(114 days)
Not Found
No
The device description and performance studies focus on mechanical properties and substantial equivalence to a predicate device, with no mention of AI/ML terms or functionalities.
No.
The device's intended use is to protect the suture/bone during transosseous fixation procedures, which is a supportive role in a surgical procedure, not to treat, mitigate, or prevent disease or affect the structure or function of the body in a therapeutic way.
No
The device, Lateral Button™, is described as an implantable mechanical device used to protect suture/bone during transosseous fixation procedures. Its intended use is to assist in distributing pressure and preventing suture migration and damage, not to diagnose a medical condition.
No
The device description clearly states it is an implanted Button made of PEEK and a disposable inserter, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect the suture/bone during transosseous fixation procedures." This is a surgical implant used directly on the patient's bone during a procedure.
- Device Description: The device is an "implanted Button" made of PEEK, designed to be inserted into a bone tunnel. This is a physical implant.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The Lateral Button™ is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Lateral Button™ is intended to protect the suture / bone during transosseous fixation procedures.
Product codes
MBI
Device Description
The Lateral Button™ consists of an implanted Button preloaded on a disposable inserter necessary for its insertion into the bone tunnel, the inserter is removed upon completion of the procedure. The implant is made of implantable grade PEEK (polyether - etherketone). The inserter is made of Polycarbonate. The Lateral Button and its inserter will be supplied sterile for single use. The implant has an O.D. of 3.1 mm, overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded through the implant, which helps to distribute the pressure created by the suture and assists in the prevention of suture migration and damage to suture and/or bone. The implant will be supplied either as a stand alone device or as part of a kit i.e. with other devices already cleared for transosseous fixation procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
With respect to technology, the performance is the same as verified by design verification. This consisted of static and dynamic testing in which the results demonstrated substantial equivalence to the predicate device. The material used PEEK (polyether - etherketone) is a standard material used in surgical implant applications. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs and functions in the same manner.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
【12296 510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|----------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Manufacturer
Address: | T.A.G. Medical Products Corporation, Ltd.
D. N. Ashrat
Kibbutz Gaaton 25130, Israel |
| | Mfg. Phone: | Tel.: +972-4-985-8400 |
| | Contact Person: | Erez Adiv |
| | Date: | November 30, 2011 |
| 2. | Regulation
Description
Device &
Classification | Regulation number 21 CFR 888.3040
Smooth or threaded metallic bone fixation fastener
Device class: 2
Product code MBI |
| 3.
4. | Name:
Predicate Devices:
Description: | Lateral Button™
K970423 - Innovasive Devices, Inc.
The Lateral Button™ consists of an implanted Button preloaded on a
disposable inserter necessary for its insertion into the bone tunnel, the
inserter is removed upon completion of the procedure. |
| | | The implant is made of implantable grade PEEK (polyether - etherketone).
The inserter is made of Polycarbonate. The Lateral Button and its inserter
will be supplied sterile for single use. The implant has an O.D. of 3.1 mm,
overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded
through the implant, which helps to distribute the pressure created by the
suture and assists in the prevention of suture migration and damage to
suture and/or bone. The implant will be supplied either as a stand alone
device or as part of a kit i.e. with other devices already cleared for
transosseous fixation procedures. |
| 5. | Intended Use: | The Lateral Button™ is intended to protect the suture / bone during
transosseous fixation procedures |
| 6. | Comparison of
Technological
Characteristics: | With respect to its indication for use, the Lateral Button is substantially
equivalent to its predicate devices in that is intended for the same clinical
purpose. |
| | | * With respect to technology, the performance is the same as verified by
design verification. This consisted of static and dynamic testing in which the
results demonstrated substantial equivalence to the predicate device. |
| | | The material used PEEK (polyether - etherketone) is a standard material
used in surgical implant applications. |
| | | Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its
device is safe and effective because it performs and functions in the same
manner |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
T.A.G. Medical Products Corporation, Ltd. % MedicSense, USA Mr. George Hattub 291 Hillside Avenue Somerset, Massachusetts 02726
DEC - 1 2011
Re: K112296
Trade/Device Name: Lateral Button™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 14, 2011 Received: November 18, 2011
Dear Mr. Hattub:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Mr. George Hattub
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ernie Keith
- Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KII2296
Indications for Use
510(k) Number (if known):
Device Name: Lateral Button™
Indications For Use: The Lateral Button™ is intended to protect the suture/bone during transosseous fixation procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Rivers for MXM
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Device
510(k) Number