ArtiClip LAA Exclusion System

K181474 · AtriCure, Inc. · PZX · Jun 28, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181474
• Device Name: ArtiClip LAA Exclusion System
• Applicant: AtriCure, Inc.
• Product Code: PZX · General, Plastic Surgery
• Decision Date: Jun 28, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

Device Story

The AtriClip LAA Exclusion System is a sterile, single-use, implantable device designed for permanent occlusion of the left atrial appendage (LAA). It consists of a self-closing clip preloaded onto a disposable applier. The applier features a handle, shaft, suture anchors, and articulation controls. During cardiac surgery, a surgeon uses the applier to place the clip over the LAA; the clip applies uniform pressure to ensure secure occlusion. The device is used in an operating room setting by a cardiac surgeon. The system provides a mechanical solution for LAA exclusion, potentially reducing the risk of thromboembolism. This specific submission covers an alternate sourcing for the PET suture material used in the implant and applier.

Clinical Evidence

Bench testing only. Testing included tensile strength, suture elongation, and friction comparison to demonstrate equivalence to the predicate. Biocompatibility testing was conducted per ISO 10993-1, including material-mediated pyrogen, genotoxicity, cytotoxicity, implantation, sensitization, irritation, and systemic toxicity.

Technological Characteristics

Implantable clip and disposable applier. Materials include PET suture. Sensing/actuation is mechanical (self-closing clip). Available in 35mm, 40mm, 45mm, and 50mm lengths. Biocompatibility evaluated per ISO 10993-1.

Indications for Use

Indicated for occlusion of the left atrial appendage in patients undergoing cardiac surgical procedures requiring direct visualization of the heart.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• AtriClip LAA Exclusion System (K180010)

Reference Devices

• AtriClip LAA Exclusion System (K093679)
• AtriClip LAA Exclusion System (K122276)
• AtriClip LAA Exclusion System (K131107)
• AtriClip LAA Exclusion System (K142120)
• AtriClip LAA Exclusion System (K150996)
• AtriClip LAA Exclusion System (K153500)
• AtriClip LAA Exclusion System (K160454)
• AtriClip LAA Exclusion System (K163261)
• AtriClip LAA Exclusion System (K172742)
• AtriClip LAA Exclusion System (K173031)

Submission Summary (Full Text)

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June 28, 2018

AtriCure, Inc. Jonathan McElwee Regulatory Affairs Manager 7555 Innovation Way Mason, Ohio 45040

Re: K181474

Trade/Device Name: AtriClip LAA Exclusion System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PZX Dated: June 1, 2018 Received: June 4, 2018

Dear Mr. McElwee:

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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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K181474

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 comprehensive regulatory information about mediation-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,

# Rachel E. Neubrander -S

for 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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# Indications for Use

510(k) Number (if known) K181474

Device Name AtriClip LAA Exclusion System

## Indications for Use (Describe)

The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

### l. Applicant Information

| Manufacturer: | AtriCure, Inc.<br>7555 Innovation Way<br>Mason, OH 45040<br>P: 513-755-4100<br>F: 513-755-4108 |
|-----------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Jonathan McElwee<br>Manager of Regulatory Affairs |
| Date Prepared: | 05/31/2018 |

### II. Device Information

Name of Device: AtriClip® LAA Exclusion System

- Implantable Clip and Clip Applier Common Name:
Classification Name: Implantable Clip and Clip Applier (21 CFR 878.4300) Class II Product Code: PZX Classification Panel: General and Plastic Surgery

- Predicate Device: The device proposed for modification in this submission is the AtriClip LAA Exclusion System cleared via K180010 on January 31, 2018.
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The following reference devices were also used in this submission:

- K093679 AtriClip LAA Exclusion System
- K122276 AtriClip LAA Exclusion System ●
- AtriClip LAA Exclusion System ● K131107
- K142120 AtriClip LAA Exclusion System
- K150996 AtriClip LAA Exclusion System
- K153500 AtriClip LAA Exclusion System
- K160454 AtriClip LAA Exclusion System
- K163261 AtriClip LAA Exclusion System ●
- K172742 AtriClip LAA Exclusion System
- K173031 AtriClip LAA Exclusion System ●

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### III. Device Description

The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.

The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains an alternate to the PET suture supply sourcing used within the AtriClip implant and Clip Appliers of the LAA Exclusion system.

### IV. Indications For Use

The AtriClip LAA Exclusion System is indicated for the left atrial appendage, under direct visualization, in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other viewing technologies.

### V. Comparison Of Technological Characteristics With The Predicate Device

- The devices have the same intended use, and;
- . No changes were made in operating principle, or specifications of performance.
- The contraindications, warnings, and precautions remain the same
- The results of the verification and validation testing:
- Demonstrated equivalency in performance O
- Device biocompatibility remains unchanged O
- Did not raise any new issues of safety o

### VI. Performance Data

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The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriClip LAA Exclusion System

# Non-clinical Bench Testing

- . Tensile Testing (Strength, Knotted Strength)
- Suture Elongation ●
- Friction Comparison Testing ●

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Image /page/5/Picture/0 description: The image shows the AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange.

# Biocompatibility Testing

The biocompatibility evaluation for the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip AOD1, and PROV Clip, AOD2 was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:

- . Material Mediated Pyrogen
- Genotoxicity
- Cytotoxicity
- Implantation
- . Sensitization
- Irritation ●
- Systemic Toxicity ●

### VII. Conclusions

AtriCure has demonstrated that the modifications made to the AtriClip LAA Exclusion System is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to intended use, operating principals, or function of the device.