(71 days)
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.
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn "M 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.
The provided text, K133858, describes a 510(k) submission for the Tensyn™ Band, a medical device for syndesmosis fixation. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device.
Therefore, many of the requested elements for acceptance criteria and study details for an AI/diagnostic device are not available in the provided text. The submission primarily relies on demonstrating similar technical characteristics and performance through mechanical testing compared to existing predicate devices.
However, I can extract the information that is present and indicate where information is not provided.
Acceptance Criteria and Study for Tensyn™ Band (K133858)
The submission for the Tensyn™ Band focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing, rather than establishing specific diagnostic acceptance criteria or conducting a clinical study with human readers, as would be typical for an AI or diagnostic device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Mechanical Performance: - Rotational loading performance - Cyclic loading performance - Ultimate load - Load at 3mm - Shear test performance | "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices." (Specific numerical performance metrics are not provided in the summary.) |
| Similar Technical Characteristics: - Physical characteristics - Design - Materials | "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." |
| Intended Use: - Fixation of syndesmosis disruptions in ankle fractures. | "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." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The studies mentioned are mechanical performance tests on the device itself, not a test set of patient data.
- Data Provenance: Not applicable in the context of mechanical testing. The testing would have been conducted in a laboratory setting by Dallen Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The "ground truth" for mechanical testing is based on established engineering standards and measurements, not expert clinical interpretation.
4. Adjudication method for the test set
- This is not applicable. Mechanical testing results are objective measurements against predefined standards.
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
- No, an MRMC comparative effectiveness study was not conducted. This is not an AI or diagnostic device as described in the submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is not an AI device.
7. The type of ground truth used
- The "ground truth" for this device, in the context of demonstrating substantial equivalence, is based on established mechanical engineering test standards and performance of predicate devices. The aim is to show that the Tensyn™ Band performs mechanically in a comparable manner to legally marketed devices for the same intended use.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the sense of machine learning. The design and manufacturing would be based on engineering principles and material science.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" for an algorithm.
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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 GSan Clemente, CA 92673(949) 218-0030 Phone(949) 218-0040 Fax |
|---|---|
| CONTACT PERSON: | Al MemmoloChief Operating Officer |
| DATE PREPARED: | February 27, 2014 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | Tensyn™ Band |
| MODEL: | 09-0025, 09-0026, 09-0027, 09-0028 |
| GENERIC/COMMONNAME | Button / Lock / Suture |
| CLASSIFICATION NAME: | Washer, Bolt Nut, CFR 888.3030 (code HTN) |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE DEVICES: | Tenysn Band (K131850)Tightrope Syndesmosis Repair Kit, Titanium, ModelAr-8920Ds; Stainless Steel. Model Ar-8921Ds (K043248)ToggleLoc System (K083070)Compressyn Band (K130431) |
Product Description:
The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn "M 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.
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Indications for Use:
Tensynth 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.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Dallen Medical. Incorporated Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo. Suite G San Clemente. California 92673
Rc: K133858
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: January 2, 2014 Received: January 3, 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 docs not mean that FDA has made a determination that your device complics 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
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Page 2 – Mr. Al Memmolo
forth in the quality systems (OS) regulation (2) 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" (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.
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number (if known): _K133858
Device Name: Tensyn™ Band
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.
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
§ 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.