SUREcore Plus Biopsy Instrument

K220611 · Uro-1, Inc. · KNW · Dec 2, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K220611
• Device Name: SUREcore Plus Biopsy Instrument
• Applicant: Uro-1, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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.

Device Story

SUREcore Plus is a single-use, spring-loaded biopsy instrument used in hospitals, clinics, and physician offices. It consists of a handle and a needle set. The physician manually cocks the handle to energize internal springs, then triggers the device to rapidly advance the needle into target tissue under imaging guidance (e.g., ultrasound, X-ray, CT). The needle's core collector captures a tissue sample. The device allows for multiple samples to be taken from different locations by re-cocking the handle. The collected tissue is removed for pathological analysis. The device is disposed of after the procedure. It benefits patients by facilitating minimally invasive tissue collection for disease diagnosis.

Clinical Evidence

No clinical or animal studies were conducted. Performance was established through bench testing, including ex vivo tissue collection capacity in liver, kidney, and prostate models, and mechanical force testing for needle deformation. Biocompatibility was established via reference to K201650.

Technological Characteristics

Manual spring-loaded biopsy instrument. Components: handle and 18-gauge needle set. Materials: biocompatible (ISO 10993 compliant). Dimensions: 5.5 in x 1.5 in x 1 in handle; 10-25 cm needle assembly; 19 mm sample notch. Operation: 2-stroke cocking lever, button-activated needle release. Sterilization: Gamma radiation. Single-use. No electronic, software, or electromagnetic components.

Indications for Use

Indicated for obtaining soft tissue biopsies (liver, kidney, prostate) in male and female patients. Not for use in bone.

Regulatory Classification

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.

Predicate Devices

• Max-Core Biopsy Instrument (K133948)

Reference Devices

• VMCore needle set (K201650)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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

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# 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) |
|--------------------------------------------------|---------------------------------------------|
|--------------------------------------------------|---------------------------------------------|

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# SECTION 5.

# 510(k) SUMMARY

# General Information

| Submitter | Uro-1, Inc. |
|-----------------------|---------------------------------------------------------|
| Address | 3703-A Alliance Drive<br>Greensboro, NC 27404 |
| Correspondence Person | Thomas Lawson, PhD<br>Regulatory Affairs<br>Uro-1, Inc. |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| Date Prepared | 1 December 2022 |

## Proposed Device

| Trade Name | SUREcore Plus Biopsy Instrument |
|----------------------------------------------|---------------------------------------------------------------|
| Common Name | SUREcore Plus |
| Regulation Number and<br>Classification Name | 21 CFR§876.1075 Gastroenterology-urology biopsy<br>instrument |
| 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. | |

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### Device Description

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.

#### 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.)
- 3. Both devices are designed to collect multiple samples.
- Both devices are made from biocompatible materials. 4.

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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 Plus<br>Biopsy Instrument<br>URO-1, Inc.<br><br>(this submission) | Max-Core Biopsy<br>Instrument<br>Bard Medical<br>(K133948) |
| Indication for use | For use in obtaining<br>biopsies from soft<br>tissues | Same |
| Intended use | The introduction of<br>the needle into the<br>body should be<br>carried out under<br>imaging control<br>(ultrasound, X-Ray,<br>CT, etc.). It is<br>provided sterile for<br>single use. | Same |
| Route of<br>advancement | Percutaneous | Same |
| Target populations | Male & Female | Same |
| Location of biopsy | Liver, kidney,<br>and prostate. | Liver, kidney, prostate,<br>spleen, lymph nodes and<br>various soft tissue<br>tumors. |
| Site of use | Hospitals, clinics,<br>and physician<br>offices | Same |
| Device Features | | |
| Components | (1) Handle<br>(2) Needle set consisting<br>of a core collector<br>and 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 |
| <b>Performance</b> | | |
| 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.

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## 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; .

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- 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.

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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 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.