(332 days)
The Uramix Curaway Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast.
The URAMIX CuraWay Automatic Core Biopsy Instrument is a single use only core biopsy device and is individually packaged and sterilized. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified to maintain the sterilization condition of the device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes. The 18 gauge is the one used for current intended marketing, for prostate and kidney biopsies.
The URAMIX CuraWay Automatic Core Biopsy Instrument is a medical device intended for obtaining biopsies from soft tissues. The provided text outlines a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., effect size of human readers, standalone performance, training set details) are not applicable or cannot be extracted from the given document as it primarily covers non-clinical engineering and design comparisons.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of diagnostic performance metrics (like sensitivity, specificity, or AUC). Instead, it provides a comparison of engineering and functional characteristics to a predicate device, aiming to show substantial equivalence. The "performance" reported is primarily in relation to these comparative metrics.
| Feature/Test | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device) | Outcome |
|---|---|---|---|
| Intended Use | Obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors). Not for bone. | Intended for use in obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors). Not for bone or breast. | Similar clinical condition, same intended purpose and site. (Note: Subject device adds "not for breast") |
| Material | Stainless steel + ABS | Shaft: Medical grade stainless steel (SUS304/06Cr19Ni10). Handle/Actuator: Acrylonitrile Butadiene Styrene (ABS). | Same material used. |
| Types/Sizes (Gauges) | 14G, 16G, 18G, 20G | 12G, 14G, 16G, 18G, 20G | 12G also available, no significant influence on clinical use. |
| Length (mm) | 100mm, 160mm, 200mm, 250mm | 80mm, 100mm, 130mm, 1600mm, 200mm, 250mm | Different lengths available, no significant influence on clinical use. |
| Slot size | 18mm | 18mm | Same. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | ISO 10993-1, ISO 10993-5, ISO 10993-10 | Same standards met. |
| Sterilization Method | EO sterilization | EO sterilization | Same. |
| Puncture Force Value | Predicate: 5.3N | Subject: 2.7N | Subject device has lower puncture force. |
| Resistance during operation | Predicate: none | Subject: none | Same. |
| Abnormal noise during operation | Predicate: none | Subject: none | Same. |
| Connection firmness (needle tube + plastic parts) | Predicate: 181 to 230N | Subject: 190 to 212N | Within comparable range. |
| Ex-vivo tissue studies (sample length & weight) | Similar length, weight between predicate and subject. | Equivalent tissue samples in terms of length and weight (porcine muscle, liver). | Equivalent. |
| Cytotoxicity | Per ISO 10993-5 | In vitro cytotoxicity performed. | Demonstrated compliance. |
| Irritation and Skin Sensitization | Per ISO 10993-10 | Tests performed. | Demonstrated compliance. |
| Systemic Toxicity | Per ISO 10883-11 | Test performed. | Demonstrated compliance. |
| Sterility Test | Per ISO 11138-2, ISO 11737-2 | Sterility test performed. | Demonstrated compliance. |
| EO Residuals | Per EN ISO 10993-7 | 1.13 mg/device | Demonstrated compliance. |
| Packaging & Shelf-life | Per ISTA2A and ASTM F1980-16 for 3-year shelf life. | 3-year shelf life. | Demonstrated compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "ex-vivo tissue studies (porcine muscle, liver)" which suggests an experimental test set. However, it does not specify the sample size for these ex-vivo studies beyond stating "equivalent tissue samples." The data provenance is implied to be laboratory testing rather than human clinical data. No country of origin for this specific testing data is given, but the manufacturer is based in China. This is not a clinical study on patient data.
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. The comparisons and tests described are for physical and material characteristics of the device, not diagnostic performance requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not an imaging or diagnostic AI device requiring adjudication of human expert interpretations. The testing focuses on mechanical and material properties.
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
Not applicable. The URAMIX CuraWay Automatic Core Biopsy Instrument is a physical medical instrument (a biopsy needle), not an AI device or an imaging/diagnostic AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo tissue studies, the ground truth was implied by the objective measurements of sample length and weight taken from the porcine tissues. For other non-clinical tests (biocompatibility, sterility, etc.), the ground truth is compliance with recognized international standards (e.g., ISO, ASTM).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is relevant for this device.
§ 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.