The SUREcore Plus biopsy instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease condition in a patient. The SUREcore Plus device consists of two elements: (1) a handle and (2) a needle set. The handle contains springs that energize the biopsy needles and when used will cause rapid advance of the needles into target tissue. This action causes tissue to be held within a component of the needle (the core collector) intact from the body. The tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. The user can re-energize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue. When the user has determined that sufficient amount of tissue has been obtained, the SUREcore Plus device is disposed in accordance with local and facility policies and procedures. The device is single-use only and is not to be resterilized by the user.

AI/ML Overview

This document is a 510(k) Premarket Notification from Uro-1, Inc. for their SUREcore Plus Biopsy Instrument. It focuses on demonstrating substantial equivalence to a predicate device, the Max-Core Biopsy Instrument. Therefore, the information provided primarily addresses the comparison between the proposed and predicate device, and the performance data presented is related to mechanical testing and biocompatibility of the device itself, not a study evaluating human reader performance with or without AI (MRMC study) or standalone AI algorithm performance.

Based on the provided text, a detailed answer to all parts of your request regarding acceptance criteria and a study proving an AI device meets these criteria cannot be fully generated. This document describes a traditional medical device (biopsy instrument), not an AI/ML medical device.

However, I can extract the relevant information regarding the performance data that was collected for this specific device (SUREcore Plus Biopsy Instrument) and how it addresses safety and effectiveness in the context of a 510(k) submission.

Here's an attempt to answer your questions based only on the provided document, highlighting what is present and what is absent due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense for an AI/ML device (e.g., target specificity, sensitivity, AUC). Instead, it focuses on demonstrating that the mechanical and biological performance of the subject device is comparable to the predicate device and safe for its intended use.

The "performance" of the device is assessed through the following:

Performance Aspect	Reported Device Performance
Biocompatibility	- Handle: Assessed for cytotoxicity, passed.
	- VMCore needle set (patient tissue contact materials): Passed cytotoxicity, sensitization, irritation, and systemic toxicity tests (referenced K201650).
Mechanical Testing	- Capacity to collect tissue: Demonstrated in ex vivo models of liver, kidney & prostate tissue.
	- Force necessary to deform the needle set: Tested.
Electrical safety & EMC	Not applicable (no electronic components).
Software V&V	Not applicable (no software).
Depth of penetration	22 mm (Similar to predicate)
Length of needle tissue collection trough (sample notch)	19 mm (Same as predicate)
Mechanics of energizing/releasing needle	2-stroke cocking action / pressing activator button (Same as predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated in numerical terms for the mechanical capacity testing. It mentions "ex vivo models of liver, kidney & prostate tissue." The number of samples or trials performed is not specified.
Data Provenance: The document does not provide details on the country of origin of the ex vivo models or whether the data collection was retrospective or prospective. It is primarily bench testing.

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)

Not applicable. This device is a mechanical biopsy instrument, not an AI diagnostic tool that requires expert annotation for ground truth. Ground truth for its performance would be assessed by physical measurements, material properties, and tissue collection efficacy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3. This is not a study involving human interpretation of medical images or data.

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. This is not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/ML device. Therefore, no standalone algorithm performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the biocompatibility testing, the ground truth is established by standards (e.g., ISO 10993) and the results of the specific biological tests (cytotoxicity, sensitization, irritation, systemic toxicity).
For mechanical testing, the ground truth involves physical measurements and observations of the device's ability to collect tissue in ex vivo models (e.g., macroscopic assessment of collected tissue integrity/size, consistency of penetration depth).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

{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.

December 2, 2022

Uro-1, Inc. Thomas Lawson Regulatory Consultant 3701-A Alliance Drive Greensboro, North Carolina 27407

Re: K220611

Trade/Device Name: SUREcore Plus Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 28, 2022 Received: March 3, 2022

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. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Image /page/1/Picture/5 description: The image shows the name "Jessica Carr -S" in a large, bold font. The name is written in black and is centered in the image. The background of the image is a light blue color. The text is clear and easy to read.

for Long Chen Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220611

Device Name

SUREcore Plus Biopsy Instrument

Indications for Use (Describe)

The SUREcore Plus Biopsy Instrument is intended for use in obt tissue such as liver, kidney, and prostate. It is not intended for use in bone.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

[X] 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

PRAStaff@fda.hhs.gov

"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 Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

SECTION 5. 510(k) SUMMARY

General Information

Submitter	Uro-1, Inc.
Address	3703-A Alliance DriveGreensboro, NC 27404
Correspondence Person	Thomas Lawson, PhDRegulatory AffairsUro-1, Inc.
Contact Information	Email: drthomlawson@gmail.comPhone: 510-206-1794
Date Prepared	1 December 2022

Proposed Device

Trade Name	SUREcore Plus Biopsy Instrument
Common Name	SUREcore Plus
Regulation Number andClassification Name	21 CFR§876.1075 Gastroenterology-urology biopsyinstrument
Product Code	KNW
Regulatory Class	II

Predicate Device

Trade Name	Max-Core Biopsy Instrument
Common Name	Max-Core
Premarket Notification	K133948
Regulation Number and	21 CFR§876.1075 Gastroenterology-urology biopsy
Classification Name	instrument
Product Code	KNW
Regulatory Class	II
Note: This predicate device has been subject to a design-related recall.

{4}------------------------------------------------

Device Description

Indications for Use

The indication for use for the SUREcore Plus biopsy instrument is:

The SUREcore Plus biopsy instrument is intended for use in obtaining biopsies from soft tissue such as liver, kidney, and prostate. It is not intended for use in bone.

Comparison to the Predicate Device

Uro-1, Inc. has identified the Max-Core Biopsy Instrument (Bard Medical) as the predicate device. The SUREcore Plus Biopsy Instrument is substantially equivalent to the predicate device based upon the following similarities:

1. The intended use of both the predicate device and the SUREcore Plus device are equivalent for the two devices, which is to obtain biopsies from soft tissues such as liver, kidney, and prostate. Neither are not intended for use in bone.
Both devices introduce a biopsy needle into the body under imaging control (e.g., 2. ultrasound, X-Ray, CT, etc.)
1. Both devices are designed to collect multiple samples.
Both devices are made from biocompatible materials. 4.

{5}------------------------------------------------

Table 1 shows the comparison of the SUREcore Plus Biopsy Instrument (the subject of this submission) to the predicate device, Max-Core Biopsy Instrument (K133948). The similarities between the two devices satisfy the criteria for a 510(k) notice.

	Subject device	Predicate device
	SUREcore PlusBiopsy InstrumentURO-1, Inc.(this submission)	Max-Core BiopsyInstrumentBard Medical(K133948)
Indication for use	For use in obtainingbiopsies from softtissues	Same
Intended use	The introduction ofthe needle into thebody should becarried out underimaging control(ultrasound, X-Ray,CT, etc.). It isprovided sterile forsingle use.	Same
Route ofadvancement	Percutaneous	Same
Target populations	Male & Female	Same
Location of biopsy	Liver, kidney,and prostate.	Liver, kidney, prostate,spleen, lymph nodes andvarious soft tissuetumors.
Site of use	Hospitals, clinics,and physicianoffices	Same
Device Features
Components	(1) Handle(2) Needle set consistingof a core collectorand an outer cannula	Same
Dimension of the handle	5.5 in X 1.5 in X 1 in	6 in X 1.4 in (cylinder diameter)
Mechanics of energizing the needle	2-stroke cocking action (using a lever on the handle)	Same
Mechanics of releasing the needle to puncture tissue	Pressing on an activator button on the handle	Same
Size of needle	18 gauge	14 to 20 ga
Length of needle tissue collection trough (sample notch)	19 mm	Same
Length of needle assembly	10-25 cm	Same
Performance
Depth of penetration	22 mm	Same
Sterilization	Gamma Radiation	ETO
Frequency of use	Single patient use	Same
Tissue contact materials	Compliant with ISO 10993	Same

Table 1. Comparison of the SUREcore Plus Biopsy Instrument to the predicate device, the Bard Max-Core Biopsy Instrument.

{6}------------------------------------------------

Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of the subject device are substantially equivalent to those of the predicate device in terms of the following:

. Equivalent intended use;
Equivalen indications for use; ●
Similar penetration depth;
Similar sample notch; .
Same mechanics of action; ●
Same mode of action;
Same energy used/delivered;
. Similar patient-contacting materials;
. Same fundamental scientific technology;
. Same patient population;
Single-use device; .

{7}------------------------------------------------

Supplied sterile; and ●
Similar packaging.

Performance Data

The performance testing conducted establishes that SUREcore Plus Biopsy Instrument does not raise new questions of the safety and effectiveness for a biopsy system.

Biocompatibility testing

The handle of the SUREcore Plus Biopsy Instrument does not come into contact with the patient, but it has been assessed for cytotoxicity and found to pass such testing. The VMCore needle set does contact patient tissue and passed all tests, as noted in K201650:

Cytotoxicity, O
O Sensitization,
Irritation, and O
Systemic toxicity. o

In this respect, the VMCore needle set is a reference device for the biocompatibility information for this submission related to the needle set.

Electrical safety and electromagnetic compatibility (EMC)

The subject and predicate devices do not have electronic components, so such testing was not required.

Software Verification and Validation Testing

Neither the subject nor predicate devices contain software.

Mechanical Testing

The mechanical testing of the subject device included:

. Capacity to collect tissue in ex vivo models of liver, kidney & prostate tissue, and
Force necessary to deform the needle set.

{8}------------------------------------------------

Preclinical (Animal) Studies

Bench testing was sufficient to demonstrate performance of the device. No preclinical testing of the subject device was necessary.

Clinical Studies

Bench testing was sufficient to demonstrate performance of the device. No clinical testing of the subject device was necessary.

Conclusion

The information submitted in this premarket notification confirms that the SUREcore Plus Biopsy Instrument raises no new questions of safety and effectiveness and that the SUREcore Plus Biopsy Instrument 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.