(62 days)
MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES
MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic. MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also.
The provided text describes Sutures India Pvt. Ltd.'s premarket notification (510k) for ABSORBABLE (POLIGLECAPRONE 25) SUTURE, named MONOGLYDE. The submission aims to demonstrate substantial equivalence to predicate devices, namely Monocryl (K930772) and Unicaprone (K072646).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the MONOGLYDE suture are based on meeting the performance requirements defined in the United States Pharmacopeia (USP) current edition (USP 29) for various parameters, and showing equivalence to predicate devices. The reported device performance is that MONOGLYDE meets or exceeds these specifications.
| Comparison Parameters (Acceptance Criteria - based on USP 29 & Predicate Equivalence) | MONOGLYDE Reported Device Performance |
|---|---|
| Absorbable (Poliglecaprone 25) suture is a synthetic Absorbable surgical suture. It is a sterile flexible monofilament thread, composed of Poliglecaprone. | Same (as predicate) |
| The sutures are inert, noncollageneous, and nonantigenic. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is dyed with D&C Violet #2 and being monofilament it is coated. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is supplied for single use only. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is sterilized by E.O. gas method. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is packaged in the same or equivalent manner, and has the same or equivalent labeling claims as that of the predicate devices. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture meets the official monograph of the United States Pharmacopeia current edition U.S.P. 29 for extractable color. | Meets / Exceeds In-house specifications and is equivalent (to predicate) |
| Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter. | Meets / Exceeds In-house specifications and is equivalent (to predicate) |
| Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the current edition of U.S.P. 29 for Tensile strength. | Meets / Exceeds In-house specifications and is equivalent (to predicate) |
| Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the current edition of U.S.P. 29 for Needle attachment. | Meets / Exceeds In-house specifications and is equivalent (to predicate) |
| Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for finished suture Length Requirement (95% of stated label length). | Meets / Exceeds In-house specifications and is equivalent (to predicate) |
| Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for sterility. | Meets / Exceeds In-house specifications and is equivalent (to predicate) |
| Absorbable (Poliglecaprone 25) suture is packed in a same or equivalent manner with sterile single or double packing having labeling conforming to 21CFR & U.S.P. 29. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is biologically compatible when tested as per ISO-10993. | Same (as predicate) |
| Absorbable (Poliglecaprone 25) suture is tested and proved to be non toxic, when tested as per ISO-10993 for toxicity. | Same (as predicate) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for the test sets used for each specific test (e.g., diameter, tensile strength, etc.). It only mentions that "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 29 demonstrates Sutures India's MONOGLYDE, Absorbable (Poliglecaprone 25) suture meets or exceeds In-house specifications".
The data provenance is from India (Sutures India Pvt. Ltd. is located in Bangalore, India). It is unclear from the provided text whether the data is retrospective or prospective. Given the context of a 510(k) submission for a medical device seeking market clearance, these tests would typically be performed prospectively as part of the device development and validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The acceptance criteria are based on established standards (USP 29, ISO-10993) and equivalence to predicate devices, rather than expert interpretation of a unique test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The study involves objective measurements against established standards, not subjective interpretations requiring 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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, where human readers evaluate cases. This submission is for a surgical suture, which is a physical device, not an interpretative AI tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone algorithm performance study was not done. As explained above, this submission is for a surgical suture, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" or reference standard for this device is based on established industry standards and regulatory monographs:
- United States Pharmacopeia (USP) current edition (USP 29): Used for physical and chemical properties like diameter, tensile strength, length, needle attachment, extractable color, and sterility. These are objective, quantitative measurements defined by the pharmacopeia.
- ISO-10993: Used for biological compatibility and toxicity testing. These are also standardized test methods with defined pass/fail criteria.
- Comparative data against predicate devices: The device demonstrates equivalence in material, design, manufacturing, colorant, packaging, and labeling claims to legally marketed predicate devices.
8. The sample size for the training set:
There is no training set in the context of this 510(k) submission. This is not an AI/ML device that requires training data. The "training" for a physical device would refer to the manufacturing processes and quality control to ensure consistency, but specific data sets for "training" an algorithm are not applicable.
9. How the ground truth for the training set was established:
As there is no training set mentioned or relevant to this type of device submission, this question is not applicable.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, 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.