(69 days)
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No
The summary describes a traditional surgical suture and does not mention any AI or ML components or functionalities.
No
The device is a surgical suture used for tissue approximation and ligation, which are restorative or supportive functions, not therapeutic.
No
Explanation: The device is described as surgical sutures used for tissue approximation and ligation, which are therapeutic and not diagnostic functions.
No
The device is a physical surgical suture, not a software-only medical device. The description focuses on material properties and physical performance metrics.
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 interaction with the patient's body during surgery, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
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 surgical suture does not fit that description.
N/A
Intended Use / Indications for Use
The Polypropylene 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
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Device Description
Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck. The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [ phthalocyaninato (2--) | copper .
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 polypropylene sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to polypropylene sutures manufactured by Davis+Geck.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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
Image /page/0/Picture/0 description: The image shows the text "R.K. MEDICAL" in a bold, sans-serif font. The letters are large and spaced closely together. A thin, double underline runs beneath the text, emphasizing the name. The overall impression is clean and professional.
35 EAGLE ROAD • DANBURY, CT 06810 U.S.A. PHONE: (203) 797-8700 · FAX: (203) 792-1465 JUN 18 1996
510(k) SUMMARY
"This summary of 510(k) 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 |
|-----------|------------------------------------------------------------------------------------------------------------|
| Contact | John A. Hutter, Plant Manager
or
George R. Krebs (President) |
Date
April 4, 1996
Name of Device
Common or Usual Name: Polypropylene Nonabsorbable Surqica1 Sutures Classification Name: Suture, nonabsorbable, synthetic, Polypropylene
Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck.
The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [ phthalocyaninato (2--) | copper .
The Polypropylene 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 outlined in USP XXIII demonstrates that R. K. Medical polypropylene sutures meet or exceed U. S. P. specifications and are equivalent in terms of the above parameters to polypropylene sutures manufactured by Davis+Geck.
John A. Hutter, Plant Manager