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510(k) Data Aggregation
(88 days)
The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients 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 SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device in adult patients only via a straight or side viewing flexible endoscope, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
The provided text is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. SureClip™ Repositionable Hemostasis Clip (K182556). This document is a premarket notification to the FDA for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than extensive clinical studies or AI algorithm performance.
Therefore, many of the requested sections regarding AI device performance metrics, expert consensus, and specific clinical study details are not applicable or cannot be extracted from this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested for an AI device. Instead, it lists various bench tests performed to demonstrate substantial equivalence to the predicate device. The general acceptance criterion implied is that the proposed device performs comparably to the predicate device, thereby meeting safety and effectiveness requirements.
| Bench Test Performed | Reported Device Performance |
|---|---|
| Dimension | Demonstrated equivalence |
| Release Force | Demonstrated equivalence |
| Clamping Strength | Demonstrated equivalence |
| Mechanical Integrity of Clip Assembly | Demonstrated equivalence |
| Tensile Strength | Demonstrated equivalence |
| Clip Assembly Repeated Open/Close | Demonstrated equivalence |
| Clip Open and Close Force | Demonstrated equivalence |
| Rotation | Demonstrated equivalence |
| Scope Compatibility/Usability | Demonstrated equivalence |
| Endoscope Damage | Demonstrated equivalence |
| Torque | Demonstrated equivalence |
| Biopsy Valve Compatibility | Demonstrated equivalence |
| Clip Approach | Demonstrated equivalence |
| Coil to Handle Tensile | Demonstrated equivalence |
| Biocompatibility | Meets ISO 10993-1, ISO 10993-7 |
| Sterilization | Meets ISO 11135 |
Note: The document states that "The testing performed demonstrated that the proposed device and predicate device are equivalent." Specific quantitative performance values for each test are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a physical medical device (hemostasis clip), not an AI algorithm evaluated on a data set. The "test set" would refer to the physical devices subjected to bench testing. The document does not specify the number of devices tested for each bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI device, and no ground truth established by experts on a test set is discussed.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI device, and no adjudication method for an AI test set is mentioned.
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. This is not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The Type of Ground Truth Used
Not applicable. For a physical device, performance is evaluated against engineering specifications and regulatory standards rather than a "ground truth" derived from expert consensus or pathology on medical images/data. The "ground truth" here is the expected performance based on the predicate device and established safety/effectiveness standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI device, so there is no training set or associated ground truth.
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(225 days)
The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects
The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
This document is a 510(k) premarket notification for a medical device, specifically a hemostasis clip. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a novel AI or diagnostic system.
The "acceptance criteria" discussed in this document refer to various engineering and biological safety standards for the device itself, rather than performance metrics for an analytical or diagnostic function.
Based on the provided text, here's an analysis regarding your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of "acceptance criteria" in the sense of predefined performance metrics (e.g., sensitivity, specificity, accuracy) that an AI or diagnostic device would need to meet. Instead, it refers to performance standards for the physical device.
The study indicates that the SureClip™ Repositionable Hemostasis Clip met the requirements of several ISO standards and underwent specific bench tests. The compliance with these standards and the results of the bench tests are the "reported device performance" in this context.
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process" | The proposed device "meets the requirements" of this standard. This implies that the device's biocompatibility has been evaluated and found acceptable according to the standard. |
| ISO 11135 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices" | The proposed device "meets the requirements" of this standard. This indicates that the ethylene oxide sterilization process for the device has been developed, validated, and controlled according to the standard, ensuring sterility. |
| ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" | The proposed device "meets the requirements" of this standard. This suggests that the levels of ethylene oxide residuals on the device after sterilization are within acceptable limits as defined by the standard. |
| Bench Tests: | Results: |
| Dimensional verification | Performed, implying that the device dimensions conform to specifications. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies that the dimensions are comparable and acceptable. |
| Mechanical Integrity of Clip Assembly | Performed, implying the clip assembly maintains its structural integrity under specified conditions. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the mechanical integrity is comparable and acceptable. |
| Clamping Strength Testing | Performed, implying the clip can exert and maintain adequate clamping force. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the clamping strength is comparable and acceptable. However, specific values are not provided. |
| Tensile Strength Testing | Performed, implying the device components can withstand specified tensile forces. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the tensile strength is comparable and acceptable. |
| Release Force Testing | Performed, implying the clip can be released with an appropriate and controlled force. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the release force is comparable and acceptable. |
| Rotation Testing | Performed, implying the device can be rotated as intended in use. The document states, "The testing performed demonstrated that the proposed and predicate delivery systems are substantial equivalent." This broadly implies the rotational capability and performance are comparable and acceptable. |
Important Note: This document does not concern an AI or diagnostic device. The "acceptance criteria" here are related to the safety and fundamental functionality of a physical medical instrument (a hemostasis clip), not to the diagnostic or predictive performance of an algorithm.
The remaining points (2-9) are not applicable to this document as they relate to studies for AI/diagnostic devices, which involve performance metrics like sensitivity, specificity, reader studies, and ground truth establishment. This 510(k) submission focuses on demonstrating substantial equivalence of a physical device through benchmark testing and compliance with recognized standards.
Specifically:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This document is about a physical device, not an algorithm being tested 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 a physical device is established through engineering specifications and test methodologies, not expert consensus on diagnostic data.
- 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. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, "ground truth" would be the device meeting its engineering design specifications and safety standards.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: Not applicable.
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(199 days)
The SureClip Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
The SureClip Clip Applier ("SureClip") is comprised of a cartridge ("SureClip Clip Applier Cartridge" or "SureClip Cartridge") (5mm or 10mm) (Class II) and a handle (Class I). Each cartridge is pre-loaded with 17 implantable titanium clips. The SureClip Clip Applier is intended to apply implantable, medium/large, titanium clips. The clips are manufactured from unalloyed implant grade titanium (ASTM F67 Grade 1 Titanium, UNS R50250). The cartridge must be assembled and locked into the handle. The handle includes a pistol grip trigger and a rotation knob for 360° rotation in either direction. The jaws, which are located at the distal end of the SureClip Cartridge, form each clip as the trigger is actuated.
The provided text does not contain information about acceptance criteria for a device's performance that can be presented in a table with reported device performance. It also does not describe a study that proves a device meets such acceptance criteria in the way requested (e.g., sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness study results).
The document is a 510(k) summary for the ConMed SureClip Clip Applier, primarily focused on establishing substantial equivalence to a predicate device. It mentions "Non-clinical Performance Testing" and "Performance testing" but does not provide specific metrics or acceptance criteria for those tests in a format suitable for the requested table.
Here's an analysis of what is available in the document regarding testing:
Key Information from the Document:
- Device Name: ConMed SureClip Clip Applier
- Intended Use / Indications for Use: The SureClip Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
- Predicate Device: LIGAMAX™ 5 Clip Applier (K110699) by Ethicon Endo-Surgery. Reference devices: LIGAMAX™ 10-M/L (K864102, K830503, and K812291)
- Testing Conducted:
- Non-clinical bench and simulated use testing
- Clip burst testing
- Clip retention testing
- Animal testing (implantation) per Good Laboratory Practice 21 CFR Part 58.
- Material analysis and biocompatibility testing (complying with ANSI/AAMI/ISO 10993-1:2009(R)/2013)
- Outcomes of Testing:
- "demonstrate the SureClip Clip Applier is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance."
- "Results of product performance testing confirm that devices comply with design specifications and applicable sections of ISO 11135:2014, AAMI/ANSI ST67:2011, ISO 10993-7:2008, ISO 14971:2007, ASTM F67-13:2013, and ASTM F2503-13:2013."
- "Product performance and animal testing demonstrate the safe and effective application of the new design features for the same intended use as the predicate device."
- "Comparison of device features and side-by-side comparison testing conducted for clip applier performance demonstrate that SureClip Clip Applier is substantially equivalent to Ethicon's Clip Applier for both the 5mm and 10mm regarding intended use/indications for use, technology, and performance specifications."
Missing Information (required by your request):
- Table of Acceptance Criteria and Reported Device Performance: Not provided explicitly. The document states compliance with design specifications and standards but doesn't list specific performance metrics (e.g., minimum burst strength, maximum clip retention force) or the exact values achieved by the device.
- Sample sizes used for the test set and data provenance: No specific sample sizes for bench, simulated, or animal testing are mentioned, nor is the data provenance (country, retrospective/prospective) described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable/not mentioned, as these are primarily engineering performance tests, not clinical evaluations requiring human expert interpretation in the way AI/diagnostic devices do.
- Adjudication method: Not applicable/not mentioned.
- MRMC comparative effectiveness study: Not conducted. This is an engineering/performance substantial equivalence claim, not an AI or diagnostic effectiveness study.
- Standalone (algorithm only) performance: Not applicable. This is a mechanical device, not an algorithm.
- Type of ground truth used: For the physical performance tests (burst, retention), the "ground truth" would be the measured physical properties themselves, established through standardized testing methodologies. For biocompatibility, it's compliance with established ISO standards. For animal testing, it's observation of biological response in live subjects.
- Sample size for the training set: Not applicable. This is not a machine learning/AI device.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the document focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison to a predicate device, rather than presenting a detailed "acceptance criteria vs. performance" table with specifics on sample sizes, expert ground truth, or MRMC studies as typically requested for diagnostic or AI-based devices.
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