(72 days)
Not Found
No
The summary describes a traditional surgical suture made from silk and does not mention any AI or ML components or functionalities.
No
A therapeutic device is used to treat a disease or condition. A suture, like the Modified Sofsilk Suture, is used for approximating tissues and ligating, which are procedural steps rather than a treatment for a disease itself.
No
The device, Modified Sofsilk Suture, is described as a nonabsorbable, sterile, flexible multifilament thread used for general soft tissue approximation and/or ligation. Its purpose is to physically join or close tissue, not to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a "flexible multifilament thread, prepared from silk fiber," which is a physical, hardware 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 in vivo (within the living body).
- Device Description: The device is a "nonabsorbable, sterile, flexible multifilament thread" used for suturing, which is a physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests in vitro (outside the living body) on biological samples. This device is clearly used in vivo for surgical purposes.
N/A
Intended Use / Indications for Use
Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.
Product codes
GAP
Device Description
Modified Sofsilk * Suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced from 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
general soft tissue, cardiovascular, ophthalmic, neural tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAR 27 1998
510(k) Summary of Safety and Effectiveness IX.
SUBMITTER:
United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856
Victor M. Clavelli CONTACT PERSON:
January 13, 1998 DATE PREPARED:
CLASSIFICATION NAME: Natural Nonabsorbable Silk Surgical Suture
Nonabsorbable Silk Suture COMMON NAME:
Modified Sofsilk* Suture PROPRIETARY NAME:
Sofsilk* (K964581) PREDICATE DEVICES:
Modified Sofsilk * Suture is a nonabsorbable, sterile, DEVICE DESCRIPTION: flexible multifilament thread, prepared from silk fiber produced from the species Bombyx mori. The primary component of silk is the high molecular weight fibrous polymer fibroin.
Modified Sofsilk* Suture has indications for use in general INTENDED USE: soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.
All component materials of the Modified Sofsilk* Suture MATERIALS: are comprised of materials which are in accordance with ISO Standard # 10993-1.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 1998
Mr. Victor Clavelli Program Manager, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk. Connecticut 06856
Re: K980124
Trade Name: Sofsilk Suture Regulatory Class: II Product Code: GAP Dated: January 13, 1998 Received: January 14, 1998
Dear Mr. Clavelli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use in general soft tissue and approximation and/or ligation to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Tuesday, October 26, 1993 (Vol. 58. No. 205, Pages 57557 and 57558). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- The Sofsilk Suture is indicated for use in general soft tissue approximation and/or 1. ligation, including use in cardiovascular, ophthalmic and neurological procedures.
-
- This device may not be manufactured from any material other than multifilamentous fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Sofsilk Suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
2
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597, or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
3
IV. Indications For Use:
510(k) Number (if known): K980124
Name: Modified Sofsilk* Suture
Indications For Use:
Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)
Division Sign-Off
Sign-Off) Division General Restorative D 510(k) Number
RA03