(72 days)
CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
CATGUT, Plain and Chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. CATGUT meets the United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures. It will be offered uncoated or coated with glycerol and with or without standard needles attached.
The acceptance criteria for the T.CAD International PLAIN/CHROMIC CATGUT surgical sutures are primarily based on conformance to established standards and similarity to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Characteristic) | Reported Device Performance (T.CAD International CATGUT) |
|---|---|
| Intended Use | Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. |
| Suture Material | Absorbable, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine. |
| Suture Characteristics (Tensile strength loss & absorption rates) | Factors which can affect tensile strength loss and absorption rates: a. Type of suture (Plain vs. Chromic), b. Infection, c. Tissue Sites (e.g., presence of proteolytic enzymes). |
| Sterilization Method | Gamma Irradiation |
| How Supplied | Sterile and undyed. Offered for Single Use Only with or without surgical needles. Also offered uncoated or coated with glycerol. |
| Suture Diameter | Meets U.S.P. Requirements |
| Suture Length | Meets U.S.P. Requirements |
| Knot Pull Tensile Strength | Meets U.S.P. Requirements |
| Needle Attachment Strength | Meets U.S.P. Requirements |
| Packaging | Packaged with an alcohol solution in Aluminum Foil and Polyester tear open packaging. |
| Labeling | In conformance with CDRH instructions of the "Medical Device Quality Manual" dated December 1996 and FDA Guidance documents "Alternate Suture Labeling," reformatted on December 17th, 1997. |
| Compliance with Standards | Conformance to U.S.P. standards, ISO 9002, EN 46002 & EN 552 Standards, and FDA Guidance documents "Alternate Suture Labeling." |
Study Proving Acceptance Criteria:
The device's acceptance was proven through non-clinical testing designed to demonstrate conformance to U.S.P. standards and substantial equivalence to the predicate device.
2. Sample Size and Data Provenance (Test Set):
- Sample Size: Not specified in the provided text for the non-clinical testing.
- Data Provenance: The testing was "Non-Clinical Testing ... conducted on the subject device." This suggests the data was generated as part of a regulatory submission process. The origin (e.g., country) of the specific data points is not mentioned, but the overall regulatory framework is the U.S. FDA. The testing is implicitly prospective as it's for a new device submission.
3. Number of Experts and Qualifications (Ground Truth for Test Set):
- This information is not applicable/not provided as there's no mention of a clinical study, expert review of images, or diagnostic interpretation. The acceptance criteria are based on physical properties and manufacturing standards, not expert interpretations of medical data.
4. Adjudication Method (Test Set):
- None specified. As the evaluation is against physical and material standards (U.S.P. requirements, etc.), expert adjudication of subjective findings is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Not available at the present time." The device is cleared based on non-clinical testing and substantial equivalence to a predicate.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a physical surgical suture, not an AI algorithm. Therefore, standalone algorithm performance is not a relevant concept for this submission.
7. Type of Ground Truth Used:
- The "ground truth" used was based on established industry standards and specifications:
- United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures.
- Relevant ISO and EN standards (ISO 9002, EN 46002 & EN 552).
- FDA Guidance documents related to suture labeling.
- The characteristics and performance of the chosen predicate device (Plain and Chromic Absorbable Surgical Sutures of Davis & Geck - K930589).
8. Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI model, this question is irrelevant to the provided information.
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.