(85 days)
No
The summary describes a mechanical device (a clip and applier) for surgical exclusion of the LAA. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the "exclusion of the heart's left atrial appendage," which is a treatment for a medical condition.
No
The device is indicated for the "exclusion of the heart's left atrial appendage", which is a treatment, not a diagnosis.
No
The device description explicitly states it "contains a clip for exclusion of the heart's left atrial appendage (LAA)" and that the "Clip is pre-loaded on a disposable Clip applier," indicating it is a physical medical device with hardware components.
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 clip and applier used to physically close off the LAA.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AtriClip does not interact with or analyze such specimens.
The AtriClip is a surgical implant/device used for a therapeutic purpose (excluding the LAA), not for diagnostic testing of biological samples.
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 Exclusion System contains a 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 Exclusion System does not contain natural rubber latex components.
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
surgeon, 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
The proposed changes do not include any change 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
Not Found
Predicate Device(s)
Reference Device(s)
K093679, K153500, K122276, K163261, K131107, K172742, K142120, K173031, K150996, K160454, K180010, K181474
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
August 21, 2019
AtriCure, Inc Jim Taufen Sr. Manager, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040
Re: K191413
Trade/Device Name: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip. AttiClip LAA Exclusion System with preloaded V-Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PZX Dated: May 24, 2019 Received: May 28, 2019
Dear Mr. Taufen:
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.
1
542 of the Act); 21 CFR 1000-1050.
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) 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-
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, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191413
Device Name AtriClip LAA Exclusion System
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)
| 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 AtriCure logo. The word "Atri" is in blue, while "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the "e" in "Cure".
510(k) Summary
l. Applicant Information
- Manufacturer: AtriCure, Inc. 7555 Innovation Way Mason, OH 45040 P: (952) 314-1507 F: (513) 755-4108 Contact Person: Jim M. Taufen Senior Manager, Regulatory Affairs Date Prepared: August 20, 2019 II. Device Information AtriClip® LAA Exclusion System Name of Device: Common Name: Implantable Clip and Clip Applier Implantable Clip and Clip Applier (21 CFR 878.4300) Classification Name: Class II Product Code: PZX Classification Panel: General and Plastic Surgery Predicate Device: The device proposed for modification in this submission is the AtriClip LAA Exclusion System cleared via K181474 on June 28, 2018. The following reference devices were also used in this submission: K093679 AtriClip LAA Exclusion System K153500 AtriClip LAA Exclusion System ● ● ● K122276 AtriClip LAA Exclusion System K163261 AtriClip LAA Exclusion System ● K131107 AtriClip LAA Exclusion System K172742 AtriClip LAA Exclusion System ● ● K142120 K173031 AtriClip LAA Exclusion System ●
●
●
- AtriClip LAA Exclusion System
- K150996 AtriClip LAA Exclusion System
- K160454 AtriClip LAA Exclusion System
- K180010 AtriClip LAA Exclusion System
- K181474 AtriClip LAA Exclusion System
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Device Description lll.
The AtriClip Exclusion System contains a 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 Exclusion System does not contain natural rubber latex components.
IV. Indications For Use
The AtriClip LAA Exclusion System is indicated for the left atrial appendage, under direct visualization, 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 any other viewing technologies.
V. Comparison of Technological Characteristics with the Predicate Device
AtriCure updated the LAA Exclusion System indications and device description in the instructions for use labeling. A comparison of the technological characteristics with the predicate device are provided in Table 1 below.
| Feature | Predicate (K181474)
AtriClip™ LAA Exclusion
System | Subject AtriClip™ LAA
Exclusion System | Equivalence
Comparison |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Proprietary
Name | AtriClip LAA Exclusion System
with Preloaded Gillinov-
Cosgrove Clip | AtriClip LAA Exclusion System
with Preloaded Gillinov-Cosgrove
Clip | n/a |
| | AtriClip® LAA Exclusion
System with preloaded V-Clip | AtriClip® LAA Exclusion System
with preloaded V-Clip | n/a |
| Model
Numbers | LAA035 LAA040 LAA045
LAA050 ACH135 ACH140
ACH145 ACH150 ACH235
ACH240 ACH245 ACH250
PRO135 PRO140 PRO145
PRO150 PRO235 PRO240
PRO245 PRO250
ACHV35 ACH40 ACHV45
ACHV50 PROV35 PROV40
PROV45 PROV50 | LAA035 LAA040 LAA045 LAA050
ACH135 ACH140 ACH145
ACH150 ACH235 ACH240
ACH245 ACH250 PRO135
PRO140 PRO145 PRO150
PRO235 PRO240 PRO245
PRO250
ACHV35 ACH40 ACHV45
ACHV50 PROV35 PROV40
PROV45 PROV50 | n/a |
| Indications for
Use | The AtriClip LAA Exclusion
System is indicated for the
occlusion of the heart's left
atrial appendage, performed | The AtriClip LAA Exclusion System
is indicated for the exclusion of the
heart's left atrial appendage,
performed under direct | Similar. AtriClip
devices have |
| Feature | Predicate (K181474)
AtriClip™ LAA Exclusion
System | Subject AtriClip™ LAA
Exclusion System | Equivalence
Comparison |
| | under direct visualization and in
conjunction with other cardiac
surgical procedures. | visualization and in conjunction
with other cardiac surgical
procedures. | the same
intended use |
| | 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. | 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. | |
| Device
Description in
the Instructions
for Use | The AtriClip LAA Exclusion
System contains the Gillinov-
Cosgrove LAA Clip (Clip) for
occlusion of the heart's left
atrial appendage (LAA). 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 component. | The AtriClip LAA Exclusion System
contains {*Clip Type} 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 {*Clip Type} Clip
does not contain natural rubber
latex component.
- AOD1: "Gillinov-Cosgrove"
- AOD2: "V" | Different.
AtriClip devices
have the same
intended use |
| Preloaded Clip | AOD1: Preloaded Gillinov-
Cosgrove Clip | AOD1: Preloaded Gillinov-
Cosgrove Clip | Same |
| | AOD2: Preloaded V-Clip | AOD2: Preloaded V-Clip | |
| Shelf Life | 3 years | 3 years | Same |
| 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 |
| Sterilization | Gamma Irradiation. | Gamma Irradiation. | Same |
Table 1: Comparison of Technological Characteristics
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Image /page/5/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the word "Cure".
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Image /page/6/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the "e" in "Cure".
| Feature | Predicate (K181474)
AtriClip™ LAA Exclusion
System | Subject AtriClip™ LAA
Exclusion System | Equivalence
Comparison |
|---------------------------------|----------------------------------------------------------|-------------------------------------------|---------------------------|
| Sterility
Assurance
Level | 10-6 SAL | 10-6 SAL | Same |
The proposed changes in the indications for use statement and instruction for use were supported by published animal and clinical data. The proposed changes do not include any change to intended use, contraindications, or precautions. Additional warnings have been added to the labeling:
Warning:
- The safety and effectiveness of this device in atrial rhythm control management, either alone or in ● combination with ablative treatment, has not been established.
- . AtriClip placement that allows blood flow into the LAA may not result in complete exclusion and/or electrical isolation.
The proposed changes have no impact on design, operating principles, performance specifications, packaging, sterilization or expiring dating.
VI. Performance Data
The proposed changes do not include any change 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.
VII. Conclusions
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 IFU do not add or remove any features of the device or change the clinical application. AtriCure has demonstrated that the AtriClip LAA Exclusion System IFU, as labeled per the proposed Indication for Use and IFU description section, is substantially equivalent to the predicate LAA Exclusion System (K181474) as there is no change to intended use, operating principals, or function of the device.