(326 days)
Not Found
No
The device description and performance studies focus on the physical properties and equivalence of a surgical suture, with no mention of AI or ML.
No
The device, a surgical suture, is used for approximating and/or ligating soft tissues, but it does not directly treat or cure a disease or condition; it is a tool used in a surgical procedure.
No
Explanation: The device described is a surgical suture used for approximation and/or ligation of soft tissues. Its function is to secure and hold re-attached tendons to bone, which is a therapeutic rather than a diagnostic action.
No
The device description clearly states it is a physical surgical suture made of synthetic material, 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 for "approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical suture, a physical material used to hold tissues together during surgery. This is a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Smith & Nephew ULTRABRAID™ II Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Smith & Nephew ULTRABRAID II is a non-absorbable, sterile, synthetic surqical suture composed of either white UHMW polyethylene and/or blue UHMW polyethylene. The proposed suture is in a braided configuration and will be offered in sizes 2-0 through 2 meeting USP requirements except for slight variation in the diameter as described in the U.S.P Monogram for synthetic nonabsorbable surgical suture. ULTRABRAID II suture will be provided either pre-loaded onto suture anchors or sold separately, with or without attached needles. When used with various anchoring implants in orthopedic procedures, the suture secures and holds the re-attached tendon to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, allograft tissue
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)
Non-clinical testing that included knot break strength, needle attachment strength, and diameter properties were performed and the results demonstrate that the Smith & Nephew ULTRABRAID II suture is substantially equivalent to the predicate ULTRABRAID suture, cleared via K041216. Biocompatibility testing was conducted and the results meet the biocompatibility requirements of ISO 10993-1 for Implant Device, Bone/Tissue contact, Permanent contact. The testing also demonstrates that the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy.
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
§ 878.5000 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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SECTION IV 510(k) SUMMARY ·
As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew ULTRABRAID™ II Suture
Date Prepared: May 14, 2010
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover MA, 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: FAX: (508) 261-3620
C. Device Name
| Trade Name: | ULTRABRAID II Suture |
|---|---|
| Common Name: | Non-absorbable Surgical Suture |
| Classification Name: | Polyethylene Non-absorbable Surgical Suture |
D. Predicate Devices
The Smith & Nephew ULTRABRAID II suture is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew ULTRABRAID suture cleared via K041216.
E. Description of Device
The Smith & Nephew ULTRABRAID II is a non-absorbable, sterile, synthetic surqical suture composed of either white UHMW polyethylene and/or blue UHMW polyethylene. The proposed suture is in a braided configuration and will be offered in sizes 2-0 through 2 meeting USP requirements except for slight variation in the diameter as described in the U.S.P Monogram for synthetic nonabsorbable surgical suture. ULTRABRAID II suture will be
Traditional 510(k) Section IV K101377 Amended 510(k) Summary 9/10/10
Page 1 of 2
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4101377
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provided either pre-loaded onto suture anchors or sold separately, with or without attached needles. When used with various anchoring implants in orthopedic procedures, the suture secures and holds the re-attached tendon to the bone.
F. Intended Use
Indications for Use:
The Smith & Nephew ULTRABRAID™ II Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
G. Comparison of Technological CharacterIstics
The Smith & Nephew ULTRABRAID II suture is substantially equivalent in intended use, technological characteristics, and is as safe and effective as its currently marketed predicate devices, the Smith & Nephew ULTRABRAID suture (K041216). The differences which include a minor change to braid configuration and a material change in the blue fiber from a polypropylene pigmented monofilament to blue polyethelene, do not raise new questions of safety or efficacy.
H. Summary Performance Data
Non-clinical testing that included knot break strength, needle attachment strength, and diameter properties were performed and the results demonstrate that the Smith & Nephew ULTRABRAID II suture is substantially equivalent to the predicate ULTRABRAID suture, cleared via K041216. Biocompatibility testing was conducted and the results meet the biocompatibility requirements of ISO 10993-1 for Implant Device, Bone/Tissue contact, Permanent contact. The testing also demonstrates that the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy.
Traditional 510(k) Section IV K101377 Amended 510(k) Summary 9/10/10
2
Image /page/2/Picture/1 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
APR - 8 2011
Re: K101377
Trade/Device Name: Smith & Nephew ULTRABRID™ II Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: March 31, 2011 Received: April 1, 2011
Dear Ms. Flores:
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
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Page 2 - Ms. Christina Flores
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) device-related 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 nectoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000, 1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1158091, prias _ the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Atig B. Rh
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
4101377 510(k) Number (if known): ___
. "
Device Name: Smith & Nephew ULTRABRAID™ II Suture
Indications For Use:
The Smith & Nephew ULTRABRAID™ II Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel Kemefer MWConcurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101377