(78 days)
The Corvocet Coaxial Introducer is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors.
The Merit Corvocet Coaxial Introducer is used as a guiding needle for a biopsy device obtaining core biopsy samples from soft tissues. It is a three-part disposable device consisting of the following: a stainless steel outer cannula with a female Luer lock hub and an echo-enhanced tip to aid with visibility under ultrasound; a stainless steel inner trocar attached to a unique trocar hub design that allows it to be released by squeezing both sides of the hub; and a flexible silicone slip ring-style depth stop that is color-coded for gauge identification and can be manually adjusted to maintain the depth of the coaxial introducer in a procedure. An optional stainless steel blunt stylet with hub can be included with 17G and 19G coaxial introducers. The blunt stylet may be used to manipulate through soft tissue and around vasculature or other organs to minimize the risk of unintentional damage to these areas. The Merit Corvocet Coaxial Introducer is supplied sterile and is single use only.
This document describes the performance testing and safety evaluations for the Merit Corvocet Coaxial Introducer (K151373) to demonstrate its substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The document lists various performance and biocompatibility tests conducted. For each test category, the report states that the device "met the standards' established acceptance criteria applicable to the safety and efficacy of the device." Specific numerical acceptance criteria and reported device performance values are not provided in this document. Instead, it indicates conformity to recognized standards and guidance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing - Bench | |
| Dimensions | Met established acceptance criteria per ISO standards |
| Tensile of Joints Needle-to-Hub | Met established acceptance criteria per ISO standards |
| Tensile of Joints Trocar-to-Hub | Met established acceptance criteria per ISO standards |
| Tensile of Joints Blunt Stylet-to-Hub | Met established acceptance criteria per ISO standards |
| Luer - Gauging | Met established acceptance criteria per ISO standards |
| Luer Liquid Leakage | Met established acceptance criteria per ISO standards |
| Luer Air Leakage | Met established acceptance criteria per ISO standards |
| Luer Separation Force | Met established acceptance criteria per ISO standards |
| Luer Unscrewing Torque | Met established acceptance criteria per ISO standards |
| Luer Ease of Assembly | Met established acceptance criteria per ISO standards |
| Luer Resistance to Overriding | Met established acceptance criteria per ISO standards |
| Luer Stress Cracking | Met established acceptance criteria per ISO standards |
| Depth Stop | Met established acceptance criteria per ISO standards |
| Introducer Visibility | Met established acceptance criteria |
| Simulated Use | Met established acceptance criteria |
| Biocompatibility Testing | |
| Cytotoxicity | Met established acceptance criteria per ISO 10993 |
| Sensitization | Met established acceptance criteria per ISO 10993 |
| Irritation | Met established acceptance criteria per ISO 10993 |
| Acute Systemic Toxicity | Met established acceptance criteria per ISO 10993 |
| Pyrogenicity | Met established acceptance criteria per USP 37, NF 32 <151> |
| Chemical Characterization | Met established acceptance criteria per ISO 10993 |
Details of the Study:
The provided document describes a series of performance and biocompatibility tests rather than a single "study" in the context of clinical trials involving human subjects or AI algorithms.
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Sample size for the test set and data provenance:
- The document does not specify the sample sizes (e.g., number of needles/introducers tested) for each individual bench test or biocompatibility test.
- The data provenance is from bench testing and laboratory biocompatibility testing of the device components and final product. There is no indication of human subject data or data from specific countries of origin for these tests beyond the device manufacturer's location (South Jordan, Utah, USA).
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Number of experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the tests described are primarily engineering performance tests and laboratory-based biocompatibility evaluations against predefined standards. There is no "ground truth" established by experts in the context of diagnosing conditions or interpreting images.
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Adjudication method for the test set:
- Not applicable for the types of tests described. Results are evaluated against objective criteria outlined in the referenced standards.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No MRMC study was done. This device is an introducer needle for biopsy, not an imaging or diagnostic AI device that would involve human readers.
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Standalone (i.e., algorithm only without human-in-the-loop performance) study:
- No standalone algorithm performance study was done. This device is a physical medical instrument, not an AI algorithm.
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Type of ground truth used:
- The "ground truth" for the performance tests is derived from recognized international and national standards and guidance documents (e.g., ISO standards, ASTM standards, FDA guidance, USP). These standards define the acceptable physical properties, functionality, and biological safety limits for such medical devices.
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Sample size for the training set:
- Not applicable. This is not a machine learning device; therefore, there is no training set in the AI sense. The design and manufacturing processes are likely informed by prior experience and engineering principles.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of AI. The device's design and manufacturing are based on established engineering principles and compliance with the referenced standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Merit Medical Systems Incorporated Ms. Ileana Garcia Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K151373
Trade/Device Name: Corvocet Coaxial Introducer Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: May 20, 2015 Received: May 21, 2015
Dear Ms. Garcia:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (21CFR 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.
Sincerelv vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Corvocet Coaxial Introducer
Indications for Use (Describe)
The Corvocet Coaxial Introducer is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Ref 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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5.0 510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4187(801) 316-4065lleana Garcia, Regulatory Affairs Specialist20 May 20151721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Corvocet Coaxial IntroducerCoaxial IntroducerBiopsy Needle KitFCG876.1075Gastroenterology/Urology |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | TruGuide® Disposable Coaxial Biopsy NeedleBiopsy Needle KitK936194Bard Peripheral Vascular, Inc.This predicate has not been subject to a design-related recall. |
| ReferenceDevice | No reference devices were used in this submission. | |
| DeviceDescription | The Merit Corvocet Coaxial Introducer is used as a guiding needle for abiopsy device obtaining core biopsy samples from soft tissues. It is athree-part disposable device consisting of the following: a stainlesssteel outer cannula with a female Luer lock hub and an echo-enhancedtip to aid with visibility under ultrasound; a stainless steel inner trocarattached to a unique trocar hub design that allows it to be released bysqueezing both sides of the hub; and a flexible silicone slip ring-styledepth stop that is color-coded for gauge identification and can bemanually adjusted to maintain the depth of the coaxial introducer in aprocedure. An optional stainless steel blunt stylet with hub can beincluded with 17G and 19G coaxial introducers. The blunt stylet may beused to manipulate through soft tissue and around vasculature or otherorgans to minimize the risk of unintentional damage to these areas.The Merit Corvocet Coaxial Introducer is supplied sterile and is singleuse only. | |
| Indications for | The Corvocet Coaxial Introducer is intended for use as a guiding | |
| Use | needle in obtaining core biopsy samples from soft tissues such as liver,kidney, prostate, spleen, breast, lung, lymph nodes and various softtissue tumors.The Indications for Use statement for the Corvocet Coaxial Introducer isnot identical to the predicate device; however, the differences do notalter the intended therapeutic use of the device nor do they affect thesafety and effectiveness of the device relative to the predicate. Both thesubject and predicate devices have the same intended use as a guidingneedle in obtaining core tissue samples from soft tissue. | |
| The technological characteristics of the subject Corvocet CoaxialIntroducer are substantially equivalent to those of the predicateTruGuide® Disposable Coaxial Biopsy Needle. | ||
| At a high level, the subject and predicate devices are based on thefollowing same elements: | ||
| Comparison toPredicateDevice | • Clinical use• Labeling• Basic design• Principle of operation• Performance• Needle gauges | |
| The following differences exist between the subject and predicatedevices: | ||
| • Soft tissues• One-handed trocar removal• Materials | ||
| PerformanceData | FDA guidance and recognized performance standards have beenestablished for biopsy needle kit under Section 514 of the Food, Drugand Cosmetic Act. A battery of tests was performed based on therequirements of the below recognized performance standards andguidance, as well as biocompatibility, sterilization, and labelingstandards and guidance. Conformity to these standards demonstratesthat the proposed Corvocet Coaxial Introducer met the standards'established acceptance criteria applicable to the safety and efficacy ofthe device. Performance testing was conducted based on the riskanalysis and based on the requirements of the following documents:• Guidance for the Content of Premarket Notifications for BiopsyDevices Used in Gastroenterology and Urology• ISO 7864:1993 – Sterile hypodermic needles for single use• ISO 7864-2:1993 – Sterile hypodermic syringes and needles –Part 2: Specification for sterile hypodermic needles for singleuse• ISO 9626:1991 Amendment 1:2001- Stainless steel needle |
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- ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for ● syringes, needles, and certain other medical equipment - Part 1: General requirements
- ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for . syringes, needles, and certain other medical equipment - Part 2: Lock fittings
- . ISO 6009:1992 - Hypodermic needles for single use - Color coding for identification
- . ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems
- ASTM D4169-09 Standard Practice for Performance Testing ● of Shipping Containers and Systems
- . ISO 2233:2001 - Packaging - Complete, filled transport packages and unit loads - Conditioning for testing
- ASTM F1980-11 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . ISO 11135:2014 - Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1:2009 Biological evaluation of medical devices -● Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 - Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 Biological evaluation of medical devices -● Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-10:2010 - Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006 - Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- United States Pharmacopoeia 37, National Formulary 32 <151> . Pyrogen Test, 2014.
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing - Bench
- Dimensions ●
- Tensile of Joints Needle-to-Hub ●
- Tensile of Joints Trocar-to-Hub ●
- Tensile of Joints Blunt Stylet-to-Hub ●
- Luer - Gauging
- Luer Liquid Leakage ●
- Luer Air Leakage ●
- Luer Separation Force ●
- Luer Unscrewing Torque ●
- Luer Ease of Assembly ●
- Luer Resistance to Overriding ●
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- Luer Stress Cracking ●
- Depth Stop
- Introducer Visibility ●
- Simulated Use
Biocompatibility testing
The biocompatibility evaluation for the Corvocet Coaxial Introducer was conducted in accordance with the FDA Blue Book Memorandum #G95-Required Biocompatibility Training and Toxicology Profiles for ー Evaluation of Medical Devices, May 1, 1995, and the International Standard ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity ●
- . Sensitization
- Irritation
- Acute Systemic Toxicity ●
- Pyrogenicity
- Chemical Characterization ●
Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing. the subject Corvocet Coaxial Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the TruGuide® Disposable Coaxial Biopsy Needle, K936194.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.