(90 days)
Not Found
No
The document describes a mechanical bone fixation device made of Nitinol and focuses on its physical properties and performance through bench testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is a surgical implant for bone fixation, not a therapeutic device designed to treat or cure a disease or condition through non-invasive means or by delivering a substance.
No
This device is a surgical implant designed for bone fixation (fracture and osteotomy fixation, joint arthrodesis), not for diagnosing medical conditions.
No
The device description explicitly states the device is a "dynaMX™ Tabbed Staple" made of "biocompatible Nitinol," which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy." This describes a surgical implant used to fix bones, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "bone fixation" device made of Nitinol, designed for surgical implantation. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the dynaMXTM Tabbed Staple is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The dynaMXTM Tabbed Staple is indicated for:
· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
· Fixation of proximal tibial metaphysis osteotomy.
Product codes
JDR
Device Description
The dynaMX™ Tabbed Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
- The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand and foot, proximal tibial metaphysis
Indicated Patient Age Range
Not Found
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)
A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Tabbed Staple for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.
These tests include:
Elastic Static Bending Testing Bending Fatigue Testing Staple Pull-Out Force Corrosion Testing Package Seal Strength Verification Transformation Temperature Determination
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2016
MX Orthopedics, Corporation Mr. Howard Schraver Regulatory Affairs Consultant 1 Broadway, 14th Floor Cambridge, Massachusetts 02142
Re: K153129 Trade/Device Name: dynaMXTM Tabbed Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: November 2, 2015 Received: November 3, 2015
Dear Mr. Schrayer:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153129
Device Name dynaMXTM Tabbed Staple
Indications for Use (Describe) The dynaMXTM Tabbed Staple is indicated for:
· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
· Fixation of proximal tibial metaphysis osteotomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
| Name:
Contact: | MӾ Orthopedics, Corp.
Howard Schrayer
Regulatory Affairs Consultant |
|--------------------|---------------------------------------------------------------------------|
| Address: | 1 Broadway, 14th Floor
Cambridge, MA 02142 |
| Telephone:
Fax: | (617) 577 - 3951
(617) 812 - 0395 |
| Date Prepared | January 6, 2016 |
General Device Information
| Product Name: | dynaMX™ Tabbed Staple |
|---|---|
| Classification: | "Bone Fixation Staple" |
| Product code: JDR - Class II | |
| 21 CFR 888.3030 |
Predicate Device
Primary Predicate
| BioMedical Enterprises | Speed™ Staple
(Originally cleared as Osstaple™ Chill)
[510(k) Number K102107] |
|------------------------|-------------------------------------------------------------------------------------|
| BioMedical Enterprises | OSStaple™ Staple
(Originally cleared as Memograph™)
[510(k) K993714] |
| MÄ– Orthopedics, Corp. | dynaMÄ–™ Compression Staple
[510(k) K143622] |
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Description
The dynaMX™ Tabbed Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
- The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.
Indications for Use
The dynaMX™ Tabbed Staple is indicated for:
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, ●
- Fixation of proximal tibial metaphysis osteotomy.
Substantial Equivalence
A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Tabbed Staple for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.
These tests include:
Elastic Static Bending Testing Bending Fatigue Testing Staple Pull-Out Force Corrosion Testing Package Seal Strength Verification Transformation Temperature Determination
This submission supports the position that the MX Orthopedics dynaMX™ Tabbed Staple is substantially equivalent to previously cleared devices, including those listed above. A number of predicate devices list the same range of clinical uses.
Conclusions
MX Orthopedics. Corp. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the MX Orthopedics dynaMX™ Tabbed Staple. The materials from which the MX Orthopedics device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines. The device is substantially equivalent to the referenced predicates.