Search Results

CARESORB® - Polyglactin 910 Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures; but not for use in cardiovascular or neurological tissues.

CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are multifilament, braided, sterile synthetic absorbable surgical sutures composed of a copolymer of 90% glycolide and 10% L-lactide. The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are coated with copolymer of Poly(glycolide-co-L-lactide) (30/70) and calcium stearate.

The CARESORB® - Polyglactin 910 suture is available dyed with FDA-approved color additive D&C Violet No. 2 - Cl 60725 or undyed in the natural beige color.

The CARESORB® RAPID - Polyglactin 910 suture is available undyed in the natural beige color only.

The CARESORB® sutures are available in USP sizes 6-0 through 1 and CARESORB® RAPID sutures in USP sizes 4-0 through 2-0, in different lengths, with or without a standard needle attached.

The CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter.

The document describes the non-clinical testing performed to demonstrate the substantial equivalence of CARESORB® and CARESORB® RAPID surgical sutures to predicate devices (Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide). The study is not an AI/ML study, but rather a set of laboratory and in-vivo tests for medical device acceptance.

Here is an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Study Type and Purpose:
This is a non-clinical comparative study designed to establish substantial equivalence of new surgical sutures (CARESORB® and CARESORB® RAPID) to existing legally marketed predicate devices (Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide). The goal is to demonstrate that the new devices are as safe and effective as the predicates.

Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally implied by "compliance with" various USP monographs and ISO standards, and "similarity"/ "comparability" to the predicate devices. The reported device performance is presented as the test outcomes indicating this compliance or similarity.

• CARESORB® Surgical Suture considered non-irritant compared to predicate VICRYL™ in short-term, mid-term, and long-term Intramuscular Implantation Tests with Histopathology.
• CARESORB® Rapid Surgical Suture considered non-irritant compared to predicate VICRYL™ Rapide in mid-term Intramuscular Implantation Test with Histopathology.
• CARESORB® Suture found to be non-pyrogenic, non-mutagenic, and non-genotoxic. |
  | Material & Physical Properties | |
  | Compliance with USP Monograph for Synthetic Absorbable Sutures | - CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter (stated to comply with USP except for slight oversize). |
  | Compliance with USP Sutures Diameter | - Complies with USP except for slight oversize in the suture diameter for both CARESORB® and CARESORB® RAPID. |
  | Compliance with USP Sutures Needle Attachment | - **Complies with USP ** for both CARESORB® and CARESORB® RAPID. |
  | Compliance with USP Tensile Strength | - **Complies with USP ** for both CARESORB® and CARESORB® RAPID. |
  | Suture Length | - ≥ 95% of the claimed label length as required by USP for both CARESORB® and CARESORB® RAPID. |
  | Absorption & Breaking Strength Retention Profile | |
  | Similar resorption profile to predicate device | - CARESORB® sutures have similar tensile strength retention profile in comparison to marketed predicate VICRYL™ sutures in an in-vivo implantation study.
• In-vivo breaking strength retention profile of CARESORB® RAPID was determined to be similar to marketed predicate VICRYL™ Rapide (based on supplier data) and independently demonstrated similar resorption profiles in an in-vitro study compared to VICRYL™ Rapide and raw material sutures.
• CARESORB® sutures and VICRYL™ sutures have very similar absorption in tissue in an in-vivo implantation study.
• CARESORB® RAPID rate of absorption in tissue was determined to be similar to marketed predicate VICRYL™ Rapide (based on supplier data). |
  | Sterility & Packaging | |
  | Validated sterile barrier packaging system | - Validated sterile barrier packaging system (Tested against ISO 11607-1, ASTM F88/F88M-15, ASTM F1140/F1140M-13, ASTM F2096-11). |
  | Sterility (USP ) | - Sterility Testing (USP 39-NF34 ) performed as part of shelf-life study and overall compliance. |
  | Minimal Ethylene Oxide Sterilization Residuals | - ISO 10993-7 Residuals testing performed. (Results not explicitly detailed, but implied compliance). |
  | Absence of Bacterial Endotoxins | - USP 39-NF 34 Bacterial Endotoxins Test performed. (Results not explicitly detailed, but implied compliance). |
  | Shelf Life | |
  | Conformance for 5-year expiration date | - Conformance to specified acceptance criteria for diameter, needle attachment, tensile strength, in vitro BSR, visual inspection, moisture content, and sterility after real-time and accelerated aging studies. Supported a 5-year expiration date. |

Detailed Information as requested:

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for each test, but studies were conducted "in vivo" and "in vitro." Standard specifications like USP monographs and ISO standards imply a certain number of samples are required for testing. For instance, the discussion mentions "samples of final sterilized devices". In vivo studies likely involved animal models, but no numbers are provided.
   • Data Provenance: The studies were conducted by CPT Sutures Co., Ltd. through various tests following international standards (ISO and USP). The in-vivo breaking strength retention and absorption rate for CARESORB® RAPID were based on "data provided by the suture material supplier from the in-vivo implantation study," suggesting external data provenance for part of the study for that specific product. The in vitro study for CARESORB® RAPID explicitly compared it to the predicate and "raw material supplier's sutures," indicating internally generated data. The document implies these are prospective tests conducted specifically for this submission. The country of origin for the submitting company is Vietnam.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as this is a medical device performance and equivalence study based on physical, chemical, and biological testing, not an AI/ML diagnostic study requiring expert human interpretation of medical images. The "ground truth" here is objective measurement against established standards (USP monographs, ISO standards) and comparison to the predicate device's known performance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as this is not a study involving human readers/interpreters or subjective assessments requiring adjudication. The methods are standardized laboratory tests.

4. 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:

   • No, a MRMC study was not done. This is a study for validating medical device characteristics, not an AI/ML diagnostic performance study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is framed for AI/ML algorithms. For a medical device like a suture, the "standalone performance" refers to the intrinsic physical, chemical, and biological properties of the suture itself, which is precisely what the non-clinical tests (biocompatibility, tensile strength, absorption profile, etc.) evaluated. There is no algorithm involved.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this study is based on:
     • Industry Standards: Compliance with established physical and chemical properties defined by USP (United States Pharmacopeia) monographs and various ISO standards for biocompatibility (e.g., ISO 10993 series), sterility, and packaging.
     • Predicate Device Performance: Direct comparison of the new device's performance to the known and accepted performance characteristics of the legally marketed predicate devices (Ethicon's VICRYL™ and VICRYL™ Rapide) in terms of absorption profiles and other key parameters.
     • Laboratory Measurements: Objective measurements of tensile strength, diameter, needle attachment, absorption rates, and biological responses (e.g., cytotoxicity, irritation via histopathology).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML study, so there is no "training set." The materials used for testing are representative samples of the manufactured surgical sutures.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI/ML training set.

Ask a specific question about this device