(77 days)
The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.
The EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit that includes pre-programmed diagnostic computer with a touchscreen display and graphical user interface (GUI).
The provided text extensively details the non-clinical and clinical studies conducted for the EpiAccess System, but it does not explicitly state specific quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating that the device meets design requirements, functions as intended, and is safe and effective through various tests compliant with recognized standards.
Despite the lack of explicit acceptance criteria values, the document implies that the device successfully met all implicit criteria of the conducted tests to achieve its 510(k) clearance.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit quantitative acceptance criteria are not provided in the document. However, the reported device performance is broadly stated as:
| Test/Category | Implicit Acceptance Criteria (implied) | Reported Device Performance | Study Type |
|---|---|---|---|
| Non-Clinical Testing | Compliance with relevant ISO and AAMI standards for dimensional, performance, electrical safety, EMC, pressure transducer, biocompatibility, sterilization, shelf life, packaging, and software. | The EpiAccess System functioned as intended and results observed were as expected. Confirmed device is safe, meets design inputs, and raises no new safety or efficacy concerns. | Bench, Animal |
| Biocompatibility Testing | Passed required tests for patient-contacting materials. | L929 Neutral Red Uptake Cytotoxicity Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Rabbit Pyrogen Test, Hemolysis Rabbit Blood Complement Activation Assay, Unactivated Partial Thromboplastin Time Assay all passed. | Bench |
| Sterilization & LAL Pyrogen Validation | Compliance with relevant ANSI/AAMI/ISO standards and FDA Guidance. | Compliance demonstrated. | Bench |
| Shelf Life & Packaging Validation | Compliance with relevant ASTM standards. | Compliance demonstrated. | Bench |
| Software Validation | Compliance with BS EN ISO 62304 and FDA Guidance. | Compliance demonstrated. | Bench |
| Comparative Animal Studies | Compliance with 21 CFR § 54 and FDA Guidance for cardiovascular devices. | Successfully demonstrated comparative usability, ensuring the device performs similarly or better than predicate devices. | Animal |
| Usability and Human Factors Testing | Compliance with SI/AAMI HE 75, IEC 62366, and FDA Guidance. | Demonstrated usability and addressed human factors. | Human Factors Study |
| Clinical Performance (Technical Success) | Ability to safely access the pericardial space and deliver a guidewire. | 100% technical success. | Clinical |
| Clinical Performance (Adverse Events) | Absence of serious adverse events or adverse events related to the device. | No serious adverse events and no adverse events related to the EpiAccess System. | Clinical |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical/Bench Testing: The document does not specify sample sizes for individual bench tests (dimensional, electrical, biocompatibility, etc.).
- Animal Studies: The sample size for comparative usability testing in animals is not specified. Data provenance is not specified (e.g., country of origin, specific animal models).
- Clinical Study (Test Set): "[T]o date there has been 100% technical success, no serious adverse events, and no adverse events related to the EpiAccess System." This implies an ongoing study. The exact number of patients enrolled to date for the purpose of this 510(k) submission is not explicitly stated.
- Data Provenance: European study (EASe Study - ClinicalTrials.gov Identifier: NCT02209064). This is a prospective, post-market clinical follow-up study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical/Bench/Animal Data: Not applicable in the context of expert ground truth.
- Clinical Data: The document does not specify the number or qualifications of experts (e.g., clinicians, electrophysiologists) involved in assessing technical success or adverse events in the EASe clinical study. However, clinical trials inherently involve medical professionals.
4. Adjudication Method for the Test Set
- Clinical Data: The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical study results. Adverse events and technical success are typically reviewed by clinical investigators and potentially a data safety monitoring board, but the specific process isn't detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The EpiAccess System is a medical device (introducer needle with pressure transducer), not an AI-assisted diagnostic imaging tool with "readers." The "AI" component is a "pre-programmed diagnostic computer" which processes internal pressure transducer data and external A-line data, not images for human interpretation. The clinical study assessed the device's technical success, ease of use, and clinical benefit of its pressure frequency information display, and adverse events, not its impact on human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence, standalone performance of the pressure transducer and its processing unit was assessed as part of the non-clinical testing. The "pre-programmed diagnostic computer" and the integrated pressure transducer were tested to standards like AAMI/ANSI BP22 and IEC 60601-2-34 which evaluate the accuracy and reliability of pressure measurement independent of human interpretation. While a human uses the device and interprets the displayed pressure information, the foundational performance of the measurement system itself is evaluated as a standalone component. The device "displays the pressurement information, which physicians may be able to use to determine needle tip location," but it "does not alert the user to tip location or provide clinical decision guidance," implying the algorithm's direct output is raw pressure data, not a diagnostic interpretation requiring human-in-the-loop validation for its accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical/Bench Testing: Ground truth was established by adherence to recognized international and national standards (e.g., ISO, ASTM, AAMI, IEC) which define expected performance characteristics and measurement accuracy. For biocompatibility, it was based on standard biological test outcomes.
- Clinical Study: Ground truth for technical success (safe access and guidewire delivery) was based on clinical observation and procedural outcomes during the epicardial electrophysiology procedures. Adverse events were identified through clinical monitoring and reporting.
8. The Sample Size for the Training Set
- Not Applicable. The EpiAccess System is a hardware device with an integrated pre-programmed diagnostic computer, not a machine learning model that undergoes a "training phase" with a labeled dataset in the conventional sense. The "pre-programmed" nature suggests fixed algorithms for pressure data processing, validated against engineering and physiological standards.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, there is no "training set" in the context of machine learning for this device. The device's "programming" and performance are validated against established engineering principles and medical standards during its design and verification phases.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2014
EpiEP, Inc. % Elsa Abruzzo President & CEO Cygnus Regulatory, LLC 8 Grandin Lane Cincinnati. Ohio 45208
Re: K142245
Trade/Device Name: EpiAccess System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRS, DXG Dated: August 11, 2014 Received: August 13, 2014
Dear Elsa Abruzzo,
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. 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 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 (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): _ K142245
Device Name: EpiAccess System
Indications for Use:
The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Page 1_of 1
{3}------------------------------------------------
510(k) SUMMARY EpiEP, Inc.'s EpiAccess System
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
EpiEP, Inc.
Phone: 513-236-0857 Facsimile: 513-898-2106
Contact Person: Elsa Chi Abruzzo, RAC, FRAPS Date Prepared: October 21, 2014
Name/Address of Sponsor
EpiEP, Inc. 142 Temple Street, Suite 206 New Haven, CT 06510, USA
| Trade Name: | EpiAccess System | ||
|---|---|---|---|
| Common or Usual Name | Epicardial Introducer System | ||
| Classification Name | Introducer, Catheter | ||
| Extravascular Blood Pressure Transducer | |||
| Single-Function, Preprogrammed Diagnostic Computer | |||
| Classification: | Class II | ||
| Product Code andRegulation: | DYB, 21 CFR 870.1340DRS, 21 CFR 870.2850DXG, 21 CFR 870.1435 | ||
| Classification Panel: | Cardiovascular | ||
| Predicate Devices: | St Jude Medical | Agilis PF Introducer System andAccessories | K11194- |
| MiradorBiomedical. Inc. | Compass™ GPCompass™ ThoracentesisCompass™ ParacentesisCompass™ Compartment PressureCompass™ Epidural AssistCompass™ Arterial Assist | K11220- |
Intended Use / Indications for Use
The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.
{4}------------------------------------------------
Technological Characteristics
The EpiAccess System consists of the following components and accessories: a sterile, single-use (disposable) Tuohy Type Needle with an integrated, distal, needle tip pressure transducer (sensor), and a reusable integrated Control Unit that includes pre-programmed diagnostic computer with a touchscreen display and graphical user interface (GUI).
The subject EpiAccess Needle is very similar or the same in design, dimensions, materials, packaging, sterilization, and intended use to the, primary predicate, the St. Jude Agilis PF Introducer. With the exception of minor dimensional differences and addition of an integrated (nonpatient contacting) fiber optic pressure transducer, the EpiAccess Needle has the same technological characteristics as the predicate introducer needle and same intended use.
The EpiAccess Control Unit provides the EpiAccess System with the additional convenience feature of integrated, direct physiological pressure measurement at the EpiAccess Needle tip. The EpiAccess Control Unit also receives input from commercially available arterial line (A-line) catheters and commercially available A-line pressure transducers. These accessories are readily available standard equipment in electrophysiology labs. A-line catheter pressure measurements are routine in electrophysiology procedures. The A-line pressure measurement function is also provided for user convenience and is displayed along with the needle tip pressure measurement on the EpiAccess user interface. The direct physiological pressure measurement functionality and indication is equivalent to that of the secondary predicate the Mirador Compass Digital Pressure Transducers (available in various models for use with various introducer needles for various anatomies).
The EpiAccess System displays the pressurement information, which phycians may be able to use to determine needle tip location based on known anatomical pressure differences. This additional information regarding needle tip location is an added convenience feature over standard Tuohy introducer needles for epicardial access. The system does not alert the user to tip location or provide clinical decision guidance. The EpiAccess Needle is placed under visualization with fluoroscopic imaging standard for electrophysiology procedures.
Performance Data
Bench, animal, and clinical tests were conducted on the EpiAccess System to demonstrate that it meets defined design requirements and can perform in a manner equivalent to devices currently on the market used for subxiphoid epicardial access and that provide pressure measurements. Testing included verification and validation testing, comparative usability testing in animals, human factors evaluations per the available guidances, and an assessment of clinical performance.
Manufacturing and traceability of devices tested were conducted in accordance with 21 CFR 820 Good Manufacturing Practices and BS EN ISO 13485:2003 Medical Devices – Quality Management Systems - Requirements for Requlatory Purposes. In all instances, the EpiAccess System functioned as intended and results observed were as expected. These test results confirm that EpiAccess System is safe, meets the design inputs, and raises no new safety or efficacy concerns. A summary of the EpiAccess Systems design control activities with regards to risk analysis and verification and validation activities is provided in this 510 (k) submission.
{5}------------------------------------------------
Nonclinical testing included:
Dimensional and Performance testing per the applicable sections of:
| ISO 594-2: 1998 | International Standard - Conical Fittings With 6 (Luer) Taper for Syringes, |
|---|---|
| Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings | |
| SO 594-1: 1986 | International Standard - Conical Fittings With 6 (Luer) Taper For Syringes, |
| Needles, and Certain Other Medical Equipment - Part 1 General Requirements | |
| ISO 7864: 1993 | International Standard - Sterile Hypodermic Needles for Single-Use |
| ISO 9626: 2001 | International Standard - Stainless Steel Needle Tubing for The Manufacture of |
| Medical Devices - Amendment 1 | |
| BS EN ISO 14971:2012 | Medical Devices - Application of Risk Management to Medical Devices |
Electrical Safety and Electromagnetic Compatibility (EMC) per the applicable sections of:
| ANSI/AAMI/IEC 60601-1-2:2007 | Medical Electrical Equipment - Part1-2: General Requirements for Basic Safetyand Essential Performance - Collateral Standard: Electromagnetic Compatibility– Requirements and Tests |
|---|---|
| IEC 60601-1 3rdEdition:2012 | International Standard - Medical Electrical Equipment - General Requirementsfor Basic Safety and Essential Performance |
| EN 61000 3-2: 2006 | Electromagnetic Compatibility (EMC) Part 3-2: Limits –Limits for HarmonicCurrent Emissions |
| EN 61000-3-3: 2008 | Electromagnetic Compatibility (EMC) Part 3-3: Limits – Limitation of VoltageCharges, Voltage Fluctuations and flick in low voltage supply systems. |
Pressure transducer testing per applicable sections of the recognized standards for product:
| AAMI/ANSI BP22:1994(R) 2011 | Blood pressure transducers |
|---|---|
| IEC 60601-2-34 Edition3.0 2011-05 | Medical electrical equipment - Part 2-34: Particular requirements for the basicsafety, including essential performance, of invasive blood pressure monitoringequipment |
Biocompatibilty Testing per relevant sections of ISO 10993, including:
| BS EN ISO 10993-11:2009 | Biological Evaluation of Medical Devices – Part 11: Tests for SystemicToxicity (ISO 10993-11:2006) |
|---|---|
| BS EN ISO 10993-4:2009 | Biological Evaluation of Medical Devices – Part 4: Selection of Tests forInteractions With Blood |
| BS EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: test for in vitrocytotoxicity |
| BS EN ISO 10993-10:2009 | Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization. |
Biocompatibilty testing passed for patient contacting materials included: L929 Neutral Red Uptake Cytotoxicity Test Kligman Maximization Test
- Intracutaneous Injection Test Systemic Injection Test Rabbit Pyrogen Test (Material Mediated) Hemolysis Rabbit Blood Complement Activation Assay
Unactivated Partial Thromboplastin Time Assay
{6}------------------------------------------------
Sterilization and LAL Pyrogen validation in compliance with applicable sections of:
| ANSI/AAMI/ISO 11135-1:2007 | Sterilization of Healthcare Products - Ethylene Oxide - Part 1:Requirements for Development, Validation, and Routine Control of aSterilization Process for Medical Devices |
|---|---|
| ISO 10993-7: 2008 | Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals. |
| ANSI/AAMI/ISO 11737-1:2006 | Sterilization of Medical Devices - Microbiological Methods - Part I:Determination of a Population of Microorganisms on Products |
| ANSI/AAMI/ISO 11737-2:2009 | Sterilization of Medical Devices - Microbiological methods - part 2: Testsof Sterility Performed in the Validation of a Sterilization Process |
| AAMI TIR: 16:2000 | Process development and performance qualification for ethylene oxidesterilization - Microbiological aspects |
| AAMI ST72: 2002(R) 2010 | Bacterial endotoxins - Test methodologies, routine monitoring andalternative to batch testing. (Sterility) |
| FDA Guidance (Jun 2012) | Guidance for Industry: Pyrogen and Endotoxins Testing: Questions andAnswers |
| FDA Guidance (Dec 12, 2008) | Draft Guidance for Industry and FDA Staff: Submission and Review ofSterility Information in Premarket Notification 510 (k) Submissions forDevices Labeled as Sterile. |
| FDA Guidance (Aug 30, 2002) | Updated 510 (k) Sterility Review Guidance K90-1: Guidance for Industryand FDA |
Shelf Life and Packaging validation in compliance with applicable sections of:
| ASTM F88-09 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
|---|---|
| ASTM D4169-09 | Standard Practice for Performance Testing of Shipping Containers andSystems |
| ASTM F1929: 2012 | Standard Test Method for Detecting Seal Leaks in Porous MedicalPackaging by Dye Penetration |
| ASTM F1980: 2007 | Standard Test Method for Accelerated Aging of Sterile Barrier Systemsfor a Medical Device |
| ASTM D5276: 1998 | Standard Test Method for Drop Test of Loaded Containers by Free Fall |
| ASTM D642: 2010 | Test method for determining compressive resistance of shippingcontainers and unit loads |
| ASTM D999:2008 | Test methods for vibration testing of shipping containers |
| ASTM D6653: 2013 | Test methods for Low Pressure (high altitude) |
| ASTM D4728: 2011 | Test methods for random vibration |
| ASTM D6344: 2009 | Test methods for concentrated impacts |
Software validation in compliance with applicable sections of:
| BS EN ISO 62304:2006 | Medical Device Software – Software Life Cycle Processes |
|---|---|
| FDA Guidance (Jan 11, 2012) | General Principles of Software Validation; Final Guidance for Industry andFDA Staff |
| FDA Guidance (Sep 9, 1999) | Off-The-Shelf Software Use in Medical Devices |
Comparative Animal Studies in compliance with applicable sections of:
| 21 CRF § 54 | Good Laboratory Practices |
|---|---|
| FDA Guidance (Jul 29, 2010) | Guidance for Industry and FDA Staff: General Considerations for AnimalStudies for Cardiovascular Devices |
Usability and Human Factors Testing in compliance with applicable sections of:
| SI/AAMI HE 75 | Human Factors engineering Design of Medical Devices |
|---|---|
| IEC 62366:2007 | Medical Devices - Application of Usability Engineering to MedicalDevices |
| FDA Guidance (Jun 22, 2011) | Human Factors Draft Guidance |
{7}------------------------------------------------
Clinical data were obtained via the Epicardial Access Study. A Post Market Clinical Follow-up Study -Europe (EASe) (ClincialTrials.gov Identifier: NCT02209064). This is a European study for the purpose of collecting post marketing data of the CE Marked EpiAccess System. The study subjects are eligible adult patients undergoing epicardial electrophysiology procedures accessed via a minimally invasive subxiphoid approach. The study report supporting this notification summarizes and discusses the clinical results, including technical success (ability to safely access the pericardial space and deliver a guidewire), ease of use and clinical benefit of the pressure frequency information display, and adverse events. To date there has been 100% technical success, no serious adverse events, and no adverse events related to the EpiAccess System.
| 42 U.S.C. 282(j), Section402(j) of the Public HealthServe Act, enacted by 121 Stat.823 Public Law 110-85 | Compliance with Clinicaltrials.gov registration |
|---|---|
| ISO 14155:2011 | International Standard - Technical Corrigendum 1 – Clinical Investigation ofMedical Devices for Human Subjects – Good Clinical Practice |
| MEDDEV 2.7.1 Rev 3 | Guidelines on Medical Devices - Clinical Evaluation: A Guide for Manufacturersand Notified Bodies |
| 21 CFR Part 50 | Good Clinical Practices- Human Subject Protection |
| 21 CFR Part 54 | Financial Disclosures By Clinical Investigators |
| 21 CFR Part 56 | Good Clinical Practices - Informed Consent |
Clinical testing complies with applicable sections of:
Substantial Equivalence
The EpiAccess System has the same intended use, and similar indications for use and technological characteristics as the predicate devices. The technological characteristics of the EpiAccess Needle are substantially equivalent to the primary predicate device the St. Jude Medical Agilis PF Introducer System including packaging, biocompatibility, sterilization, and labeling. Where differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed device or different question of safety and efficacy.
The addition of integrated pressure measurement at the needle tip for an epicardial introducer needle does not change the overall intended use or raise different questions of safety and efficacy. This additional feature serves the same purpose as other separate pressure wires that can be used in conjunction with the Agilis™ PF predicate, disposable pressure transducer wires/displays that attach to introducer needles, or other devices for epicardial access. The EpiAccess simply offers the user the additional convenience of having this capability integrated with the needle component. The Mirador Compass provides similar pressure measurement capability for use with introducer needles. The addition of this feature, integrated with the EpiAccess needle, enhances user convenience and does not alter the intended use of the EpiAccess System relative to its predicates.
The results from preclinical and clinical testing demonstrate that the technological and performance characteristics of the EpiAccess System meet defined design requirements and can perform in a manner equivalent to devices currently on the market used for epicardial access and quidewire delivery and measuring physiological pressure. Performance data demonstrate that the EpiAccess System performs as intended and is substantially equivalent to its predicates.
Conclusions
The data and information presented within this submission support a determination of substantial equivalence to the predicates listed above, and therefore market clearance of the subject EpiAccess System for its intended use. This conclusion is based upon the device similarities in design, materials technological characteristics, principles of operation, and indications for use.
§ 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).