(127 days)
Not Found
No
The description focuses on the mechanical aspects of the biopsy device and does not mention any AI or ML capabilities.
No.
This device is designed to obtain tissue samples for diagnostic purposes, not to treat a disease or condition.
No
Explanation: The device is a biopsy system used to obtain tissue samples. These samples are then used for diagnosis, but the device itself does not perform the diagnostic function.
No
The device description clearly outlines a physical, mechanical device (core needle biopsy device) with hardware components like a spring, cutting needle, triggers, and an echo-enhanced tip. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Corvocet Biopsy System's Function: The Corvocet Biopsy System is a tool used to obtain the tissue sample from the body. It is an invasive device used in vivo (within the living body) to collect the specimen. It does not perform any analysis or testing on the sample itself.
The tissue sample obtained by the Corvocet Biopsy System would then likely be sent to a laboratory for in vitro diagnostic testing (e.g., pathology, histology), but the biopsy system itself is not the IVD.
N/A
Intended Use / Indications for Use
The disposable Corvocet Biopsy System is intended for use in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
Merit's Corvocet Biopsy System is a core needle biopsy device intended to obtain core biopsy samples from soft tissues. It is an automatic device that uses a spring coupled to a cutting needle to obtain full core soft tissue specimens. It has an echo-enhanced tip to aid with visibility under ultrasound, fully adjustable throw length (10-25mm) and depth markings on the needle. The device also features a light weight design, ergonomic grip, dual firing triggers, a ready indicator, and an optional safety interlock.
The Corvocet Biopsy System is available in several needle gauge sizes and lengths to accommodate soft tissue biopsy needs. The top and rear firing triggers are color coded according to the various gauge sizes (e.g. yellow = 20G, pink = 18G, purple = 16G, and green = 14G). The biopsy system will be offered as stand-alone as well as paired with the Corvocet™ Coaxial Introducer.
The Merit Corvocet Biopsy System is supplied sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
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 included:
- Dimensional verification
- Tensile of joints
- Adjustable throw accuracy
- Multiple Samples
- Cycle/Fatigue
- Device Visibility
- Ink adherence
- Simulated Use
The Corvocet Biopsy System met the acceptance criteria for all performance testing.
Biocompatibility testing included:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Chemical Characterization
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single, unified shape. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2016
Merit Medical Systems, Inc. Ms. Ileana Davis Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K153337
Trade/Device Name: Corvocet Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 25, 2016 Received: February 26, 2016
Dear Ms. Davis:
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 of medical devicerelated 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.
1
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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K153337
Device Name Corvocet Biopsy System
Indications for Use (Describe)
The disposable Corvocet Biopsy System is intended for use in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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
| General
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (801) 208-4187 | |
| Fax Number: | (801) 316-4065 | |
| Contact Person: | Ileana Davis, Regulatory Affairs Specialist | |
| Date Prepared: | 18 November 2015 | |
| Registration Number: | 1721504 | |
| Subject Device | Trade Name: | Corvocet Biopsy System |
| Common/Usual Name: | Biopsy System | |
| Classification Name: | Instrument, Biopsy | |
| Device Class: | II | |
| Product Code: | KNW | |
| Classification Regulation: | CFR 876.1075 | |
| Predicate | ||
| Device | Trade Name: | Max-Core® Disposable Core Biopsy |
| Instrument | ||
| Classification Name: | Instrument, Biopsy | |
| Premarket Notification: | K133948 | |
| Manufacturer: | Bard Peripheral Vascular, Inc. | |
| Device | ||
| Description | Merit's Corvocet Biopsy System is a core needle biopsy device intended | |
| to obtain core biopsy samples from soft tissues. It is an automatic device | ||
| that uses a spring coupled to a cutting needle to obtain full core soft | ||
| tissue specimens. It has an echo-enhanced tip to aid with visibility under | ||
| ultrasound, fully adjustable throw length (10-25mm) and depth markings | ||
| on the needle. The device also features a light weight design, ergonomic | ||
| grip, dual firing triggers, a ready indicator, and an optional safety | ||
| interlock. |
The Corvocet Biopsy System is available in several needle gauge sizes
and lengths to accommodate soft tissue biopsy needs. The top and rear
firing triggers are color coded according to the various gauge sizes (e.g.
yellow = 20G, pink = 18G, purple = 16G, and green = 14G). The biopsy
system will be offered as stand-alone as well as paired with the
Corvocet™ Coaxial Introducer.
The Merit Corvocet Biopsy System is supplied sterile and is intended for
single use only. | |
| Indications for
Use | The disposable Corvocet Biopsy System is intended for use in obtaining
core biopsy samples from soft tissues such as liver, kidney, prostate | |
| intended for use in bone. | | |
| The Indications for Use statement for the Corvocet Biopsy System 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 of obtaining core
biopsy samples from soft tissues. | | |
| The technological characteristics of the subject Corvocet Biopsy System
are substantially equivalent to those of the predicate Max-Core®
Disposable Core Biopsy Instrument. | | |
| Comparison to
Predicate
Device | At a high level, the subject and predicate devices are based on the
following same elements:
• Clinical use
• Labeling
• Basic design
• Principle of operation
• Performance
• Needle gauges | |
| | The following differences exist between the subject and predicate
devices:
• Soft tissues
• Materials
• Adjustable throw length | |
| Performance
Data | FDA guidance and recognized performance standards have been
established for biopsy instrument 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 Biopsy System 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
tubing for manufacture of medical devices
• ISO 6009:1992 – Hypodermic needles for single use – Color
coding for identification | |
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spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not
5
- 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 - 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
- Dimensional verification ●
- Tensile of joints ●
- Adjustable throw accuracy ●
- Multiple Samples ●
- Cycle/Fatigue
- Device Visibility ●
- Ink adherence ●
- Simulated Use .
The Corvocet Biopsy System met the acceptance criteria for all performance testing.
Biocompatibility testing
The biocompatibility evaluation for the Corvocet Biopsy System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" 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:
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| 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 Biopsy System meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Max-Core® Disposable Core Biopsy Instrument, K133948. |