(106 days)
No
The document describes a mechanical fixation device and its intended uses. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to provide fixation during the healing process following syndesmotic trauma, acromioclavicular separations, and other bone and soft tissue repairs, which are therapeutic interventions.
No.
The device description, intended use, and performance studies all indicate that the Tensyn Plug is a surgical implant designed for fixation during the healing process of various injuries, not for diagnosing medical conditions.
No
The device description clearly states that the Tensyn Plug is comprised of physical components (coated flat polyethylene terephthalate (PET) suture band, narrow button, locking cap assembly) and is available in stainless steel. This indicates it is a physical medical device, not software-only.
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 device used for fixation during the healing process of various musculoskeletal injuries and procedures. This involves providing mechanical support and stabilization within the body.
- Device Description: The device is described as a "knotless system for fixation" comprised of a suture band, button, and locking cap. This is a physical implantable device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Tensyn Plug does not involve any such testing or analysis of biological samples.
The Tensyn Plug is a surgical implant used for mechanical support and fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Product codes
HTN
Device Description
The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromio-clavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
syndesmosis, Weber B and C ankle, acromioclavicular, metaphyseal, periarticular, radiolunar ligament (DRUL), Tarasometatarsal (TMT), foot, 1st metatarsal, 2nd metatarsal, bone, soft-tissue, ligament, tendon, Carpal Metacarpal (CMC) joint, thumb metacarpal, first metacarpal, second metacarpal, trapezium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn Plug is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tensyn Band (K141264), Tensyn Band (K131850), Arthrex, Inc. Mini TightRope Repair Kit (K061925), Arthrex, Inc. CMC Mini TightRope (K140328), Biomet, Inc. ToggleLoc System (K083070)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2015
Dallen Medical, Incorporated Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo, Suite G San Clemente, California 92673
Re: K143092 Trade/Device Name: Tensyn™ Plug Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: January 13, 2015 Received: January 15, 2015
Dear Mr. Memmolo:
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
1
(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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Lori A. Wiggins -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 Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Page 1 of 1
Device Name: Tensyn™ Plug
Indications for Use:
Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissueto-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the logo for Dallen Medical. The word "dallen" is written in a thin, sans-serif font in gray color. Below "dallen", the word "MEDICAL" is written in a bold, sans-serif font in gold color. The logo is simple and modern.
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
GENERAL INFORMATION
| APPLICANT: | Dallen Medical, Inc.
1046 Calle Recodo, Suite G
San Clemente, CA 92673
(949) 218-0030 Phone
(949) 218-0040 Fax |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Al Memmolo
Chief Operating Officer |
| DATE PREPARED: | February 3, 2015 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | Tensyn™ Plug |
| GENERIC/COMMONNAME: | Button / Lock / Suture |
| CLASSIFICATION NAME: | Washer, Bolt Nut, CFR 888.3030 (code HTN) |
| DEVICE CLASSIFICATION: | Class II |
| | PREDICATE DEVICES:
Tensyn Band (K141264)
Tensyn Band (K131850)
Arthrex, Inc. Mini TightRope Repair Kit (K061925)
Arthrex, Inc. CMC Mini TightRope (K140328)
Biomet, Inc. ToggleLoc System (K083070) |
Product Description:
The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromio-clavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel.
4
Dallen Medical, Inc. 510(k) K143092 - Amendment 3 February 3, 2015 - Tensyn™ Plug
llen
MEDICAL
Indications for Use:
Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft- tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Technical Characteristics:
The Tensyn Plug has similar physical and technical characteristics to the predicate devices since all devices achieve fixation through a suture between two metal fasteners.
Performance Data:
All necessary testing has been performed with the Tensyn Plug to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn Plug is substantially equivalent to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing the technical information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Tensyn Plug is determined to be substantially equivalent to existing legally marketed devices.