(245 days)
Not Found
Not Found
No
The summary describes a simple surgical wire and does not mention any AI or ML components or functionalities.
No.
The device is a surgical wire used for approximation, ligation, and repair of tissues, which is an interventional device rather than a therapeutic device that treats a disease or condition.
No
The device description indicates it is a surgical wire for soft tissue approximation and ligation, which are therapeutic or reparative procedures, not diagnostic ones.
No
The device description clearly states it is a physical surgical wire with an attached barb and needle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "surgical wire" intended for "soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair." This describes a device used within the body during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, laboratory testing, or providing diagnostic information based on such analysis.
Therefore, the Synthes Titanium Wire is a surgical device used for internal fixation and repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.
Product codes
GAQ
Device Description
The Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm and has a permanently attached stainless steel needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Synthes Titanium Wire
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is located underneath the word "SYNTHES".
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
.
MAY 2 7 2005
1000 States of the status and the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the
( / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) Titanium Wire |
| CLASSIFICATION: | Class II § 21 CFR 878.4495: Stainless Steel Suture |
| PREDICATE DEVICE: | Synthes Titanium Wire |
| DEVICE DESCRIPTION: | The Synthes Titanium Wire with Barb is a nonabsorbable, monofilament,
sterile surgical wire with an attached barb. The 28 gauge titanium wire with
barb is available in a length of 538mm and has a permanently attached
stainless steel needle. |
| INTENDED USE: | Synthes (USA) Titanium Wire is indicated for use in soft tissue
approximation and/or ligation, for canthoplasty, canthopexy and/or canthal
tendon repair. |
| SUBSTANTIAL
EQUIVALENCE: | Comparative information presented supports substantial equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or flowing lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Ms. Kathy Anderson RA Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K042606 Trade/Device Name: Synthes (USA) Titanium Wire Regulation Number: 21 CFR 848.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: May 16, 2005 Received: May 17, 2005
Dear Ms. Anderson:
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 for access a not 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 11 70ar action is examined 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 r hat FDA has made a determination that your device complies with other requirements of the Act than I Dr deral statutes and regulations administered by other Federal agencies. You must or any I 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This leaver will anow yourse of substantial equivalence of your device to a legally premarket noticate 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 If you dealer specific as noliance at (240) 276-0115. 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 other general 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/industry/support/index.html.
Sincerely yours,
Stupt Rhodes
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 2.0
Page _ 1 _____________________________________________________________________________________________________________________________________________________________________
KO42606 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________ Device Name:
Indications:
:
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.
OR X Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ataturk
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K042606
Confidential