(98 days)
Not Found
No
The 510(k) summary describes a mechanical fixation device and does not mention any AI or ML components or functionalities.
No
The device is described as a "knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder" that "provides fixation during the healing process." It acts as a mechanical support during healing, rather than actively treating a disease or condition itself.
No
The device description and intended use indicate that the Tensyn™ Band is a fixation device used during the healing process following trauma, not for diagnosing conditions.
No
The device description clearly states it is comprised of physical components (polymer coated flat polyethylene terephthalate (PET) suture band, button, and lock) and is available in titanium and stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for fixation during the healing process of injuries (syndesmotic trauma, acromioclavicular separations). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a "knotless system for fixation" comprised of a suture band, button, and lock. This is consistent with a surgical implant or fixation device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information about a physiological state, health, or disease.
IVD devices are used in vitro (outside the body) to examine specimens. This device is clearly intended for in vivo (inside the body) use for structural support and fixation.
N/A
Intended Use / Indications for Use
Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder. The Tensyn™ Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
syndesmosis (ankle), acromioclavicular (shoulder)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
All necessary testing has been performed with the Tensyn™ Band 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™ Band is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tensyn™ Band (K133858), OrthoHelix Syndesmosis Fixation Devices (K132733)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Dallen Medical, Inc. Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo Suite G San Clemente, California 92673
Re: K141264
Trade/Device Name: Tensyn™ Band 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: June 27, 2014 Received: June 30, 2014
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
Page 2 - Mr. Al Memmolo
(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,
Image /page/1/Picture/8 description: The image shows the name "Lori A. Wiggins -S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.
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
Page 1 of 1
K141264 510(k) Number (if known):
Device Name: Tensyn™ Band
Indications for Use:
Tensyn 110 Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.
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)
3
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: | August 15, 2014 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | Tensyn™ Band |
| GENERIC/COMMONNAME | Button / Lock / Suture |
| CLASSIFICATION NAME: | Washer, Bolt Nut, CFR 888.3030 (code HTN) |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE DEVICES: | Tensyn™ Band (K133858)
OrthoHelix Syndesmosis Fixation Devices (K132733) |
Product Description:
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder. The Tensyn™ Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.
4
Indications for Use:
Tensyn " Band 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™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn 100 Band is used in conjunction with, but not connected to, supplemental fixation.
Technical Characteristics:
The Tensyn™ Band 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™ Band 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™ Band 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™ Band is determined to be substantially equivalent to existing legally marketed devices.