(100 days)
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.q., 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 proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated control unit handle (the CASSI II handle), a valve block, battery, cryogen, a biopsy needle (CASSI QuadPoint comprised of a sticking needle and cutting cannula/piston assembly), and a 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CASSI™ II Rotational Core Biopsy System, addressing your requested points:
The provided document is a 510(k) summary for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, this 510(k) submission is for an updated branding and packaging configuration, along with minor modifications, of an already cleared predicate device (Sanarus CASSI™ II Rotational Core Biopsy System K051581). Therefore, the regulatory decision is based on substantial equivalence to that predicate device, not on new performance studies establishing new acceptance criteria.
The core argument in this 510(k) is that the modified device "do[es] not raise any new or significant questions of safety and efficacy and are substantially equivalent to the predicate Sanarus CASSI II Rotational Core Biopsy System." This implies that the original predicate device would have had studies and acceptance criteria to demonstrate its safety and efficacy, but those details are not present in this document.
Therefore, I cannot populate most of your requested information based on the provided text. However, I can explain why for each point:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The submission relies on substantial equivalence to a predicate device. | Not specified in this document. The submission relies on substantial equivalence to a predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. No new performance study data is described in this 510(k) summary.
- Data provenance: Not applicable. No new performance study data is described in this 510(k) summary.
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)
- Not applicable. No new performance study requiring ground truth establishment is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance study requiring adjudication is described in this 510(k) summary.
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
- No MRMC study was done. This device is a biopsy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a biopsy system, not an algorithm, and the submission does not describe a standalone performance study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new performance study requiring ground truth is described in this 510(k) summary.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/algorithmic device and no new performance study data is presented.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth establishment is mentioned.
Summary of what the document does indicate:
- Device: CASSI™ II Rotational Core Biopsy System with the CASSI QuadPoint™ Disposable
- Purpose of Submission: Seek clearance for updated branding and packaging, and summarize minor modifications to the predicate device (Sanarus CASSI™ II Rotational Core Biopsy System, K051581).
- Conclusion: The manufacturer believes the modified device is substantially equivalent to the predicate and does not raise new safety or efficacy questions.
- Indications for Use: Obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors, and breast abnormalities). Not intended for use in bone.
- Classification: Class II, 21 CFR 876.1075 (Gastroenterology-urology biopsy instrument).
§ 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.