(78 days)
No reference devices were used in this submission.
No
The device description focuses on mechanical components and physical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are also focused on physical and material properties.
No.
The device is used to guide a biopsy device and obtain samples, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: This device is an introducer for obtaining biopsy samples, which are subsequently analyzed for diagnosis. It does not perform the diagnostic analysis itself.
No
The device description explicitly details physical components made of stainless steel and silicone, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a guiding needle for obtaining core biopsy samples from soft tissues. This is a surgical or procedural device used to collect a sample from the body.
- Device Description: The description details a physical needle and its components used for insertion into the body to facilitate tissue collection.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnostic purposes. This device is used to obtain the specimen, not to analyze it.
The device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test, but the device itself is not performing the diagnostic analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
FCG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors.
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)
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
- Luer Stress Cracking
- Depth Stop
- Introducer Visibility
- Simulated Use
Biocompatibility testing:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Chemical Characterization
Conformity to established standards and guidance demonstrates that the proposed Corvocet Coaxial Introducer met the standards' established acceptance criteria applicable to the safety and efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design, suggesting a connection between health, humanity, and national service.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5.0 510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4187
(801) 316-4065
lleana Garcia, Regulatory Affairs Specialist
20 May 2015
1721504 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Corvocet Coaxial Introducer
Coaxial Introducer
Biopsy Needle Kit
FCG
876.1075
Gastroenterology/Urology |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | TruGuide® Disposable Coaxial Biopsy Needle
Biopsy Needle Kit
K936194
Bard Peripheral Vascular, Inc.
This predicate has not been subject to a design-related recall. |
| Reference
Device | | No reference devices were used in this submission. |
| Device
Description | 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. | |
| 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 soft
tissue tumors.
The Indications for Use statement for the Corvocet Coaxial Introducer is
not identical to the predicate device; however, the differences do not
alter the intended therapeutic use of the device nor do they affect the
safety and effectiveness of the device relative to the predicate. Both the
subject and predicate devices have the same intended use as a guiding
needle in obtaining core tissue samples from soft tissue. | |
| | The technological characteristics of the subject Corvocet Coaxial
Introducer are substantially equivalent to those of the predicate
TruGuide® Disposable Coaxial Biopsy Needle. | |
| | At a high level, the subject and predicate devices are based on the
following same elements: | |
| Comparison to
Predicate
Device | • Clinical use
• Labeling
• Basic design
• Principle of operation
• Performance
• Needle gauges | |
| | The following differences exist between the subject and predicate
devices: | |
| | • Soft tissues
• One-handed trocar removal
• Materials | |
| Performance
Data | FDA guidance and recognized performance standards have been
established for biopsy needle kit under Section 514 of the Food, Drug
and Cosmetic Act. A battery of tests was performed based on the
requirements of the below recognized performance standards and
guidance, as well as biocompatibility, sterilization, and labeling
standards and guidance. Conformity to these standards demonstrates
that the proposed Corvocet Coaxial Introducer met the standards'
established acceptance criteria applicable to the safety and efficacy of
the device. Performance testing was conducted based on the risk
analysis and based on the requirements of the following documents:
• Guidance for the Content of Premarket Notifications for Biopsy
Devices 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 single
use
• ISO 9626:1991 Amendment 1:2001- Stainless steel needle | |
4
5
- 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 . 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 ●
6
- 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.