(28 days)
Not Found
No
The 510(k) summary describes a surgical suture and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a supportive function during healing rather than a direct therapeutic intervention to treat a disease or condition.
No
Explanation: The device is a surgical suture used for approximation and ligation of soft tissues, which is a treatment and repair function, not a diagnostic one.
No
The device description clearly states it is a surgical 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 for "approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical suture" composed of materials like UHMW Polyethylene and polypropylene. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair tissues within the body.
N/A
Intended Use / 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.
Product codes
GAT
Device Description
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
0
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.
1
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
2
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.
3
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
4
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