(63 days)
Perma-Hand® Nonabsorbable Silk Surgical Suture (Ethicon, Inc.), Nonabsorbable Silk Surgical Suture (Davis & Geck), SOFSILK® Nonabsorbable Silk Surgical Suture (U. S. Surgical Corp.)
Not Found
No
The device description and testing focus on the physical properties and biological compatibility of a surgical suture, with no mention of AI or ML technologies.
No.
The device is a surgical suture used for approximation and/or ligation of tissue. It is not intended for the treatment, diagnosis, or prevention of disease, which would qualify it as a therapeutic device.
No
The device is a surgical suture used for approximation and/or ligation of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical, braided multifilament thread (suture) and describes physical testing, biosafety studies, and implant studies, indicating it is a hardware medical device.
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 on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "flexible, braided multifilament thread" used as a surgical suture. This is a physical implant/tool used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical tool used for physical repair.
N/A
Intended Use / Indications for Use
Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAP
Device Description
The subject device is a nonabsorbable, sterile, flexible, braided multifilament thread composed of an organic protein called fibroin. It is derived from the domesticated silkworm species Bombyx mori, of the family Bombicidae, and is indicated for general soft tissue approximation and/or ligation. It meets all applicable requirements of the U. S. Pharmacopeia Official Monograph for Nonabsorbable Surgical Sutures (Class I). It will be offered undyed, and dyed with the FDA listed colorant Logwood extract in accordance with Title 21 CFR, $73.1410. It will be offered uncoated, or with a coating to enhance certain characteristics. It will be available with and without standard needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use
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)
Non-Clinical testing conducted on the subject device to demonstrate its substantial equivalence to predicate devices included physical testing for all parameters identified above and to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, and 12 and 24 month implant studies in animals to demonstrate retention of tensile strength.
The results of all testing demonstrated the substantial equivalence, if not superiority, of the subject device to one or more predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Perma-Hand® Nonabsorbable Silk Surgical Suture (Ethicon, Inc.), Nonabsorbable Silk Surgical Suture (Davis & Geck), SOFSILK® Nonabsorbable Silk Surgical Suture (U. S. Surgical Corp.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
3/15/99
VII. 510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR $807), and in particular $807.92, the following summary of safety and effectiveness information is provided:
A. Submitted By
Steve Reitzler, RAC Regulatory Consultant to AESCULAP® 13221 Maricotte Place San Diego, California 92130 Telephone: (619) 977-1465 Telefacsimile: (619) 794-7601
Regulatory Agent for: AESCULAP® 1000 Gateway Boulevard South San Francisco, California 94080-7030 Telephone: (650) 876-7000 Contact: Victoria Mackinnon, Director of Regulatory Affairs & Quality Assurance Date Prepared: January 7, 1999
B. Device Name
| Trade or Proprietary Name: | Silkam® Nonabsorbable Silk Surgical Suture |
|---|---|
| Common or Usual Name: | Nonabsorbable Silk Surgical Suture |
| Classification Name: | Natural Nonabsorbable Silk Surgical Suture |
C. Predicate Devices
- Perma-Hand® Nonabsorbable Silk Surgical Suture (Ethicon, Inc.) ●
- Nonabsorbable Silk Surgical Suture (Davis & Geck)
- SOFSILK® Nonabsorbable Silk Surgical Suture (U. S. Surgical Corp.) .
The subject device is substantially equivalent to predicate devices listed above.
1
: : : : : :
D. Device Description
The subject device is a nonabsorbable, sterile, flexible, braided multifilament thread composed of an organic protein called fibroin. It is derived from the domesticated silkworm species Bombyx mori, of the family Bombicidae, and is indicated for general soft tissue approximation and/or ligation. It meets all applicable requirements of the U. S. Pharmacopeia Official Monograph for Nonabsorbable Surgical Sutures (Class I). It will be offered undyed, and dyed with the FDA listed colorant Logwood extract in accordance with Title 21 CFR, $73.1410. It will be offered uncoated, or with a coating to enhance certain characteristics. It will be available with and without standard needles attached.
E. Intended Use
Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
F. Comparison to Predicate Devices
The subject Silkam® Nonabsorbable Silk Surgical Suture is composed of the same material as are the predicate devices, that being the organic protein fibroin in the form of degummed silk derived from domesticated B. mori. Further, as are the predicate devices, the subject device is offered undyed, and dyed with Logwood extract, or hematein, at a concentration of $1.0% by suture weight in accordance with Title 21 CFR, §73.1410. In addition, as are the predicate devices, the suture is offered both uncoated, or treated with a biocompatible coating to enhance its handling properties.
The subject device has the same design as do the predicate devices, being a sterile, flexible, braided multifilament thread which is offered in a variety of lengths and a range of diameters conforming with the requirements of U.S. Pharmacopeia (U.S.P.) XXIII, and which is offered with or without one of a selection of standard needles attached. Further, as is the case with the predicate devices, the subject device conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIII, including Sutures -- Diameter, Sutures -- Needle Attachment, and &81> Tensile Strength.
2
Physical properties of the subject device are substantially equivalent to those of the predicate devices, including fiber diameter, knot pull tensile strength, knot security, capillarity, and needle attachment strength.
The subject device is manufactured in the same manner as the predicate devices, being produced from degummed and bleached yarns of natural silk harvested through sericulture of B. mori, and braided in operations considered standard in the fiber industry to form the finished suture fiber. As such, the suture fiber from which the subject device is made has essentially the same physical and chemical properties, and hence, biosafety profile and in vivo performance characteristics, as do the predicate devices.
The subject device is packaged and sterilized in the same or equivalent manner, and has the same labeling claims, as do the predicate devices.
G. Summary of Non-Clinical Tests
Non-Clinical testing conducted on the subject device to demonstrate its substantial equivalence to predicate devices included physical testing for all parameters identified above and to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, and 12 and 24 month implant studies in animals to demonstrate retention of tensile strength.
H. Summary of Clinical Tests
(Not applicable)
I. Conclusions of Non-Clinical and Clinical Tests
The results of all testing demonstrated the substantial equivalence, if not superiority, of the subject device to one or more predicate devices.
ધ્યુ ૫ ।
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Mr. Steve Reitzler Regulatory Consultant to AESCULAP® 13221 Maricotte Place San Diego, California 92130
Re: K990089
Trade Name: Silkam @ Nonabsorbable Silk Surgical Suture Regulatory Class: II Product Code: GAP Dated: January 7, 1999 Received: January 11, 1999
Dear Mr. Reitzler:
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 the indications for use stated in the enclosure) 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 Silkam® Nonabsorbable Surgical Suture is indicated for use in general soft tissue approximation and/or 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 Silkam® Nonabsorbable Surgical 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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Page 2 - Mr. Steve Reitzler, RAC
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
Enclosure
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V. Draft Labeling
A. Indications for Use
510(k) Number (if known): K990089
Device Name: Silkam® Nonabsorbable Silk Surgical Suture
Indications for Use:
Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| General Restorative Devices | |
| K90089 | |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
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