(195 days)
Not Found
No
The device description and performance studies focus on the mechanical function and clinical outcomes of a physical implant and applier, with no mention of AI/ML components or data processing for decision-making.
Yes
The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, which is a medical intervention aimed at treating or preventing a medical condition (e.g., stroke risk associated with atrial fibrillation).
No.
The AtriClip LAA Exclusion System is an implantable device used to occlude the left atrial appendage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components: an implantable clip, a clip applier, and a selection guide. It also describes the materials and mechanical action of these components.
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 "occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures." This describes a surgical procedure performed directly on a patient's organ.
- Device Description: The device is an implantable clip and applier designed to physically close off the left atrial appendage. This is a mechanical intervention within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
The AtriClip LAA Exclusion System is a surgical implant and delivery system, not an IVD.
N/A
Intended Use / Indications for Use
The AtriClip LAA Exclusion System is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier, and a Selection Guide to aid in appropriate Clip size selection. The frame assembly of the implantable Clip consists of two springs connecting two opposing tubes which are covered with pressure pads. This assembly is covered with a knit fabric. 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 available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.
The Clip Applier is a disposable device with a handle, shaft, and an end effector which contains the Clip. Both sides of the Clip are free to move within the end effector when activated. Pulling the thumb lever proximally opens the Clip. The bias of the Clip allows both the clip and the lever to return to the closed position when the lever is released.
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)
Non-Clinical Testing: The AtriClip was tested on in both acute and chronic models ranging from 7 days to 90 days. Testing presented in the 510(k) document demonstrated complete appendage duration. exclusion both acutely and long-term in all animals with no adverse events attributed to the Clip device. Post-implant verification of efficacy confirmed there was no communication between the LAA and left atrium in all animals.
Clinical Testing: The AtriClip has been evaluated for safety and efficacy in a controlled clinical study of seventy subjects. The results of the study demonstrate the excellent performance of the product in its ability to exclude the LAA in a safe and efficient manner. Efficacy has been demonstrated at a very high rate intra-procedurally and this rate has been shown to improve as further healing was achieved. The observed exclusion rate of 95.1% composite (both intra-operative and 3 month) and 98% at 3 month follow-up support that this procedure can achieve excellent efficacy results.
The safety of the device and procedure has been well established through a careful scrutiny of all events reported in the study. Independent physician adjudication has demonstrated that there were no events that were in any way linked to the device or the procedure. The primary safety endpoint event rate in this trial is 0%. These results confirm the safety of the product and the procedure. The results further support the technical comparability of the product to other currently marketed options for LAA exclusion and therefore provides the clinical support to demonstrate a substantial equivalence of the AtriClip to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Observed exclusion rate: 95.1% composite (both intra-operative and 3 month) and 98% at 3 month follow-up.
Primary safety endpoint event rate: 0%.
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.
K030311, K031623, K032696, K040398, K023030, K043056
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
§ 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 word "AtriCure" in a stylized font. The letters "A," "t," "r," and "i" are in a bold, sans-serif font, while the "Cure" portion of the word is outlined. There is a solid black circle inside the "C" of "Cure." The "e" in "Cure" has a small trademark symbol next to it.
KC093679
ﯿﻨﮧ ﮨ
510(k) Summary
JUN 1 0 2010
General Information
| Classification | Class 2 |
|---|---|
| Trade name | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
| Common name | Implantable Clip |
| Classification Name | Clip, Implantable (21 CFR 878.4300, Product Code FZP) |
| Manufacturer | AtriCure, Inc. |
| 6217 Centre Park Dr. | |
| West Chester, OH 45069 | |
| P: 513-755-4100 | |
| F: 513-755-4108 | |
| Contact | James Lucky, RAC |
| Vice President Quality Assurance and Regulatory Affairs | |
| Date of Submission | November 27, 2009 |
Intended Use
The AtriClip LAA Exclusion System is indicated for the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Predicate Devices
The predicate devices for the AtriClip LAA Exclusion System are the Weck Hem-O-Lok® Ligating Clip and Clip Applier (K030311), Medtronic VNUS U-Clip and Applier (K031623), Tyco AutoSuture TA and GIA Staplers (K032696), Power Medical SurgASSIST® Straight Linear 4 Row No Knife DLUs with Reloads (K040398), Demetech Braided Nonabsorbable Polyester Suture and needle driver (K023030) and Gore SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (K043056).
Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier, and a Selection Guide to aid in appropriate Clip size selection. The frame assembly of the implantable Clip consists of two springs connecting two opposing tubes which are covered with pressure pads. This assembly is covered with a knit fabric. 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).
1
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 Applier is a disposable device with a handle, shaft, and an end effector which contains the Clip. Both sides of the Clip are free to move within the end effector when activated. Pulling the thumb lever proximally opens the Clip. The bias of the Clip allows both the clip and the lever to return to the closed position when the lever is released.
Materials
All materials in the AtriClip LAA Exclusion System are suitable for their intended use and have been used in previously cleared products. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.
Predicate Comparison
The technological characteristics of the device are the same as the predicate devices. The same materials are used in the AtriClip and predicate devices. The sizes of the devices are equivalent and are provided in similar ranges. The method of LAA closure, permanent approximation of the sides of the LAA, is the same for the AtriClip and the predicates. All of the devices may be repositioned on the LAA prior to deployment and once deployed exert similar pressures on the tissue.
Non-Clinical Testing
The AtriClip was tested on in both acute and chronic models ranging from 7 days to 90 days Testing presented in the 510(k) document demonstrated complete appendage duration. exclusion both acutely and long-term in all animals with no adverse events attributed to the Clip device. Post-implant verification of efficacy confirmed there was no communication between the LAA and left atrium in all animals.
Clinical Testing
The AtriClip has been evaluated for safety and efficacy in a controlled clinical study of seventy subjects. The results of the study demonstrate the excellent performance of the product in its ability to exclude the LAA in a safe and efficient manner. Efficacy has been demonstrated at a very high rate intra-procedurally and this rate has been shown to improve as further healing was achieved. The observed exclusion rate of 95.1% composite (both intra-operative and 3 month) and 98% at 3 month follow-up support that this procedure can achieve excellent efficacy results.
The safety of the device and procedure has been well established through a careful scrutiny of all events reported in the study. Independent physician adjudication has demonstrated that there were no events that were in any way linked to the device or the procedure. The primary safety endpoint event rate in this trial is 0%. These results confirm the safety of the product and the procedure. The results further support the technical comparability of the product to other currently marketed options for LAA exclusion and therefore provides the clinical support to demonstrate a substantial equivalence of the AtriClip to the identified predicate devices.
2
AtriCure®
Summary of Substantial Equivalence
As demonstrated by the predicate comparison of technological characteristics, data provided in the non-clinical studies and clinical testing, the AtriClip LAA Exclusion System is equivalent to the predicate products. The data presented in K093679 demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device.
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird with its wings spread, positioned to the right of a circular inscription. The inscription reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the bird. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 1 0 2010
AtriCure, Inc. c/o Mr. James Lucky Vice President of Quality Assurance and Regulatory Affairs 6217 Centre Park Drive West Chester, OH 45069
Re: K093679
AtriClip™ LAA Exclusion System w/Pre-loaded Gillnov-Cosgrove™ Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: June 1, 2010 Received: June 2, 2010
Dear Mr. Lucky:
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.
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.
4
Page 2 - Mr. James Lucky
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT: INDICATION FOR USE
K093679 510 (k) Number:
Device Name: AtriClip LAA Exclusion System
Indications for Use:
The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Prescription Use X Over the Counter Use (Part 21 CFR 801 Subpart D) and/or (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.W.A.
ardiovascular Devices
510(k) Number K093679