(24 days)
No
The summary describes a mechanical device for surgical occlusion and does not mention any AI/ML components or functions.
Yes
The device is used for the "occlusion of the heart's left atrial appendage," which is a treatment for a medical condition, making it a therapeutic device.
No
Explanation: The device is designed for the occlusion of the heart's left atrial appendage, which is a therapeutic function, not a diagnostic one. It is an implantable clip used during surgical procedures.
No
The device description clearly outlines physical components including an implantable clip, a clip applier with a handle, shaft, and controls, and a selection guide. It also mentions bench testing and biocompatibility evaluations for these physical components. There is no mention of software as a component of the device.
Based on the provided information, the AtriClip LAA Exclusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to physically occlude the left atrial appendage of the heart during surgery. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (the clip) and an instrument for deploying it (the applier). These are tools used in a surgical procedure.
- Lack of Diagnostic Function: The device does not perform any tests on samples taken from the body (like blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status. Its purpose is purely therapeutic/interventional.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The AtriClip does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PZX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrial appendage (LAA)
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)
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
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
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.
K093679, K122276, K131107, K142120, K150996, K153500, K160454, K163261, K172742, K173031
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
l. Applicant Information
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
P: 513-755-4100
F: 513-755-4108 |
|-----------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Jonathan McElwee
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.
●
●
●
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
- Demonstrated equivalency in performance O
- The results of the verification and validation testing:
VI. Performance Data
●
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.