Search Results

The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of : 1) Endoscopic marking; 2) Hemostasis for: A) Mucosal/sub-mucosal defects

The proposed device is consisted of a clip section. The delivery section. The delivery section include: slide bar, slip ring, protective sleeve, rotation head, coated spring tube, slip ring holder, traction assembly, connecting tube, decoupled piece, decoupled shrapnel, rotation sleeve. And the clip section include: clip, sliding block, shaft and rocker arm. The clip is made of stainless steel. The clip can be opened and closed more than five times prior to deployment, aiding in repositioning of the lesion site. The proposed device is available in single ring and three ring models, and each case is divided into rotatable and non-rotatable clip. The effective length of the proposed device includes 1250mm, 1650mm, 2350mm and the opening width is 9mm, 11mm. 13mm and 16mm. The proposed devices are provided in sterile and single use.

The provided text describes the 510(k) submission for a medical device, the "Disposable Hemostatic Clips." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Crucially, the document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide information regarding:

• Acceptance Criteria and Reported Device Performance (Table): There are no clinical performance metrics of the device against "acceptance criteria" presented from a clinical study. The document details non-clinical tests and their pass/fail status, indicating they met product requirements, but not against specific acceptance criteria for clinical performance.
• Sample size and data provenance (test set): No clinical test set.
• Number of experts and qualifications (ground truth for test set): Not applicable for a clinical test set.
• Adjudication method (test set): Not applicable.
• MRMC comparative effectiveness study: Not conducted.
• Standalone (algorithm only) performance: Not applicable as this is a mechanical device, not an AI algorithm.
• Type of ground truth used (clinical): No clinical data to establish ground truth.
• Sample size for training set: No clinical training set.
• How ground truth for training set was established: No clinical training set.

However, I can provide information based on the non-clinical testing summarized in the document, framed as how the device "meets the acceptance criteria" for functional and safety performance, as demonstrated by bench testing and biocompatibility assessments.

Non-Clinical Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through a series of non-clinical tests to verify it met design specifications and standards, demonstrating substantial equivalence to the predicate device. The "acceptance criteria" for these tests are implicitly that the device passes the specified tests and complies with the relevant ISO and ASTM standards.

Here's a summary of the non-clinical tests and their outcomes:

• Appearance
• Rotation performance
• Release force
• Clamping strength
• Relocation
• Tensile strength
• Dimension
• Mechanical integrity of clip assembly
• Scope compatibility/usability
• Endoscope damage
• Torque
• Clip approach
• Three ring handle strength

Specifically noted that the three-ring model's tension tests showed results similar to the predicate device, able to withstand clinical use forces. |

Study Proving the Device Meets Acceptance Criteria (Non-Clinical)

The "study" proving the device meets its non-clinical acceptance criteria consists of the comprehensive set of Non-Clinical Tests and Biocompatibility Testing.

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify the exact sample sizes for each non-clinical test (e.g., number of units tested for tensile strength or rotation performance). It states "all tests were passed."
   • Data Provenance: The tests were performed by Ningbo Xinwell Medical Technology Co., Ltd. (China) or their designated testing facilities, as per the submission. This is internal testing data for the 510(k) submission.

2. 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 non-clinical, bench testing. The "ground truth" for these tests is defined by the established industry standards (ISO, ASTM, USP) and the device's design specifications. Conformance to these standards and specifications is evaluated through laboratory testing.

3. Adjudication method for the test set:

   • Not applicable as this refers to human review of clinical data. Non-clinical tests have pass/fail criteria based on objective measurements against defined standards.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, a MRMC comparative effectiveness study was not done. The submission states: "No clinical study is included in this submission." This implies no clinical performance data involving human readers or patients, only bench and biocompatibility testing. The comparison to the predicate device is based on functional equivalence and meeting, or not raising new questions about, safety and effectiveness through non-clinical data.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a mechanical hemostatic clip and delivery system, not an algorithm or AI-powered device.

6. The type of ground truth used:

   • For non-clinical performance and safety: The ground truth is defined by established international and national standards (ISO 10993, ISO 11135, ASTM F1929, ASTM F88/F88M, ASTM F1886/F1886M, USP , ASTM D4169, ASTM F1980) and the device's internal design specifications and requirements. The "truth" is whether the device's physical properties and performance characteristics meet these objective, measurable standards.

7. The sample size for the training set:

   • Not applicable as there is no clinical study data, training set, or machine learning component cited.

8. How the ground truth for the training set was established:

   • Not applicable as there is no clinical study data, training set, or machine learning component cited.

Ask a specific question about this device

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm.

The device is sterilized by ethylene oxide. The shelf life is 3 years.

The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.

This is a 510(k) premarket notification for a medical device (Disposable Injection Needles), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than complex performance criteria for AI/ML devices. Therefore, many of the requested categories for AI/ML device performance are not applicable to this submission.

Based on the provided document, here's an analysis of the acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" in the way one might expect for a digital health or AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with established medical device standards and demonstrating performance comparable to the predicate device. The Reported Device Performance is stated as meeting the requirements of these standards.

The document concludes that "The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device Injection Needle (K213914)." This general statement serves as the overall reported device performance and proof that it meets the implicit acceptance criteria of substantial equivalence.

The following information is not applicable to this traditional medical device submission, as it pertains to AI/ML device evaluations:

2. Sample size used for the test set and the data provenance: Not applicable. The tests are physical and chemical bench tests on the device materials and functional aspects, not AI performance on data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device often involves expert annotation. For this physical device, "ground truth" is measured by adherence to established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For this device, the "ground truth" is adherence to performance specifications outlined in the referenced ISO and ASTM standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device