The Tensyn™ Band is intended to provide fixation during the healing process following a isolated syndesmotic trauma, such as fixation of syndesmosis disruptions).

Device Description

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn™ Band is a low profile system comprised of a flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in stainless steel.

AI/ML Overview

The Tensyn™ Band is a medical device intended for fixation of syndesmosis disruptions during the healing process following isolated syndesmotic trauma. The device's performance was evaluated through various mechanical tests to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Type)	Reported Device Performance
Rotational Loading	Demonstrated substantial equivalence to predicate devices.
Cyclic Loading	Demonstrated substantial equivalence to predicate devices.
Ultimate Load	Demonstrated substantial equivalence to predicate devices.
Load at 3 mm	Demonstrated substantial equivalence to predicate devices.
Shear Test	Demonstrated substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for each mechanical test. The data provenance is not explicitly stated in terms of country of origin but is implicitly from Dallen Medical, Inc. The nature of the testing (mechanical tests on the device itself) means it is not retrospective or prospective in the clinical sense, but rather laboratory-based testing on the device prototypes.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for this device's performance is established through mechanical engineering principles and laboratory testing, not expert clinical consensus or interpretation of medical images.

4. Adjudication Method for the Test Set:

Not applicable. As the device evaluation is based on mechanical testing, there is no need for expert adjudication of results in the traditional sense. The results are quantitative measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The Tensyn™ Band is a surgical implant, and its performance is evaluated through mechanical testing.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a mechanical implant and does not involve an algorithm. The performance is the inherent mechanical properties of the device itself.

7. Type of Ground Truth Used:

The ground truth used is based on mechanical engineering principles and physical measurements from laboratory testing. The device's performance is compared against the known performance characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation focuses on the physical properties and mechanical behavior of the device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of medical device.

Summary

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NOV 15 2013

Image /page/0/Picture/2 description: The image shows the logo for Dallen Medical. The word "dallen" is written in a lowercase sans-serif font, with the "d" and "l" extending above the other letters. Below "dallen" is the word "MEDICAL" in all capital letters, also in a sans-serif font, but with a more blocky and slightly distressed appearance.

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

GENERAL INFORMATION

Dallen Medical, Inc. APPLICANT: 1046 Calle Recodo, Suite G San Clemente, CA 92673 (949) 218-0030 Phone (949) 218-0040 Fax

CONTACT PERSON:

Al Memmolo Chief Operating Officer

November 14, 2013

DATE PREPARED:

DEVICE DESCRIPTION:

Tensyn™ Band TRADE NAME:

MODEL: 09-0006

Button / Lock / Suture GENERIC/COMMONNAME

Washer, Bolt Nut, CFR 888.3030 (code HTN) CLASSIFICATION NAME:

DEVICE CLASSIFICATION: Class II

Tightrope Syndesmosis Repair Kit, Titanium, Model PREDICATE DEVICES: Ar-8920Ds; Stainless Steel. Model Ar-8921Ds (K043248) ToggleLoc System (K083070)

Product Description:

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Image /page/1/Picture/1 description: The image shows the logo for Dallen Medical. The word "dallen" is in a sans-serif font with the "d" and the two "l"s having extended vertical lines. Below "dallen" is the word "MEDICAL" in a blocky, sans-serif font. The logo is in black and white.

Indications for Use:

The Tensyn™ Band is intended to provide fixation during the healing process following a isolated syndesmotic trauma, such as fixation of syndesmosis disruptions).

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol that resembles a human figure embracing a bird or eagle, representing care and protection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2013

Dallen Medical, Incorporated Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo, Suite G San Clemente, California 92673

Re: K131850

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: October 10, 2013 Received: October 11, 2013

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Al Memmolo

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 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,

Laurence D. Coyne -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

KI31850 510(k) Number (if known):

. .

Device Name: Tensyn™ Band

Indications for Use:

יינגייי

The Tensyn™ Band is intended to provide fixation during the healing process following an isolated syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions).

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

Page 1 of 1

Regulation Number and Section

§ 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.