The UR0-1 SUREcore Prime Device is a reusable system for histological core biopsies. It is used to obtain tissue from transrectal or transperineal biopsy of the prostate. It has a throw (advancement) of 25 mm and is used in conjunction with a single use SUREcore biopsy needle.

Device Description

The SUREcore Prime 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 Prime 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 reenergize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue.

AI/ML Overview

This document is a 510(k) summary for the URO-1 SUREcore Prime Biopsy Instrument. It focuses on demonstrating substantial equivalence to a predicate device, the Cook BX Biopsy Device, rather than presenting a study proving that the device meets specific acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, or AUC) as one might expect for an AI/software as a medical device (SaMD) product.

Therefore, many of the requested elements regarding acceptance criteria and study design for diagnostic performance (such as sample size, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission, as it is for a mechanical biopsy instrument.

However, the document does describe performance testing relevant to the function of a mechanical biopsy device.

Here's a breakdown based on the provided text, addressing the points where information is available or indicating when a point is not applicable to this type of device submission:

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

The document doesn't explicitly list "acceptance criteria" in a quantitative diagnostic sense with target thresholds (e.g., "sensitivity > 90%"). Instead, the performance testing described is functional and safety-related for a mechanical device. The "performance" is implicitly demonstrated by passing these tests and showing similarity to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: No cytotoxicity, sensitization, irritation, or systemic toxicity from patient-contacting materials (needle set). Handle material should also not show cytotoxicity.	Needle set passed all tests: Cytotoxicity, Sensitization, Irritation, and Systemic toxicity (as noted in K220611). Handle assessed for cytotoxicity and found to pass.
Mechanical Function: Capacity to collect tissue from a prostate model.	Successfully collected tissue in a prostate model.
Mechanical Strength: Withstand deformation.	Force necessary to deform the needle set (16 and 18 gauge) was tested. (Specific force values not provided, but implies it met internal specifications).
Electrical Safety/EMC: (Not applicable for non-electrical device)	"Not required" as the device has no electronic components.
Software V&V: (Not applicable for non-software device)	"Neither the subject nor predicate devices contain software."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in terms of a "test set" of patient cases for diagnostic performance, as this is a mechanical device. For mechanical testing, the number of units tested (e.g., prostate models, individual needles) is not detailed.
Data Provenance: Not applicable in the context of clinical data for diagnostic performance. The mechanical testing was described as "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission does not involve diagnostic interpretation studies requiring expert ground truth for imaging or similar data. The "ground truth" for mechanical testing would be the physical properties and functionality of the device itself (e.g., did it puncture, did it collect tissue).

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

Not applicable. No expert adjudication was needed for this type of mechanical device testing.

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 a mechanical biopsy instrument, not an AI/SaMD product. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

No. This is a mechanical device, not an algorithm.

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

For biocompatibility: Laboratory testing against ISO standards (Cytotoxicity, Sensitization, Irritation, Systemic toxicity).
For mechanical function: Physical observation in a prostate model and force measurement for deformation. There isn't a "ground truth" in the diagnostic sense; it's about meeting pre-defined mechanical specifications.

8. The sample size for the training set

Not applicable. This is a mechanical device and does not involve AI or machine learning algorithms that require training data.

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

Not applicable. As above, no training set or ground truth in this context is relevant.

In summary, this FDA submission for the URO-1 SUREcore Prime Biopsy Instrument focuses on demonstrating "substantial equivalence" to a predicate mechanical device through design comparisons and basic functional/safety bench testing, rather than through complex clinical studies evaluating diagnostic performance or AI algorithms. The "acceptance criteria" are implicitly met by passing the described biocompatibility and mechanical tests, and by showing equivalence to a legally marketed predicate.

Summary

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November 29, 2023

Uro-1 Medical, Inc. Thomas Lawson, Ph.D. Regulatory Consultant 3701-A Alliance Drive Greensboro. NC 27407

Re: K230646 Trade/Device Name: SUREcore Prime Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: November 1, 2023 Received: November 2, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Mark R. Kreitz -S

for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230646

Device Name SUREcore Prime Biopsy Instrument

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)

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510(k) SUMMARY

General Information

Submitter	Uro-1, Inc.
Address	3703-A Alliance DriveGreensboro, NC 27404
Correspondence Person	Thomas Lawson, PhDRegulatoryAffairs Uro-1,Inc.
Contact Information	Email: drthomlawson@gmail.comPhone: 510-206-1794
Date Prepared	15 November 2023

Proposed Device

Trade Name	SUREcore Prime Biopsy Instrument
Common Name	SUREcore Prime
Regulation Number and Classification Name	21 CFR§876.1075 Gastroenterology-urology biopsy instrument
Product Code	KNW
Regulatory Class	II
Note: This is the first 510(k) submission for this device.

Predicate Device

Trade Name	Cook BX Biopsy Device
Common Name	BX Biopsy Device
Premarket Notification	K980226
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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Device Description

Indications for Use

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

The URO-1 SUREcore Prime Device is a reusable system for histological core biopsies. It is used to obtain tissue from transrectal or transperineal biopsy of the prostate. It has a throw (advancement) of 25 mm and is used in conjunction with a single use SUREcore biopsy needle.

Comparison to the Predicate Device

Uro-1, Inc. has identified the Cook BX Biopsy Device (Cook Medical) as the predicate device. The SUREcore Prime 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 Prime device is exactly the same for both devices, which is to obtain biopsies from the prostate.
1. Both devices introduce a biopsy needle into the body under imaging control (e.g., ultrasound, X-Ray, CT, etc.)
1. Both devices are designed to collect multiple samples.
1. Both devices are made from biocompatible materials.

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K230646 Page 3 of 6

Table 1 shows the comparison of the SUREcore Prime Biopsy Device (the subject of this submission) to the predicate device, Cook BX Biopsy Device. The similarities between the two devices satisfy the criteria for a 510(k) notice.

Table 1. Comparison of the SUREcore Prime Biopsy Device to the predicate device, the Cook BX Biopsy Device.

	Predicate device	Subject device
	Cook BX Biopsy DeviceCook Medical(K980226)	SUREcore PrimeBiopsy InstrumentURO-1, Inc.(this submission)
Indication foruse	For obtaininghistological corebiopsies of tissue	Same
Intended Use	Used to obtain tissuecore biopsies fromtransrectal ortransperineal biopsy ofthe prostate	Same
Route ofadvancement	Transrectal ortransperineal	Same
Targetpopulations	Male	Same
Location ofbiopsy	Prostate	Same
Site of use	Hospitals, clinics,and physicianoffices	Same

Device Features

Components	(1) Handle/Gun(2) Needle set consistingof a core collectorand outer cannula	Same
------------	-----------------------------------------------------------------------------------------	------

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Dimensions of the handle	6.3 inches long x 1.3 inches tall x 1.4 inches wide (2.3 inches wide at cocking grip)	6.3 inches long x 1.9 inches tall x 1 inch wide (2 inches wide at cocking grips)
Mechanics of Energizing the needle	2-stroke cocking action (using lever on handle)	2-stroke cocking action (using cocking grips on handle)
Mechanics of Releasing the needle to puncture tissue	Pressing an activator button on the handle	Same
Size of needle	14-20 ga	Same
Length of needle Tissue collection trough (sample notch)	18-19 mm	19 mm
Length of needle assembly	10-20 cm	Same

Performance

Depth of penetrationpossible (needle)	25 mm	Same
Sterilization	Not provided sterile	Same
Frequency of use	Reusable	Same
Tissue contactmaterials	Instrument does notcontact tissue	Same

Comparison of Technological Characteristics of the Subject Device 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:

The exact same intended use .
The exact same indications for use •
. Similar penetration depth
Similar sample notch .
Same mechanics of action •
Same mode of action •
Same energy used/delivered .

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. Similar patient-contacting materials (needles)
Same fundamental scientific technology
. Same patient population

Performance Data

The performance testing conducted establishes that SUREcore Prime Biopsy Device 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 needle set does contact patient tissue and passed all tests (as noted in K220611):

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

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 a prostate model; and
. Force necessary to deform the needle set (16 and 18 gauge).

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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 Prime Biopsy Instrument raises no new questions of safety and effectiveness and that the SUREcore Prime Biopsy Device 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.