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510(k) Data Aggregation
(357 days)
Anchora Medical, Ltd.
The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.
The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).
The Su2ura Approximation Device is a sterile, single-use endoscopic suturing device with the following acceptance criteria and reported performances:
1. Acceptance Criteria and Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Evaluate all patient contact materials in accordance with ISO 10993-1. | Biocompatibility assessments were performed in accordance with ISO 10933-1. Testing included extractable and leachable studies (ISO 10993-18) and a toxicological risk assessment (ISO 10993-17). Implied that the device met the criteria. |
| Human Factors | Verify the usability of the device with representative users. Training provided and Instructions for Use (IFU) must be clear and accurate. | A Human Factors Engineering (HFE) Study was performed with 18 representative users, evaluating the usability of all tasks. The study confirmed device usability and demonstrated that the training and IFU were clear and accurate. Implied that the device met the criteria. |
| Pre-Clinical Safety & Performance | Assess safety and performance under GLP conditions, in compliance with ISO 10993-6. Incision sites should be successfully closed, and long-term safety should be similar between test and control items. | An animal study (8 pigs) was performed under GLP conditions and in compliance with ISO 10993-6. 5 pigs for the test item and 3 for control. All incisions were successfully closed, and histopathological data indicated long-term safety was similar between Test and Control Items. Implied that the device met the criteria. |
| Mechanical Performance | Conform to USP requirements, applicable standards, product specifications (e.g., dimensional verification, component compatibility, tissue anchoring pull-out, corrosion, deployment reliability, suture pull-out strength, tensile strength). | Bench testing included dimensional verification, component compatibility, tissue anchoring pull-out, corrosion testing per ASTM F2129, deployment reliability, suture pull-out strength, and tensile strength per USP . The results of all studies confirmed substantial equivalence between the subject and predicate designs, implying these criteria were met. |
| MRI Safety & Compatibility | Verified per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119. | MRI safety and compatibility was verified per the specified ASTM standards. The device was deemed MR Conditional. Implied that the device met the criteria. |
| Packaging Integrity | Confirmed by testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16. | Packaging integrity was confirmed by testing in accordance with the specified ASTM standards. Implied that the device met the criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: Not explicitly stated as a test set with a specific sample size of biological samples, but rather a set of material characterization studies (extractables and leachables) and toxicological risk assessments. The input does not provide information on the number of samples for these tests.
- Human Factors: 18 representative users. The provenance of the users (e.g., country of origin, whether they were clinicians or laypersons, etc.) is not specified. The study appears to be prospective.
- Pre-Clinical Performance (Animal Study): 8 pigs (5 for test items, 3 for control items). The provenance of the data is a GLP animal study. It is a prospective study.
- Mechanical Performance, MRI Safety, Packaging Integrity: These involved various bench tests. The sample sizes for each specific test (e.g., number of devices tested for tensile strength or deployment reliability) are not explicitly stated in the provided text. The data provenance is from laboratory/bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Biocompatibility: No explicit external experts are mentioned for establishing ground truth. Compliance was based on ISO standards.
- Human Factors: The "representative users" assessed usability. It's not stated whether these were "experts" in the sense of clinicians or if their feedback constituted a "ground truth" to be adjudicated. Their feedback was used to confirm usability.
- Pre-Clinical Performance (Animal Study): Not explicitly stated how many experts were involved in evaluating the histopathological data, but it would typically involve veterinary pathologists. Their specific qualifications are not detailed.
- Mechanical Performance, MRI Safety, Packaging Integrity: Ground truth for these studies relies on recognized ASTM and USP standards and internal engineering measurements. No external "experts" were mentioned for ground truth establishment beyond standard scientific and engineering practices.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (like 2+1 or 3+1) for the various studies conducted as part of the regulatory submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical tool, and its effectiveness is not assessed through human reader interpretation of images, but rather through direct use in surgery, performance in bench tests, and pre-clinical animal studies. Clinical testing was expressly stated as "not required to demonstrate substantial equivalence."
6. Standalone Performance Study
The studies described (bench testing, animal study, human factors) are essentially "standalone" in the sense that they evaluate the device itself. However, the term "standalone performance" often refers to the algorithm-only performance of AI devices without human-in-the-loop. This device is a mechanical surgical tool, not an AI or imaging diagnostic device, so this concept does not directly apply.
7. Type of Ground Truth Used
- Biocompatibility: Compliance with ISO 10993 standards (e.g., acceptable levels of extractables/leachables, lack of toxicological risk).
- Human Factors: User feedback and observed usability were used to confirm clarity of training and IFU, and the overall usability of the device. This is a form of self-reported or observed performance against predetermined usability goals.
- Pre-Clinical Performance (Animal Study): Histopathological data (from tissue analysis) and clinical monitoring of animals provided the ground truth for safety and performance (e.g., successful closure, similar long-term safety profile to controls).
- Mechanical Performance, MRI Safety, Packaging Integrity: These rely on objective measurements and adherence to established industry standards (ASTM, USP) and predefined product specifications.
8. Sample Size for the Training Set
This question is not applicable. The Su2ura® Approximation Device is a mechanical surgical device, not a machine learning or AI model, so there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
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