(178 days)
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No
The description focuses on the mechanical and electrosurgical functions of the device for obtaining biopsy samples. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
No.
The device is used to obtain biopsy samples, which is a diagnostic procedure, not a therapeutic one. It cuts tissue for sample collection, it does not treat or cure a disease.
No
Explanation: The device is used to obtain biopsy samples, which are then used for diagnosis, but the device itself is a sampling tool, not a diagnostic one.
No
The device description clearly outlines multiple physical components (locator needle, locator wire, dilator, electrode) and describes a manual cutting mechanism in addition to the electrosurgical function, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the intended purpose of obtaining soft tissue core biopsy samples." This describes a device used to collect a sample from the body.
- Device Description: The description details a surgical tool used to cut and core tissue. It's a physical device used in vivo (within the living body) to acquire a sample.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the living body) to examine samples (like blood, urine, tissue) to diagnose diseases or conditions. They typically involve reagents, analyzers, or other components used to test the sample itself. This device does not perform any analysis or testing of the sample; it only collects it.
Therefore, the Sure-Core Biopsy Electrode Kit is a surgical device used for tissue acquisition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Sure-Core Biopsy Electrode Kit consists of four components: a locator needle, a locator wire, a soft tissue dillator, and the Sure-Core electrosurgical core cutting electrode. The Sure Core Biopsy Electrode is both a manual core cutting device and a monopolar electrosurgical device that is used to cut soft tissue for the purpose of obtain a biopsy sample. The distal tip is a sharp stainless steel cutting blade which cores the tissue distal to the end of the dilator. The most difficult aspect of obtaining a true core biopsy is the detachment of the core from the remaining tissue. The Sure-Core Biopey Electrode overcomes this obstacle by means of a monopolar electrosurgical wire. The electrosurgical wire cuts the tissue perpendicular to the distal blade.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physician controlled surgical procedure.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Interventional Concepts, Inc.
K963813 mar 2 0 1997
510(K) SAFETY AND EFFECTIVENESS SUMMARY
Date: September 20, 1996
Prepared By: William McPherson
Common/Ususal Name: Monopolar Electrosurgical Electrode
Proprietary Name: Sure Core Biopsy Electrode
Classification: Class II
Description: The Sure-Core Biopsy Electrode Kit consists of four components: a locator needle, a locator wire, a soft tissue dillator, and the Sure-Core electrosurgical core cutting electrode. The Sure Core Biopsy Electrode is both a manual core cutting device and a monopolar electrosurgical device that is used to cut soft tissue for the purpose of obtain a biopsy sample. The distal tip is a sharp stainless steel cutting blade which cores the tissue distal to the end of the dilator. The most difficult aspect of obtaining a true core biopsy is the detachment of the core from the remaining tissue. The Sure-Core Biopey Electrode overcomes this obstacle by means of a monopolar electrosurgical wire. The electrosurgical wire cuts the tissue perpendicular to the distal blade.
Substantial Equilvalence: The Sure Core Bioney Electrode and accessory items are substantially equivalent to numerous currently marketed soft tissue biopsy devices in both design features and intended use. The Sure Core Biopsv Electrode has similar design features as the needle assembly for the ABBI (Advanced Breast Biopsy Instrumentation) except that the ABBI is computer controlled and the Sure Core Biopsy Electrode is a physician controlled surgical procedure. In addition, the Sure Core Biopsy Electrode is a monopolar electrosurgical electrode. The core tissue sample is detached or severed from the remaining tissue by activation of this feature. Again, numerous monopolar electrosurgical electrodes are currently marketed by Aaron Medical. Unimed Surgical, and Weck for cutting and coagulation of soft tissue.
Conclusion: The Sure Core Biopsy Electrode Kit and asseccory components are safe and effective for the intended purpose of obtaining soft tissue core biopsy samples.