(40 days)
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None
No
The device is a surgical suture, and the summary focuses on material properties and performance metrics relevant to sutures, with no mention of AI/ML or related concepts.
No
The device is a surgical suture, which is used for soft tissue approximation and/or ligation, not for treating or curing a disease or condition.
No
Explanation: This device is a surgical suture used for approximation and ligation of tissues, which is a therapeutic function, not a diagnostic one. It does not collect or analyze data to determine the presence or nature of a medical condition.
No
The device description clearly states it is a physical surgical suture made of nylon, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation" during surgical procedures. This is a direct surgical intervention on the body, not a test performed on samples taken from the body.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The nylon nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurologica1 procedures.
Product codes
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Device Description
Nylon nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to nylon nonabsorbable surgical sutures manufactured by Davis + Geck.
The nylon sutures manufactured by R. K. Medica1 and D+G can be monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or blue or undyed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
general soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength according to methods outlined in USP XXIII demonstrates that R. K. Medical nylon sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to nylon sutures manufactured by Davis + Geck.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.
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