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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.

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POLYS YN™ Polyglycolic Acid (PGA) Suture 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.

PGA Sutures are supplied as braided or monofilament, dyed (violet) or undyed and coated or uncoated. The pigment for the violet is D&C Violet #2. Where applicable, the coating is a copolymer of polycarpolactone and calcium stearate. The PGA Suture is available in Size 2 through Size 10-0.

This document describes the 510(k) summary for the PolySynTM (PGA) Surgical Suture. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically for additional diameter sizes (USP Size 7-0 through 10-0).

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the PolySynTM (PGA) Surgical Suture are conformity to the USP monograph for absorbable sutures and demonstration of substantial equivalence to predicate devices through various performance tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes for each test in the non-clinical laboratory performance testing. It generally refers to "performance testing."

The data provenance is from non-clinical laboratory performance testing. The country of origin of the data is not explicitly stated, but it is implied to be generated by the applicant, Surgical Specialties Corporation, in the United States (given their address). The data is retrospective testing done to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a surgical suture, and the evaluation is based on non-clinical laboratory performance testing against established standards (USP monograph) and predicate device characteristics, not on expert interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation is based on objective laboratory measurements against predefined specifications and comparisons to predicate device data, not on subjective assessments requiring adjudication.

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. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a traditional medical device (surgical suture), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for evaluation is based on:

• USP (United States Pharmacopeia) monograph for absorbable sutures: These are established, scientifically vetted standards for the physical and performance characteristics of surgical sutures.
• Predicate device characteristics: These are the established performance parameters of the legally marketed devices (K965162 and K022269) to which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a traditional medical device (surgical suture) and does not involve machine learning or AI, thus no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for it.

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The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor.

The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics:

• Localized
• Unresectable
• Low to Moderate Radiosensitivity

The tumors may be of the following type:

• Superficial
• Intrathoracic
• Intra-abdominal
• Lung, Pancreas, Prostate, Head and Neck
• Residual following external beam radiation or excision of primary tumor
• Recurrent

The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel

The provided text is a 510(k) Premarket Notification for the BEBIG Brachytherapy Strand Device. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than conducting a performance study with defined acceptance criteria and device performance evaluation as one might find for a diagnostic AI/ML device.

Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in this regulatory document.

However, I can extract the comparison to predicate device table which serves a similar purpose in this context: to show that the new device is comparable to existing, legally marketed devices.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria in the format typically seen for a diagnostic or AI/ML device's performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison of characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a medical device for brachytherapy, and the submission is for substantial equivalence based on material and design comparison, not a clinical performance study with a test set of data.

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. Ground truth for a test set is not established for this type of regulatory submission.

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

Not applicable. Adjudication is not relevant for this type of regulatory submission.

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. This is a physical medical device, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. Ground truth, in the context of a performance study for AI/ML or diagnostic devices, is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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