(60 days)
Not Found
No
The device description focuses on mechanical components and visualization tools, with no mention of AI or ML capabilities. The performance studies are limited to bench testing of mechanical properties and biocompatibility.
Yes
The device is described as an "Epicardial Access System" intended to "access the epicardial surface of the heart via a subxiphoid approach," allowing for puncture and guidewire passage. This describes a medical intervention directly addressing a physiological issue.
No
Explanation: The device is intended to access the epicardial surface of the heart for intervention (delivery of guidewire, endoscope insertion for visualization during blunt dissection), not for diagnosis. While it provides visualization, it's for guiding a procedure, not for making a medical diagnosis.
No
The device description clearly outlines physical components such as a blunt distal tip, suction port, needle, lumen, handle, and stopcock, indicating it is a hardware medical device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EPi-Ease™ Epicardial Access System is a surgical tool designed to physically access the epicardial surface of the heart. It is used during a medical procedure to facilitate access, not to analyze a sample taken from the body.
- Intended Use: The intended use clearly states "to access the epicardial surface of the heart via a subxiphoid approach." This describes a procedural action, not a diagnostic test.
- Device Description: The description details the physical components and how they are used for access and delivery of other instruments (needle, guidewire, endoscope). There is no mention of analyzing biological samples.
- Performance Studies: The performance studies focus on mechanical testing, biocompatibility, shelf-life, and sterilization – all related to the physical function and safety of a surgical device. There are no studies related to the accuracy of a diagnostic test.
In summary, the EPi-Ease™ Epicardial Access System is a surgical access device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EPI-Ease™ Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
EPi-Ease is composed of a radiopaque blunt distal tip, a distal suction port designed to draw pericardial tissue into the device, a hollow 22-gauge Tuohy needle that enables puncture of the pericardium internal to the device, and a lumen to allow for insertion of an endoscope to provide direct visualization during blunt dissection, needle puncture, and guidewire delivery. The distal suction port connects to the device handle and terminates in a standard luer connection. The needle connects to the handle and terminates in a needle actuator, which enables extension, and rotation of the encased needle a limited distance within the distal tip and provides a port for insertion of a commercially available guidewire. After puncture, the device allows passage of a standard, commercially available .014" guidewire. An additional flushing port is available using the 3-way stopcock.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy required
Anatomical Site
epicardial surface of the heart
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 substantial equivalence to the previously cleared Agilis Introducer. The EPi-Ease device met the predetermined acceptance criteria ensuring substantial equivalence to the predicate. No new safety or effectiveness issues were raised during testing.
Non-clinical Bench Testing:
- Mechanical Testing: Endoscope testing, guidewire compatibility, structural integrity - PASS
- Biocompatibility Testing per ISO 10993-1 - PASS
- Shelf-Life Testing ASTM F1980-16 - PASS
- Transit Testing per ISTA 3A - PASS
- Sterilization per ISO 11137 - PASS
- Synthetic Model (CADet) testing - PASS
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.
Not Found
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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February 13, 2024
AtriCure, Inc. Jenifer Ulrikson Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K233959
Trade/Device Name: EPi-EaseTM Epicardial Access Device (EAS) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 14, 2023 Received: December 15, 2023
Dear Jenifer Ulrikson:
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.
1
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" (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 QS 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.
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).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
2
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) K233959
Device Name
EPi-Ease™ Epicardial Access System (EAS)
Indications for Use (Describe)
The EPI-Ease™ Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K233959
510(k) Summary
Applicant Information
Manufacturer:
AtriCure, Inc. 7555 Innovation Way Mason Ohio 45040
Contact Person:
Jeni Ulrikson Senior Regulatory Affairs Specialist Cell: 763-691-3904
| Device Information | |
|---|---|
| Proprietary Name: | EPi-Ease™ Epicardial Access System (EAS) |
| Common Name: | EPi-Ease |
| Classification: | Introducer, Catheter |
| Regulatory Class: Class II; per 21 CFR 870.1340 | |
| Product Code: DYB | |
| Classification Panel: Cardiovascular | |
| Predicate Device: | Agilis PF Introducer System |
| (K111943, September 29, 2011) |
Device Description
EPi-Ease is composed of a radiopaque blunt distal tip, a distal suction port designed to draw pericardial tissue into the device, a hollow 22-gauge Tuohy needle that enables puncture of the pericardium internal to the device, and a lumen to allow for insertion of an endoscope to provide direct visualization during blunt dissection, needle puncture, and guidewire delivery. The distal suction port connects to the device handle and terminates in a standard luer connection. The needle connects to the handle and terminates in a needle actuator, which enables extension, and rotation of the encased needle a limited distance within the distal tip and provides a port for insertion of a commercially available guidewire. After puncture, the device allows passage of a standard, commercially available .014" guidewire. An additional flushing port is available using the 3-way stopcock.
5
Intended Use / Indications for Use
The EPi-Ease™ Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.
Comparison of Technological Characteristics
- . The devices include an equivalent intended use, and;
- No changes were made in operating principle, and; ●
- The results of the verification and validation testing:
- Demonstrated equivalency in performance o
- o Did not raise any new issues of safety
| | Feature | Predicate:
Agilis Epicardial Access System | Proposed:
AtriCure EPi-Ease System |
|---|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Access | Sub-xiphoid | Sub-xiphoid |
| 2 | Needle size and
Device Profile | 17 ga. Tuohy Needle
18 Fr. Device Profile | 22 ga. Tuohy Needle
13 Fr. Device Profile |
| 3 | Visualization | Fluoroscopy required
No endoscopic visualization | Fluoroscopy required
Endoscopic visualization |
| 4 | Indication for Use | The Epicardial Access System is
intended to access the epicardial
surface of the heart via a subxiphoid
approach to facilitate
electrophysiology studies | The EPi-Ease™ Epicardial Access
System is intended to access the
epicardial surface of the heart via
subxiphoid approach |
| 5 | Vacuum | N/A | Vacuum-enabled retraction |
| 6 | Radiopaque marker | Yes—distal tip | Yes—distal tip |
| 7 | Operating Principles | Advancement through adipose tissue to
reach pericardial sac, needle punctures
pericardial sac, guidewire advances
through needle into pericardial sac,
introducer advances over guidewire and
pre- dilates pericardial sac, sheath
advances over guidewire into pericardial
sac to access epicardial surface of the
heart. | Equivalent. EPi-Ease adds direct
visualization, vacuum, and needle
advancement limits to mitigate risks
associated with the predicate |
6
Performance Data
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate substantial equivalence to the previously cleared Agilis Introducer. The EPi-Ease device met the predetermined acceptance criteria ensuring substantial equivalence to the predicate. No new safety or effectiveness issues were raised during testing.
Non-clinical Bench Testing:
| Test Description | Results |
|---|---|
| Mechanical Testing: Endoscope | |
| testing, guidewire compatibility, | |
| structural integrity | PASS |
| Biocompatibility Testing per ISO | |
| 10993-1 | PASS |
| Shelf-Life Testing ASTM F1980-16 | PASS |
| Transit Testing per ISTA 3A | PASS |
| Sterilization per ISO 11137 | PASS |
| Synthetic Model (CADet) testing | PASS |
Conclusion
AtriCure has demonstrated that the EPi-Ease Epicardial Access Device is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use to the predicate device, the Agilis PF Introducer System.