(89 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML.
No.
A therapeutic device is one that treats or cures a disease or condition. This device, a surgical suture, is used for soft tissue approximation and ligation, which is a supportive role in surgical procedures rather than a direct therapeutic action on a disease.
No
This device is a surgical suture used for approximation and/or ligation of soft tissues, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical surgical suture made of organic protein, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The description and intended use of the Deknatel® Silk Surgical Suture clearly state that it is a surgical suture used for in vivo procedures (within the living body) for soft tissue approximation and ligation. It is a physical material used to hold tissues together during surgery.
- Lack of In Vitro Testing: The document describes non-clinical testing related to the physical properties of the suture and biocompatibility, but there is no mention of testing involving human specimens or providing diagnostic information.
Therefore, based on the provided information, the Deknatel® Silk Surgical Suture is a surgical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAP
Device Description
Deknatel Silk Suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk Suture is waxed, braided or twisted, and provided dyed (black) or undyed (natural white).
Silk Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 10-0 through 5 (metric sizes 0.2 through 7). The suture is supplied sterile, waxed, and braided or twisted. The suture is provided in a variety of lengths, with and without needles, with and without pledgets, and may be supplied in a variety of cut lengths or on ligating reels. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical testing has been performed in accordance USP (United States Pharmacopeia) Nonabsorbable Sutures, 36-NF 31 Sutures -Diameter, Sutures- Needle Attachment, and Tensile Strength in order to verify mordant material change of the proposed Deknatel Silk Surgical Sutures are substantially equivalent to the predicate devices.
The biocompatibility evaluation for the Deknatel Silk Surgical Suture was conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standards ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standards ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic toxicity ●
- Subchronic toxicity
- Genotoxicity ●
- Implantation
- Haemocompatibility
- Pyrogen testing
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2016
Teleflex Medical, Inc Ms. Natalie Hichak Sr. Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K162396
Trade/Device Name: Silk Surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: August 24, 2016 Received: August 26, 2016
Dear Ms. Hichak:
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 (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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162396
Device Name Deknatel® Silk Surgical Sutures
Indications for Use (Describe)
Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Deknatel® Silk Surgical Sutures
I. SUBMITTER
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-8049 Fax: 919-433-4996
Contact Person: Natalie Hichak, Senior Regulatory Affairs Specialist Date Prepared: August 24, 2016
II. DEVICE
| Name of Device | Deknatel Silk Surgical Suture |
|---|---|
| Common Name | Suture, Nonabsorbable, Silk |
| Classification Name | Natural Nonabsorbable Silk Surgical Suture |
| Regulatory Class | II |
| Product Code | GAP |
| Regulation | 878.5030 |
III. PREDICATE DEVICE
Deknatel® Nonabsorbable Surgical Sutures, K153076
IV. DEVICE DESCRIPTION
Deknatel Silk Suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk Suture is waxed, braided or twisted, and provided dyed (black) or undyed (natural white).
Silk Suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 10-0 through 5 (metric sizes 0.2 through 7). The suture is supplied sterile, waxed, and braided or twisted. The suture is provided in a variety of lengths, with and without needles, with and without pledgets, and may be supplied in a variety of cut lengths or on ligating reels. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.
V. INDICATIONS FOR USE
Deknatel Silk Surgical Sutures is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
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The Indications for Use statement for Deknatel Silk Surgical Sutures is identical to the predicate device.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed Deknatel Silk Surgical Sutures have the same technology, indications for use and functional characteristics as the predicate system. The proposed modification is a dying process change to replace the current mordant, Sodium Dichromate with Ferrous Sulfate.
A comparison of the technological characteristics of the proposed Deknatel Silk Surgical Sutures and the predicate has been performed. The results of this comparison demonstrate that the Silk Surgical Sutures are equivalent to the marketed predicate devices in performance characteristics.
VII. PERFORMANCE DATA
Non-clinical testing has been performed in accordance USP (United States Pharmacopeia) Nonabsorbable Sutures, 36-NF 31 Sutures -Diameter, Sutures- Needle Attachment, and Tensile Strength in order to verify mordant material change of the proposed Deknatel Silk Surgical Sutures are substantially equivalent to the predicate devices.
Biocompatibility Testing
The biocompatibility evaluation for the Deknatel Silk Surgical Suture was conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standards ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standards ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic toxicity ●
- Subchronic toxicity
- Genotoxicity ●
- Implantation
- Haemocompatibility
- Pyrogen testing
The Deknatel Silk Surgical Sutures is considered a permanent implant (> 30 days) and the nature of body contact is tissue/bone and blood. Deknatel Silk
5
Suture is composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Silk Suture is waxed with beeswax or a beeswax and paraffin mixture. Black silk suture is dyed with Logwood dye.
VII. CONCLUSIONS
Based upon the comparative test results, the proposed Deknatel Silk Surgical Sutures are substantially equivalent in performance to the predicate devices cleared to market via 510(k)s K153076.