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.

AI/ML Overview

The provided text describes a 510(k) summary for the VMCore Biopsy Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a clinical study with detailed metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.

Therefore, the information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy, along with details about study design (sample size, ground truth, expert adjudication, MRMC studies, effect size, standalone performance, training set details), is not present in the provided document.

This submission focuses on:

Intended Use and Indications for Use: Demonstrating the VMCore Biopsy Needle has the same intended use as the predicate device (obtaining soft tissue biopsies).
Technological Characteristics Comparison: Showing that the VMCore Biopsy Needle has technological characteristics similar to its predicate device (RP Cutting Needle, K092059) and a reference device (Reprise Bladder Injection System, K180214). This includes materials, dimensions, mechanism of action, and accessory devices.
Performance Data (Non-Clinical): Providing testing results for biocompatibility and mechanical properties to show that the new device does not raise new questions of safety and effectiveness.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of diagnostic accuracy for this submission. The "acceptance criteria" presented are related to non-clinical performance and substantial equivalence, not statistical measures of diagnostic performance typically associated with AI/ML devices.

Non-Clinical Performance Data (as reported):

Performance Test	Reported Device Performance
Biocompatibility	VMCore Biopsy Needle made from Stainless Steel 304, passed cytotoxicity testing after sterilization. (Reference made to Reprise Bladder Injection System (K180214) for comparable results on Cytotoxicity, Sensitization, and Irritation tests.)
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 and last sample from an in vitro model.- Strength of the attachment of the hub to the needle.- Bend strength of the needle cannula.

Important Note: For each mechanical test, the document states what was measured but does not provide specific numerical outcomes or pre-defined acceptance limits (e.g., "volume of tissue collected was X mL, meeting criterion of > Y mL"). It simply states that the testing "establishes that the VMCore Biopsy Needle does not raise new questions of the safety and effectiveness."

Missing Information (for an AI/ML diagnostic device study):

Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing of a physical biopsy needle.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not discussed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device. The "ground truth" for a biopsy needle's performance is typically its ability to collect a tissue sample suitable for pathological examination, and its safety/material properties.
The sample size for the training set: Not applicable. There is no AI/ML algorithm involved requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (biopsy needle), not an AI/ML-based diagnostic device. Therefore, the detailed performance metrics and study design elements you requested, which are typical for AI/ML device evaluations, are not present in this submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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.

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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)

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

Submitter	URO-1, Inc.
Address	URO-1, Inc.111 North Chestnut StreetSuite 106Winston Salem, NC 27101
FDA Registration Number	No yet assigned
Correspondence Person	Thomas Lawson, PhD
Contact Information	Email: drthomlawson@gmail.comPhone: 510-206-1794
Date Prepared	15 January 2021

Proposed Device

Trade Name	VMCore Biopsy Needle
Common Name	VMCore Biopsy Needle
Regulation Number and	21 CFR§876.1075, Gastroenterology-Urology Biopsy
Classification Name	Instrument
Product Code	KNW
Regulatory Class	II

Predicate Device

Trade Name	RP Cutting Needle
Common Name	RP Cutting Needle
Premarket Notification	K092059
Regulation Number andClassification Name	21 CFR§876.1075, Gastroenterology-Urology BiopsyInstrument
Product Code	KNW
Regulatory Class	II
Note: This predicate device has not been subject to a design-related recall.

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Trade Name	Reprise Bladder Injection System
Common Name	Reprise Injector
Premarket Notification	K180214
Regulation Number andClassification Name	21 CFR§876.1500, Endoscope and Accessories
Product Code	FBK
Regulatory Class	II
Note: This reference device has not been subject to a design-related recall.

Device Description

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 Device	Predicate Device
	VMCore BiopsyNeedle	RP Cutting Needle(Riverpoint Medical)
	(URO-1, Inc.)(This Submission)	K092059
Device Class	II	II
FDA Product Code	KNW	KNW
ProductClassification	876.1075	876.1075
Indication for Use	The VMCore BiopsyNeedle is indicated foruse with the BardMagnum reusablebiopsy instrument forbiopsies of soft tissue,such as prostate, lung,kidney, or liver.	The RP Cutting Needle isindicated for use bymedical professionalswith the Bard Magnumreusable biopsyinstrument for biopsies ofsoft tissue, such as liver,lung, kidney, or prostate.
Intended use	To obtain biopsies fromsoft tissue, such as	To obtain biopsies fromsoft 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.
TechnicalCharacteristics
Components of theSet	Outer CannulaCore Collector Needle	Outer CannulaBiopsy Needle
Outer Diameter(OD) of needle	16 & 18 gauge	14 to 20 gauge
Length of needleassembly	20 cm and 25 cm	10 and 25 cm
Needle material	Stainless Steel	Same
Needle hubmaterial	PolycarbonateAcrylonitrile butadienestyrene (ABS)	Plastic not identified inlabeling
OperationalCharacteristics
Mechanism ofaction	Single puncture andsample	Same
Accessory Device	Bard Magnum BiopsyInstrument	Same
Method ofadvancement	Advanced under imageguidance	Same
Location ofProcedure	Hospitals, clinics,physician offices	Same
Duration of use	< 24 hours	< 24 hours
Single-use catheter	Yes	Yes
Provided Sterile	Yes	Yes

Performance Data

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. This material is the same as was used in the construction of another device marketed by Uro-1, Inc., the Reprise Bladder Injection System, and that

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K201650

device was reviewed and cleared under K180214. The results of testing the Repris device for the following tests:

o Cytotoxicity;
Sensitization; and O
Irritation. o

are comparable to expected results with the VMCore Biopsy Needle so they were not necessary to repeat.

Mechanical Testing

The mechanical testing of the subject device included:

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; and ●
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.

Conclusion

The information submitted in this premarket notification confirms that the VMCore Biopsy Needle raises no new questions of safety and effectiveness and that the VMCore Biopsy Needle is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.