(30 days)
Not Found
No
The device description focuses on the physical components and materials of the annuloplasty rings and bands, and the intended use is purely mechanical support. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is implanted in patients undergoing surgery for diseased or damaged mitral or tricuspid valves to provide support and restrict expansion of the annulus, which is a therapeutic intervention.
No
The device description indicates that it is an annuloplasty ring and band designed to support the mitral or tricuspid annulus and restrict its expansion during valve repair surgery. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly details physical components made of materials like polyester fabric, MP35N wire, silicone, and sutures, which are implanted in the body. This indicates a hardware 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 to provide support and restrict expansion of the mitral or tricuspid annulus during surgery for diseased or damaged valves. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implantable device (ring and band) made of materials like polyester fabric, MP35N wire, and silicone. It is designed to be surgically placed within the body.
- 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 screening. The "Radiographic visualization" mentioned is for confirming the placement of the implant within the body, not for analyzing biological samples.
In summary, the SimuPlus and SimuForm annuloplasty rings and bands are surgical implants used to repair heart valves, not devices used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SimuPlus flexible annuloplasty ring and band are in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimulPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.
The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
SimuPlus Flexible Annuloplasty Ring and Band
The SimuPlus flexible annuloplasty ring (Model 7700FR) and band (Model 7700FB) consist of a flexible braided polyester fabric with a 3 mm cross-section. The ring or band may be implanted in the mitral annulus to stabilize the annulus following valve repair. The band may be implanted in the tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the centerline of the ring or band. The individual ring or band size (26 mm to 42 mm increments) refers to the circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation.
The SimuPlus annuloplasty ring and band holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the holder opening above the typical area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chord knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.
SimuForm Semi-Rigid Annuloplasty Ring
The SimuForm semi-rigid annuloplasty ring (Model 7800RR) consists of a MP35N wire stiffener in the posterior segment, running from trigone to trigone. The ring stiffener is enclosed within a close-coiled MP35N spring that passes around the circumference of the annuloplasty ring. The spring is covered by a thin silicone sheath. Braided polyester fabric is used to cover and form the body of the ring. The ring has two green markers to indicate the anterior and posterior trigones. A green demarcation suture runs around the upper face of the ring. The individual ring size (24 mm to 40 mm in 2 mm increments) refers to the inner circumference between the green trigone markers on the ring. The internal spring and stiffener provide radiographic visualization around the circumference of the ring.
The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral annulus, tricuspid annulus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, patients undergoing 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was not required to support labeling changes made to align with standard industry sizing.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
July 1, 2020
Medtronic, Inc. Lisa Corbin Sr. Regulatory Affairs Specialist 1851 E. Deere Ave. Santa Ana, California 92705
Re: K201449
Trade/Device Name: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: May 29, 2020 Received: June 1, 2020
Dear Lisa Corbin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm_identifies_combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jaime Raben Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201449
Device Name SimuPlus™ Flexible Annuloplasty Ring SimuPlus™ Flexible Annuloplasty Band SimuForm™ Semi-Rigid Annuloplasty Ring
Indications for Use (Describe)
The SimuPlus flexible annuloplasty ring and band are in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimulPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.
The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
1.0 510(k) Summary
1.1 Applicant Information
| Date Prepared: | May 29, 2020 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Heart Valves Division | |
| 1851 E. Deere Ave. | |
| Santa Ana, CA 92705 | |
| Contact Person: | Lisa Corbin |
| Sr. Regulatory Affairs Specialist | |
| Phone: (949) 399-1670 | |
| Email: lisa.corbin@medtronic.com | |
| Alternate Contact: | Zach Larsen |
| Sr. Regulatory Affairs Supervisor | |
| Phone: (949) 382-1034 | |
| Email: zach.s.larsen@medtronic.com |
4
1.2 Device Name and Classification
| Trade Name | Predicate Device | Common
Name | Classification
Name | Regulation
Number | Product
Classification | Product
Code | Classification
Panel | Special
Controls |
|----------------------------------------------------------------|------------------------------------------------------------------------|----------------------|------------------------|----------------------|---------------------------|-----------------|---------------------------------|---------------------|
| SimuPlus™
Flexible
Annuloplasty Ring,
Model 7700FR | Simulus™ Flexible
Annuloplasty Ring,
Model 700FF
(K052565) | | | | | | | |
| SimuPlus™
Flexible
Annuloplasty Band,
Model 7700FB | Simulus™ Flexible
Annuloplasty Band,
Model 700FC
(K052899) | Annuloplasty
Ring | Ring,
Annuloplasty | 21 CFR
870.3800 | Class II | KRH | Cardiovascular
Devices Panel | Yes |
| SimuForm™ Semi-
Rigid Annuloplasty
Ring, Model
7800RR | Simulus™ Semi-
Rigid Annuloplasty
Ring, Model 800SR
(K072655) | | | | | | | |
Table 1-1: Device Name and Classification for Rebranded Simulus Devices
5
1.3 Design and Manufacturing Facility Addresses
| Design Site: | Medtronic Heart Valves Division
1851 E. Deere Ave.
Santa Ana, CA 92705
Establishment Registration Number: 2025587 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site: | Medtronic Mexico S. de R.L. de CV
Av. Paseo Cucapah 10510 El Lago
Tijuana, Baja California Mexico C.P. 22210
Establishment Registration Number: 9617601 |
Device Description 1.4
SimuPlus Flexible Annuloplasty Ring and Band 1.4.1
The SimuPlus flexible annuloplasty ring (Model 7700FR) and band (Model 7700FB) consist of a flexible braided polyester fabric with a 3 mm cross-section. The ring or band may be implanted in the mitral annulus to stabilize the annulus following valve repair. The band may be implanted in the tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the centerline of the ring or band. The individual ring or band size (26 mm to 42 mm increments) refers to the circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation.
The SimuPlus annuloplasty ring and band holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the holder opening above the typical area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chord knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.
1.4.2 SimuForm Semi-Rigid Annuloplasty Ring
The SimuForm semi-rigid annuloplasty ring (Model 7800RR) consists of a MP35N wire stiffener in the posterior segment, running from trigone to trigone. The ring stiffener is enclosed within a close-coiled MP35N spring that passes around the circumference of the annuloplasty ring. The spring is covered by a thin silicone sheath. Braided polyester fabric is used to cover and form the body of the ring. The ring has two green markers to indicate the anterior and posterior trigones. A green demarcation suture runs around the upper face of the ring. The individual ring size (24 mm to 40 mm in 2 mm increments) refers to the inner circumference between the green trigone markers on the ring. The internal spring and stiffener provide radiographic visualization around the circumference of the ring.
The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring
6
holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.
1.5 Indications for Use
Table 1-2: Indications for Use for SimuPlus, SimuForm Rings and Bands
| Device Name | Indications for Use |
|---|---|
| SimuPlus Flexible | |
| Annuloplasty Ring, | |
| Model 7700FR | The SimuPlus flexible annuloplasty ring and band are indicated for use in patients |
| undergoing surgery for diseased or damaged mitral valves. The band is indicated for the | |
| same use for tricuspid valves. The SimuPlus flexible annuloplasty ring and band | |
| provide support for the mitral annulus or tricuspid annulus (band only) and restrict | |
| expansion of the annulus. | |
| SimuPlus Flexible | |
| Annuloplasty Band, | |
| Model 7700FB | |
| SimuForm Semi-Rigid | |
| Annuloplasty Ring, | |
| Model 7800RR | The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery |
| for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring | |
| provides support for the mitral annulus and restricts expansion of the annulus. |
1.6 Comparison to Predicate Devices
SimuPlus Flexible Annuloplasty Ring and Band 1.6.1
The following characteristics of the SimuPlus flexible annuloplasty ring and band are identical to the Simulus flexible annuloplasty ring and band: implantable ring/band, intended use, principles of operation, sterilization, shelf life, and packaging. The SimuPlus flexible annuloplasty ring and band are substantially equivalent to the Simulus flexible annuloplasty ring and band as summarized in Table 1-3.
| Characteristic | SimuPlus Flexible
Annuloplasty Ring and Band
(Subject) | Simulus Flexible
Annuloplasty Ring and Band
(Predicate) | Equivalence |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | The SimuPlus flexible
annuloplasty ring and band are
indicated for use in patients
undergoing surgery for diseased or
damaged mitral valves. The band
is indicated for the same use for
tricuspid valves. The SimuPlus
flexible annuloplasty ring and
band provide support for the
mitral annulus or tricuspid annulus
(band only) and restrict expansion
of the annulus. | The ATS SIMULUS
Annuloplasty Rings are for use in
those patients undergoing surgery
of diseased or damaged mitral or
tricuspid valves in whom the
surgeon determines that the valve
can be preserved by employing
the appropriate surgical repair.
The annuloplasty rings provide
support for the mitral or tricuspid
annulus and restrict expansion of
the annulus. | Substantially
Equivalent |
Table 1-3: Flexible Rinq and Band Substantial Equivalence Comparison
7
| Characteristic | SimuPlus Flexible
Annuloplasty Ring and Band
(Subject) | Simulus Flexible
Annuloplasty Ring and Band
(Predicate) | Equivalence |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | | The ATS SIMULUS FC
Annuloplasty Bands are for use in
those patients undergoing surgery
of diseased or damaged mitral or
tricuspid valves in whom the
surgeon determines that the valve
can be preserved by employing
the appropriate surgical repair.
The annuloplasty bands provide
support for the mitral or tricuspid
annulus and restrict expansion of
the annulus | |
| Labeled Size Range* | 26 mm, 28 mm, 30 mm, 32 mm,
34 mm, 36 mm, 38 mm, 40 mm,
42 mm | 23 mm, 25 mm, 27 mm, 29 mm,
31 mm, 33 mm, 35 mm, 37 mm,
39 mm | Substantially
Equivalent |
| Product Labeling | Update to product name,
indications, labeled size range Update handle compatibility
to Model 7686 annuloplasty
handle Update to 29-language eIFU,
6-language paper IFU | Compatible with Model 752
annuloplasty handle 16-language eIFU, 16-
language paper IFU | Substantially
Equivalent |
| *Note that there is no change to the construction or dimensions of the implantable ring/band. Modifications to the
labeled size range reflect dimensional changes to the sizer accessory to align with standard industry sizing. | | | |
Table 1-3: Flexible Ring and Band Substantial Equivalence Comparison
1.6.2 SimuForm Semi-Rigid Annuloplasty Ring
The following characteristics of the SimuForm semi-rigid annuloplasty ring are identical to the Simulus semi-rigid ring: implantable ring, intended use, principles of operation, size range, sterilization, shelf life, and packaging. The SimuForm semi-rigid ring is substantially equivalent to the Simulus semi-rigid ring as summarized in Table 1-4.
Table 1-4: Semi-rigid Ring Substantial Equivalence Comparison
| Characteristic | SimuForm Semi-rigid
Annuloplasty Ring (Subject) | Simulus Semi-rigid
Annuloplasty Ring
(Predicate) | Equivalence |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | The SimuForm semi-rigid
annuloplasty rings are for use in
patients undergoing surgery for
diseased or damaged mitral
valves. The SimuForm semi-rigid | The ATS SIMULUS™ Semi-
Rigid Mitral Annuloplasty Rings
are for use in those patients
undergoing surgery of diseased or
damaged mitral valves in whom | Substantially
Equivalent |
8
| Characteristic | SimuForm Semi-rigid
Annuloplasty Ring (Subject) | Simulus Semi-rigid
Annuloplasty Ring
(Predicate) | Equivalence |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | annuloplasty ring provides support
for the mitral annulus and restricts
expansion of the annulus. | the surgeon determines that the
valve can be preserved by
employing the appropriate
surgical repair. The annuloplasty
rings provide support for the
natural annulus and restrict
expansion of the annulus. | |
| Product Labeling | Update to product name Update handle compatibility
to Model 7686 annuloplasty
handle Update to include 29-
language eIFU, 6-language
paper IFU | Compatible with Model 752
annuloplasty handle 16-language eIFU, 16-
language paper IFU | Substantially
Equivalent |
1.7 Summary of Performance Data
Performance testing was not required to support labeling changes made to align with standard industry sizing.
1.8 Conclusion
The modifications to the Simulus devices do not impact the intended use or alter the fundamental scientific technology of the devices. There is no change to the implantable rings and bands. The SimuPlus and SimuForm rings and bands are therefore substantially equivalent to the currently marketed predicate devices.