The Smith & Nephew ULTRABRAID™ II Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Smith & Nephew ULTRABRAID™ II Suture." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove performance from scratch. Therefore, the information requested in the prompt, which typically relates to performance studies for novel devices or AI/software, is largely not applicable in this context.

Here's an breakdown of why specific points are not available and what information is present:

Context of the Document:

The 510(k) summary (K101377) for the Smith & Nephew ULTRABRAID™ II Suture is a premarket notification to the FDA. Its primary goal is to show that the new device is substantially equivalent in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device (Smith & Nephew ULTRABRAID suture, K041216). This means it does not typically involve establishing new acceptance criteria or conducting extensive clinical trials as one would for a novel device. Instead, the focus is on comparing against the known characteristics and performance of the predicate.

Information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission comparing to a predicate, new explicit "acceptance criteria" in the sense of performance thresholds for a novel device are not defined in the provided text. The criteria are implicitly met by demonstrating equivalence to the predicate's performance.

Acceptance Criteria Category (Implicit)	Reported Device Performance (ULTRABRAID II Suture)
Mechanical Performance	Demonstrated substantial equivalence to predicate in:
Knot Break Strength	Performed, results show substantial equivalence
Needle Attachment Strength	Performed, results show substantial equivalence
Diameter Properties	Performed, results show substantial equivalence
Biocompatibility	Meets biocompatibility requirements of ISO 10993-1 for Implant Device, Bone/Tissue contact, Permanent contact

Note on "Acceptance Criteria": The document states: "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." This implies that the 'acceptance criteria' are met if these changes do not negatively impact safety or efficacy compared to the predicate, and existing standards (like USP for suture diameter, and ISO 10993-1 for biocompatibility) are met.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "Non-clinical testing that included knot break strength, needle attachment strength, and diameter properties were performed". The exact number of samples tested for each of these physical properties is not disclosed in this summary.
Data Provenance: The "test set" here refers to physical samples of the ULTRABRAID II Suture. The data would be generated from laboratory testing of these physical samples. The country of origin of the data is implicit as part of the Smith & Nephew company, based in Andover, MA, USA. The data is prospective as it was generated specifically for this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This is a physical medical device (suture), not an AI/software device requiring expert human review to establish ground truth for image interpretation or diagnosis. The "ground truth" for its performance is established through objective physical and chemical testing (tensile strength, diameter measurement, biocompatibility panels), not expert consensus.

4. Adjudication Method for Test Set

Not Applicable. As above, this is for physical testing, not a clinical study involving human readers or evaluators requiring adjudication. The results would be objectively measured values, typically compared against specifications or predicate device data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This type of study is relevant for AI-powered diagnostic or screening tools where the algorithm assists human readers. The ULTRABRAID II Suture is a surgical implant, not a diagnostic tool, and therefore MRMC studies are not relevant.

6. Standalone Performance Study

Yes, in the context of physical testing. The "non-clinical testing" (knot break strength, needle attachment strength, diameter properties, and biocompatibility) represents standalone performance evaluation of the ULTRABRAID II Suture itself. There is no "human-in-the-loop" concept here as it's a physical product being tested for its intrinsic properties.

7. Type of Ground Truth Used

Physical/Chemical Properties and Standards: The ground truth for the device's performance is established through:
- Objective measurements: Knot break strength, needle attachment strength, and diameter properties are directly measured values.
- Compliance with standards: USP (United States Pharmacopeia) requirements for suture properties (with noted slight variation in diameter) and ISO 10993-1 for biocompatibility.
- Comparison to predicate device: The ultimate "truth" for this submission is that its performance on these metrics is substantially equivalent to the cleared predicate device (K041216).

8. Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

9. How Ground Truth for Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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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

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

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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

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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

Regulation Number and Section

§ 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.