(88 days)
The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and parotis. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Spirotome system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles and liver. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the human cervix. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities by inspection or colposcopy. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the skin. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from bony structures. The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from the human body. The Coramate/Spirotome system consists of 2 major components: the set of needles (Spirotome) and a powered device that operates the needles (Coramate). The set of needles can be operated manually as well (single-use and reusable Spirotome). The needle set contains 3 needles that work in conjunction.
The provided text describes a 510(k) premarket notification for the Coramate/Spirotome system, a mechanical biopsy device. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in a quantitative manner as typically expected for AI/ML device performance.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and states that "Thorough preclinical testing was performed to ensure the device performs as intended" and "Clinical testing indicates that all performance and safety aims are reached." It's a qualitative assertion rather than a presentation of specific metrics.
Therefore, for many of the requested items, the information is either not present or cannot be inferred from the provided document.
Here's a breakdown based on the request and the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., a specific percentage of adequate samples, or a particular diagnostic accuracy). The overarching "acceptance criteria" appear to be that the device performs "as intended" with "aimed performance and maximal safety," similar to predicate devices, and without complications.
Reported Device Performance:
| Performance Aspect | Reported Performance |
|---|---|
| Tissue Sampling Adequacy | "adequate samples" for histological and biomolecular detection and confirmation of abnormalities (as stated in the Indications for Use). The document asserts that the system performs "as intended" and provides "adequate sampling of human tissue... to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion." |
| Safety | "maximal safety" and "no complication was noted up to now in the clinical tests and subsequent vigilance quality control follow-up." |
| Clinical Equivalence | Performs "similar to the 'Indications for Use' of the predicate device." "Substantially equivalent" to the predicate devices and existing macrobiopsy systems (K060384). Meets "aims" of performance and safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or patients from a defined clinical study. The document mentions "clinical tests" and "clinical international + LLN relating to the performance in various other soft tissues than the breast," but no numbers are provided.
- Data Provenance: The document states that "Most of the clinical work has been done in human breast tissues as has been published in international PEER reviewed Journals and Meetings. In addition, recent clinical international + LLN relating to the performance in various other soft tissues than the breast." This implies prospective and/or retrospective clinical data from multiple international sources, but no specific countries or study designs are elaborated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It can be inferred that experts in pathology or relevant medical specialties would be involved in assessing the biopsy samples, but no details are given.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this type of study is not mentioned as this device is a physical biopsy instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting results with or without AI assistance.
6. Standalone Performance Study
- Standalone Performance: Not applicable in the context of an AI algorithm. The performance described relates to the device's ability to extract adequate tissue samples, which is inherent to the device's mechanical function, not an algorithm running independently. The "clinical testing" mentioned is the closest equivalent, demonstrating the device's performance in a real-world setting.
7. Type of Ground Truth Used
- Ground Truth: The primary ground truth for the performance of a biopsy device is the histological and biomolecular analysis of the tissue samples obtained. The text repeatedly mentions the device's intention "to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities" and "to make a reliable diagnosis of benignancy or malignancy." This implies the ground truth is established through laboratory analysis of the collected tissue.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a mechanical biopsy tool, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no AI/ML training set.
§ 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.