves (Medtronic) |
|---|---|
| Company Address: | 7000 Central Avenue N.E. |
| Minneapolis, MN 55432 | |
| Company Phone: | |
| Company Facsimile: | (612) 514-2700 |
| (612) 514-2890 | |
| Contact Person: | Julie Sherman |
| Product Regulation Manager | |
| Date Summary Prepared: | December 10, 1998 |
II DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Medtronic KHONSARI™ Annuloplasty Band |
|---|---|
| [Model H609M] | |
| 21 CFR Reference: | 870.3800 |
| 21 CFR Common Name: | Ring, Annuloplasty |
| Class: | Pre-amendment Class III |
| Panel: | CV (74) KRH |
III IDENTIFICATION OF PREDICATE DEVICE
| Device | 510(k) # |
|---|---|
| Medtronic SCULPTOR® Annuloplasty Ring | |
| [Model 605M] | K905175 |
The 510(k) also includes references to the following marketed devices:
| Medtronic Posterior Annuloplasty Ring [Model 607] | K960356 |
|---|---|
| Cosgrove-Edwards™ Annuloplasty System [Model 4600] | K923367 |
| Medtronic DURAN Annuloplasty Ring [Model H608H] | K980534 |
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IV DEVICE DESCRIPTION
The Medtronic KHONSARI Annuloplasty Band [Model H609M] is an implantable, flexible, adjustable band. The band reduces and stabilizes the mitral valve annulus in patients undergoing mitral valve repair. The body of the band is made of braided polyester and has drawstrings that permit segments of the annulus to be independently shortened.
The band contains a flexible (non-metallic) radiopaque marker that enables radiographic visualization of its entire length. Eight radially spaced surgeon's flags indicate recommended locations for implantation sutures. Each annuloplasty band is attached to a holder. A circumferential groove in the holder protects the drawstrings from entrapment by the implanting sutures. The stem of the handle is malleable to facilitate seating of the band during placement.
The four adjustable drawstrings are coiled within cylindrical canisters on the holder. A retaining suture secures each end of the band to the holder. The drawstrings will automatically release from the holder as it is removed from the band.
V DESCRIPTION OF INTENDED USE
The Medtronic KHONSARI Annuloplasty Band is for use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.
VI SUBSTANTIAL EQUIVALENCE
The Medtronic KHONSARI Annuloplasty Band [Model H609M] is substantially equivalent to the Medtronic SCULPTOR Annuloplasty Ring [Model 605M]. The KHONSARI Annuloplasty Band is manufactured based on modifications to the manufacturing processes of the SCULPTOR Annuloplasty Band. Both devices contain equivalent raw materials and are produced using equivalent manufacturing, packaging and sterilization processes. Both devices are indicated for surgical repair of mitral valves.
The KHONSARI Annuloplasty Band is also equivalent to the Posterior Annuloplasty Band [Model 607] manufactured by Medtronic and the Cosgrove-Edwards™ Annuloplasty System [Model 4600] by virtue of the flexible, open band configuration (no stiffener) of all three devices.
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TECHNOLOGICAL CHARACTERISTICS VII
Both the KHONSARI Annuloplasty Band and the SCULPTOR Annuloplasty Ring are manufactured using the same white polyester braided fabric as is used in the predicate device. The radiopaque marker, identification tag and suture used for sewing of the polyester fabric and surgeon markers remains the same. The drawstrings are made from the same raw material. Both products are manufactured using equivalent manufacturing, packaging and sterilization processes. The KHONSARI Annuloplasty Band is manufactured as an open configuration with a completely flexible band, whereas the SCULPTOR Annuloplasty Ring is manufactured as a complete flexible ring with a a rigid anterior portion.
PERFORMANCE DATA VIII
The KHONSARI Annuloplasty Band was subjected to verification and validation studies to demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device.
Manufacturing process validation was performed. The modified manufacturing processes meet all procedure requirements. Physical performance studies were conducted to verify that the device performs as intended after routine sterilization and accelerated aging cycles. Sterilization validation of the device was also completed. Based on the results of the study, the sterility assurance level (SAL) of the sterlization process was qualified at 10 ° sterilization level at a minimum sterilization dose of 25kGy. The verification/validation studies demonstrate that the modifications to the manufacturing process are appropriate and do not affect the intended use of the product.
No changes have been made to the manufacturing or sterilization of this device to warrant new or additional biocompatibility testing of the device components.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 19 1999
Ms. Julie Sherman Product Requlation Manager Medtronic Cardiac Surgery 7000 Central Avenue, NE Minneapolis, MN 55432-3576
Re : K984435 Medtronic Khonsari™ Annuloplasty Band [Model H609M] Regulatory Class: III (Three) Product Code: KRH Dated: December 10, 1998 Received: December 11, 1998
Dear Ms. Sherman:
This letter corrects our substantially equivalent letter of January 7, 1999, regarding the incorrect trade name and model number .
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandinq and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good
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Page 2 - Ms. Julie Sherman
Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological 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): K98
Device Name: Medtronic KHONSARI ™ Annuloplasty Band [Model H609M]
Indications for Use:
For use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V Per 21 CFR 801.109
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Bette K Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices X 98.44 510(k) Number_