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510(k) Data Aggregation
(181 days)
Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.
The provided text describes the 510(k) summary for a Non Absorbable Surgical Polypropylene Suture (K230746). It focuses on demonstrating substantial equivalence to a predicate device (K080684) through non-clinical performance data.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly provide a single table listing "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists the standards the device complies with for various performance aspects and states that the test results met these requirements.
However, some specific acceptance criteria and general performance statements are given:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Diameter of suture | Comply with USP <861> | "the test result shows that the length and diameter of the proposed device met the acceptance criteria." (General statement, implies compliance with USP <861>) |
| Needle Attachment | Comply with USP <871> | Reported as "Same" as predicate, implying compliance with USP <871> |
| Tensile Strength | Comply with USP <881> | Implied compliance with USP <881> |
| Length | Not less than 95.0% of the length stated on the label | "the test result shows that the length and diameter of the proposed device met the acceptance criteria." (General statement, implies compliance with this criterion) |
| Cytotoxicity | The viability is not reduced to less than 70% | The device passed, implying viability was not reduced to less than 70% |
| Sensitization | The Magnusson and Kligman grades is less than 1. | The device passed, implying grades less than 1. |
| Intracutaneous Reactivity | The erythema and edema grades is less than 1.0. | The device passed, implying grades less than 1.0. |
| Acute systemic toxicity | No animal died or abnormal behavior occurred. | The device passed, implying no animal died or abnormal behavior occurred. |
| Pyrogen | Temperature raise is less than 0.5℃ No behavioral change or sign of toxicity was observed. Clinical pathology parameter within the reference range. | The device passed, implying these conditions were met. |
| Subacute Systemic Toxicity | No macroscopic changes in the viscera at necropsy. Histopathology within normal histomorphological limits | The device passed, implying these conditions were met. |
| Bacterial Reverse Mutation | No obviously increase in the mean number of revertant of colonies between the test group and control group. | The device passed, implying no obvious increase. |
| Chromosome Aberration | No significant difference in the percentage of cells with chromosome aberrations between the test group and control group. | The device passed, implying no significant difference. |
| Gene Mutation | There was no significant difference in the TFT-resistant mutant frequency between the test article | The device passed, implying no significant difference. |
| Implantation | No lesion at the implantation site. The irritation score is less than 1.0. | The device passed, implying no lesion and irritation score less than 1.0. |
| Hemolysis | Hemolytic index is less than 2% | The device passed, implying hemolytic index less than 2%. |
| Seal Strength | Complies with ASTM F88/F88M-15 | "The test results demonstrated that the subject device complies with the following standards" (including ASTM F88/F88M-15). |
| Detecting Seal Leaks | Complies with ASTM F1929-15 | "The test results demonstrated that the subject device complies with the following standards" (including ASTM F1929-15). |
| Hemolytic Properties | Complies with ASTM F756-17 | "The test results demonstrated that the subject device complies with the following standards" (including ASTM F756-17). |
| EO Sterilization Residuals | Complies with ISO 10993-7:2008 | "The test results demonstrated that the subject device complies with the following standards" (including ISO 10993-7:2008). |
| Penetration Testing of Needles | Complies with ASTM F3014-14 | "The test results demonstrated that the subject device complies with the following standards" (including ASTM F3014-14). |
| Bend Testing of Needles | Complies with ASTM F1874-98 | "The test results demonstrated that the subject device complies with the following standards" (including ASTM F1874-98). |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for any of the non-clinical tests mentioned.
The data provenance is also not specified, as these are bench tests and biological evaluations, not human data. It is implied these tests were conducted by the manufacturer or a contracted lab to meet international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided information. The tests conducted are non-clinical (bench testing, biocompatibility). There is no "test set" requiring expert ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., USP, ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or diagnostic performance evaluations involving human interpretation. The reported tests are non-clinical lab tests and biocompatibility assessments, where results are typically objective measurements or observations against predefined criteria.
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
This question is not applicable. The device is a surgical suture, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a surgical suture, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is established by adherence to recognized international standards and pharmacopeial monographs. For example:
- USP <861>, <871>, <881>: These are pharmacopeial standards defining requirements for suture diameter, needle attachment, and tensile strength.
- ISO 10993 series: These are international standards for the biological evaluation of medical devices, covering aspects like cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, and hemolysis.
- ASTM standards: These are industrial standards covering material properties and packaging (e.g., seal strength, dye penetration, needle bend/penetration).
The ground truth is based on the objective criteria and methodologies outlined in these standards.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission focuses on verifying the physical and biological characteristics of a mechanical device against established standards.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
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(121 days)
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.
This document (K231183) is a 510(k) Premarket Notification for a Non-absorbable Surgical Polyester Suture. It seeks to demonstrate substantial equivalence to a predicate device (K172149). The information provided focuses on the physical and biological compatibility of the suture, rather than the performance of a software or AI-driven medical device in a diagnostic context. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with various ISO, USP, and ASTM standards. The "acceptance criteria" are implied by these standards, meaning the device must "Pass" or "Comply" with the requirements of each standard.
| Test Category | Specific Test / Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical Performance | USP <861> Sutures - Diameter | Comply with USP <861> | Comply with USP <861> |
| USP <871> Sutures - Needle Attachment | Comply with USP <871> | Comply with USP <871> | |
| USP <881> Tensile Strength | Comply with USP <881> | Comply with USP <881> | |
| Length (of suture) | Not less than 95.0% of the length stated on the label | Met the criteria (stated in Analysis 3) | |
| Packaging & Sterility | ASTM F88/F88M-15 Seal Strength of Flexible Barrier Materials | Comply with ASTM F88/F88M-15 | Comply with ASTM F88/F88M-15 |
| ASTM F1929-15 Detecting Seal Leaks by Dye Penetration | Comply with ASTM F1929-15 | Comply with ASTM F1929-15 | |
| USP <85> Bacterial Endotoxins Test | Comply with USP <85> | Comply with USP <85> | |
| ISO 10993-7:2008 Ethylene oxide sterilization residuals | Acceptable Residual Levels | (Not explicitly stated Pass/Fail, but implied by compliance with ISO 10993-1) | |
| Biocompatibility | ISO 10993-5 Cytotoxicity | Pass | Pass |
| ISO 10993-10 Sensitization | Pass | Pass | |
| ISO 10993-10 Intracutaneous Reactivity | Pass | Pass | |
| ISO 10993-11 Acute systemic toxicity | Pass | Pass | |
| USP <151> Pyrogen Test | Pass | Pass (also stated as Comply to USP<151>) | |
| ISO 10993-11 Subacute Systemic Toxicity | Pass | Pass | |
| ISO 10993-3 Bacterial Reverse Mutation | Pass | Pass | |
| ISO 10993-3 Chromosome Aberration | Pass | Pass | |
| ISO 10993-3 Gene Mutation | Pass | Pass | |
| ISO 10993-6 Implantation | Pass | Pass | |
| ASTM F756-17 Hemolysis | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For non-clinical tests like those listed (USP, ASTM, ISO standards), specific sample sizes and testing methodologies are defined within the respective standards. The document only states that the tests were "conducted" and "complies" or "passed." The data provenance (country of origin, retrospective/prospective) is also not specified, as these are lab-based tests rather than patient studies.
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. This document describes the testing of a physical medical device (suture) against established performance and biocompatibility standards. "Ground truth" in the context of expert consensus, typical for diagnostic software or AI, is not relevant here. The "ground truth" for physical device performance is defined by the objective measurement criteria within the specified international and national standards (e.g., USP monographs for suture diameter, tensile strength).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As described above, this is not a study involving human interpretation of diagnostic data that would require an adjudication method.
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. An MRMC study is relevant for diagnostic software performance, particularly AI-driven tools. This submission is for a physical surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the reference standard) for this device is based on established objective measurements and criteria defined by validated international and national standards (e.g., USP Monographs for physical properties, ISO 10993 series for biocompatibility). These standards specify methodologies and acceptance limits that the device must meet.
8. The sample size for the training set
Not Applicable. This is not an AI or machine learning device that requires a training set. The device is a physical product.
9. How the ground truth for the training set was established
Not Applicable. As this device does not use a training set, no ground truth needs to be established for it.
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