(27 days)
Not Found
No
The summary describes a mechanical device for surgical occlusion and does not mention any AI/ML components or functionalities.
Yes
The device is indicated for the "occlusion of the heart's left atrial appendage," which is a treatment for a medical condition.
No
The device is used for the occlusion of the heart's left atrial appendage, which is a therapeutic intervention, not a diagnostic one.
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:
- Intended Use: The intended use is for the occlusion of the heart's left atrial appendage during cardiac surgical procedures. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (a clip) and an applier used to surgically close off a part of the heart. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The AtriClip LAA Exclusion System is a surgical tool and implant used for a therapeutic purpose.
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
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 along with a selection guide. 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 PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment end-effector containing the 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
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 PRO-V device. The PRO-V device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared PRO-V device. No new safety or performance issues were raising during testina.
Non-clinical Bench Testing:
- . Reliability Testing
- Mechanical Testing ●
- . Confirmatory Biologic Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 25, 2017
AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K173031
Trade/Device Name: AtriClip® LAA Exclusion System with Preloaded PRO-VTM Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: September 27, 2017 Received: September 28, 2017
Dear Ms. Smallwood:
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Nicole G. Ibrahim -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) K173031
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, 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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 logo for AtriCure. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot above the "C" in "Cure". There is a registered trademark symbol to the right of the word "Cure".
510(k) Summary
l. Applicant Information
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-644-4736
F: 513-895-9013 |
|--------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Melissa Smallwood
Regulatory Affairs Specialist |
| Alternate Contact: | Jonathan McElwee, RAC
Manager, Regulatory Affairs |
| Date Prepared: | 09/27/2017 |
ll. Device Information
| Proprietary Name: | AtriClip® LAA Exclusion System with Preloaded PRO·V™ Clip |
|---|---|
| Common Name: | Implantable Clip and Clip Applier |
| Classification: | Implantable Clip and Clip Applier |
| Regulatory Class: Class II; per 21 CFR 878.4300 | |
| Product Code: FZP | |
| Classification Panel: General and Plastic Surgery | |
| Predicate Device: | AtriClip LAA Exclusion System with Preloaded PRO·V Clip |
| (K153500, FZP, May 19, 2017) |
lll. Device Description
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. 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 PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment end-effector containing the Clip.
4
IV. 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.
V. Comparison of Technological Characteristics (PRO-V cleared via K153500)
Minor dimensional modifications were made to internal components of the end effector of the Clip Applier, and a minor internal component was replaced with an equivalent component in the handle of the Clip Applier. A minor dimensional modification was also made to the PRO-V Clip Implant.
- . The devices have the same intended use and;
- . No changes were made in operating principle, or specifications of performance.
- . No changes were made to the labeling.
- No changes were required in packaging sterilization or expiration dating.
- The PRO·V Clip continues to be made of titanium and polyester. .
VI. Performance Data
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared PRO-V device. The PRO-V device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared PRO-V device. No new safety or performance issues were raising during testina.
Non-clinical Bench Testing:
- . Reliability Testing
- Mechanical Testing ●
- . Confirmatory Biologic Testing
VII. Conclusions
AtriCure has demonstrated that the modifications made for the PRO V device are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use as the previously cleared device: AtriClip LAA Exclusion System with Preloaded PRO·V Clip