(26 days)
No
The summary describes a mechanical fixation device and does not mention any AI or ML components or functionalities.
No
The device is described for fixation of tissue during ligament reconstruction, which is a structural and support function rather than a direct therapeutic action to treat a disease or condition.
No
Explanation: The device is intended for fixation during cruciate ligament reconstruction procedures, which is a treatment/surgical function, not a diagnostic one.
No
The device description clearly states it consists of a physical screw and sheath, indicating it is a hardware device, not software-only.
Based on the provided information, the Arthrex BioComposite GraftBolt is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "fixation of tissue including ligament or tendon to bone and bone tendon bone during cruciate ligament reconstruction procedures." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description of a "pre-packaged mating sheath and a screw pair" further supports its use as a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The Arthrex BioComposite GraftBolt's function is purely mechanical and structural within the body during surgery.
N/A
Intended Use / Indications for Use
The Arthrex BioComposite GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone during cruciate ligament reconstruction procedures.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
The Arthrex BioComposite GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in various sizes.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The submitted degradation and biomechanical testing data demonstrates that the ultimate load strength of the proposed devices meets or exceeds the minimum acceptance criteria.
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.
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.
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
K 12.0540 (1/2)
Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012
MAR 2 0 2012
Arthrex SPECIAL 510(K); ARTHREX BIOCOMPOSITE GRAFTBOLT
510(k) Summary of Safety and Effectiveness 2
| Date Summary Prepared | February 15, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Manager, Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: courtney.smith@arthrex.com | |
| Trade Name | Arthrex BioComposite GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code -Classification | |
| Name | HWC - Screw, fixation, bone |
| MAI - Fastener, fixation, biodegradable | |
| CFR | 21 CFR 888.3030: Single/multiple component metallic bone |
| fixation appliances & accessories | |
| Predicate Device | K093912, K103060: Arthrex Tibial GraftBolt |
| K112040: Arthrex BioComposite Transfix | |
| K071177: Arthrex BioComposite Interference Screws | |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain clearance for the BioComposite GraftBolt, which is a | |
| line-extension of the Arthrex Tibial GraftBolt (K093912, | |
| K103060). | |
| Device Description and Intended | |
| Use | The Arthrex BioComposite GraftBolt consists of a pre- |
| packaged mating sheath and a screw pair offered in various | |
| sizes. |
The Arthrex BioComposite GraftBolt is intended to be used
for fixation of tissue including ligament or tendon to bone and
bone tendon bone during cruciate ligament reconstruction
procedures. |
| Substantial Equivalence
Summary | The Arthrex BioComposite GraftBolt is substantially
equivalent to the Arthrex Tibial GraftBolt (K093912,
K103060) in which the basic features, and intended uses are
the same. The biocomposite material is the same material
used in the Arthrex BioComposite Transfix (K112040) and |
| BioComposite Interference Screws (K071177). | Any differences between the BioComposite GraftBolt and
the predicate devices are considered minor and do not raise
questions concerning safety and effectiveness.
The submitted degradation and biomechanical testing data
demonstrates that the ultimate load strength of the proposed
devices meets or exceeds the minimum acceptance criteria.
Based on the indication for use, technological characteristics
and the comparison to the predicate devices, Arthrex, Inc. ha
determined that the Arthrex BioComposite GraftBolt is
substantially equivalent to currently marketed predicate
devices. |
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Comments of the country
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Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012
Arthrait SPECIAL 510(K): ARTHREX BIOCOMPOSITE GRAFTBOLT .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard -Naples, Florida 34108
MAR 2 0 2012
Re: K120540
Trade/Device Name: Arthrex BioComposite GraftBolt Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II Product Code: MAI, HWC Dated: March 6, 2012 Received: March 8, 2012
Dear Ms. Smith:
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
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Page 2 - Ms. Courtney Smith
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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for At. B. A.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012
Arthrex SPECIAL 510(K): ARTHREX BIOCOMPOSITE GRAFTBOLT
Indications for Use Form
Indications for Use
510(k) Number:
1
Device Name:
Arthrex BioComposite GraftBolt
Indications For Use:
The Arthrex BioComposite GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone during cruciate ligament reconstruction procedures.
AND/OR Over-The-Counter Use Prescription Use V (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
10 of 241
K 120540(11)