(146 days)
No
The summary describes a mechanical bone staple made of NiTiNOL and its intended uses and performance testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is described as an orthopedic implant used for fracture and osteotomy fixation and joint arthrodesis, which are therapeutic medical procedures.
No
The MedShape DynaClip Bone Staple is an orthopedic implant used for fixation of fractures and osteotomies, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, single-use orthopedic implant comprised of Nickel Titanium alloy, which is a physical material, not software.
Based on the provided information, the MedShape DynaClip Bone Staple is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "Fracture and osteotomy fixation and joint arthrodesis of the hand and foot," "Fixation of proximal tibial metaphysis osteotomy," and "Fixation of small bone fragments." These are all surgical procedures performed in vivo (within the 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 during surgery.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The DynaClip Bone Staple does not perform this function.
The DynaClip Bone Staple is an implantable orthopedic device used in surgical procedures.
N/A
Intended Use / Indications for Use
The MedShape DynaClip Bone Staple is intended to be used for the following: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
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 used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, 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; proximal tibial metaphysis; long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 proposed device was subjected to the following performance tests to support the assertion of substantial equivalence: Bench testing per ASTM F564, Standard Specification and Test Methods for . Metallic Bone Staples; Pull-out fixation strength, Elastic static bending strength, 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; Mechanical comparison via Finite Element Analysis. No new questions of safety or effectiveness were identified during device testing. No clinical data was collected, as it was deemed unnecessary to support the assertion of safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MedShape, Inc. Jack Griffis Sr. VP, Advanced Research 1575 Northside Drive NW, Suite 440 Atlanta, Georgia 30318
Re: K193305
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: March 20, 2020 Received: March 25, 2020
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
April 23, 2020
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
FOR Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|---|
| Expiration Date: 06/30/2020 | Food and Drug Administration |
| See PRA Statement below. | Indications for Use |
| 510(k) Number ( if known ) | K193305 |
|---|---|
| Device Name | DynaClip Bone Staple |
| Indications for Use (Describe) | The MedShape DynaClip Bone Staple is intended to be used for the following: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.Fixation of proximal tibial metaphysis osteotomy.Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum. |
| 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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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
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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 a combination of a square and a circle, with the square positioned above the circle.
510(k) Summary
510(k) Number: K193305
March 20th, 2020 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: Jack Griffis 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: BioMedical Enterprises (BME), Inc. (now DePuySynthes), Elite™ Implant, K150125 BioMedical Enterprises (BME), Inc. (now DePuySynthes), Speed™, Speed Arc™, Speed Titan™ Implant, K142292
- F. Reference Predicate Device(s): MedShape, Inc., DynaClip Implant, K181781
- G. 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 used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, 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.
4
H. Indications for Use:
The MedShape DynaClip Bone Staple is intended to be used for the following:
- . Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy. .
- . Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
- l. Comparison of Characteristics:
The MedShape DynaClip Bone Staple was designed to have equivalent technological characteristics as the BioMedical Enterprises (BME), Inc. (now DePuy-Synthes), Elite™ Implant cleared under K150125 and the Speed™, Speed Arc™, Speed Titan™ Implant, cleared under K142292. They all 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.
NOTE: The proposed DynaClip device is identical to the previously cleared device (under K181781), except for the addition of some configurations with 4-legs, and this traditional Premarket Notification is primarily for expanded indications for use.
J. Substantial Equivalence – Non-Clinical Testing:
The proposed device was subjected to the following performance tests to support the assertion of substantial equivalence:
- Bench testing per ASTM F564, Standard Specification and Test Methods for . Metallic Bone Staples;
- o Pull-out fixation strength
- Elastic static bending strength o
- Constant amplitude bending fatigue strength o
- . 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
- Mechanical comparison via Finite Element Analysis
- No clinical data was collected, as it was deemed unnecessary to support the 0 assertion of safety
Image /page/4/Picture/19 description: The image contains the logo for MedShape. The logo consists of a blue abstract shape resembling interconnected circles and a square, followed by the word "MEDSHAPE" in a gray, sans-serif font. The word is slightly stylized, with a registered trademark symbol next to it.
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Substantial Equivalence – Conclusions: K.
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. In addition, MedShape asserts that any differences from the predicate devices do not affect safety or effectiveness.
Jack Griffis
SVP, Advanced Research
(404) 678-3311(direct)
(404) 249-9158 (fax) jack.griffis@medshape.com
Image /page/5/Picture/5 description: The image shows the logo for MedShape. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape is a combination of a square and a circle. The word "MEDSHAPE" is written in a sans-serif font.