(20 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 wright 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 Corvocet Biopsy System will be offered as a 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 describes a 510(k) summary for the Corvocet Biopsy System. It outlines the device description, indications for use, comparison to a predicate device, and performance data. However, the document primarily focuses on bench testing (mechanical and functional performance of the device itself), biocompatibility testing, and sterilization validation, rather than clinical performance (e.g., diagnostic accuracy) involving human or simulated human-in-the-loop studies.
Therefore, many of the requested points related to acceptance criteria for AI/clinical performance, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for diagnostic purposes are not applicable or available in this specific document, as the device is a mechanical biopsy instrument, not an AI or imaging diagnostic tool.
I will address the relevant points based on the provided text, and explicitly state when information is not present or not applicable.
Acceptance Criteria and Device Performance for the Corvocet Biopsy System
Based on the provided 510(k) summary for the Corvocet Biopsy System (K180450), the acceptance criteria and performance data primarily revolve around the mechanical and functional aspects of the biopsy instrument, rather than a clinical diagnostic performance (e.g., of an AI algorithm).
1. A table of acceptance criteria and the reported device performance:
The document states that "The results of the testing demonstrated that the subject Corvocet Biopsy System met the predetermined acceptance criteria applicable to the safety and efficacy of the device." However, no specific quantitative acceptance criteria or detailed numerical results are provided in a table format for performance testing, only the types of tests performed are mentioned.
| Performance Test Category | Purpose/Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | To ensure materials used (excluding spacer) are safe for human contact, given their use history in the predicate device for limited duration (≤ 24 hours). The spacer had no direct contact. | All materials (excluding spacer) were used in the predicate device with same intended use, contact, processing, and sterilization, rendering further testing unnecessary. Spacer had no direct/indirect contact. |
| Simulate Use – Biopsy Sample | To ensure the aspect of the biopsy sample is clinically acceptable. | "Met the predetermined acceptance criteria applicable to the safety and efficacy of the device." (Specific results not detailed) |
| Simulate Use – Multiple Samples | To measure the mass of a simulated tissue that is harvested from a biopsy. To confirm that the biopsy device can successfully retrieve biopsy samples multiple cycles. | "Met the predetermined acceptance criteria applicable to the safety and efficacy of the device." (Specific results not detailed) |
| Cycle / Fatigue | To ensure the device joints can withstand multiple cycles without device failure. | "Met the predetermined acceptance criteria applicable to the safety and efficacy of the device." (Specific results not detailed) |
| Device Diameter Compatibility | To evaluate device compatibility with corresponding coaxial introducer. | "Met the predetermined acceptance criteria applicable to the safety and efficacy of the device." (Specific results not detailed) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The performance tests (Simulate Use – Biopsy Sample, Simulate Use – Multiple Samples, Cycle / Fatigue, Device Diameter Compatibility) are bench tests performed on the physical device. The "sample size" here would refer to the number of devices or biopsy cycles tested. This detail is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data for a diagnostic device. The tests are bench tests performed on the physical device. The location of the testing laboratories is not specified, nor is there any mention of retrospective or prospective data collection as it pertains to patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This device is a mechanical biopsy instrument, not a diagnostic imaging or AI algorithm. There is no mention of experts establishing a "ground truth" for diagnostic accuracy. The tests performed are engineering and functional performance tests for the device itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Not relevant for bench testing of a mechanical device. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, especially with multiple readers or challenging cases.
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: No MRMC study was performed or is relevant to this type of device. The Corvocet Biopsy System is a biopsy tool, not an AI-assisted diagnostic system that aids human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device (biopsy system), not an algorithm. There is no "standalone performance" in the sense of an algorithm. Its "performance" is its mechanical function and ability to obtain tissue samples.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the clinical diagnostic sense: Given that this is a mechanical biopsy device, the "ground truth" for its performance would involve whether it successfully obtains a tissue core, the quality and integrity of that core (as observed in a lab setting, "clinically acceptable" aspect mentioned), and the device's mechanical durability and safety. The document states that the "aspect of the biopsy sample is clinically acceptable," implying some form of physical assessment, but no specific "ground truth" methodology (e.g., comparing to pathology slides from a human patient) is detailed as this is a device performance study, not a diagnostic accuracy study.
8. The sample size for the training set:
- Not Applicable: This device is a mechanical product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable: As there is no training set for a machine learning model, this question is not relevant.
In summary: The provided document is a 510(k) summary for a mechanical biopsy instrument. The "study that proves the device meets the acceptance criteria" refers to a series of bench tests and validations concerning the device's mechanical function, material safety (biocompatibility), and sterilization. It does not involve clinical performance studies, AI algorithms, or diagnostic accuracy assessments typical for AI-powered medical devices. Therefore, most of the questions pertaining to those aspects are not addressed in this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2018
Merit Medical Systems, Inc. Ms. Angela Brady Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K180450
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 16, 2018 Received: February 20, 2018
Dear Ms. Brady:
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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
{1}------------------------------------------------
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
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
{2}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K180450 |
|---|---|
| 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) |
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
"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."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
SUCH Services (100) 2446 (100) 244 846 (100 PM
្រះក្
{3}------------------------------------------------
510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4818(801) 316-4878Ms. Angela Brady, MSSenior Regulatory Affairs Specialistabrady@merit.comFebruary 16, 20181721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Corvocet Biopsy SystemBiopsy SystemInstrument, BiopsyIIKNW876.107578 Gastroenterology/Urology |
| PredicateDevice | Trade Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Premarket Notification:Manufacturer:Review Panel: | Corvocet Biopsy SystemInstrument, BiopsyIIKNW876.1075K153337Merit Medical Systems, Inc.78 Gastroenterology/Urology |
{4}------------------------------------------------
| DeviceDescription | Merit's Corvocet Biopsy System is a core needle biopsy deviceintended to obtain core biopsy samples from soft tissues. It is anautomatic device that uses a spring coupled to a cutting needle toobtain full core soft tissue specimens. It has an echo-enhanced tip toaid with visibility under ultrasound, fully adjustable throw length (10-25mm) and depth markings on the needle. The device also features alight wright design, ergonomic grip, dual firing triggers, a readyindicator, and an optional safety interlock.The Corvocet Biopsy System is available in several needle gauge sizesand lengths to accommodate soft tissue biopsy needs. The top andrear firing triggers are color coded according to the various gauge sizes(e.g. yellow = 20G, pink = 18G, purple = 16G, and green = 14G). TheCorvocet Biopsy System will be offered as a stand-alone as well aspaired with the Corvocet™ Coaxial Introducer.The Merit Corvocet Biopsy System is supplied sterile and is intendedfor single use only. |
|---|---|
| Indications forUse | The disposable Corvocet Biopsy System is intended for use inobtaining core biopsy samples from soft tissues such as liver, kidney,prostate, spleen, breast, lung, lymph nodes and various soft tissuetumors. It is not intended for use in bone.There is no change in the Indications for Use Statement from thepredicate to the subject device. |
| Comparison toPredicateDevice | The technological characteristics of the subject Corvocet BiopsySystem are identical to those of predicate device Corvocet BiopsySystem. The subject device has the same basic design as thepredicate device. The main difference between the subject and thepredicate devices is the spacing of internal components were changedto capture and release biopsy samples. The comparison between thesubject and predicate devices is based on the following:• Same intended use• Same indications for use• Similar material types that meet ISO 10993 biocompatibilityrequirements• Same sterilization methods• Same fundamental technology/principal of operation/userinterface |
| PerformanceData | 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 FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" June 2016 ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)] 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 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)] AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1(2014)] ISO 2233:2000, Packaging – Complete, filled transport packages and unit loads – Conditioning for testing ASTM D4169-14:2014, Standard Practice for Performance Testing of shipping Containers and systems ASTM F1980-07:2007, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Reapproved 2011) AAMI/ANSI ST72:2011/(R)2016, Bacterial Endotoxins – Test methods, routine monitoring, and alternatives to batch testing |
{5}------------------------------------------------
{6}------------------------------------------------
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
All materials of the subject device (excluding the spacer) are used in the legally marketed predicate Corvocet Biopsy System with the same intended use, patient contact, processing and sterilization methods. Therefore, no further biocompatibility testing is required for these materials. The spacer is categorized as having no direct or indirect contact with the human body.
The Corvocet Biopsy System is an Externally Communicating Device with Tissue Contact for a Limited (≤ 24 hour) Duration.
Safety & Performance
Performance Testing-Bench
| 1 | |
|---|---|
| ctc16 | CC1L |
Performance Testing-Bench
| Simulate Use –Biopsy Sample | To ensure the aspect of the biopsy sample isclinically acceptable. |
|---|---|
| Simulate Use –Multiple Samples | To measure the mass of a simulated tissue thatis harvested from a biopsy. To confirm that thebiopsy device can successfully retrieve biopsysamples multiple cycles. |
| Cycle / Fatigue | To ensure the device joints can withstandmultiple cycles without device failure. |
| Device DiameterCompatibility | To evaluate device compatibility withcorresponding coaxial introducer. |
The results of the testing demonstrated that the subject Corvocet Biopsy System met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
| Summary ofSubstantialEquivalence | Based on the indications for use, design, and performance testingconducted between the subject Corvocet Biopsy System and thepredicate device, the Corvocet Biopsy System, meets the requirementsthat are considered essential for its intended use and is substantiallyequivalent to the predicate device, the Corvocet Biopsy System,K153337 manufactured by Merit Medical Systems, Inc. |
|---|---|
| ------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.