(193 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a surgical suture, with no mention of AI or ML technology.
No
This device is a surgical suture used for approximation and ligation of soft tissue, which is a supportive function rather than a therapeutic one (i.e., treating or curing a disease/condition).
No
The device is a surgical suture used for approximation and ligation of soft tissue, which are treatment procedures, not diagnostic ones.
No
The device description clearly describes a physical surgical suture made of silk fibers, coated with silicone, and colored black. It undergoes physical and mechanical performance testing, biocompatibility evaluation, and stability studies, all indicative of a hardware medical device. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly indicates this is a surgical device used in vivo (within a living organism), not in vitro (in a test tube or lab setting).
N/A
Intended Use / Indications for Use
Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.
Product codes (comma separated list FDA assigned to the subject device)
GAP
Device Description
Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving sutures prior to employing this device.
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)
Performance data: The performance of the subject Sofsilk™ Coated Braided Silk Suture has been evaluated through bench tests. The following finished product physical and mechanical performance tests were conducted: USP/EP diameter, USP needle attachment, and USP tensile strength were tested, and it was found that the subject Sofsilk™ Coated Braided Silk Suture performed equivalently to the predicate and currently marketed Sofsilk™ Coated Braided Silk Suture. Both subject and predicate sutures meet or exceed requirements of U.S.P. Stability Studies were conducted, and the proposed device shelf life was demonstrated.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 03, 2024
Covidien Nicole Boroumand Senior Regulatory Affairs Specialist 60 Middletown Ave North Haven, Connecticut 06473
Re: K241486
Trade/Device Name: Sofsilk™ Coated Braided Silk Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: May 17, 2024 Received: May 24, 2024
Dear Nicole Boroumand:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tek N.
Lamichhane -S
Digitally signed by
Tek N. Lamichhane -S
Date: 2024.12.03
16:07:49 -05'00'
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241486
Device Name Sofsilk™ Coated Braided Silk Suture
Indications for Use (Describe)
Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary- K241486
| Date Prepared: | February 14, 2024 |
|---|---|
| Submitter: | Covidien II (subsidiary of Medtronic) |
| 60 Middletown Ave | |
| North Haven, CT 06473 | |
| United States | |
| Contact: | Nicole Boroumand |
| Senior Regulatory Affairs Specialist | |
| 60 Middletown Ave | |
| North Haven, CT 06473 | |
| United States | |
| Telephone: (626) 375-3597 | |
| Email: Nicole.boroumand@medtronic.com | |
| Name of Device: | |
| Trade/Proprietary | |
| name: | Sofsilk™ Coated Braided Silk Suture |
| Common name: | Natural nonabsorbable silk surgical suture |
| Classification name: | Class II |
| Panel number and product code: GAP | |
| Regulation Number 21 CFR 878.5030 | |
| Predicate Device: | |
| Trade/Proprietary | |
| name: | |
| Common name: | Sofsilk™ Coated Braided Silk Suture |
| Silk Suture | |
| Classification name: | Natural nonabsorbable silk surgical suture |
| Panel number and product code: GAP | |
| Regulation Number 21 CFR 878.5030 | |
| 510(k) Number: | K980124 |
| Manufacturer: | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE |
| 150 GLOVER AVE | |
| NORWALK, CT 06856 | |
| Device Description: | Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, |
| non-mutagenic surgical sutures composed of natural proteinaceous silk fibers | |
| called fibroin. This protein is derived from the domesticated silkworm species | |
| Bombyx mori of the family bombycidae. The silk fibers are treated to remove | |
| the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical | |
| silk sutures. The braided sutures are coated uniformly with silicone to reduce | |
| capillarity and to increase surface lubricity, which enhances handling | |
| characteristics, ease of passage through tissue, and knot run-down properties. | |
| Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). | |
| Sofsilk™ sutures meet all requirements established by the United States | |
| Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable | |
| surgical sutures, Sofsilk™ Coated Braided Silk Suture. | |
| Sofsilk™ sutures are indicated for use in soft tissue approximation and/or | |
| ligation. | |
| Intended users are healthcare professionals who have been trained in | |
| applicable surgical procedures and approaches involving sutures prior to | |
| employing this device. | |
| Intended Use: | The intended purpose of the device is soft tissue approximation and/or |
| ligation. | |
| Indications for use: | Sofsilk™ sutures are indicated for use in soft tissue approximation and/or |
| ligation. |
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6
| | Subject Device | Predicate Device
(K980124) | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Sofsilk™ sutures are
indicated for use in
soft tissue
approximation
and/or ligation. | Modified Sofsilk™ Suture
has indications for use in
general soft tissue
approximation
and/or ligation, including
cardiovascular,
ophthalmic, microsurgery
and neural tissue. | Similar, the subject device's
intended use is more
restrictive than the
predicate device. Therefore,
there is no concern
regarding substantial
equivalence. |
| Classification | Pannel number: 79
Product code: GAP,
per 21 CFR 878.5030
Natural
nonabsorbable silk
surgical suture | Pannel number: 79
Product code: GAP, per 21
CFR 878.5030 Natural
nonabsorbable silk
surgical suture | Identical, therefore no
concern regarding
substantial equivalence. |
| Materials | Suture: silk from
silkworm dyed with
Logwood extract
(21CFR73.1410) with
a ferrous-based
mordant and coated
with silicone
Needles: Stainless
steel with silicone
coating | Suture: silk from silkworm
Dye: Logwood extract
(21CFR73.1410) with a
chromium-based mordant
Suture coating: MED 2245
Silicone
Needles: Stainless steel
with silicone coating | Similar, the subject device
uses a different mordant.
The new mordant does not
affect performance.
Therefore, no concern
regarding substantial
equivalence. |
| Sizes | Only sizes 6-0 and 7-0
are in scope for the
510(k). | Sizes 5 through 9-0 | Similar, the subject device
has fewer sizes. Therefore,
no concern regarding
substantial equivalence. |
| Product
Configurations | pre-cut lengths and
ligating reels, non-
needled or
affixed to needles
using both
permanent and
removable needle
attachment
techniques. | pre-cut lengths and
ligating reels, non-needled
or affixed to needles using
both permanent and
removable needle
attachment techniques: in
one, two and three dozen
box quantities. | Similar, the subject device
has fewer configurations.
Therefore, no concern
regarding substantial
equivalence. |
| Sterilization | ETO sterilization with
a minimum Sterility
Assurance Level (SAL)
of 10-6 | Gamma radiation (25.1-40
kGy) with a minimum
Sterility Assurance Level
(SAL) of 10-6 | Different
The subject device is
sterilized with ETO
sterilization, whereas the
predicate device is sterilized
via Gamma. The subject's
sterilization process results
in a SAL of 10-6 and is a
Category A sterilization
method. |
| Packaging | Tyvek® and nylon
pouches or Tyvek®
and paper pouches | Tyvek® and
nylon/polyethylene
pouches or aluminum
foil/laminate packages | Similar, The subject device
can also be packaged in
Tyvek® and paper pouch.
This additional configuration
does not affect sterility or
shelf life. Therefore, no
concern regarding
substantial equivalence. |
| Shelf life | 5 years | 5 years | Identical, there is no change
to shelf life between the
subject and predicate
devices. |
Summary comparing the technological characteristics of the subject and predicate device:
7
Sofsilk™ Coated Braided Silk Suture has been evaluated and found compliant with the following standards:
- International standard, ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: . Evaluation and testing",
- . Food and Drug Administration (FDA, USA) "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' – Guidance for Industry and Food and Drug Administration Staff", issued September 8, 2023,
- Performance data: The performance of the subject Sofsilk™ Coated Braided Silk Suture has been evaluated through bench tests. The following finished product physical and mechanical performance tests were conducted: USP/EP diameter, USP needle attachment, and USP tensile strength were tested, and it was found that the subject Sofsilk™ Coated Braided Silk Suture performed equivalently to the predicate and currently marketed Sofsilk™ Coated Braided Silk Suture. Both subject and predicate sutures meet or exceed requirements of U.S.P. Stability Studies were conducted, and the proposed device shelf life was demonstrated.
8
Biocompatibility evaluation was performed and confirmed that Sofsilk™ Coated Braided Silk Suture is compliant with ISO Standard 10993-1 for its intended patient contact profile. This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
- The evidence and testing demonstrate that the subject Sofsilk™ Coated Conclusion: Braided Silk Suture with new mordant and sterilization method is substantially equivalent to the predicate Sofsilk™ Coated Braided Silk Suture (K980124).