(125 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an implant for fracture and osteotomy fixation and joint arthrodesis, which is an orthopedic implant, not a therapeutic device.
No
The device is an orthopedic implant for fracture and osteotomy fixation, not for diagnosing conditions.
No
The device description clearly states it is a sterile, single-use orthopedic implant made of Nickel Titanium alloy, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture and osteotomy fixation and joint arthrodesis of the hand and foot." This describes a surgical procedure performed directly on the patient's body to fix bones.
- Device Description: The device is described as a "sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site." This is a physical implant used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not interact with or analyze such specimens.
- Anatomical Site: The anatomical site is the "hand and foot," which are parts of the body where the implant is placed, not where specimens are collected for analysis.
The information provided clearly indicates this is a surgical implant used for orthopedic fixation, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MedShape DynaClip™ Bone Staple is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Product codes
JDR
Device Description
The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be implanted in the bones of the hand or foot and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
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 device was subjected to the following performance tests to support the assertion of substantial equivalence:
- Comparative bench testing per ASTM F564, Standard Specification and Test ● Methods for Metallic Bone Staples;
- Pull-out fixation strength o
- Elastic static bending strength o
- o Constant amplitude bending fatigue strength
- Corrosion resistance testing per ASTM F2129, Standard Test Method for . Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
No new questions of safety or effectiveness were identified during device testing; therefore, the DynaClip Bone Staple is considered substantially equivalent to the predicate device.
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.
0
November 5, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
MedShape, Inc. Jack Griffis Sr. VP, Advanced Research 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318
Re: K181781
Trade/Device Name: DynaClip™ Bone 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: October 5, 2018 Received: October 9, 2018
Dear Jack Griffis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2018.11.05 17:26:51 -05'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DynaClip Bone Staple
Indications for Use (Describe)
The MedShape DynaClip™ Bone Staple is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
| 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) |
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3
Image /page/3/Picture/0 description: The image shows the MedShape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape is made up of a square and a circle connected together. The word "MEDSHAPE" is written in a sans-serif font.
K181781 Page 1 of 2
510(k) Summary
510(k) Number: K181781
June 30th, 2018 Date Submitted:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 (877) 343-7016
- B. Company Contact: SVP, Advanced Research (678) 235-3311 (direct) (404) 249-9158 (fax) jack.griffis@medshape.com
- C. Device Information: Trade Name: DynaClip™ Bone Staple Common Name: Staple, Fixation, Bone
- D. Classification: Orthopedic Panel JDR, 21 CFR 888.3030 Class II
- ட். Predicate Device: Solana Surgical, LLC (now Wright Medical), FuseForce® Implant, K124045
F. Physical Description:
The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be implanted in the bones of the hand or foot and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.
- G. Indications for Use:
The MedShape DynaClip Bone Staple is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
4
- H. Comparison of Characteristics / Performance Testing / Substantial Equivalence:
- The MedShape DynaClip Bone Staple was designed to have equivalent technological characteristics as the Solana Surgical, LLC (now Wright Medical), FuseForce® Implant cleared under K124045. They both have the same materials (NiTiNOL construction as per ASTM 2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants), method of operation (pre-loaded on an inserter), method of sterilization (gamma irradiation) and operate under the same principles of interference fixation and sustained compression to promote fusion of bone. The devices differ only by cross-section and physical sizes offered. MedShape asserts that any differences from the predicate device do not affect safety or effectiveness, and that the proposed DynaClip™ device is, therefore, substantially equivalent.
In addition, the device was subjected to the following performance tests to support the assertion of substantial equivalence:
- Comparative bench testing per ASTM F564, Standard Specification and Test ● Methods for Metallic Bone Staples;
- Pull-out fixation strength o
- Elastic static bending strength o
- o Constant amplitude bending fatigue strength
- Corrosion resistance testing per ASTM F2129, Standard Test Method for . Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
No new questions of safety or effectiveness were identified during device testing; therefore, the DynaClip Bone Staple is considered substantially equivalent to the predicate device.
Jack Griffis SVP, Advanced Research (404) 678-3311(direct) (404) 249-9158 (fax) jack.griffis@medshape.com
Image /page/4/Picture/13 description: The image contains the MedShape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape appears to be a combination of a square and a circle. The word "MEDSHAPE" is in a sans-serif font, and there is a registered trademark symbol next to it.