(170 days)
Not Found
No
The summary describes a mechanical device for surgical fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device components are used for fixation of soft tissue grafts during cruciate ligament reconstruction, but do not directly treat a disease or condition itself.
No
The device is used for fixation of soft tissue grafts during cruciate ligament reconstruction, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it consists of two physical components, a sleeve and a screw, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of soft tissue grafts during cruciate ligament reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components (sleeve and screw) are physical implants used to secure tissue within a surgically created tunnel.
- 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, diagnose a condition, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair structures within the body during surgery.
N/A
Intended Use / Indications for Use
The Smith & Nephew GTS Sleeve and GTS Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Product codes
HWC
Device Description
The Smith & Nephew GTS Sleeve and GTS Tapered Screw consist of two (2) components, the sleeve and screw. The sleeve manages, protects, and separates the graft tendon bundle and creates a central path for concentric placement of the tapered screw, which forces a larger surface area of the tendons against the tibial tunnel wall within a surgically created tunnel.
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
Smith & Nephew GTS Sleeve and GTS Tapered Screw utilize design features and Shifth & Nephow OFD breat are redicate device. The in vitro performance testing, material biocompatibility and sterilization validation demonstrate the device is safe, matorial of over intended, and supports a decision of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Intrafix™ Tibial Sheath and Intrafix™ Tibial Tapered Screw, K983560, K032224, K992396
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K040542 pg. 1 of 2
AUG 1 9 2004
We are smith&nepher
Endoscopy Division Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810
1978-749-1371 F 978-149-1443 www.smith-nephew.com
SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
The Smith & Nephew GTS Sleeve and GTS Tapered Screw Date Prepared: 1 March 2004
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Marion W. Gordon, RAC Regulatory Affairs Specialist Fax: 978-749-1443 Phone: 978-749-1371
C. Device Name
| Trade Name: | The Smith & Nephew GTS Sleeve and GTS Tapered Screw |
|---|---|
| Common Name: | Fixation, bone, screw |
| Classification Name: | Smooth or metallic bone fixation fastener |
| per 21 CFR § 888.3040 |
D. Predicate Devices
The Smith & Nephew GTS Sleeve and GTS Tapered Screw are substantially equivalent to Intrafix™ Tibial Sheath and Intrafix™ Tibial Tapered Screw, manufactured by Innovasive Devices, Inc. (acquired by Johnson & Johnson, November 1999) and found substantially equivalent on 28 January 1999 under K983560. In addition, the proposed GTS Tapered Screw is substantially equivalent to Smith & Nephew, Inc. K032224 (SE 08/05/03) and K992396 (SE 01/12/00) BioRCT® Screws.
E. Description of Device
The Smith & Nephew GTS Sleeve and GTS Tapered Screw consist of two (2) components, the sleeve and screw. The sleeve manages, protects, and separates the graft tendon bundle and creates a central path for concentric placement of the tapered screw, which forces a larger surface area of the tendons against the tibial tunnel wall within a surgically created tunnel.
GTS Page 032 of 076
1
pge 2/2
We are smith&nephow
SECTION IV cont.
F. Intended Use
The Smith & Nephew GTS Sleeve and GTS Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
G. Comparison of Technological Characteristics
Comparison of Technological GTS Sleeve and GTS Tapered Screw and the I he proposed Shillth & Nephew OTB Bloove and Ore of Screw share the same indications for Intrallx ... Tiolal Sheath and mittallis - rapers - Both employ a multi channeled, single construct device (one channel for central screw placement) to manage, protect and construct device (one channel for ochara sthe ... The tapered screw creates the final fixation within a created tibial tunnel. The bioresorbable GTS Tapered Screw and nonwithin a created troial tunnol. The similar geometries and range of sizes. Each device is packaged as single patient use and EO sterilized.
H. Summary Performance Data
Suith & Nephew GTS Sleeve and GTS Tapered Screw utilize design features and Shifth & Nephow OFD breat are redicate device. The in vitro performance testing, material biocompatibility and sterilization validation demonstrate the device is safe, matorial of over intended, and supports a decision of substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Ms. Debra Connors Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K040542
Trade/Device Name: GTS Sleeve and GTS Tapered Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 9, 2004 Received: June 10, 2004
Dear Ms. Connors:
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 work in 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 may be subject to such 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 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); 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.
3
Page 2 - Ms. Debra Connors
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
Mark N Wilkerson
for
Julie M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Smith & Nephew GTS Sleeve and GTS Tapered Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
fo Mark A. Mellema
Division Sign Off
Division Sion ... Division of General, Restorative, and Neurological Devices
510(k) Number K040542
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
110 Over-The-Counter Use (Per 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)
Page 1 of __