(72 days)
Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.
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.
The provided text is a 510(k) summary for the Modified Sofsilk Suture and does not describe a study involving an AI/CAD/software device, therefore most of the requested information is not applicable. The document focuses on establishing substantial equivalence of a physical medical device (suture) to a predicate device.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way it would for a performance study of a device like AI. Instead, it refers to the device being "substantially equivalent" to a predicate device, Sofsilk* (K964581). This implies that the Modified Sofsilk Suture met the same performance characteristics as the predicate device, which would include physical properties relevant to sutures (e.g., tensile strength, knot security, biocompatibility).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device Sofsilk* (K964581) | Modified Sofsilk* Suture is determined to be substantially equivalent to the predicate device for its intended use in general soft tissue approximation and/or ligation. |
| Material composition (non-absorbable, multifilament, fibroin from Bombyx mori) | "fibers composed of fibroin, an organic protein that is derived from the domesticated species Bombyx mori (B. mori)" |
| ISO Standard # 10993-1 compliance | "All component materials of the Modified Sofsilk* Suture are comprised of materials which are in accordance with ISO Standard # 10993-1." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a physical medical device (suture) and not a software/AI device that would involve a test set of data. The "test set" in this context would refer to the samples of the Modified Sofsilk Suture manufactured for testing physical properties to demonstrate equivalence. The document does not specify the number of suture samples tested or the provenance of any data beyond the general manufacturing and testing processes that would occur for such a device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth, in the context of AI/software devices, refers to expert labeling of data. For a physical device like a suture, "ground truth" would relate to objective measurements of its physical and biological properties against established standards, not expert interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation of data, often in the context of AI performance evaluation, to resolve discrepancies in expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. MRMC studies are used to evaluate the performance of human readers, with or without AI assistance, on a collection of cases. This document concerns a physical surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to the performance of an algorithm without human intervention, which is not relevant to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" as typically defined for AI/software devices is not applicable. For this physical medical device, demonstrating compliance with "ground truth" would involve proving that the suture meets established physical, chemical, and biological standards through laboratory testing (e.g., tensile strength, biocompatibility, sterility).
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical medical device like a suture as there is no algorithm being trained.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above; there is no training set for this type of device.
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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.
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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.
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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
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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
§ 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.