(51 days)
No
The summary describes a mechanical clip and applier system for surgical LAA occlusion, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is indicated for the occlusion of the heart's left atrial appendage, which is a structural intervention to treat a medical condition.
No
The device is described as an "LAA Exclusion System" indicated for the "occlusion of the heart's left atrial appendage." Its purpose is to physically close off a part of the heart, not to diagnose a condition.
No
The device description clearly states it consists of a physical, implantable clip and a disposable applier, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The AtriClip LAA Exclusion System is an implantable device used to physically occlude the left atrial appendage during open heart surgery. It is a surgical tool and implant, not a device that analyzes biological specimens.
- Intended Use: The intended use clearly states it's for the "occlusion of the heart's left atrial appendage... in conjunction with other open cardiac surgical procedures." This is a surgical intervention, not a diagnostic test performed on a specimen.
The description focuses on the physical components of the device and its mechanical function in a surgical setting. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
Product codes
FZP
Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable PRO-V Clip preloaded on a Single Use Clip Applier. When closed, the PRO·V Clip applies uniform pressure over the length of the clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The PRO-V Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm (PROV35), 40 mm (PROV40), 45 mm (PROV45), and 50 mm (PROV50).
The PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the PRO·V Clip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart's left atrial appendage (LAA)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical (open cardiac surgical procedures)
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
Animal Study: AtriCure conducted a preclinical chronic animal study per 21 CFR Part 58 to evaluate the safety and performance of the PRO-V System in a live cardiac tissue model and to compare performance to the predicate Clip device. Safety results demonstrated that there were no adverse events or complications associated with the use of the device or the exclusion procedure.
Non-clinical Bench Testing:
- Mechanical Testing
- Reliability Testing
- Leak Testing
- Corrosion Testing
- Magnetic Resonance Testing Per FDA Guidance (December 11, 2014) Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
- Bench Testing on an Animal Model
Biocompatibility Testing: The biocompatibility evaluation for the PRO-V Clip and Clip Applier 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: - Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogen
- Genotoxicity
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K093679, K131107, K142120, K150996
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2016
AtriCure, Inc. Mr. Jonathan McElwee Senior Regulatory Specialist 6217 Centre Park Drive West Chester, Ohio 45069
Re: K153500
Trade/Device Name: AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Pro-V Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: December 4, 2015 Received: December 7, 2015
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, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Willhemen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
AtriClip LAA Exclusion System with Gillinov-Cosgrove PRO·V Clip
Indications for Use (Describe)
The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
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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Image /page/3/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. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the "e" in "Cure".
510(k) Summary
l. Submitter
| Manufacturer: | AtriCure, Inc.
6217 Centre Park Dr.
West Chester, OH 45069
P: 513-755-4100
F: 513-755-4108 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Jonathan McElwee, RAC
Senior Regulatory Specialist |
| Alternate Contact: | Jim Taufen
Sr. Manager of Regulatory Affairs |
| Date Prepared: | 12/4/2015 |
| II.
Device | |
| Name of Device: | AtriClip® LAA Exclusion System with Preloaded Gillinov-Cosgrove®
PRO·V™ Clip |
| Common Name: | Implantable Clip and Clip Applier |
| Classification Name: | Implantable Clip and Clip Applier (21 CFR 878.4300) |
| Regulatory Class: | Class II |
| Product Code: | FZP |
lll. Predicate Device
The primary predicate device, AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, was cleared via 510(k) K122276 on August 29, 2012 under the Product Code FZP.
The predicate device has not been subject to a design-related recall.
The following reference devices were also used in this submission:
- . K093679 AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip
- AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip . K131107
- K142120 AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip ●
- . K150996 AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip
IV. Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable PRO-V Clip preloaded on a Single Use Clip Applier. When closed, the PRO·V Clip applies uniform pressure over the length of the clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The PRO-V Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm (PROV35), 40 mm (PROV40), 45 mm (PROV45), and 50 mm (PROV50).
1
4
The PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the PRO·V Clip.
V. Indications For Use
The AtriClip LAA Exclusion System is indicated for the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple)).
VI. Comparison Of Technological Characteristics With The Predicate Device
- Same intended use
- Same operating principle
- No changes were made in operating principle, or specifications of performance .
- . The same force profile
- The same pressure profile ●
- The contact shape and appendage surface area are the same;
- . The knit braided polyester is the same as that in the predicate device;
- The PRO V Clip is made out of titanium and polyester. The predicate Clip is made of ● titanium, polyester, nitinol, and carbothane. Biocompatibility of the PRO·V device remains the same.
- The same Gamma sterilization parameters .
VII. Performance Data
Animal Studv
AtriCure conducted a preclinical chronic animal study per 21 CFR Part 58 to evaluate the safety and performance of the PRO-V System in a live cardiac tissue model and to compare performance to the predicate Clip device. Safety results demonstrated that there were no adverse events or complications associated with the use of the device or the exclusion procedure.
Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify PRO-V device's conformance to design controls and specification. Testing determined that the PRO V device conformed to design controls and product specifications.
Non-clinical Bench Testing
- Mechanical Testing ●
- . Reliability Testing
- Leak Testing
- Corrosion Testing
- Magnetic Resonance Testing Per FDA Guidance (December 11, 2014) Establishing Safety ● and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
- . Bench Testing on an Animal Model
Biocompatibility Testing
The biocompatibility evaluation for the PRO-V Clip and Clip Applier was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1:
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Image /page/5/Picture/0 description: The image shows the logo for AtriCure. The logo is in two colors, blue and orange. The first part of the name, "Atri," is in blue, while the second part, "Cure," is in orange. There is a blue dot in the middle of the "C".
Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- . Sensitization
- . Irritation
- . Systemic Toxicity
- Material Mediated Pvrogen .
- . Genotoxicity
The PRO V Clip is categorized as an "Implant Device", contact for "Tissue/Bone" and permanent contact duration of "greater than 30 days". The PRO-V Clip Applier is categorized as an "External Communicating Device," contact for "Tissue/Bone" and contact duration for "under 24 hours."
VIII. Conclusions
Based on the indications for use, technological characteristics, and safety and performance testing, the proposed AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove PRO·V Clip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the AtriClip LAA Exclusion System (PRO1) previously cleared via 510(k) K122276 on August 29, 2012.