(67 days)
Polyviolene
None
No
The summary describes a surgical suture made of braided polyester, a purely mechanical device. There is no mention of software, algorithms, or any technology that would involve AI or ML.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a supportive rather than a therapeutic function.
No
Explanation: The device, Smith & Nephew Durabraid™ Suture, is a surgical suture used for approximation and/or ligation of soft tissues. Its function is to hold tissues together, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a braided polyester suture, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "approximation and/or ligation of soft tissues." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical suture comprised of braided polyester." This is a physical material used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on these in vitro tests.
Therefore, the Smith & Nephew Durabraid™ Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew DuraBraid Suture is indicated for use in approximation and/or ligation of soft tissues.
Product codes
GAT
Device Description
DuraBraid Suture is a nonabsorbable, sterile, surgical suture comprised of braided polyester. It is supplied in several USP sizes white and green, and is available with and it swaged needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Polyviolene
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(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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KOye7sq
We are
/3
Ainuteman Road over, MA 01810
978 749 1000
978 749 1599 Fax
www.smith-nephew.com
JUN - 4 2004
VI.510(k) Summary DuraBraid™ Suture Date Prepared: March 26, 2004
This 510(k) summary is being submitted in accordance with the requirement
A. Submitter Smith & Nephew, Inc.
B. Company Contact
Bill McCallum
Sr. Regulatory Specialist
C. Device Name
Trade Name: DuraBraid Sutu Suber France: Braided Polyester Surgical Suture
Common Name: Braided Polyester Surgical Suture
Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical sutu
D. Predicate Device
The Smith & Nephew Dura r its sintin & Trepliew Durgeau Suture is substantially equivals in tubsigh,
materials, function and intended use to the following device in commercial distribution
surgical
E. Description of Device
DuraBraid Suture is a nonabsorbable, sterile, surgical suture comprised of braided polyester. It is supplied in several USP sizes white and green, and is available with and it swaged needles attached.
raBraid suture is classified by the General and Plastic Surgery Devices panel, S , nonabsorbable poly(ethylene terephthalate) surgical s
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F. Intended Use
The Smith & Nephew DuraBraid Suture is indicated for use in approximation and/or ligation of soft tissues.
G. Comparison of Technological Characteristics
The Smith & Nephew DuraBraid suture has the same technological characteristics and is composed of the material as the predicate device. The range of sizes offered by Smith & Nephew is within the marketed range of predicate sizes.
The DuraBraid Suture material conforms to the following Recognized Consensus Standards:
Item 97: USP 26, Nonabsorbable Surgical Sutures
Item 100: USP 26, Tensile Strength
Item 101: USP 26, Sutures - Diameter
Item 102: USP 26, Sutures Needle Attachment
Item 51: AAMI/ANSI/ISO 10993-1: 1997, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing
Item 76: AAMI/ANSI/ISO 10993-7: (R) 2001, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
Item 103: AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices
Item 75: AAMI/ANSI/ISO 11137: 1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization and ISO 11137: 1995 (Amendment 1:2002)
Item 25: AAMI/ANSI/ISO 11135: 1994 Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization.
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K04 0789
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The design of the Smith & Nephew DuraBraid surgical suture is in conformance with the above identified standards. The signed Declaration of Conformance with Consensus Standards is located in section II of this Abbreviated 510(k) submission.
Summary of Features and Technological Characteristics in comparison to the Predicate Device
| Attribute | DuraBraid | Polyviolene (predicate) |
|---|---|---|
| Suture Material | Braided polyester, nonabsorbable | |
| (Ashaway) | Braided polyester, nonabsorbable | |
| (Ashaway) | ||
| Suture Treatment | Uncoated, and silicone coated | |
| (Ashaway) | Uncoated, and silicone coated | |
| (Ashaway) | ||
| Configuration | With and without needles, tipped | With needles and pledgets |
| Tipping | Kollidon | Unknown |
| Dyed | D&C Green No. 6 | D&C Green No. 6 |
| Undyed | White | White |
| Sizes | USP sizes 3-0 through 5, USP | USP sizes 11-0 through 5, USP |
| Needles | T-13 and T-5, Taper point, ½ Circle | Various Needle Types and lengths |
| Indications | Indicated for use in approximation | |
| and/or ligation of soft tissues. | Indicated for use in general soft tissue | |
| approximation and/or ligation, | ||
| including use in cardiovascular, | ||
| ophthalmic and neurological | ||
| procedures | ||
| Packaging | Sterile, pouches 12 to a carton | Sterile, pouches 12 to a carton |
Bill McCallum Senior Regulatory Specialist
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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central symbol consists of three curved lines that resemble a stylized bird or abstract shape. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 4 2004
Mr. Bill McCallum Senior Regulatory Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K040789
Trade/Device Name: DuraBraid™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: March 26, 2004 Received: March 29, 2004
Dear Mr. McCallum:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Bill McCallum
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K 046789 510(K) Number:
DuraBraid ™ Suture Device Name:
Indications For Use: Smith & Nephew Durabraid™ Suture is indicated for use in approximation and/or ligation of soft tissues.
Prescription Use X AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CDRAL, Office of Device Evaluatio
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Ko40-510(k) Number_