(127 days)
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.
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.
The provided text is a 510(k) summary for the Corvocet Biopsy System. It contains information about the device, its intended use, comparison to a predicate device, and performance data. However, it does not include specific details about a clinical study with a test set, ground truth establishment by experts, sample sizes for training or testing sets, MRMC studies, or standalone algorithm performance.
The submission focuses on bench performance testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the information that is available in the provided text, and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Performance Testing | |
| Dimensional verification | Met the acceptance criteria |
| Tensile of joints | Met the acceptance criteria |
| Adjustable throw accuracy | Met the acceptance criteria |
| Multiple Samples | Met the acceptance criteria |
| Cycle/Fatigue | Met the acceptance criteria |
| Device Visibility | Met the acceptance criteria |
| Ink adherence | Met the acceptance criteria |
| Simulated Use | Met the acceptance criteria |
| Biocompatibility Testing | |
| Cytotoxicity | Met the acceptance criteria |
| Sensitization | Met the acceptance criteria |
| Irritation | Met the acceptance criteria |
| Acute Systemic Toxicity | Met the acceptance criteria |
| Pyrogenicity | Met the acceptance criteria |
| Chemical Characterization | Met the acceptance criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing refers to "Performance Testing - Bench" which implies laboratory testing, not a clinical study with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As there's no mention of a clinical test set with patient data, there's no discussion of experts establishing ground truth for such a set. The performance data relates to mechanical and biological characteristics of the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No clinical test set means no adjudication method described.
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
An MRMC comparative effectiveness study was not conducted. This device is a biopsy instrument, not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical biopsy instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench performance and biocompatibility testing, the "ground truth" used would be established through engineering specifications, recognized standards (e.g., ISO, ASTM), and laboratory protocols. For example, dimensional verification would be compared against design specifications, and biocompatibility tests against established criteria for toxicity. There is no mention of clinical ground truth like pathology or outcomes data for a patient test set.
8. The sample size for the training set
This information is not provided and is not applicable. There is no "training set" as this is not an AI/ML-based device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no training set mentioned or implied.
In summary, the provided document details the regulatory submission for a physical medical device (a biopsy system) and focuses on demonstrating its safety and effectiveness through bench testing against established engineering and biological standards, rather than through clinical studies involving patient data, expert review, or AI algorithms.
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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.
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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
| GeneralProvisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth 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 | |
| PredicateDevice | Trade Name: | Max-Core® Disposable Core BiopsyInstrument |
| Classification Name: | Instrument, Biopsy | |
| Premarket Notification: | K133948 | |
| Manufacturer: | Bard Peripheral Vascular, Inc. | |
| DeviceDescription | Merit's Corvocet Biopsy System is a core needle biopsy device intendedto obtain core biopsy samples from soft tissues. It is an automatic devicethat uses a spring coupled to a cutting needle to obtain full core softtissue specimens. It has an echo-enhanced tip to aid with visibility underultrasound, fully adjustable throw length (10-25mm) and depth markingson the needle. The device also features a light weight design, ergonomicgrip, dual firing triggers, a ready indicator, and an optional safetyinterlock.The Corvocet Biopsy System is available in several needle gauge sizesand lengths to accommodate soft tissue biopsy needs. The top and rearfiring triggers are color coded according to the various gauge sizes (e.g.yellow = 20G, pink = 18G, purple = 16G, and green = 14G). The biopsysystem will be offered as stand-alone as well as paired with theCorvocet™ Coaxial Introducer.The Merit Corvocet Biopsy System is supplied sterile and is intended forsingle use only. | |
| Indications forUse | The disposable Corvocet Biopsy System is intended for use in obtainingcore 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 notidentical to the predicate device; however, the differences do not alterthe intended therapeutic use of the device nor do they affect the safetyand effectiveness of the device relative to the predicate. Both the subjectand predicate devices have the same intended use of obtaining corebiopsy samples from soft tissues. | ||
| The technological characteristics of the subject Corvocet Biopsy Systemare substantially equivalent to those of the predicate Max-Core®Disposable Core Biopsy Instrument. | ||
| Comparison toPredicateDevice | At a high level, the subject and predicate devices are based on thefollowing same elements:• Clinical use• Labeling• Basic design• Principle of operation• Performance• Needle gauges | |
| The following differences exist between the subject and predicatedevices:• Soft tissues• Materials• Adjustable throw length | ||
| PerformanceData | FDA guidance and recognized performance standards have beenestablished for biopsy instrument 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 labeling standardsand guidance. Conformity to these standards demonstrates that theproposed Corvocet Biopsy System met the standards' establishedacceptance criteria applicable to the safety and efficacy of the device.Performance testing was conducted based on the risk analysis andbased 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 single use• ISO 9626:1991 Amendment 1:2001- Stainless steel needletubing for manufacture of medical devices• ISO 6009:1992 – Hypodermic needles for single use – Colorcoding for identification |
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spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not
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- 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 <151> 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. |
§ 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.