K Number
K201650
Device Name
VMCore Biopsy Needle
Manufacturer
Date Cleared
2021-01-15

(211 days)

Product Code
Regulation Number
876.1075
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle is not intended for use in bone.
Device Description
The VMCore Biopsy Needle Set is a set of two disposable needles used for collection of tissue samples. The set consists of an Outer Cannula and the Core Collector. The needles are made of stainless steel and have a plastic hub attached at their proximal ends.
More Information

No
The summary describes a mechanical biopsy needle and does not mention any AI/ML components or functions.

No.
The device is used for collecting tissue samples (biopsy) for diagnostic purposes, not for treating a disease or condition.

No

The VMCore biopsy needle is used to collect tissue samples. It is a tool for obtaining specimens for analysis, not for diagnosing conditions itself.

No

The device description clearly states it is a set of disposable needles made of stainless steel with plastic hubs, which are physical components, not software.

Based on the provided information, the VMCore biopsy needle is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to collect tissue samples from soft tissues. This is a procedure for obtaining a specimen, not for performing a diagnostic test on a sample in vitro (outside the body).
  • Device Description: The device is a needle designed for tissue collection. It doesn't contain reagents, assays, or components for analyzing biological samples.
  • Lack of Diagnostic Function: The description focuses on the mechanical function of obtaining a tissue sample. There is no mention of the device itself performing any analysis or providing diagnostic information about the collected tissue. The diagnosis would be made by a pathologist examining the collected tissue sample, which is a separate process.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. The VMCore biopsy needle's function is solely to acquire the sample.

N/A

Intended Use / Indications for Use

The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle is not intended for use in bone

Product codes (comma separated list FDA assigned to the subject device)

KNW

Device Description

The VMCore Biopsy Needle Set is a set of two disposable needles used for collection of tissue samples. The set consists of an Outer Cannula and the Core Collector. The needles are made of stainless steel and have a plastic hub attached at their proximal ends.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissues, such as the prostate, lung, kidney, or liver. not intended for use in bone.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospitals, clinics, physician offices

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)

The performance testing conducted establishes that the VMCore Biopsy Needle does not raise new questions of the safety and effectiveness.

Biocompatibility testing:

  • The VMCore Biopsy Needle is made from Stainless Steel 304 and passed cytotoxicity testing following sterilization.
  • The material is the same as was used in the construction of another device marketed by Uro-1, Inc., the Reprise Bladder Injection System (K180214).
  • The results of testing the Repris device for Cytotoxicity, Sensitization, and Irritation are comparable to expected results with the VMCore Biopsy Needle so they were not necessary to repeat.

Mechanical Testing:

  • Dimensions of the device at one-month real-time aging.
  • Volume of tissue collection in an in vitro model.
  • Volume of tissue collected from 3 different depths of insertion in an in vitro model.
  • Measurement of the tissue weight collected in the first sample taken and the last sample taken by the device from an in vitro model.
  • Measure of the strength of the attachment of the hub to the needle.
  • Bend strength of the needle cannula.

Animal Testing: No preclinical testing of the subject device was necessary.

Clinical Studies: No clinical testing of the subject device was necessary.

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.

K092059

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.

K180214

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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January 15, 2021

URO-1, Inc. Thomas Lawson, Ph.D. Director, Regulatory Affairs 111 North Chestnut Street. Suite 106 Winston Salem, NC 27101

Re: K201650 Trade/Device Name: VMCore Biopsy Needle Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: December 14, 2020 Received: December 15, 2020

Dear Thomas Lawson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thelma Valdes, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201650

Device Name VMCore Biopsy Needle

Indications for Use (Describe)

The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle 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)☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5.

510(k) SUMMARY

General Information

SubmitterURO-1, Inc.
AddressURO-1, Inc.
111 North Chestnut Street
Suite 106
Winston Salem, NC 27101
FDA Registration NumberNo yet assigned
Correspondence PersonThomas Lawson, PhD
Contact InformationEmail: drthomlawson@gmail.com
Phone: 510-206-1794
Date Prepared15 January 2021

Proposed Device

Trade NameVMCore Biopsy Needle
Common NameVMCore Biopsy Needle
Regulation Number and21 CFR§876.1075, Gastroenterology-Urology Biopsy
Classification NameInstrument
Product CodeKNW
Regulatory ClassII

Predicate Device

Trade NameRP Cutting Needle
Common NameRP Cutting Needle
Premarket NotificationK092059
Regulation Number and
Classification Name21 CFR§876.1075, Gastroenterology-Urology Biopsy
Instrument
Product CodeKNW
Regulatory ClassII
Note: This predicate device has not been subject to a design-related recall.

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Trade NameReprise Bladder Injection System
Common NameReprise Injector
Premarket NotificationK180214
Regulation Number and
Classification Name21 CFR§876.1500, Endoscope and Accessories
Product CodeFBK
Regulatory ClassII
Note: This reference device has not been subject to a design-related recall.

Device Description

The VMCore Biopsy Needle Set is a set of two disposable needles used for collection of tissue samples. The set consists of an Outer Cannula and the Core Collector. The needles are made of stainless steel and have a plastic hub attached at their proximal ends.

Indications for Use

The indications for use for the VMCore Biopsy Needle is:

The VMCore Biopsy Needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissue, such as prostate, lung, kidney, or liver. The VMCore Biopsy Needle is not intended for use in bone.

Both the subject device and the predicate device have intended use of obtaining tissue samples during biopsy of soft tissue.

Comparison of Technological Characteristics with the Predicate Device

URO-1, Inc. has identified the RP Cutting Needle (K092059) as the predicate device. The VMCore Biopsy Needle is substantially equivalent to the predicate device based upon the following similarities:

  • The intended use of the predicate device and the subject device is for obtaining 1. biopsies from soft tissue;
    1. The two devices are introduced into the body under imaging control;

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    1. Both needles are advanced into tissue via a biopsy gun, specifically the Bard Magnum Biopsy Reusable Biopsy Instrument;
    1. The subject device is similar to the predicate device in terms of dimensions of the needles: and
  • న్. Both devices are made from biocompatible materials.

The Repris Bladder Injection System (K180214) is also manufactured for Uro-1, Inc. and is a reference device in this submission since the VMCore Biopsy Needle will use the material for its needles as did the Repris device, will be packaged in the exact same pouch as is the Repris device for a single unit, they both are sterilized by radiation.

Subject DevicePredicate Device
VMCore Biopsy
NeedleRP Cutting Needle
(Riverpoint Medical)
(URO-1, Inc.)
(This Submission)K092059
Device ClassIIII
FDA Product CodeKNWKNW
Product
Classification876.1075876.1075
Indication for UseThe VMCore Biopsy
Needle is indicated for
use with the Bard
Magnum reusable
biopsy instrument for
biopsies of soft tissue,
such as prostate, lung,
kidney, or liver.The RP Cutting Needle is
indicated for use by
medical professionals
with the Bard Magnum
reusable biopsy
instrument for biopsies of
soft tissue, such as liver,
lung, kidney, or prostate.
Intended useTo obtain biopsies from
soft tissue, such asTo obtain biopsies from
soft tissue, such as liver,

Comparison of the VMCore Biopsy Needle to the predicate device, the RP Cutting Needle.

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VMCore Biopsy Needle

prostate, lung, kidney, or liver. It is not intended for use in bone.lung, kidney, or prostate. It is not intended for use in bone.
Technical
Characteristics
Components of the
SetOuter Cannula
Core Collector NeedleOuter Cannula
Biopsy Needle
Outer Diameter
(OD) of needle16 & 18 gauge14 to 20 gauge
Length of needle
assembly20 cm and 25 cm10 and 25 cm
Needle materialStainless SteelSame
Needle hub
materialPolycarbonate
Acrylonitrile butadiene
styrene (ABS)Plastic not identified in
labeling
Operational
Characteristics
Mechanism of
actionSingle puncture and
sampleSame
Accessory DeviceBard Magnum Biopsy
InstrumentSame
Method of
advancementAdvanced under image
guidanceSame
Location of
ProcedureHospitals, clinics,
physician officesSame
Duration of use