(203 days)
Arthrex Mini Tightrope, K061925
Not Found
No
The summary describes a mechanical implant for correcting foot deformities and includes performance testing related to strength, not data analysis or algorithmic processing. There are no mentions of AI, ML, image processing, or data sets.
Yes
The device is intended to assist in the correction of Hallux Valgus deformities, which is a therapeutic purpose.
No
The device description states its purpose is to assist in the correction of Hallux Valgus deformities, indicating a therapeutic or corrective function, not a diagnostic one.
No
The device description explicitly states it is made of Titanium and is designed to be implanted, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- FastForward Device Function: The description clearly states the FastForward device is an implantable button designed to assist in the surgical correction of a Hallux Valgus deformity by providing mechanical reduction of the 1st Intermetatarsal angle. It is a physical device used in the body, not a test performed on a sample taken from the body.
The information provided about the device's intended use, description, materials, and performance testing all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.
Product codes
HTN
Device Description
The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button designed to be implanted on the lateral aspect of the 200 metatarsal with suture or suture tape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st Intermetatarsal angle
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)
Pullout/fracture strength testing of the predicate and proposed devices was conducted. The proposed device was evaluated in conjunction with various suture sizes and materials. Monotonic and cyclic tension and shear testing was completed on full constructs which included 185 metatarsal fixation. Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arthrex Mini Tightrope, K061925
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
MedShape, Incorporated Mr. Jeremy Blair Project Manager 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
Re: K141420 Trade/Device Name: FastForward 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: November 14, 2014 Received: November 17, 2014
Dear Mr. Blair:
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
1
Page 2 - Mr. Jeremy Blair
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Mark N. Melkerson -S
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: _ K141420
Device Name: FastForward
Indications for Use:
The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for MedShape. The logo consists of a stylized blue shape resembling a figure eight with a square at the top. To the right of the shape is the word "MEDSHAPE" in gray, with the letters in a bold, sans-serif font. A trademark symbol is present after the word "MEDSHAPE".
510(k) Summary
510(k) Number: K141420
Date Prepared: November 10, 2014
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
-
A. Submitter:
MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 -
B. Company Contact:
Jeremy Blair Project Manager (678) 235-3319(direct) (404) 249-9158 (fax) Jeremy.Blair@MedShape.com -
C. Device Information:
Trade Name: FastForward Common Name: Button -
D. Classification Name: Washer, Bolt Nut HTN: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030
-
E. Predicate Device(s):
Arthrex Mini Tightrope, K061925
- ட். Physical Description:
The FastForward device, consisting of Titanium (Ti-6AL-4V ELI), is a button designed to be implanted on the lateral aspect of the 200 metatarsal with suture or suture tape.
4
G. Indications for Use:
The FastForward device is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st Intermetatarsal angle.
H. Comparison of Technological Characteristics:
The FastForward is substantially equivalent in design, function and intended use to the following predicate device:
Arthrex Mini Tightrope, K061925
Any differences between the proposed and predicate devices do not raise safety or efficacy concerns. Pullout/fracture strength testing of the predicate and proposed devices was conducted. The proposed device was evaluated in conjunction with various suture sizes and materials. Monotonic and cyclic tension and shear testing was completed on full constructs which included 185 metatarsal fixation. Testing and analysis substantiates the statement that the proposed device performs equivalently to the predicate device.
Image /page/4/Picture/6 description: The image contains the MedShape logo. The logo features a stylized letter "M" in teal, with a square on top and a circle on the bottom. The word "MEDSHAPE" is written in gray, block letters to the right of the stylized "M". The logo appears to be for a medical or healthcare-related company.