(63 days)
No reference devices were used in this submission.
No
The device description and intended use focus on a mechanical clip and applier for surgical occlusion, with no mention of AI/ML components or functions.
Yes
The device is used to occlude the left atrial appendage, which is a therapeutic intervention to prevent potential complications like stroke.
No
The device is an implantable system designed for the occlusion of the left atrial appendage during cardiac surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components: an implantable Clip and a disposable Clip Applier. The submission focuses on manufacturing modifications to the material of the implant.
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 heart's left atrial appendage" during open cardiac surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable clip and an applier used to physically close off a part of the heart.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Direct Visualization: The intended use explicitly states "under direct visualization," meaning the surgeon is seeing the heart directly, not through any diagnostic imaging or testing.
The device is a surgical implant and delivery system, not a diagnostic tool.
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 performed by sternotomy (full or partial as well as thoracotomy (single or multiple).
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.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains manufacturing modifications to the proposed AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.
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
surgeon, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Chemical characterization and in vitro biocompatibility screening testing was conducted to demonstrate equivalence of the knit braided polyester sourced from the various suppliers of PET raw material.
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.
K093679, K122276, K131107, K142120
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.
No reference devices were used in this submission.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Atricure, Inc. Brittany Lowe Regulatory Affairs 6217 Centre Park Drive West Chester, Ohio 45069
Re: K150996
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: June 1, 2015 Received: June 2, 2015
Dear Ms. Lowe:
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
1
Page 2 - Brittany Lowe
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 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,
Kenneth J. Cavanaugh -S
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) K150996
Device Name
Atriclip Laa Exclusion System With Preloaded Gillinov-cosgrove 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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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".
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: | Brittany Lowe
Regulatory Affairs |
| Alternate Contact: | Jonathan McElwee, RAC
Senior Regulatory Specialist |
| Date Prepared: | 04/14/2015 |
| II.
Device | |
| Name of Device: | AtriClip™ LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
| Common Name: | Implantable Clip and Clip Applier |
| Classification Name: | Implantable Clip and Clip Applier (21 CFR 878.4300 and 4800) |
| Regulatory Class: | Class II |
| Product Code: | FZP |
lll. Predicate 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, K122276 on August 29, 2012, K131107 on May 14, 2013, and K142120 on August 28, 2014.
The predicate devices have not been subject to a design-related recall.
No reference devices were used in this submission.
IV. 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.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains manufacturing modifications to the proposed
4
AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.
V. 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.
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
- The devices have the same intended use and; .
- No changes were made in operating principle, or specifications of performance.
- The results of the verification and validation testing:
- Demonstrated equivalency in performance ■
- . Device biocompatibility remains unchanged
- . Did not raise any new issues of safety
- No changes were made to the labeling. ●
- No changes were required in packaging sterilization or expiration dating. ●
VII. Performance Data
Chemical characterization and in vitro biocompatibility screening testing was conducted to demonstrate equivalence of the knit braided polyester sourced from the various suppliers of PET raw material.
VIII. Conclusions
The modified AtriClip LAA Exclusion System is equivalent to the previously cleared AtriClip LAA Exclusion System as there is no change to intended use or the basic design of the Clip.