(90 days)
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No
The device description focuses on the material properties (Nitinol Shape Memory Alloy) and mechanical function of the staple for bone fixation. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is a bone fixation device, not a therapeutic device. It is designed to provide compression and fixation for bones.
No
The provided text describes a staple system used for bone fixation and compression. Its intended use is for surgical procedures to fix bones and soft tissues, not for diagnosing conditions.
No
The device description clearly states it is a bone fixation device fabricated from Nitinol Shape Memory Alloy, which is a physical material and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DYNAMIC COMPRESSION SMA Staple System is a surgical implant used to fix bones and soft tissue within the body. It is a mechanical device that provides structural support and compression.
- Intended Use: The intended uses listed are all related to surgical procedures and fixation of anatomical structures, not the analysis of biological samples.
Therefore, based on the provided information, the DYNAMIC COMPRESSION SMA Staple System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DYNAMIC COMPRESSION SMA Staple System is indicated for use in: (1) Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, (2) Fixation of proximal tibial metaphysis osteotomy, and (3) Fixation of soft tissue to bone such as in anterior cruciate ligament reconstruction.
Product codes
JDR
Device Description
The DYNAMIC COMPRESSION SMA Staple is fabricated from Nitinol Shape Memory Alloy. This bone fixation device consists of both two and four prong staples and is intended to achieve compression in fixation of bones in the hand, foot, tibia and ankle. Nitinol can change its configuration (shape) based on temperature. At room temperature, the material is pliant and the staple prongs can be straightened. This allows for easy insertion into the bone. After the staple has reached body temperature, the staple prongs deflect inward to their original shape. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site. This inward bending creates a claw effect, and helps prevent the staple from backing out of the bone.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hand, foot, tibia, ankle
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
OCT - 1 2001
DYNAMIC COMPRESSION Shape Memory Alloy (SMA) Staple System 510(k) Summary of Safety and Effectiveness June 2001
Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: DYNAMIC COMPRESSION Shape Memory II. Alloy (SMA) Staple System
III. Product Description
The DYNAMIC COMPRESSION SMA Staple is fabricated from Nitinol Shape Memory Alloy. This bone fixation device consists of both two and four prong staples and is intended to achieve compression in fixation of bones in the hand, foot, tibia and ankle. Nitinol can change its configuration (shape) based on temperature. At room temperature, the material is pliant and the staple prongs can be straightened. This allows for easy insertion into the bone. After the staple has reached body temperature, the staple prongs deflect inward to their original shape. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site. This inward bending creates a claw effect, and helps prevent the staple from backing out of the bone.
IV. Indications
The DYNAMIC COMPRESSION SMA Staple System is indicated for use in: (1) Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, (2) Fixation of proximal tibial metaphysis osteotomy, and (3) Fixation of soft tissue to bone such as in anterior cruciate ligament reconstruction.
V. Substantial Equivalence
Documentation was provided which demonstrated the DYNAMIC COMPRESSION SMA Staple System to be substantially equivalent to other previously cleared shape memory alloy staples.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle. The text is in a sans-serif font and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2001
Dr. Richard W. Treharne Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K012081
Trade Name: Dynamic Compression Shape Memory Alloy (SMA) Staple System Regulation Number: 888.3030 Regulatory Class: II Product Code: JDR Dated: June 29, 2001 Received: July 3, 2001
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Dr. Richard W. Treharne
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K012081
DYNAMIC COMPRESSION Shape Memory Alloy Staple System Device Name:
Indications for Use:
The DYNAMIC COMPRESSION SMA Staple System is indicated for use in: (1) Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, (2) Fixation of proximal tibial metaphysis osteotomy, and (3) Fixation of soft tissue to bone such as in anterior cruciate ligament reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use y 2 (Per 21 CFR 801.109)
OR
Over-the-counter Use No
(Optional 1-2-96)
Mark N. Mulkerin
Division Sion-C Division of General, Restorative and Neurological Devices
510(k) Number _
KO12081