(105 days)
No
The device description and performance studies focus on the mechanical properties and surgical use of a suture anchor, with no mention of AI or ML.
No
A therapeutic device is one that treats or heals a medical condition. This device is used for fixation of suture material and reattachment of soft tissue to bone, which are surgical procedures, not a form of therapy or treatment in itself.
No
Explanation: The device is a suture anchor intended for the fixation and reattachment of soft tissue to bone during surgical procedures, not for diagnosis.
No
The device description clearly states it consists of a titanium alloy suture anchor, non-absorbable sutures with needles, and an insertion device, all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of non-absorbable, synthetic, surgical suture material" for various orthopedic repairs in the shoulder, foot and ankle, elbow, wrist and hand, and knee. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is a suture anchor and sutures designed to reattach soft tissue to bone. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo during surgery.
N/A
Intended Use / Indications for Use
Smith & Nephew TWINFIX® Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.
Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs
Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions
Elbow. Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral ligament repair, Posterior oblique ligament, lliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement
Product codes
MBI
Device Description
The Smith & Nephew TWINFIX* Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL are designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL consists of a titanium alloy suture anchor and non-absorbable sutures with attached stainless steel needles. The non-absorbable sutures are offered either braided, silicone or PTFE impregnated, polyester (USP) or braided, uncoated, UHMW polyethylene and UHMW polyethylene with monofilament polypropylene or nylon co-braid. An insertion device is also offered which contains a stainless steel shaft with a ABS and polycarbonate handle. The TWINFIX Ti is designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist and Hand, Knee
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)
Mechanical test data demonstrates the device has met the performance specifications for insertion and pull out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Smith & Nephew, Inc. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL Traditional Premarket Notification
| 510(k) Summary | Date Prepared: February 1, 2013 | |
|---|---|---|
| Submitter Information | Contact Information | |
| Smith & Nephew, Inc., Endoscopy Division | Catherine Kilshaw | |
| 150 Minuteman Road | Senior Regulatory Affairs Specialist | |
| Andover, MA 01810 | Phone: (508) 337-4104 | |
| Fax: (978) 749-1443 |
| Device Name (Unmodified) | |
|---|---|
| Trade or proprietary name | TWINFIX® Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 and |
| Needles, SL | |
| Common or usual name | Soft Tissue Fixation Device (MBI) |
| Classification name | 21 CFR 888.3040 Fastener, fixation, nondegradable, soft tissue |
| (Class II) |
Legally Marketed Predicate Device
The Smith & Nephew TWINFIX® Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
- K053344 Bioraptor Suture Anchor, TWINFIX Ti 2.8mm & TWINFIX 3.5mm (Cleared February 23, 2006)
- K972326 PEBA Anchor/Suture Combination (Cleared February 6, 1998)
Device Description . . 、「お気になる」ということです。 この時間のお気に
The Smith & Nephew TWINFIX* Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL are designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL consists of a titanium alloy suture anchor and non-absorbable sutures with attached stainless steel needles. The non-absorbable sutures are offered either braided, silicone or PTFE impregnated, polyester (USP) or braided, uncoated, UHMW polyethylene and UHMW polyethylene with monofilament polypropylene or nylon co-braid. An insertion device is also offered which contains a stainless steel shaft with a ABS and polycarbonate handle. The TWINFIX Ti is designed to provide secure reattachment of soft tissue to bone. Attachment of soft tissue is performed by the surgeon's preferred technique.
1
K123425
Smith & Nephew, Inc. TWINFIX® Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL Traditional Premarket Notification
Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Smith & Nephew TWINFIX® Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.
Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs
Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions
Elbow. Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral ligament repair, Posterior oblique ligament, lliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement
Technological Characteristics ------------------------------------------------------------------------------------------------------------------------------------------------11. 11. 11. 12.
The Smith & Nephew TWINFIX® Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL is substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy.
Performance Data
Mechanical test data demonstrates the device has met the performance specifications for insertion and pull out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle around the top of the caduceus. The word "DEPART" is at the bottom of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2013
Smith & Nephew, Inc., Endoscopy Division . % Ms. Catherine Kilshaw Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K123425
Trade/Device Name: TWINFIX™ Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 6, 2012 Received: November 26, 2012
Dear Ms. Kilshaw:
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 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
3
Page 2 -- Ms. Catherine Kilshaw
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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/ucm115809.htm for 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin . Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Smith & Nephew, Inc. TWINFIX Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL Traditional Premarket Notification
Indications for Use
510(k) Number (if known): K123425
Device Name: TWINFIX* Ti 3.5 Suture Anchor with two ULTRABRAID Sutures #2 with Needles, SL
Indications for Use:
Smith & Nephew TWINFIX Ti Preloaded Suture Anchor with Needles, SL are intended for use only for the fixation of non-absorbable, synthetic, surgical suture material for the following indications.
Shoulder
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsulolabral reconstructions, Biceps tenodesis, and Deltoid Repairs
Foot and Ankle
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist and Hand
Scapholunate ligament reconstruction, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repairs: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement
Prescription Use _______ X AND/OR AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use _
(21 CFR 807 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD
Division of Orthopedic Device 2013.02.15 14:59:29-05'00'