Tri-Ad 2.0 Adams Tricuspid Band

K181132 · Medtronic · KRH · May 29, 2018 · Cardiovascular

Device Facts

• Record ID: K181132
• Device Name: Tri-Ad 2.0 Adams Tricuspid Band
• Applicant: Medtronic
• Product Code: KRH · Cardiovascular
• Decision Date: May 29, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Tri-Ad 2.0 Adams is an implantable annuloplasty band for tricuspid valve repair; consists of MP35N wire stiffener covered in braided polyester fabric; features radial green markers and green demarcation suture for surgical orientation; radiopaque core provides visualization. Device implanted by cardiac surgeons during open-heart procedures to remodel and stabilize enlarged tricuspid annulus; restricts annular expansion to improve valve function. No software or electronic components; purely mechanical implant.

Clinical Evidence

Bench testing only. No clinical data provided. Verification studies included visual inspection, biocompatibility, sterilization, and design validation/human factors engineering.

Technological Characteristics

Materials: MP35N wire stiffener, braided polyester fabric cover. Form factor: Annuloplasty band with 3 radial green markers and green demarcation suture. Sizes: 26 mm, 28 mm, 32 mm, 34 mm, 36 mm. Radiopaque core for visualization. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring reconstruction or remodeling of pathological tricuspid valves to provide support and restrict expansion of the tricuspid annulus.

Regulatory Classification

Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”

Predicate Devices

• Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring (K093903)

Submission Summary (Full Text)

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# 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: [phone] Email: [e-mail]

# Alternate Contact

Zach Larsen Regulatory Affairs Specialist Medtronic Phone: [phone] Email: [e-mail]

#### 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 | | |

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## 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.

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# 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<br>tricuspid band<br>(Subject) | Tri-Ad Semi-Flexible<br>Tricuspid Annuloplasty Ring<br>(Predicate) | Equivalency |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | The Tri-Ad 2.0 Adams<br>tricuspid band is indicated<br>for the reconstruction or<br>remodeling of pathological<br>tricuspid valves. The band<br>provides support and<br>restricts expansion of the<br>tricuspid annulus. | The Tri-Ad Semi-Flexible<br>Tricuspid Annuloplasty Ring is<br>indicated for use in patients<br>undergoing surgery for diseased<br>or damaged tricuspid valves. The<br>Tri-Ad Semi-Flexible Tricuspid<br>Annuloplasty Ring provides<br>support for and restricts<br>expansion of the tricuspid<br>annulus. | Substantially<br>Equivalent |
| Product Labeling | Minor modifications<br>including:<br>• Update to product<br>name<br>• Addition of new<br>handle | | Substantially<br>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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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);

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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 ([e-mail]) or phone [phone] 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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