(30 days)
No
The provided 510(k) summary describes a mechanical device for surgical LAA exclusion. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are bench tests focused on mechanical and reliability aspects.
Yes
The device is implanted to exclude the heart's left atrial appendage, which is a therapeutic intervention.
No
The device is designed 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, applier, handle, knobs, shaft, and end effector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AtriClip LAA Exclusion System is a surgical implant used to physically exclude the left atrial appendage of the heart. It is a device used during a surgical procedure on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it is for "exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures." This describes a surgical intervention, not a diagnostic test.
Therefore, the AtriClip LAA Exclusion System falls under the category of a surgical device or implant, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
PZX
Device Description
The AtriClip PRO-Mini LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip (AtriClip Mini) 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). The Clip is then deployed and is left as a permanent implant, and excludes the LAA, resulting in electrical isolation of the 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 PRO-Mini device is a disposable device with a handle, leftright and up/down articulation knobs, articulation lock, deployment tab, shaft, suture anchors, and end effector containing the AtriClip Mini.
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
Surgeon, clinical setting ("in conjunction with other 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)
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriClip LAA Exclusion System devices (ACHM, PRO2). The AtriClip PRO-Mini LAA Exclusion System (PROM) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriClip LAA Exclusion System devices (ACHM, PRO2). No new safety or performance issues were raised during testing.
Non-clinical Bench Testing:
- Mechanical Testing
- Reliability Testing
- Tissue Testing
- Dose Audit Testing
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.
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 & 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2025
AtriCure, Inc. Diane Sung Senior Regulatory Affairs Specialist 7555 Innovation Wav Mason, Ohio 45040
Re: K243860
Trade/Device Name: AtriClip PRO-Mini LAA Exclusion System (PROM) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PZX Dated: December 16, 2024 Received: December 16, 2024
Dear Diane Sung:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely, Kalkidan Molla -S
Kalkidan A. Molla, MS Acting 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
3
Indications for Use
510(k) Number (if known) K243860
Device Name AtriClip PRO-Mini LAA Exclusion System (PROM)
Indications for Use (Describe)
The AtriClip LAA Exclusion System is indicated for the exclusion of the heat'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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Applicant Information
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason Ohio 45040 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Diane Sung
Senior Regulatory Affairs Specialist
P: 513-600-1804 |
| Alternate Contact: | Jim Taufen
Director, Regulatory Affairs
P: 952-314-1507 |
| Date Prepared: | December 16, 2024 |
| Device Information | |
| Proprietary Name: | AtriClip PRO-Mini LAA Exclusion System (PROM) |
| 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: | AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125, July 29, 2024) |
| Reference Device: | AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip
(PRO2) (K160454, March 18, 2016, and K172742, October 11, 2017) |
Device Description
The AtriClip PRO-Mini LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip (AtriClip Mini) 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). The Clip is then deployed and is left as a permanent implant, and excludes the LAA, resulting in electrical isolation of the 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 PRO-Mini device is a disposable device with a handle, leftright and up/down articulation knobs, articulation lock, deployment tab, shaft, suture anchors, and end effector containing the AtriClip Mini.
5
Intended Use / Indications for Use
The AtriClip LAA Exclusion System is indicated for 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.
Comparison of Technological Characteristics
- The devices include the same intended use and indications for use, and; ●
- . No changes were made in operating principle, and;
- The results of the verification and validation testing: .
- o Demonstrated equivalency in performance
- O Did not raise any new issues of safety
| # | Feature | AtriClip FLEX-Mini
LAA Exclusion
System with AtriClip
Mini
(ACHM)
(Predicate)
K234125 | AtriClip LAA
Exclusion System
with Preloaded
Gillinov-Cosgrove
LAA Clip (PRO2)
(Reference)
K160454, K172742 | PRO-Mini
(PROM)
(Proposed) | Equivalence
Comparison |
|--------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| 1 | Proprietary
Name | AtriClip FLEX-Mini LAA
Exclusion System | AtriClip LAA Exclusion
System with Preloaded
Gillinov-Cosgrove Clip | AtriClip PRO-Mini LAA
Exclusion System | N/A |
| 2 | Product
Code(s) | ACHM35 ACHM40
ACHM45 ACHM50 | PRO235 PRO240
PRO245 PRO250 | PROM35 PROM40
PROM45 PROM50 | N/A |
| 3 | 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, | 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, | 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, | Same as predicate
and reference
devices. |
| | | with or without
assistance from a
camera, endoscope,
etc., or other
appropriate viewing
technologies. | with or without
assistance from a
camera, endoscope,
etc., or other
appropriate viewing
technologies. | with or without
assistance from a
camera, endoscope,
etc., or other
appropriate viewing
technologies. | |
| 4 | Packaging | Sterile, Single use,
disposable device | Sterile, Single use,
disposable device | Sterile, Single use,
disposable device | Same as predicate
and reference
devices. |
| 5 | Biocompatibility | Materials have been
assessed based on ISO
10993 and are
commonly employed in
tissue contacting
devices. | Materials have been
assessed based on ISO
10993-1 and are
commonly employed in
tissue contacting
devices. | Materials have been
assessed based on ISO
10993-1 and are
commonly employed in
tissue contacting
devices. | Same as predicate
and reference
devices. |
| 6 | Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Same as predicate
and reference
devices. |
| 7 | Sterility
Assurance
Level | $10^{-6}$ SAL | $10^{-6}$ SAL | $10^{-6}$ SAL | Same as predicate
and reference
devices. |
| Clip | | | | | |
| 8 | Preloaded Clip | AtriClip Mini (AOD3) | N/A | AtriClip Mini (AOD3) | Same as predicate
device. |
| 9 | Operating
Mechanism | Uniform pressure along
length of the Clip | N/A | Uniform pressure along
length of the Clip | Same as predicate
device. |
| 10 | Contact
Surface | Knit Braided Polyester | N/A | Knit Braided Polyester | Same as predicate
device. |
| Clip Applier | | | | | |
| 11 | Deployment
End Effector | N/A | Stainless steel jaws that
open and close, as well
as provide the pathway
for stainless steel
cables to route and
attach to the Clip. | Stainless steel jaws that
open and close, as well
as provide the pathway
for stainless steel
cables to route and
attach to the Clip. | Same as
reference device. |
| 12 | Shaft | N/A | Stainless Steel | Stainless Steel | Same as
reference device. |
| 13 | Handle | N/A | Polycarbonate | Polycarbonate | Same as
reference device. |
6
7
Performance Data
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriClip LAA Exclusion System devices (ACHM, PRO2). The AtriClip PRO-Mini LAA Exclusion System (PROM) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriClip LAA Exclusion System devices (ACHM, PRO2). No new safety or performance issues were raised during testing.
Non-clinical Bench Testing:
- Mechanical Testing
- . Reliability Testing
- Tissue Testing ●
- Dose Audit Testing .
Conclusions
AtriCure has demonstrated that the AtriClip PRO-Mini LAA Exclusion System (PROM) is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared AtriClip FLEX-Mini LAA Exclusion System (ACHM) per K234125 and AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (PRO2) per K160454 and K172742.