(29 days)
Not Found
No
The description focuses on the physical structure and materials of a tricuspid band for surgical implantation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the reconstruction or remodeling of pathological tricuspid valves, providing support and restricting expansion of the tricuspid annulus, which directly treats a medical condition.
No
Explanation: The device is described as an implantable band for the reconstruction or remodeling of tricuspid valves, providing support and restricting expansion of the tricuspid annulus. Its function is therapeutic/reparative, not diagnostic.
No
The device description clearly outlines physical components (wire stiffener, end caps, braided polyester fabric, markers, suture) and mentions radiographic visualization, indicating a physical implantable device, not software.
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 or remodeling of pathological tricuspid valves." This is a surgical procedure performed directly on the patient's anatomy.
- Device Description: The device is a physical implantable band designed to provide structural support to the tricuspid annulus.
- Lack of Diagnostic Function: The device does not perform any tests on samples taken from the body (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status. Its function is purely therapeutic/reconstructive.
IVD devices are used in vitro (outside the body) to examine specimens for diagnostic purposes. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.
Product codes (comma separated list FDA assigned to the subject device)
KRH
Device Description
The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band: - The end of the stiffener section at the posteroseptal commissure. - The anteroposterior commissure. ● - The end of the stiffener section in the anterior segment of the band. ● A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tricuspid valves, tricuspid annulus
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)
Verification testing was used to verify the performance characteristics of the Tri-Ad™ 2.0 Adams tricuspid band. The following studies were performed: - Visual Inspection ● - Biocompatibility ● - Sterilization ● - Design Validation / Human Factors Engineering
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
1.0 510(k) Summary
1.1 Applicant Information
Date Prepared: April 27, 2018
- Applicant: Medtronic Medtronic Heart Valves Division 1851 East Deere Ave Santa Ana, CA 92705
- Contact Person: Tracy Gray Regulatory Affairs Medtronic Phone: (949) 399-1678 Email: tracy.l.gray@medtronic.com
Alternate Contact
Zach Larsen Regulatory Affairs Specialist Medtronic Phone: (949) 382-1034 Email: zach.s.larsen@medtronic.com
1.2 Device Name and Classification
| Trade Name: | Tri-Ad™ 2.0 Adams tricuspid band | ||
|---|---|---|---|
| Common Name: | Tri-Ad 2.0 Adams | ||
| Classification Name: | Annuloplasty Ring | ||
| Predicate Device: | Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring (K093903) | ||
| Regulation Number: | 21 CFR 870.3800 | ||
| Product Classification: | Class II | ||
| Product Code: | KRH | ||
| Classification Panel: | Cardiovascular Devices Panel | ||
| Special Controls: | Yes |
1
1.3 Address of Manufacturing Facilities
Design Site: Manufacturing Site: Medtronic Heart Valves Division Medtronic Mexico S. de R.L. de CV 1851 E Deere Ave Av. Paseo Cucapah 10510 El Lago Tijuana, Baja California Mexico C.P. 22210 Establishment Registration Number: 2025587 Establishment Registration Number: 9617601
1.4 Device Description
The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band:
- The end of the stiffener section at the posteroseptal commissure.
- The anteroposterior commissure. ●
- The end of the stiffener section in the anterior segment of the band. ●
A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.
1.5 Indications for use
The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.
2
1.6 Comparison to Predicate Devices
The Tri-Ad 2.0 Adams tricuspid band is identical to the Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring in the following characteristics: Intended Use, Principles of Operation, Sterilization, Shelf Life, Packaging and Size Range. The Tri-Ad 2.0 Adams tricuspid band is substantially equivalent to the Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring according to the comparison table below.
| Characteristic | Tri-Ad 2.0 Adams
tricuspid band
(Subject) | Tri-Ad Semi-Flexible
Tricuspid Annuloplasty Ring
(Predicate) | Equivalency |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | The Tri-Ad 2.0 Adams
tricuspid band is indicated
for the reconstruction or
remodeling of pathological
tricuspid valves. The band
provides support and
restricts expansion of the
tricuspid annulus. | The Tri-Ad Semi-Flexible
Tricuspid Annuloplasty Ring is
indicated for use in patients
undergoing surgery for diseased
or damaged tricuspid valves. The
Tri-Ad Semi-Flexible Tricuspid
Annuloplasty Ring provides
support for and restricts
expansion of the tricuspid
annulus. | Substantially
Equivalent |
| Product Labeling | Minor modifications
including:
• Update to product
name
• Addition of new
handle | | Substantially
Equivalent |
Summary of Performance Data 1.7
Verification testing was used to verify the performance characteristics of the Tri-Ad™ 2.0 Adams tricuspid band. The following studies were performed:
- Visual Inspection ●
- Biocompatibility ●
- Sterilization ●
- Design Validation / Human Factors Engineering
1.8 Conclusion
Based upon the testing performed, the modifications to the Tri-Ad 2.0 Adams do not affect the intended use of the devices or alter the fundamental scientific technology of the devices. No change has been made to the implantable band. Therefore, Tri-Ad 2.0 Adams is substantially equivalent to the currently marketed predicate device.
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Image /page/3/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
May 29, 2018
Medtronic Ms. Tracy Gray Regulatory Affairs 1851 East Deere Ave Santa Ana, California 92705
Re: K181132
Trade/Device Name: Tri-AdTM 2.0 Adams Tricuspid Band Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II Product Code: KRH Dated: April 27, 2018 Received: April 30, 2018
Dear Ms. Gray:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
4
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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