(29 days)
Not Found
No
The summary describes a mechanical device for surgical exclusion of the left atrial appendage and does not mention any AI or ML components or functionalities.
Yes
The device is used for the exclusion of the heart's left atrial appendage, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is used for the exclusion of the left atrial appendage, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components including an implantable clip, a clip applier with a handle, shaft, suture anchors, articulation controls, and a deployment loop. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the AtriClip LAA Exclusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the exclusion of the heart's left atrial appendage during cardiac surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implantable clip and an applier used to physically close off the LAA.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The AtriClip does not perform any such diagnostic function. It is a therapeutic device used for a surgical intervention.
Therefore, the AtriClip LAA Exclusion System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The AtriClip LAA Exclusion System is indicated for the exclusion 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
PZX
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 exclusion of the left atrial appendage (LAA). Preclinical animal studies (Kamohara 2005,2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies.
The Clip is available in the following lengths to accommodate difference sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls and deployment loop which contains 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 (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)
A review of the risk analysis concluded there is no overall change to the risk profile of the proposed AtriClip LAA Exclusion System versus the previously cleared AtriClip LAA Exclusion System as the modifications to the proposed AtriClip LAA Exclusion System do not add or remove any features of the device or change the clinical application.
The proposed changes do not include any chanqe to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System.
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 contains 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, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2021
AtriCure, Inc. Mary Galeano Senior Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K210293
Trade/Device Name: AtriClip LAA Exclusion System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PZX Dated: January 29, 2021 Received: February 2, 2021
Dear Mary Galeano:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210293
Device Name
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
Indications for Use (Describe)
The AtriClip LAA Exclusion System is indicated for the exclusion 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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l. Applicant Information
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040 |
|--------------------|-----------------------------------------------------------------------------|
| Contact Person: | Mary Galeano, RAC
Sr. Regulatory Affairs Specialist
P: 513-257-6279 |
| Alternate Contact: | Jonathan McElwee, RAC
Sr. Manager, Regulatory Affairs
P: 513-795-9127 |
| Date Prepared: | 03/03/2021 |
ll. Device Information
| Proprietary Name: | AtriClip™ LAA Exclusion System with preloaded Gillinov-
Cosgrove Clip
(LAA0, ACH1, ACH2, PRO1, and PRO2)
AtriClip™ LAA Exclusion System with preloaded V-Clip
(PROV and ACHV) |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Implantable Clip and Clip Applier |
| Classification: | Implantable Clip and Clip Applier
Regulatory Class: Class II; per 21 CFR 878.4300
Product Code: PZX
Classification Panel: Cardiovascular |
| Predicate Device: | The device proposed for modification in this submission is the
AtriClip LAA Exclusion System cleared via K191413 on August 21
2019. |
III. 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 exclusion of the left atrial appendage (LAA). Preclinical animal studies (Kamohara 2005,2006) demonstrate that complete exclusion with the Clip also results in acute and chronic electrical isolation of the LAA. A human clinical study (Starck 2012) has demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies.
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The Clip is available in the following lengths to accommodate difference sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls and deployment loop which contains the Clip.
Intended Use/ Indications for Use
The AtriClip LAA Exclusion System is indicated for the exclusion 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.
IV. Comparison of Technological Characteristics with the Predicate Device (AtriClip LAA Exclusion System - K191413)
| # | Feature | Previously Cleared AtriClip™ LAA
Exclusion System | Modified AtriClip™ LAA Exclusion
System | Equivalence
Comparison |
|------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 1 | Proprietary Name | AOD1: AtriClip LAA Exclusion System with
Preloaded Gillinov-Cosgrove Clip
AOD2: AtriClip LAA Exclusion System with
Preloaded PROV Clip | AOD1: AtriClip LAA Exclusion System with
Preloaded Gillinov-Cosgrove Clip
AOD2: AtriClip LAA Exclusion System with
PROV Clip | Same |
| | | 2 | Clip Applier
Product Code(s) | |
| 3 | Device
Classification | 21 CFR 878.4300,
product code: PZX | 21 CFR 878.4300,
product code: PZX | Same |
| 4 | Regulatory Class | Class II | Class II | Same |
| 5 | FDA Division | Cardiovascular | Cardiovascular | Same |
| 6 | Performance
Standards | No performance standards applicable to
this product have been promulgated by
FDA | No performance standards applicable to
this product have been promulgated by
FDA | Same |
| 7 | Intended Use | The AtriClip LAA Exclusion System is
indicated for the exclusion 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. | The AtriClip LAA Exclusion System is
indicated for the exclusion 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. | Same |
| # | Feature | Previously Cleared AtriClip™ LAA
Exclusion System | Modified AtriClip™ LAA Exclusion
System | Equivalence
Comparison |
| 8 | Device
Description in the
Instructions for
Use | The AtriClip LAA Exclusion System
contains the Gillinov-Cosgrove LAA Clip
(Clip) for exclusion of the heart's left atrial
appendage (LAA). Preclinical animal
studies (Kamohara 2005, 2006)
demonstrate that complete exclusion with
the Clip also results in acute and chronic
electrical isolation of the LAA. A human
clinical study (Starck 2012) has
demonstrated acute electrical isolation.
Chronic electrical isolation has not been
evaluated in human clinical studies.
The Clip is pre-loaded on a disposable
Clip applier. The AtriClip LAA Exclusion
System with preloaded Gillinov-Cosgrove
Clip does not contain natural rubber latex
components. | The AtriClip LAA Exclusion System
contains the Gillinov-Cosgrove LAA Clip
(Clip) for exclusion of the heart's left atrial
appendage (LAA). Preclinical animal
studies (Kamohara 2005, 2006)
demonstrate that complete exclusion with
the Clip also results in acute and chronic
electrical isolation of the LAA. A human
clinical study (Starck 2012) has
demonstrated acute electrical isolation.
Chronic electrical isolation has not been
evaluated in human clinical studies.
The Clip is pre-loaded on a disposable
Clip applier. The AtriClip LAA Exclusion
System with preloaded Gillinov-Cosgrove
Clip does not contain natural rubber latex
components. | Same |
| 9 | Software | This product does not contain software. | This product does not contain software. | Same |
| 10 | Shelf Life | 3 years. | 3 years. | Same |
| 11 | Biocompatibility | Passed. Materials have been assessed
based on ISO 10993 and are commonly
employed in tissue contacting devices. | Passed. Materials have been assessed
based on ISO 10993 and are commonly
employed in tissue contacting devices. | Same |
| 12 | Sterilization | Gamma Irradiation. | Gamma Irradiation. | Same |
| 13 | Sterility
Assurance Level | 10-6 SAL | 10-6 SAL | Same |
| 14 | Pyrogen | Non-Pyrogenic. | Non-Pyrogenic. | Same |
| Clip | | | | |
| 15 | Suture Material | Polyethylene Terephthalate | Polyethylene Terephthalate | Same |
| 16 | Preloaded Clip | AOD1: Preloaded Gillinov-Cosgrove Clip
AOD2: Preloaded V-Clip | AOD1: Preloaded Gillinov-Cosgrove Clip
AOD2: Preloaded V-Clip | Same |
| 17 | Clip Opening | AOD1: Opens 12.5mm ± 1.5mm as
measured between the beams of the
AOD1 clip.
AOD2: Opens AOD2 Clip to a minimum of
12mm at the distal end and 4mm at the
proximal end of the clip. | AOD1: Opens 12.5mm ± 1.5mm as
measured between the beams of the
AOD1 clip.
AOD2: Opens AOD2 Clip to a minimum of
12mm at the distal end and 4mm at the
proximal end of the clip. | Same |
| 19 | Biocompatibility | Passed. Materials have been assessed
based on ISO 10993 and are commonly
employed in tissue contacting devices. | Passed. Materials have been assessed
based on ISO 10993 and are commonly
employed in tissue contacting devices. | Same |
| 20 | Sterilization | Gamma Irradiation. | Gamma Irradiation. | Same |
AtriCure added an alternate raw material supplier of the titanium for the AOD1 clip.
5
- The devices have the same intended use, and;
- No changes were made in operating principle, or specifications of performance.
- · The contraindications, warnings, and precautions remain the same
- The results of the verification and validation testing:
- o Demonstrated equivalency in performance
- Device biocompatibility remains unchanged o
- Did not raise any new issues of safety o
6
V. Performance Data
A review of the risk analysis concluded there is no overall change to the risk profile of the proposed AtriClip LAA Exclusion System versus the previously cleared AtriClip LAA Exclusion System as the modifications to the proposed AtriClip LAA Exclusion System do not add or remove any features of the device or change the clinical application.
The proposed changes do not include any chanqe to design or performance specifications of the AtriClip LAA Exclusion System. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriClip LAA Exclusion System.
VI. Conclusions
AtriCure has demonstrated that the modifications made to the AtriClip LAA Exclusion System are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip LAA Exclusion System) per K191413.