(30 days)
Not Found
No
The description focuses on mechanical modifications to a surgical clip applier and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the occlusion of the heart's left atrial appendage, which is a therapeutic intervention aimed at treating or preventing a medical condition (e.g., stroke risk due to atrial fibrillation).
No
The AtriClip LAA Exclusion System is an implantable device designed to occlude the left atrial appendage, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of a physical, implantable Clip and a disposable Clip Applier, both of which are hardware components. The 510(k) focuses on modifications to the hardware (Clip Applier).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "occlusion of the heart's 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 an applier used to physically close off a part of the heart. This is a surgical device, not a device used to test samples outside of 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 perform any such testing on specimens.
The AtriClip LAA Exclusion System is a surgical implant and delivery system.
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 heart's 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. 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. This Special 510(k) does not include any changes to the Clip.
The Clip Applier is a disposable device with a handle, shaft, and an end effector which contains the Clip. This Special 510(k) includes modifications to the Clip Applier including both lateral and vertical articulation of the end effector and deployment via pulling a deployment tab at the proximal end of the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrial appendage (LAA), heart's left atrial appendage
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
The modified Clip Applier was tested on the cadaver model to confirm the modifications do not affect the ability to successfully deploy the Clip on the left atrial appendage. Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Clip Applier's conformance to design controls and specification. Testing determined that the modified Clip Applier was able to successfully deploy the Clip on the LAA and that the modified Clip Applier conformed to design controls and product specifications.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
K 122276
510(k) Summary
AUG 2 9 2012
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 Systems and Regulatory Affairs | |
| Date of Submission | July 24, 2012 |
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.
Cleared Device
The device proposed for modification in this submission is the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip cleared via 510(k) K093679 on June 10, 2010.
Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier. 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. This Special 510(k) does not include any changes to the Clip.
The Clip Applier is a disposable device with a handle, shaft, and an end effector which contains the Clip. This Special 510(k) includes modifications to the Clip Applier including both lateral and vertical articulation of the end effector and deployment via pulling a deployment tab at the proximal end of the handle.
Materials
All materials in the modified Clip Applier are suitable for their intended use. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.
1
AtriCure®
Testing
The modified Clip Applier was tested on the cadaver model to confirm the modifications do not affect the ability to successfully deploy the Clip on the left atrial appendage. Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Clip Applier's conformance to design controls and specification. Testing determined that the modified Clip Applier was able to successfully deploy the Clip on the LAA and that the modified Clip Applier conformed to design controls and product specifications.
Summary of Equivalence
The modified AtriClip LAA Exclusion System is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to indications for use/intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip Applier. The modifications to the Clip Applier do not affect the ability of the Clip to be successfully deployment on the LAA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 9 2012
AtriCure James Lucky, RAC Vice President of Quality Systems and Regulatory Affairs 6217 Centre Park Drive West Chester, OH 45069
Re: K122276
Trade/Device Name: AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove™ Clip
Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: July 24, 2012 Received: July 31, 2012
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. 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.
3
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.
M.S. Hillebert
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)______________________
Device Name: AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip
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.
X Prescription Use (Part 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use (21 CRF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tmy Willer
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number_K122276