(274 days)
No
The description focuses solely on the mechanical function of the biopsy instrument and does not mention any computational or analytical capabilities that would involve AI/ML.
No
The device is described as an instrument for collecting tissue samples for diagnosis, not for treating a disease or condition.
No
The device collects a tissue sample for analysis, which then assists with a diagnosis. The device itself is not performing the diagnostic function.
No
The device description clearly outlines physical components (handle, needle set, springs, cocking slide) and mechanical actions (rapid advance of needles, tissue collection). There is no mention of software as a component or function of the device.
Based on the provided information, the SUREcore Plus Biopsy Instrument is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body to provide information for diagnosis. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- The SUREcore Plus Biopsy Instrument is a tool used to collect the tissue sample from the body. Its function is to obtain the specimen, not to perform a diagnostic test on it.
- The description explicitly states that the tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. This indicates that the diagnostic analysis happens after the tissue is collected by this device, and is performed by other means (e.g., microscopy, staining, molecular tests).
Therefore, the SUREcore Plus Biopsy Instrument is a surgical instrument used for tissue collection, which is a step prior to in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, X-Ray, CT
Anatomical Site
soft tissue such as liver, kidney, and prostate.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, clinics, and 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 SUREcore Plus Biopsy Instrument does not raise new questions of the safety and effectiveness for a biopsy system.
Mechanical Testing:
- Capacity to collect tissue in ex vivo models of liver, kidney & prostate tissue, and
- Force necessary to deform the needle set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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,
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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
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) |
|---|---|
| -------------------------------------------------- | --------------------------------------------- |
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SECTION 5.
510(k) SUMMARY
General Information
| Submitter | Uro-1, Inc. |
|---|---|
| Address | 3703-A Alliance Drive |
| Greensboro, NC 27404 | |
| Correspondence Person | Thomas Lawson, PhD |
| Regulatory Affairs | |
| Uro-1, Inc. | |
| Contact Information | Email: drthomlawson@gmail.com |
| Phone: 510-206-1794 | |
| Date Prepared | 1 December 2022 |
Proposed Device
| Trade Name | SUREcore Plus Biopsy Instrument |
|---|---|
| Common Name | SUREcore Plus |
| Regulation Number and | |
| Classification Name | 21 CFR§876.1075 Gastroenterology-urology biopsy |
| 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:
-
- 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.)
-
- 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 Plus | ||
| Biopsy Instrument | ||
| URO-1, Inc. |
(this submission) | Max-Core Biopsy
Instrument
Bard Medical
(K133948) |
| Indication for use | For use in obtaining
biopsies from soft
tissues | Same |
| Intended use | The introduction of
the needle into the
body should be
carried out under
imaging control
(ultrasound, X-Ray,
CT, etc.). It is
provided sterile for
single use. | Same |
| Route of
advancement | Percutaneous | Same |
| Target populations | Male & Female | Same |
| Location of biopsy | Liver, kidney,
and prostate. | Liver, kidney, prostate,
spleen, lymph nodes and
various soft tissue
tumors. |
| Site of use | Hospitals, clinics,
and physician
offices | Same |
| Device Features | | |
| Components | (1) Handle
(2) Needle set consisting
of a core collector
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 |
| 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.
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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.
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.