(177 days)
The dynaMX™ Compression Staple is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
Fixation of proximal tibial metaphysis osteotomy
The dynaMX Compression Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
The dynaMX Compression Staples are made of biocompatible Nitinol. The legs of the staple are designed to exhibit superelastic properties at room temperature.
Staples with a bridge length of 11mm and longer are designed with a bridge that can be bent to contour to the bone surface.
This document is a 510(k) Premarket Notification from MX Orthopedics, Corp. for their dynaMX™ Compression Staple. It declares substantial equivalence to predicate devices and describes the device, its indications for use, and the studies conducted to support its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists the types of laboratory studies conducted to "verify the suitability...establish Substantial Equivalence...and confirm reproducibility." The implication is that the device met the internal acceptance criteria for each of these tests to demonstrate substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Elastic Static Bending (Suitability for intended use) | Conducted |
| Bending Fatigue (Suitability for intended use) | Conducted |
| Staple Pull-Out Force (Suitability for intended use) | Conducted |
| Corrosion (Biocompatibility and Durability) | Conducted |
| Package Seal Strength (Reproducibility & Shelf-life) | Conducted |
| Biocompatibility (Material safety) | Well-established for Nitinol (referenced publication appended) |
| Shelf-life / Stability | Protocol appended |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "A series of laboratory studies (bench tests)" but does not specify the sample size for any of these tests. It also does not provide information on the data provenance in terms of country of origin or whether the studies were retrospective or prospective. These are bench tests, so they would not typically involve human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the studies conducted were "laboratory studies (bench tests)" on the device itself, not studies involving human interpretation or clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the studies were bench tests and did not involve human adjudication for establishing ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study involving human readers or AI in the provided document. The current submission is for a medical device (compression staple), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the submission is for a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the engineering specifications and performance targets defined for each test (e.g., a specific pull-out force, a bending fatigue limit). These are inherent properties measured directly from the device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific tests.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this submission is for a physical medical device and does not involve machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
MX Orthopedics, Corporation Mr. Howard L. Schrayer Regulatory Affairs Consultant 12 Suburban Park Drive Billerica, Massachusetts 01821
Re: K143622
Trade/Device Name: dynaMX™ Compression 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: May 8, 2015 Received: May 11, 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
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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143622
Device Name dynaMX Compression Staple
Indications for Use (Describe)
The dynaMX Compression 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name:Contact: | MX Orthopedics, Corp.Howard SchrayerRegulatory Affairs Consultant |
|---|---|
| Address: | 12 Suburban Park DriveBillerica, MA 01821 |
| Telephone:Fax: | (978) 294 - 8114(978) 232 - 9998 |
| Date Prepared | June 12, 2015 |
General Device Information
| Product Name: | dynaMX TM Compression Staple |
|---|---|
| Classification: | "Bone Fixation Staple"Product code: JDR - Class II21 CFR 888.3030 |
Predicate Device
| BioMedical Enterprises | Speed™ Staple(Originally cleared as Osstaple™ Chill)[510(k) Number K102107] |
|---|---|
| BioMedical Enterprises | OSStaple™ Staple(Originally cleared as Memograph™)[510(k) K993714] |
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Description
The dynaMX Compression Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
- . The dynaMX Compression Staples are made of biocompatible Nitinol. The legs of the staple are designed to exhibit superelastic properties at room temperature.
- Staples with a bridge length of 11mm and longer are designed with a bridge that can . be bent to contour to the bone surface.
Indications for Use
The dynaMX™ Compression Staple is indicated for:
- 0 Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
- Fixation of proximal tibial metaphysis osteotomy 0
Substantial Equivalence
A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Compression 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
The biocompatibility of Nitinol has been well-established. A reference publication that describes the biocompatibility is also appended, together with a copy of the shelf-life / stability protocol.
This submission supports the position that the MX Orthopedics dvnaMX™ Compression 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™ Compression 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.
§ 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.