(43 days)
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple cores of tissue sampling from sites including, but not limited to the prostate, kidney, liver, lung, breast, lymph nodes, and different tumors for histological evaluation.
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple core tissue sampling from sites including, but not limited to, the prostate, kidney, liver, lung, breast, lymph nodes and different tumors for histological evaluation. The Cook® Sidearm Core Tissue Biopsy Device/Set allows adjustment for an 18mm or 23mm sample, allows the sample to be easily exposed, is a one-handed operation, and will not fire when the sample size is in the incorrect position. The construction of the Cook® Sidearm Core Tissue Biopsy Device is Ryton, Anodized aluminum, Silicone, Delrin, and Stainless Steel. The construction of the Cook® Sidearm Needles are stainless steel and polycarbonate.
The provided document is a 510(k) Premarket Notification for the Cook® Sidearm Core Tissue Biopsy Device/Set. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methodologies as would be found in a study demonstrating novel device performance against predefined metrics.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document focuses on demonstrating substantial equivalence to existing predicate devices, not on meeting specific performance acceptance criteria. It claims the device "meets requirements for substantial equivalency according to section 510(k) guidelines" and is "comparable to existing predicate devices in distribution." There are no quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or success rates) or corresponding acceptance criteria presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing. No test set or clinical study data is presented. The submission relies on a comparison to predicate devices, not on new performance data from a specific test set.
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):
- Missing. No test set or ground truth determination process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing. No test set or adjudication process is described.
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:
- Missing. This device is a mechanical biopsy instrument, not an AI-powered diagnostic tool, so an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing. This device is a mechanical biopsy instrument; thus, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing. No ground truth is established as there is no performance study. The device is intended to obtain tissue for histological evaluation (which would then be the ground truth for diagnosis), but its own performance isn't evaluated against a ground truth in this document.
8. The sample size for the training set:
- Missing. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Missing. Not applicable.
Summary of Device and Claim:
The Cook® Sidearm Core Tissue Biopsy Device/Set is an automated biopsy instrument designed to obtain multiple core tissue samples from various sites (prostate, kidney, liver, lung, breast, lymph nodes, tumors) for histological evaluation.
The basis for market clearance (510(k) K041544) is substantial equivalence to several predicate devices, including:
- Magnum Biopsy System (K871390) by C.R. Bard, Incorporated
- EMS Biopsy Instrument (K930083) by Engineered Medical Systems
- High Speed Core Cut Biopsy Device (K905556) by BIP USA, Incorporated
- Manan Pro-Mag Automatic Biopsy Device (K914874) by Manan Medical Products, Incorporated
- (Roth) Spiral Rotating Prostatic Biopsy Needle (K863385) by Cook Urological, Incorporated
The document asserts that the Cook® Sidearm Core Tissue Biopsy Device/Set is substantially equivalent due to:
- Similar indications for use.
- Similar technological construction.
- Similar materials (stainless steel, polycarbonate for needles; Ryton, Anodized aluminum, Silicone, Delrin for device).
- Standard manufacturing controls and Quality Assurance Program.
- Similar packaging to currently marketed devices.
The review of this 510(k) submission does not involve the generation or analysis of new clinical performance data specifically demonstrating the Cook® Sidearm Core Tissue Biopsy Device/Set meets predefined acceptance criteria. Instead, it argues that because it is similar to already cleared devices, it is safe and effective for its intended use.
§ 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.