(73 days)
K/DEN number is not in the text.
NOT FOUND
No
The document describes a standard surgical suture and its equivalence to a predicate device, with no mention of AI or ML technology.
No
This product is a surgical suture, which is used to approximate tissue and is not a therapeutic device.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of polyester, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that this device is a "polyester nonabsorbable surgical suture." Its intended use is for "general soft tissue approximation and/or ligation," which means it's used to sew tissues together or tie off blood vessels within the body during surgery.
The information provided describes a surgical implant, not a device used for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The polyester nonabsorbable surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
Not Found
Device Description
Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck.
The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck's Ti-cron* is dyed blue (D&C Blue #6).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 described in USP XXIII demonstrates that R.K. Medical Polyester nonabsorbable surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to polyester nonabsorbable surgical sutures manufactured by Davis & Geck.
Key Metrics
Not Found
Predicate Device(s)
Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.
0
JUL 29 1996
510 (k) SUMMAR Y
35 EAGLE ROAD • DANBURY, CT 06810 U.S.A. PHONE: (203) 797-8700 • FAX: (203) 792-1465
"This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. "
Applicant: R.K. Medical L.L.C. 35 Eagle Road Danbury. CT 06810 Tele: (203) 797-8700 Fax: (203) 792-1465
Contact:
Mr. John A. Hutter, Plant Manager or Mr. George R. Krebs, President
Date: 5/15/96
Name of Device:
Common or Usual Name: Polyester Nonabsorbable Surgical Sutures Classification Name: Suture, Nonabsorbable, Synthetic, Polyester
Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck.
The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck's Ti-cron* is dyed blue (D&C Blue #6).
The polyester nonabsorbable surgical 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 described in USP XXIII demonstrates that R.K. Medical Polyester nonabsorbable surgical sutures meet or exceed USP specifications and are equivalent in terms of the above parameters to polyester nonabsorbable surgical sutures manufactured by Davis & Geck.
John A. Hutter, Plant Manager
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