(105 days)
The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
The Cypris eXact Suture (PDO) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.
The Cypris eXact Suturing System is comprised of the Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device. The Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device are for use in general soft tissue approximation by surgeons, are single-use, and are provided sterile.
The Cypris eXact Suture is a synthetic, monofilament suture available in three different materials: polypropylene (PP), polydioxanone (PDO), and polytetraflouroethylene (PTFE). The Cypris eXact Suture (PP) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. The Cypris eXact Suture (PTFE) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 2-0 and 3-0. The Cypris eXact Suture (PDO) is an absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. Each 24-inch suture has a stainless-steel BB needle attached to one end of the suture.
Cypris eXact Sutures can be used with the Cypris eXact 5.1 Suture Placement Device, a handheld device used for the placement of a surgical suture.
The FDA 510(k) clearance document for the Cypris eXact Suturing System (K233355) indicates that the device's substantial equivalence to predicate devices is based on non-clinical testing rather than a study involving human-in-the-loop performance or diagnostic accuracy of an AI algorithm. Therefore, many of the requested criteria related to AI/MRMC studies, number of experts, adjudication methods, and training/test set ground truth for AI models are not applicable.
The document primarily focuses on demonstrating that the Cypris eXact Sutures are identical in formulation, processing, sterilization, and geometry to previously cleared sutures and that their performance meets established USP and FDA guidance standards for surgical sutures. The Cypris eXact 5.1 Suture Placement Device is evaluated for its integrity and functionality.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP/FDA Guidance Standards) | Reported Device Performance (Cypris eXact Suture) |
|---|---|
| Suture Diameter meets USP requirements | All suture sizes meet USP requirements |
| Suture Tensile Strength meets USP requirements | All suture sizes meet USP requirements |
| Needle Attachment Strength meets USP requirements | All suture sizes meet USP requirements |
| Biocompatibility (as per ISO 10993-1:2018 for implanted devices with long-term contact) | All evaluated endpoints met (cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, and implantation). |
| Sterile Barrier Integrity (for 5.1 Suture Placement Device) | Demonstrated following 3 years of real-time aging. |
| Functionality (for 5.1 Suture Placement Device) | Demonstrated following 3 years of real-time aging. |
| Shelf-life for Sutures | 5 years |
| Shelf-life for Suture Placement Device | 3 years |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state "sample sizes for a test set" in the context of an AI-driven study. Instead, it refers to performance testing of the physical sutures and the placement device. The data provenance is not described as medical cases or patient data, but rather as results from laboratory testing performed in accordance with USP and ISO standards. The country of origin of the data is not specified beyond being generated for an FDA submission. The studies were likely prospective in that they were designed and performed to meet regulatory requirements prior to submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is compliance with established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
Not applicable. This is not an AI/diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI/diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device. The "standalone" performance relates to the physical and biological characteristics of the suture materials and the mechanical functionality of the placement device as tested in laboratory settings.
7. The Type of Ground Truth Used:
The ground truth used for evaluating the performance of the sutures and placement device are established industry standards and regulatory guidelines:
- **USP , , ** requirements for surgical sutures (diameter, tensile strength, needle attachment strength).
- ISO 10993-1:2018 standards for biological evaluation of medical devices (biocompatibility endpoints).
- FDA's Guidance for Industry and FDA Staff: Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff (issued June 3, 2003).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a series of non-clinical, laboratory-based performance and biocompatibility tests.
- Device Tested: Cypris eXact Sutures (PP, PTFE, PDO) and Cypris eXact 5.1 Suture Placement Device.
- Tests Performed:
- Suture Testing: Measurement of suture diameter, tensile strength, and needle attachment strength for various suture sizes and materials. These tests were conducted according to the specific methods outlined in the United States Pharmacopeia (USP) standards (, , ).
- Biocompatibility Testing: Evaluation of material interactions with biological systems, including cytotoxicity, sensitization, irritation (for the placement device), acute systemic toxicity, material-mediated pyrogenicity, subacute and subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, and implantation (for the sutures). These tests followed ISO 10993-1:2018 guidelines.
- Shelf-life Testing: Evaluation of sterile barrier integrity and device functionality for the Cypris eXact 5.1 Suture Placement Device after 3 years of real-time aging to establish its shelf-life. The sutures had a separate, longer shelf-life of 5 years.
- Acceptance Criteria Basis: The acceptance criteria for each test were defined by the adherence to the requirements specified in the aforementioned USP standards, ISO 10993-1:2018, and FDA's specific guidance for surgical sutures.
- Conclusion: The tests demonstrated that the Cypris eXact Sutures meet all specified USP requirements and that all materials used are biocompatible. The Cypris eXact Sutures are explicitly stated as being "identical in their final finished form in formulation, processing, sterilization, and geometry to the sutures previously cleared" under the predicate devices (K131224, K160744, K063680). The Cypris eXact 5.1 Suture Placement Device also demonstrated integrity and functionality over its claimed shelf-life. This body of non-clinical evidence provided the basis for the FDA's determination of substantial equivalence.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.