Search Results
Found 1 results
510(k) Data Aggregation
(74 days)
Mermaid Medical A/S
(N301) Disposable Semi-Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination.
(N302) Coaxial Introducer Needle is used as a guiding needle for (N301)
The M-Biopsy™ Semi-Automatic Biopsy Instrument is a disposable lightweight spring loaded biopsy instrument with a biopsy needle fitted into a plastic handle.
The needle has a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.
The M-Biopsy™ Coaxial Introducer Needle has a trocar stylet and a distal echogenic marker and centimeter markings to facilitate precise depth placement and may be visualized by X-ray, CT or ultrasound.
The device (M-Biopsy™ Semi-Automatic Biopsy Instrument) is sold as a single device and as a set combination (M-Biopsy™ Semi-Automatic Biopsy Instrument and M-Biopsy™ Coaxial Introducer Needle).
The M-Biopsy™ Semi-Automatic Biopsy Instrument is used to obtain multiple core biopsy samples from soft tissue such as the liver, kidney, prostate, breast, lymph nodes, etc.
The M-Biopsy™ Coaxial Introducer Needle is used as a guiding needle for the M-Biopsy™ Semi-Automatic Biopsy Instrument.
The M-Biopsy™ device family can be used as transient use less than 60 minutes.
The M-Biopsy™ device family is available from Gauge 14 to Gauge 20 in different lengths ranging from 6 cm to 30 cm.
The M-Biopsy™ Semi-Automatic Biopsy Instrument consists of: Mandrill, Needle, House Lit, House base, Spring bushings, Spring, Cannula sledge, Trigger, Protecting sheath and Silicone coating.
The M-Biopsy™ Coaxial Introducer Needle consists of: Mandrill, Needle, Luer, Hub, Stopper, Protecting sheath and Silicone coating.
The M-Biopsy™ Semi Automatic Instrument and Coaxial Needle (set combination) consists of the above mentioned parts and a 3 Cavity clips to keep the part in place in the pouch.
This document is a 510(k) premarket notification for a medical device called the "M-Biopsy Semi-Automatic Biopsy Instrument" and associated needles. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific clinical acceptance criteria for an AI or diagnostic device.
Therefore, the requested information about acceptance criteria and a study proving a device meets them (especially in the context of AI, multi-reader multi-case studies, standalone performance, and ground truth establishment) is not present in this document. This document describes a traditional medical device (a biopsy instrument) and its bench testing for mechanical and material properties, rather than a diagnostic device with performance metrics like sensitivity, specificity, or AUC.
Here's what can be extracted based on the provided text, while acknowledging that it doesn't fit the typical "diagnostic device acceptance criteria" framework:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various performance tests and states that the device "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. Instead, it broadly states the device "conformed to and/or passed the testing standard."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design | Met predetermined criteria and demonstrated substantial equivalence to predicate. |
| Handle design | (Implied: Equivalent to predicate) |
| Loading handle and trigger | (Implied: Equivalent to predicate) |
| Echogenic band | (Implied: Present and functional) |
| Cannula and Mandrill grind | (Implied: Equivalent to predicate) |
| Mandrill protrudes | (Implied: Equivalent to predicate) |
| ID of product Color code | (Implied: Present) |
| Gauge size/length size print | (Present, claimed improvement over predicate) |
| Visibility (Fluoroscopic, US) | (Implied: Good visualization) |
| Cm markers on cannula shaft | (Implied: Present and functional) |
| Biopsy harvest method | (Implied: Similar to predicate) |
| Biopsy sample size | (Implied: Similar to predicate) |
| Optional stroke length | (10mm and 20mm options available) |
| Spring operated | (Yes) |
| Geometric | Met predetermined criteria and demonstrated substantial equivalence to predicate. |
| Needle gauge | (Implied: Conforms to specified gauges) |
| Needle size | (Implied: Conforms to specified sizes) |
| Stilet size | (Implied: Conforms to specified sizes) |
| Needle advancement/penetration depth | (Implied: Equivalent to predicate) |
| Sample notch size | (Implied: Equivalent to predicate) |
| Number of samples | (Implied: Multiple samples can be obtained, similar to predicate) |
| Spring operated | (Yes) |
| Single puncture and sample | (Implied: Yes, for each sample) |
| Safety features | (Implied: Present and functional) |
| Materials in contact | Met biocompatibility standards. |
| Target organs | (Implied: Specified, similar to predicate) |
| Target population justification | (Implied: Clear) |
| Visualization techniques | (X-ray, CT or ultrasound visualization) |
| Method placement | (Implied: Similar to predicate) |
| Mechanical Test & Product Comparisons | Met predetermined criteria and demonstrated substantial equivalence to predicate. |
| Tensile pull testing | (Implied: Conformed to standard) |
| Loading and shooting force test 10mm | Demonstrated equivalence or improvement compared to predicate. |
| Loading and shooting force test 20mm | Demonstrated equivalence or improvement compared to predicate. |
| Trigger firing force test | (Implied: Conformed to standard) |
| Weight comparison test | (Lighter than predicate) |
| Performance Tests | Performed simulated biopsy tests in two media; form and length of biopsy sample recorded. |
| Packaging Test | Met predetermined criteria. |
| Sterile barrier Integrity | (Implied: Conformed to standard) |
| Transportation test | (Implied: Conformed to standard) |
| World Wide Condition test | (Implied: Conformed to standard) |
| Shelf life | (Implied: Determined) |
| Sterilization | EO sterilization, passed. |
| Biocompatibility | Conformed to ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Each product has been fired 10 times each" for the simulated biopsy performance test. It does not provide further details on the sample size for other mechanical tests or the "test set" in the context of a diagnostic device. Data provenance refers to bench testing, performed by the manufacturer, not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This is a mechanical device, and "ground truth" in the diagnostic sense (e.g., expert consensus on images or pathology) is not established or reported. The tests conducted are physical and material property assessments.
4. Adjudication Method for the Test Set:
Not applicable. There is no expert review or adjudication process for the bench tests described. The tests are directly measured against predetermined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a diagnostic device involving human readers interpreting images.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This is not an algorithm or AI device. The performance refers to the physical function of the biopsy instrument.
7. Type of Ground Truth Used:
Not applicable in the diagnostic sense. The "ground truth" or reference standards for the tests performed are typically engineering specifications, material standards, and functional requirements for a biopsy device (e.g., consistent sample size, sufficient cutting force, sterility, biocompatibility). For the simulated biopsy test, the "form and length of the biopsy sample" was recorded, implying these were the measured outcomes compared against expected values or predicate performance.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set or associated ground truth.
Ask a specific question about this device
Page 1 of 1