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510(k) Data Aggregation
(42 days)
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Sanarus Cassi II Rotational Core Biopsy System consists of a fully integrated control unit (Handle), Biopsy Needle Unit (comprised of a sticking needle and cutting cannula) and sample collection tray. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.
The Sanarus Cassi™ II Rotational Core Biopsy System is a medical device used for obtaining biopsies from soft tissues. The information provided is from a 510(k) premarket notification (K051581) to the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a comprehensive clinical study to "prove" the device meets specific performance criteria.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" or detailed "reported device performance" metrics in the way one might expect from a clinical trial with pre-defined endpoints (e.g., sensitivity, specificity, accuracy, or specific biopsy yield rates). Instead, the core of the submission is to demonstrate equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Quality of samples obtained equivalent to predicate device | Performance testing confirms the quality of samples obtained with Sanarus Cassi II is equivalent to the predicate device. |
| Same Indications for Use as predicate device | Yes, the Sanarus Cassi II has the same indications for use. |
| Same Technological Characteristics as predicate device | Yes, the Sanarus Cassi II has the same technological characteristics. |
| Patient contact components and materials equivalent to predicate | Yes, patient contact components and materials are the same. |
| Packaging, sterilization, and sterility assurance equivalent | Yes, packaging materials, configurations, sterilization methods, and sterility assurance level are equivalent. |
| Does not raise significant new questions of safety and effectiveness | Based on indications, characteristics, and performance testing, it does not. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Performance testing confirms that the quality of samples obtained with the Sanarus Cassi II Rotational Core Biopsy System is equivalent to the predicate device." However, it does not provide any details on:
- The sample size used for this "performance testing."
- The data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
No information is provided regarding the number of experts, their qualifications, or how ground truth was established for any test set. The submission relies on demonstrating equivalence rather than an independent clinical validation with expert-derived ground truth.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study, nor any effect size of human readers improving with AI vs. without AI assistance. This device is a biopsy system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this is a physical medical device (biopsy system), not an algorithm or AI product.
7. Type of Ground Truth Used
The document does not specify the type of "ground truth" used for performance testing, other than stating "quality of samples obtained." Given it's a biopsy device, the implicit "ground truth" for sample quality would likely involve histological assessment by a pathologist, but this is not explicitly stated, nor are details of such assessment provided.
8. Sample Size for the Training Set
Not applicable. This is a physical biopsy system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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