(101 days)
The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair
The Titanium Suture Anchor is a titanium alloy threaded device designed to attach soft tissues to bone when used in conjunction with suture.
This is a 510(k) summary for a medical device called the Titanium Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of diagnostic or AI-driven devices.
Here's a breakdown of the information provided, tailored to your request, but acknowledging the nature of this particular submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (Titanium Suture Anchor), the "acceptance criteria" are related to mechanical performance and demonstrating equivalence to a predicate device. The document does not describe a clinical study comparing the device against specific clinical outcome metrics with statistical acceptance thresholds as one might see for a diagnostic tool or an AI algorithm. Instead, it relies on nonclinical mechanical testing.
| Acceptance Criteria (Functional/Mechanical) | Reported Device Performance |
|---|---|
| Simulated Use Testing: Not explicitly defined criteria, but implied successful operation under simulated use conditions. | Performance met all specified criteria. |
| Axial Insertion Force Testing: Not explicitly defined criteria, but implied acceptable force for insertion. | Performance met all specified criteria. |
| Ultimate Strength Testing: Not explicitly defined criteria, but implied acceptable strength to perform its intended function. | Performance met all specified criteria. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a nonclinical testing program.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical value (e.g., N=X units). The document states, "All testing was performed on test units representative of finished devices." This implies multiple units were tested for each type of nonclinical test.
- Data Provenance: Not applicable in the traditional sense of patient data. The "data" comes from laboratory mechanical testing of manufactured device units. It is not patient-derived or clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For mechanical tests of a physical device, ground truth is established by engineering standards, test methods, and measurement equipment, rather than expert interpretation of data. The expertise resides in the engineers and technicians performing and validating the tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies, typically in clinical readings or image analysis. Mechanical testing results are objective measurements.
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. This is a physical medical device (suture anchor), not an AI diagnostic or assistive technology. No MRMC study was conducted or is relevant for this type of submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device. There is no algorithm to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests is based on engineering specifications, established test methods, and measurable physical properties deemed acceptable for a device of its type and in comparison to its predicate device. This is the closest equivalent to ground truth for this kind of submission.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense. The "design" of the device is developed through engineering principles, prototyping, and iterative testing, not through a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm. The device's design is validated against engineering requirements and established safety/performance standards for similar devices.
{0}------------------------------------------------
K133229 Page 1 of 2
510(k) Summary
JAN 30 2014
| Device Trade Name: | Titanium Suture Anchor |
|---|---|
| Manufacturer: | MTP Solutions LLC124 South 600 West. Suite 100Logan, UT 84321 |
| Contact: | Mr. Robert HoyDirector of Technical & Clinical ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@venturemd.com |
| Prepared by: | Musculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798 |
| Date Prepared: | October 18, 2013 |
| Common Name: | Fastener, Fixation, Soft Tissue |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
Indications for Use:
Product Codes:
The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
MBI
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Scapholunate Ligament Reconstruction. Carpal Hand/Wrist: Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
{1}------------------------------------------------
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair
Device Description:
The Titanium Suture Anchor is a titanium alloy threaded device designed to attach soft tissues to bone when used in conjunction with suture.
Predicate Device:
The Titanium Suture Anchor is substantially equivalent to the Arthrex Tak (K050749 & K061863) with respect to its indications for use, design, function, and performance.
Technological Characteristics Comparison:
The Titanium Suture Anchor and its predicate device are similar in size and shape. Both devices are generally cylindrical and have features on their outer diameter for engaging bone tunnel walls. In addition both devices are designed to be deployed in conjunction with suture. The Titanium Suture Anchor is manufactured from titanium allov and the predicate is manufactured from one of two resorbable polymers. This material difference does not raise any new issues of safety or effectiveness. There are no substantial differences in technological characteristics between the two devices and as such the Titanium Suture Anchor introduces no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the Titanium Suture Anchor to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data was not needed to support the safety and effectiveness of the subject device.
The device design was qualified through the following tests:
- . Simulated Use Testing
- Axial Insertion Force Testing .
- Ultimate Strength Testing .
Conclusion:
The Titanium Suture Anchor met all specified criteria and did not raise new safety or performance questions. The Indication/Intended Use and the fundamental scientific technology of the Titanium Suture Anchor are the same as those described in the predicate device. The Titanium Suture Anchor is determined by MTP Solutions to be substantially equivalent to the Arthrex Tak (K050749 & K061863).
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
MTP Solutions LLC Mr. Robert Hov Director of Technical & Clinical Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K133229
.
Trade/Device Name: Titanium Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 16, 2013 Received: December 17, 2013
Dear Mr. Hoy:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Mr. Robert Hov
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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,
Vincent Jincent -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Titanium Suture Anchor - Traditional 510(k)
4. Indications for Use
510(k) Number (if known): K133229
Device Name: Titanium Suture Anchor
Indications for Use:
The Titanium Suture Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 1 of 1 Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
MTP Solutions LLC
§ 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.