(73 days)
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No
The 510(k) summary describes a traditional surgical suture made of biological material, with no mention of AI or ML technology in its intended use, device description, or performance studies.
Yes
The device is a surgical suture used for tissue approximation and ligation, which are therapeutic medical procedures.
No.
The device description indicates that it is a sterile surgical suture used for tissue approximation and ligation, which is a therapeutic rather than a diagnostic function.
No
The device described is a physical surgical suture, not a software-only medical device. The description focuses on the material composition, manufacturing process, and physical properties of the suture.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes a surgical suture used for "general soft tissue approximation and/or ligation." This is a device used directly on the body during a surgical procedure. It is not used to examine specimens outside the body to provide diagnostic information.
The information provided about the device's composition, manufacturing, sterilization, and performance testing all relate to its function as a surgical implant, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
Plain and chromic gut surgical sutures USP are 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.
Product codes
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Device Description
Plain and chromic gut absorbable surgical sutures.
Plain and chromic gut surgical sutures USP manufactured by R.K. Medical, L.L.C. are equivalent to plain and chromic gut surgical sutures manufactured by Davis & Geck. These sutures are absorbable, sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
The plain and chromic gut sutures are packaged in packing fluid composed of isopropanol, water, and triethanolamine.
R.K. Medical plain and chromic gut surgical sutures are sterilized by gamma irradiation.
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, ophthalmic
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 plain and chromic gut surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to plain and chromic gut 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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§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.
0
R.K. MEDICAL
35 EAGLE ROAD • DANBURY, CT 06810 • U.S.A. PHONE: (203) 797-8700 • FAX: (203) 792-1465
510 (k) SUMMAR Y
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
Applicant:
R.K. Medical L.L.C. 35 Eagle Road Danbury, CT 06810 Tel: (203) 797-8700 Fax: (203) 792-1465
K96193|
Contact:
Mr. John A. Hutter, Plant Manager Or Mr. George R. Krebs, President
Date: 5/13/96
Name of Device: Common or Usual Name: Plain and chromic gut absorbable surgical sutures.
Classification Name: Suture, absorbable, natural
Plain and chromic gut surgical sutures USP manufactured by R.K. Medical, L.L.C. are equivalent to plain and chromic gut surgical sutures manufactured by Davis & Geck. These sutures are absorbable, sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
The plain and chromic gut sutures are packaged in packing fluid composed of isopropanol, water, and triethanolamine.
R.K. Medical plain and chromic gut surgical sutures are sterilized by gamma irradiation.
Plain and chromic gut surgical sutures USP are 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.
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 plain and chromic gut surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to plain and chromic gut sutures manufactured by Davis & Geck.
John A. Hutter, Plant Manager
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