(602 days)
The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.
The EndoDrill® Model X biopsy instrument consists of a single-use handle with a flexible sheath and a cylinder tip that can be rotated to collect tissue samples. An outer sheath covers the tip to facilitate smooth insertion, positioning of the instrument and extraction. The hollow cylinder allows for multiple samples being taken continuously without removing the instrument for harvesting between biopsies. Rotation is facilitated by an isolated reusable electrical motor controlled by the user. No current, heat, smoke or sparks are introduced into the patient. The device is designed to be used in flexible endoscopic instruments with ultrasound (EUS) used for examinations of the gastrointestinal tract. The single-use biopsy instrument consists of a needle and handle that are supplied sterile and is for single patient use only. The needle contains all patient contact pathways and is fully disposable. Cleaning, reprocessing and/or re- sterilization of the instrument is prohibited. The needle is inserted through the working channel of a flexible endoscope and fixed at the endoscope handle. The single-use and handle consists of the following pre-assembled, sterile components: 1. A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated. 2. An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site. 3. A handle that is mounted to the working channel of an endoscope, used to control sampling and attaches to a reusable drive cable that mechanically transfers rotation. The reusable electrical motor and drive cable facilitating the rotation of the tip are supplied non-sterile and reusable. The motor unit contains an on/off safety switch and rotation is activated with a pedal attached to the motor. The drive cable that mechanically transmits rotation to the needle is mounted on the handle prior to sampling. The motor unit accommodates a DC motor which includes a power indicator light and attachments for power cable, drive cable and pedal. The motor is isolated and provides mechanical rotation to the single-use handle via the drive cable. No current, heat, smoke or sparks are introduced into the patient.
The provided text describes a 510(k) premarket notification for a medical device called "EndoDrill® Model X." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.
Therefore, the document does not contain the information typically associated with a study proving a device meets acceptance criteria derived from a full clinical trial or a deep learning AI model performance. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy). This document focuses on demonstrating comparable characteristics to predicate devices and performance in bench testing, not clinical performance metrics.
- Sample sizes for test sets where clinical performance is evaluated. The testing described is primarily engineering bench testing.
- Number of experts used to establish ground truth, their qualifications, and adjudication methods. Ground truth is not established in the clinical sense in this submission.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone (algorithm only) performance. This is a physical biopsy instrument, not an algorithm.
- Type of ground truth used (pathology, outcomes data, etc.) relevant to clinical efficacy.
- Sample size for training set or how ground truth for training set was established. This refers to machine learning models, not physical devices.
Instead, the document details bench testing to demonstrate the safety and fundamental performance of the device and its substantial equivalence to predicate devices.
Here's an analysis of the provided information relevant to "acceptance criteria" and "study" in the context of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of acceptance criteria with numerical performance targets and reported values in the typical sense of a clinical diagnostic study (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the comprehensive list of bench engineering tests performed to ensure the device performs as intended and meets safety standards applicable to a Class II device.
The study proves the device meets (implied) acceptance criteria through:
- Engineering comparative testing: Evaluating the effectiveness of needle advance/retreat, visibility, withdrawal from endoscope, repetition test, needle durability (including bending), proper functioning of motor/drive train/controls during penetration, and ultrasound compatibility.
- Endoscope compatibility.
- Locking mechanisms performance.
- Tissue penetration and collection.
- Tissue transport.
- Evaluation of tissue artifacts (absence of heat/burning/crushing).
- Determination of tissue penetration force.
- Sample acquisition and evaluation of sample quality.
- Performance testing of drive motor, drive cable, and controls.
- Sterilization/Shelf Life testing.
- Biocompatibility testing.
- IEC 60601 Electrical safety and EMC.
The overall acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate. The performance testing listed above serves to demonstrate this.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for individual bench tests. Bench testing for medical devices often involves a sufficient number of units to demonstrate robust and reproducible performance, but exact sample sizes are typically detailed in the full test reports, not the public 510(k) summary. For example, "repetition test" implies multiple repetitions, and "needle durability" tests would involve multiple cycles or stress tests.
- Data Provenance: The testing was "non-clinical (bench) testing" performed by the manufacturer, Bibbinstruments AB (based in Sweden, as indicated by the address: S-223 81 Lund, SWEDEN). The data is retrospective in the sense that it was generated pre-submission for regulatory clearance. No external or patient data provenance is relevant here as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of bench testing for a physical device. Ground truth as understood in diagnostic AI or clinical trials (e.g., pathological diagnosis, clinical outcomes) is not established here. The "ground truth" for these tests are engineering specifications and performance metrics related to the device's physical functions.
4. Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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. This is a physical biopsy instrument, 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 is a physical biopsy instrument.
7. The type of ground truth used:
- The "ground truth" for this submission is based on engineering specifications, verified physical properties, and functional performance metrics established through bench testing, demonstrating that the device operates as intended and is comparable to predicate devices in terms of its mechanical function (e.g., ability to penetrate tissue, collect samples, durability, electrical safety). There is no "pathology" or "outcomes data" ground truth directly presented for the device's diagnostic accuracy in a clinical setting, as this type of clearance relies on equivalence for the instrument itself.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical device's regulatory submission using bench testing. This term typically refers to data used to train machine learning models.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.
§ 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.