(28 days)
Smith & Nephew ULTRABRAID Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.
The Smith & Nephew™ ULTRABRAID™ Suture is a nonabsorbable, sterile, surgical suture composed The online white ultra hight (UHMW) Polyethylene or white UHMW Polyethylene or emer with blue monofilament polypropylenc. ULTRABRAID suture is provided braided and undyed. ULTRABRAID sutures are USP except for diameter.
This is a 510(k) premarket notification for a surgical suture. This type of submission does not typically include detailed studies proving performance against acceptance criteria in the same way a diagnostic device or a more complex medical device would. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested categories for a study proving device meeting acceptance criteria will not be applicable.
Here's an attempt to answer based on the provided document, addressing the structure of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) for a surgical suture, the "acceptance criteria" are not usually explicit numerical performance targets like sensitivity/specificity for a diagnostic. Instead, they relate to demonstrating equivalence in design, materials, and function to a legally marketed predicate device.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Characteristics of ULTRABRAID™ Suture) |
|---|---|
| Design: Substantially similar design to predicate devices. | ULTRABRAID™ Suture is a nonabsorbable, sterile, surgical suture composed of ultra high molecular weight (UHMW) Polyethylene or UHMW Polyethylene mixed with blue monofilament polypropylene. It is provided braided and undyed. It only differs from predicate devices in suture tipping to stiffen the suture ends. |
| Materials: Use of equivalent materials. | Composed of UHMW Polyethylene, which is a common material for nonabsorbable surgical sutures. |
| Function/Intended Use: Performs similarly to predicate devices for the same intended use. | Indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries, which is a standard indication for nonabsorbable sutures. ULTRABRAID sutures are USP (United States Pharmacopeia) except for diameter. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | The submission asserts that the device is substantially equivalent, implying no new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) is based on a demonstration of substantial equivalence to predicate devices, not on a clinical or performance study with a "test set" in the context of diagnostic or complex device evaluation. The data provenance would be the characteristics of the device itself and its comparison to the predicate, likely based on engineering specifications and material properties, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for studies (e.g., pathology for diagnostic imaging) is not part of a substantial equivalence review for a surgical suture.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" and thus no adjudication method in the context of clinical or diagnostic performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC study is not relevant for a surgical suture 510(k) submission. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices (Teleflex Medical, Force Fiber™ and Teleflex Medical, Force Fiber™ Blue Co-Braid Polyethylene Nonabsorbable Surgical Suture). The ULTRABRAID™ Suture demonstrates that it is substantially equivalent to these devices. This equivalence is often established through:
- Comparison of raw materials and manufacturing processes.
- Mechanical testing (e.g., tensile strength, knot security) to meet recognized standards (like USP) or match predicate device performance.
- Biocompatibility testing.
8. The sample size for the training set
Not applicable. No "training set" in the context of a statistical model or algorithm for a surgical suture.
9. How the ground truth for the training set was established
Not applicable. No "training set" or explicit ground truth established for it in this context.
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JUN - 7 2004
K04/2/6 8/2
We are
Endoscopy kip 11: 5 frampiow, 10 130 Forbes Blvd Auto from MA 12048 308 251 3600 508 261 3616 117 www.smith-nephew.com
510(k) SUMMARY VI. Smith & Nephew™ ULTRABRAID™ Suture Date Prepared: May 7, 2004
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Denise Lima Regulatory Affairs Specialist
C. Device Name
| Trade Name: | Smith & Nephew™ ULTRABRAID™ Suture |
|---|---|
| Common Name: | Nonabsorbable Surgical Suture |
| Classification Name: | Polyethylene Nonabsorbable Surgical Suture |
Predicate Devices D.
The Smith & Nephew ULTRABRAID™ Suture is substantially equivalent in design, materials, function The online & Nephen ODTreasing devices in commercial distribution: Teleflex Medical, Force Fiber™ and mended about the 1010 Subscal Suture, K033654 and Teleflex Medical, Force Fiber™ Blue Co-Braid Polyethylene Nonabsorbable Surgical Suture, K040472.
Description of Device E.
The Smith & Nephew™ ULTRABRAID™ Suture is a nonabsorbable, sterile, surgical suture composed The online white ultra hight (UHMW) Polyethylene or white UHMW Polyethylene or emer with blue monofilament polypropylenc. ULTRABRAID suture is provided braided and undyed. ULTRABRAID sutures are USP except for diameter.
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of numbers and letters. The top line reads '204 1216 6/2'. Below this, there is a partial sentence that begins with 'We are smuch'. The text is written in dark ink on a white background.
Intended Use F.
Smith & Nephew ULTRABRAID 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 suture has the same technological characteristics and materials The Simill & Nephew OETINDIC IID battle the product design is in conformance with the consensus as the predicate devices lacintried abover The Smith & Nephew ULTRABRAID sutures only differ from the predicate device in suture tipping to stiffen the suture ends.
Denise Lima 5/7/04
Denise Lima Regulatory Affairs Specialist
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 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 an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Ms. Denise Lima Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K041216
K041210
Trade/Device Name: Smith & Nephew™ ULTRABRAID™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable suture Regulatory Class: II Product Code: GAT Dated: May 7, 2004 Received: May 10, 2004
Dear Ms. Lima:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosure) to regary the Medical Device Americal Device American Property. De commerce price to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Treefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, ulcrezone, market the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 rryour device is olassified (600 a00 ro) cols. Existing major regulations affecting your device can may oc subject to such address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reams concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dris issuality of the complies with other requirements of the Act that I DA has made a actorinmations administered by other Federal agencies. You must of any recetal statutes and regalanents .including, but not limited to: registration and listing (21 comply with an the 11ct 31equirements)01); good manufacturing practice requirements as set CI'N I all 607), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whit anow you to begin mailing of substantial equivalence of your device to a legally premarket notification. The Pri mailing of cation 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 If you uesn't specific advice for your as (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Compilance in (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on your response 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,
Sincerely yours,
Mark N Milken
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
| 510(K) Number: | (if known) |
|---|---|
| Device Name: | Smith & Nephew™ ULTRABRAID™ Suture |
| Indications For Use: | Smith & Nephew ULTRABRAID Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries. |
Over-The-Counter Use AND/OR Prescription Use x____x_________________________________________________________________________________________________________________________________________________ (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)
Mark N. Milkeno
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K041216
§ 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.