(51 days)
K11943
Not Found
No
The device description and performance studies focus on mechanical and procedural aspects, with no mention of AI/ML, image processing, or data-driven analysis.
No.
The device is used to facilitate electrophysiology studies, which are diagnostic procedures, not therapeutic interventions.
No
The device is an access system intended to facilitate electrophysiology studies by providing access to the epicardial surface of the heart, rather than diagnosing a condition itself.
No
The device description explicitly lists physical components such as a needle, sheath, dilator, guidewire, introducer, and stylet, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Epicardial Access System is a surgical tool used to directly access the epicardial surface of the heart within the patient's body. It facilitates a procedure (electrophysiology studies) but does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for accessing the epicardial surface to facilitate electrophysiology studies, which are performed directly on the heart.
- Device Description: The components are needles, sheaths, dilators, and guidewires – all tools for physical access and manipulation within the body.
The device is an invasive surgical device used for a diagnostic procedure performed in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Epicardial Access System by Baylis Medical Company Inc. is a sinqle use device that is supplied sterile to the user. The System is comprised of the following devices:
. Epicardial Access Needle
Epicardial Steerable Guiding Sheath containing: .
Steerable Sheath, o
Dilator and o
J-Tip Guidewire o
. Epicardial Introducer and Stylet
The device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.
The Epicardial Access System's intended use is achieved through the following steps:
The needle advances through adipose tissue to reach the pericardial sac;
. The needle punctures the pericardial sac;
. The quidewire advances through the needle's inner lumen into the pericardial space;
. The introducer advances over the quidewire and pre-dilate the pericardial sac; and
. The Steerable Guiding Sheath (and Dilator) advances over the quidewire into the pericardial space to access the epicardial surface of the heart to facilitate electrophysiology studies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
epicardial surface of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.
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)
Performance Testing has been completed to demonstrate substantial equivalence of the subject device and predicate device. All test requirements were met as specified by applicable standard and the test protocols. The device was subjected to Mechanical Testing, General Physical Testing, Biocompatibility Verification, Sterilization Validation, Pyrogen Testing, Packaging Validation, and Bench-top Validation.
For the Bench-top Validation, a minimum of 15 users drawn from populations familiar with catheter-based procedures were presented with a sequence of actions to perform with a benchtop model representative of a clinical workflow involving the device. Observations regarding ease of use and errors made were recorded and evaluated to conclude if customer requirement were met. The validation testing demonstrated the devices contained in the Epicardial Access System meet the intended use to support substantial equivalence.
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.
K11943
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
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.
August 2, 2019
Baylis Medical Company Inc. May Tsai Manager, Regulatory Affairs 2580 Matheson Blvd. East Mississauga, L4W 4J1 Ontario, Canada
Re: K191546
Trade/Device Name: Epicardial Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 11, 2019 Received: June 12, 2019
Dear May Tsai:
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,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring 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) K191546
Device Name Epicardial Access System
Indications for Use (Describe)
The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.
| 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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510(K) SUMMARY
Submitter Information
| A. Company Name: | Baylis Medical Company Inc. |
|---|---|
| B. Company Address: | 2580 Matheson Blvd. East |
| Mississauga, Ontario, L4W 4J1 | |
| Canada | |
| C. Company Phone: | +1 (905) 602-4875 |
| D. Company Facsimile: | +1 (905) 602-5671 |
| E. Contact Person: | May Tsai |
| Manager, Regulatory Affairs | |
| F. Summary Prepared on: | 11-JUN-2019 |
Device Identification
| A. Device Trade Name: | Epicardial Access System |
|---|---|
| B. Device Common Name: | Catheter Introducer |
| C. Classification Name: | Catheter Introducer (21 CFR 870.1340) |
| D. Product Code: | DYB |
| E. Review Panel: | Cardiovascular |
| F. Device Class: | Class II |
Identification of Legally Marketed Device
| A. Predicate Device: | St Jude Medical Agilis™ PF Introducer System |
|---|---|
| B. Manufacturer: | St Jude Medical |
- ﻥ 510(k) K11943
- The Agilis™ PF Introducer System is intended to D. Indications for Use access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.
Indications for Use
The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.
4
Device Description
The Epicardial Access System by Baylis Medical Company Inc. is a sinqle use device that is supplied sterile to the user. The System is comprised of the following devices:
- . Epicardial Access Needle
- Epicardial Steerable Guiding Sheath containing: .
- Steerable Sheath, o
- Dilator and o
- J-Tip Guidewire o
- . Epicardial Introducer and Stylet
The device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.
The Epicardial Access System's intended use is achieved through the following steps:
- The needle advances through adipose tissue to reach the pericardial sac;
- . The needle punctures the pericardial sac;
- . The quidewire advances through the needle's inner lumen into the pericardial space;
- . The introducer advances over the quidewire and pre-dilate the pericardial sac; and
- . The Steerable Guiding Sheath (and Dilator) advances over the quidewire into the pericardial space to access the epicardial surface of the heart to facilitate electrophysiology studies.
Comparison to Predicate Device
The Epicardial Access System and predicate device share the same intended use/indications for use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design between the predicate and subject devices do not raise any different questions. The results of verification and validation testing provide reasonable assurance for the Epicardial Access System.
| Characteristic | Comparison Results |
|---|---|
| Intended Use | Identical |
| Indications for Use | Identical |
| Fundamental Scientific Technology | Identical |
| Operating Principles | Identical |
| Mechanism of Action | Identical |
| Materials | Similar |
| Technological Aspects | Similar |
| Packaging and Sterilization | Similar |
Table 11.1: Comparison of Subject and Predicate Device
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Performance Testing Summary
Performance Testing has been completed to demonstrate substantial equivalence of the subject device and predicate device. All test requirements were met as specified by applicable standard and the test protocols. The device was subjected to the following verification and validation activities.
Mechanical Testing
Mechanical verification testing was conducted for the devices contained in the Epicardial Access System to ensure compliance with the requirements of ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. The following mechanical tests were performed:
- . Epicardial Access Needle:
- Air and Liquid Leakage o
- o Resistance to Separation
- Stress Cracking o
- Strength of Union Hub to Hypotube O
- Strength of Union Stylet Cap to Stylet O
- Epicardial Steerable Guiding Sheath: ●
- Sheath Torque Transmission + Hub to Shaft Strength of Union O
- Sheath Air and Liquid Leakage Hemostasis Valve O
- Sheath Air and Liquid Leakage O
- Sheath Strength of Union Tip to Sheath Body O
- Sheath Strength of Union Hub to Sheath Body O
- Sheath Strength of Union Hub to Hub Cap O
- Sheath Strength of Union Hub to Tubing O
- Sheath Strength of Union Stopcock to Tubing O
- Sheath Strength of Union Crimp to Pull Wire O
- Sheath Strength of Union Inner Knob to Outer Knob Snap Fit O
- Sheath Strength of Union End Cap to Handle Snap Fit O
- Sheath Tip Transition O
- Snap Fit O
- Valve Insertion O
- Dilator Torque Transmission Hub to Tubing Joint O
- Dilator Air and Liguid Leakage O
- Dilator Strength of Union Tip to Tubing O
- Dilator Strength of Union Butt Weld Joint O
- Dilator Strength of Union Hub to Tubing o
- Epicardial Introducer and Stylet: ●
- Air and Liquid Leakage Hemostasis Valve o
- Air and Liquid Leakage O
- O Flow Rate
- Tip Integrity O
- Three-Point Bend O
- Torque Withstand Test O
- Tensile Test Stylet Hub to Rod O
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- Tensile Test Sideport Tubing to Hub o
- Tensile Test Stylet Threads to Proximal Threads O
- O Tensile Test – Distal Hub to Shaft
- Tensile Test Distal Hub to Proximal Hub O
- Tensile Test Stopcock to Sideport Tubing O
General Physical Testing
General physical verification testing was conducted for the devices contained in the Epicardial Access System to ensure compliance with ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. The following general physical tests were performed:
- Epicardial Access Needle: ●
- Corrosion Resistance O
- Epicardial Steerable Guiding Sheath:
- Sheath Surface Defects o
- Sheath Range of Motion and Geometry O
- Sheath Curve Retention and Integrity O
- O Sheath Friction
- Sheath Handle Lubricity o
- Sheath Tip Stiffness O
- Compatibility O
- Dilator Surface Defects O
- O Dilator Flexural Modulus
- Sheath Clinical Valve O
- Epicardial Introducer and Stylet: ●
- Corrosion Resistance O
Biocompatibility Verification
The biological safety of the devices comprising the subject Epicardial Access System was verified in accordance with the requirements of ISO 10993-1:2009/Cor.1:2010 and the June 16, 2016 FDA quidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Sterilization Validation
Sterilization verification was completed for the devices comprising the subject Epicardial Access System to the requirements of ISO 11134-1:2014. Sterilization is performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. Residual limits are in accordance with ISO 10993-7:2008/Cor.1:2009.
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Pvrogen Testina
The Epicardial Access System is supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method was conducted to ensure the devices meet current FDA and USP pyrogen limit specifications.
Packaging Validation
Ship testing was performed on each packaging system in the Epicardial Access System to ensure the integrity of the device packaging through the rigors of shipping and handling. The sterile barrier integrity was validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2) over the shelf life of the device.
Bench-top Validation
Customer requirements that could not be verified through compliance to appropriate standards were validated through a benchtop validation study. A minimum of 15 users drawn from populations familiar with catheter-based procedures were presented with a sequence of actions to perform with a benchtop model representative of a clinical workflow involving the device. Observations regarding ease of use and errors made were recorded and evaluated to conclude if customer requirement were met. The validation testing demonstrated the devices contained in the Epicardial Access System meet the intended use to support substantial equivalence.
Conclusion
The intended use and fundamental scientific technology, including principles of operation and mechanism of action, of the subject Epicardial Access System are identical to those of the predicate St. Jude Medical Agilis™ PF Introducer System (K111943). Differences in design and technological characteristics do not raise any different questions. The results of verification and validation activities provide reasonable assurance for the use of the Epicardial Access System and support the substantial equivalence of the subject and predicate devices.