(40 days)
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No
The summary describes a traditional surgical suture and provides performance data based on physical properties, with no mention of AI or ML.
Yes
The device, "silk nonabsorbable sutures, USP," is used for "general soft tissue approximation and/or ligation," which are therapeutic medical procedures.
No
Explanation: The device is a surgical suture, which is used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical medical device (surgical sutures) and does not mention any software component.
Based on the provided information, 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," which is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical suture, a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
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Device Description
Silk nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to silk nonabsorbable surgical sutures manufactured by Davis + Geck. The silk sutures manufactured by R. K. Medical and D+G can be twisted, or braided, coated with silicone, or wax, or uncoated, dyed black (Logwood) 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 silk sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to silk 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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§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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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Image /page/0/Picture/1 description: The image shows the text "R.K. MEDICAL" in a bold, sans-serif font. The letters are large and black, and there is a thin line underneath the text. The text appears to be a title or heading, possibly for a medical-related business or organization.
(S EAGLE ROAD · DANBURY CT 06810 U.S.A. PHONE: (203) 797-8700 · FAX: (203) 792-1465
510(k) SUMMARY
MAR - 4 1996
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92."
R. K. Medical L. L. C. Applicant 35 Eaqle Road Danbury, CT 06810 Tel: (203) 797-8700 Fax: (203) 792-1465 Contact John A. Hutter, Plant Manager or
George R. Krebs (President)
Date
January 23, 1996
Name of Device:
Common or Usual Name: Silk Nonabsorbable Surqical Sutures Classification Name: Suture, nonabsorbable, silk
Silk nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to silk nonabsorbable surgical sutures manufactured by Davis + Geck.
The silk sutures manufactured by R. K. Medical and D+G can be twisted, or braided, coated with silicone, or wax, or uncoated, dyed black (Logwood) or undyed.
The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures .
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 silk sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to silk sutures manufactured by Davis + Geck.
John a. Dutter
John A. Hutter, Plant Manager