(62 days)
No
The summary describes a traditional surgical suture made from silk fiber and does not mention any AI or ML components or functionalities.
No
Explanation: A therapeutic device is one that treats or heals a disease or condition. This device, a non-absorbable suture, is used for tissue approximation and support, which is a supportive function, not a direct therapeutic treatment.
No
Explanation: The device description clearly states it is a "suture," which is used for approximating tissues, not for diagnosing conditions.
No
The device description clearly states it is a "flexible multifilament thread, prepared from silk fiber," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the approximation of tissues where prolonged retention of tensile strength is required." This describes a surgical or medical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "sterile, flexible multifilament thread, prepared from silk fiber." This is a physical material used for suturing, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
Therefore, this device, a surgical suture, falls under the category of a medical device used for treatment or repair, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
SOFSILK* suture is intended for the approximation of tissues where prolonged retention of tensile strength is required.
Product codes
Not Found
Device Description
SOFSILK* suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced by the species Bombyx mori. The primary component of silk is the high molecular weight fibrous polymer fibroin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
United States Surgical Corporation 510(k) Premarket Notification modified SOFSILK* Suture
JAN 16 1997
510(k) SUMMARY OF INFORMATION:
- K964581 United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000
- Janet G. Johnson CONTACT PERSON:
- October 31, 1996 DATE PREPARED:
- CLASSIFICATION NAME: Natural Nonabsorbable Silk Surgical Suture
- Nonabsorbable Silk Suture COMMON NAME:
- PROPRIETARY NAME: SOFSILK*
- SOFSILK* (K900840, K902874 and K903509) PREDICATE DEVICE:
- DEVICE DESCRIPTION: SOFSILK* suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced by the species Bombyx mori. The primary component of silk is the high molecular weight fibrous polymer fibroin.
- Due to its nonabsorbable nature, SOFSILK* suture is INTENDED USE: intended for the approximation of tissues where prolonged retention of tensile strength is required.
- All component materials of the SOFSILK* suture are MATERIALS: comprised of materials which are in accordance with ISO Standard #10993-1.