(131 days)
No
The device description and performance data focus on the mechanical properties and biocompatibility of the tissue anchors, with no mention of AI or ML.
Yes
The device is intended for the reattachment of soft tissue to bone for various orthopedic indications, which aligns with the definition of a therapeutic medical device that treats or alleviates a condition.
No
This device is a surgical implant designed for reattaching soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of physical components (medial, lateral, and labral anchors) made of PEEK material, 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 clearly describes a surgical device for reattaching soft tissue to bone. This is a therapeutic and structural function within the body.
- Device Description: The description details physical implants (anchors) made of PEEK material, designed to be inserted into the body.
- Performance Studies: The performance studies focus on mechanical testing, biocompatibility, sterilization, and packaging – all relevant to an implantable surgical device. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any of the typical characteristics of an in vitro diagnostic device.
In vitro diagnostic devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Tigon Medical Tissue Anchor System does not perform this function.
N/A
Intended Use / Indications for Use
The Tigon Medical Tissue Anchor System is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions). Acromnioclavicular separation repairs, Rotator cuff repairs, Bicep tenodesis;
Elbow, Wrist, and Hand: Biceps tendon reattachmnent, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;
Knee: Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medials obliquous advancement), Illiotibial band tenodesis;
Foot and Ankle: Hallux valgus repairs. Medial or Lateral instability repairs/reconstructions. Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
Product codes
MBI
Device Description
The Tigon Medical Tissue Anchor System consists of multiple-sized medial, lateral tissue anchors, and a single sized labral anchor. The medial anchors are threaded and are offered in 5.5 and 6.5 mm outer diameter sizes. The lateral anchors are conically barbed and are offered in 4.8 and 6 mm outer diameter sizes. The lateral anchors also offer unique angled locking slits to eliminate the need for knotting to secure the suture. The labral anchors are also barbed, and are offered in a 2.9 mm outer diameter, and are available with grooves, and two groove-less, knotless varieties (with and without locking slit). Tigon Tissue Anchors can be used with Tigon 2mm CuffTape and Tigon #2CuffCable (sold separately). Each tissue anchor will have a similar inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Wrist, Hand, Knee, Foot, Ankle
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)
Non-Clinical Performance Data Summary:
- ASTM F-543 Testing
- Limulus Amebocyte Lysate (LAL) Testing
- Material-Mediated Pyrogen (MMP) Testing
- Pre-validated Medical Packaging: Sealing and five year real time aging of QSEAL® pouch packaging systems per ASTM F1886/F1886M, ASTM F88/F88M, ASTM F1929, and ISO 11137-1.
- Instrument Cleaning validation as outlined by AAMI TIR12-2010
- Pre-vac steam sterilization validation per ANSI/AAMI ST79:2017
- Pre-vac drying time validation per ANSI/AAMI ST79:2017
Clinical Performance Data Summary:
No clinical testing was required.
Conclusions:
The Tigon Medical Tissue Anchors implants are manufactured from well-known biocompatible material PEEK (ASTM F2026). The Tigon Medical Tissue Anchors material, PEEK, of the final device is identical to the predicate device in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). No Biocompatibility testing was necessary.
Endotoxin, Pyrogenicity, Sterility, Shelf life, Packaging, and Mechanical testing has been completed. The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria and is substantially equivalent to current predicate systems.
Based on testing results and the comparisons provided, the Tigon Medical Tissue Anchors are considered substantially equivalent to the Knotless Suture Anchors (K121018) and the Cayenne Medical Quattro Link Knotless Anchor (K122314) in material, construction, and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith and Nephew BIORAPTOR Knotless Suture Anchors (K121018), Cayenne Medical Quattro Link Knotless Anchor (K122314)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 21, 2019
Tigon Medical % Lee Strnad President Intrepid Orthopedics, LLC 3953 Humphrey Road Richfield, Ohio 44286
Re: K182507
Trade/Device Name: Tigon Medical Tissue Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 21, 2018 Received: November 23, 2018
Dear Mr. Strnad:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182507
Device Name Tigon Medical Tissue Anchors
Indications for Use (Describe)
The Tigon Medical Tissue Anchor System is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions). Acromnioclavicular separation repairs, Rotator cuff repairs, Bicep tenodesis;
Elbow, Wrist, and Hand: Biceps tendon reattachmnent, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;
Knee: Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medials obliquous advancement), Illiotibial band tenodesis;
Foot and Ankle: Hallux valgus repairs. Medial or Lateral instability repairs/reconstructions. Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) number : K182507 Date submitted: September 12th, 2018
Image /page/3/Picture/1 description: The image is a logo for Tigon Medical. The word "Tigon" is written in bold, black letters. The "T" in Tigon is stylized to look like a screw. The "O" in Tigon is stylized to look like a tiger's eye. Underneath the word "Tigon" is the word "Medical" written in smaller, gray letters.
05. 510(k) Summary
Submitter Information
| Applicant: | Tigon Medical |
|---|---|
| Contact Person: | Lee A. Strnad |
| Management Representative | |
| Intrepid Orthopedics | |
| 3953 Humphrey Rd | |
| Richfield, OH 44286 | |
| (440) 465-4321 | |
| Date Prepared: | 8/7/18 |
| Name of Device: | Tigon Medical Tissue Anchor |
| Common Name: | Tissue/Suture Anchor |
| Classification Name | Smooth or threaded metallic bone fixation fastener (per 21 |
| CFR 888.3040) | |
| Product Code/Panel: | MBI |
| Predicate Devices: | Smith and Nephew BIORAPTOR Knotless Suture Anchors |
| (K121018) | |
| Intended Use: | Cayenne Medical Quattro Link Knotless Anchor (K122314) |
The Tigon Medical Tissue Anchor System is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromnioclavicular separation repairs Deltoid repairs Rotator cuff repairs Bicep tenodesis Elbow, Wrist, and Hand Biceps tendon reattachmnent Ulnar or radial collateral ligament reconstruction
4
Image /page/4/Picture/0 description: The image shows the logo for Tigon Medical. The word "Tigon" is written in bold, black letters, with the "I" resembling a screw and the "O" replaced by a stylized tiger eye. Below the word "Tigon" is the word "Medical" in smaller, thinner, black letters.
05. 510(k) Summary
Lateral epicondylitis repair
Knee Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medials obliquous advancement Illiotibial band tenodesis Foot and Ankle Hallux valgus repairs Medial or Lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Device Description
The Tigon Medical Tissue Anchor System consists of multiple-sized medial, lateral tissue anchors, and a single sized labral anchor. The medial anchors are threaded and are offered in 5.5 and 6.5 mm outer diameter sizes. The lateral anchors are conically barbed and are offered in 4.8 and 6 mm outer diameter sizes. The lateral anchors also offer unique angled locking slits to eliminate the need for knotting to secure the suture. The labral anchors are also barbed, and are offered in a 2.9 mm outer diameter, and are available with grooves, and two groove-less, knotless varieties (with and without locking slit). Tigon Tissue Anchors can be used with Tigon 2mm CuffTape and Tigon #2CuffCable (sold separately). Each tissue anchor will have a similar inserter.
Technological Characteristics
The Tigon Medical Tissue Anchors have the same intended use as the predicate devices. The Tigon Medical Tissue Anchors have similar indications for use as the predicate devices. The Tigon Medical Tissue Anchors are manufactured from the same material as the predicate devices. Tigon Medical Tissue Anchor implants are manufactured from PEEK per ASTM F-2026 or equivalent. The range of sizes of the Tigon Medical Tissue Anchors are similar to the predicate devices.
5
Image /page/5/Picture/0 description: The image shows the logo for Tigon Medical. The word "Tigon" is written in bold, black letters, with the "T" stylized to look like a screw. The "O" is replaced with a stylized tiger eye. Below the word "Tigon" is the word "Medical" in smaller, sans-serif font.
05. 510(k) Summary
Non-Clinical Performance Data Summary
-
- ASTM F-543 Testing
-
- Limulus Amebocyte Lysate (LAL) Testing
-
- Material-Mediated Pyrogen (MMP) Testing
-
- Pre-validated Medical Packaging: Sealing and five year real time aging of QSEAL® pouch packaging systems per ASTM F1886/F1886M, ASTM F88/F88M, ASTM F1929, and ISO 11137-1.
-
- Instrument Cleaning validation as outlined by AAMI TIR12-2010
-
- Pre-vac steam sterilization validation per ANSI/AAMI ST79:2017
-
- Pre-vac drying time validation per ANSI/AAMI ST79:2017
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
The Tigon Medical Tissue Anchors implants are manufactured from well-known biocompatible material PEEK (ASTM F2026). The Tigon Medical Tissue Anchors material, PEEK, of the final device is identical to the predicate device in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). No Biocompatibility testing was necessary.
Endotoxin, Pyrogenicity, Sterility, Shelf life, Packaging, and Mechanical testing has been completed. The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria and is substantially equivalent to current predicate systems.
Based on testing results and the comparisons provided, the Tigon Medical Tissue Anchors are considered substantially equivalent to the Knotless Suture Anchors (K121018) and the Cayenne Medical Quattro Link Knotless Anchor (K122314) in material, construction, and performance characteristics.