(151 days)
-Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
-Fixation of proximal tibial metaphysis osteotomy.
-Fixation of small fragments of bone (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 bones such as the pelvis, scapula, and sternum.
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 lmplants). The staple is provided pre-loaded on a disposable inserter.
The provided FDA 510(k) summary for the MedShape DynaClip® Bone Staple (K220812) does not contain information related to a study involving image analysis, AI, or human reader performance.
Instead, this document describes a bone staple, which is a physical medical device intended for fracture and osteotomy fixation. The acceptance criteria and the study proving the device meets these criteria are based on mechanical testing, material characterization, and biocompatibility assessments, not on performance in interpreting medical images or improving human interpretation.
Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) as they pertain to image analysis or AI/human-in-the-loop performance, because this information is not present in the provided text.
The closest relevant information, regarding performance testing to support substantial equivalence, is listed as:
- Corrosion resistance testing per ASTM F2129
- Transformation temperature thermal analysis testing per ASTM F2004-17
- Bacterial endotoxin testing per ANSI/AAMI ST72:2011
- Mechanical comparison via Finite Element Analysis
The document explicitly states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety." This further confirms that no studies involving human or AI interpretation of images were conducted or are described here.
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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 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.
August 19, 2022
MedShape, Inc. Courtney Kline Engineering Manager 1575 Northside Dr. NW, Suite 440 Atlanta, Georgia 30318
Re: K220812
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: July 21, 2022 Received: July 22, 2022
Dear Courtney Kline:
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
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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 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 (QS) 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,
Limin Sun, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K220812
Device Name DynaClip® Bone Staple
Indications for Use (Describe)
-Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
-Fixation of proximal tibial metaphysis osteotomy.
-Fixation of small fragments of bone (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 bones such as the pelvis, scapula, and sternum.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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.
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Image /page/3/Picture/1 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 by a curved line. The word "MEDSHAPE" is in a sans-serif font, and the "®" symbol is located to the right of the word.
510(k) Summary
510(k) Number: K220812
August 19th, 2022 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 (404) 249-9155
- B. Company Contact: Courtney Kline Engineering Manager (727) 543-6624 (direct) (404) 249-9158 (fax) courtney.kline@djoglobal.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
- E. Predicate Device: MedShape DynaClip® Bone Staple, K193305
- 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 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 lmplants). The staple is provided pre-loaded on a disposable inserter.
- G. Indications for Use:
- Fracture, osteotomy fixation and joint arthrodesis of the hand and foot. .
- Fixation of proximal tibial metaphysis osteotomy. ●
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- Fixation of small fragments of bone (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 bones such as the pelvis, scapula, and sternum.
- H. Comparison of Characteristics / Performance Testing / Substantial Equivalence: The MedShape DynaClip® Bone Staple was designed to have equivalent technological characteristics as the previously cleared MedShape DynaClip® Bone Staple device, cleared under K193305. 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 size configurations offered. MedShape asserts that any differences from the predicate device do not affect safety or effectiveness.
In addition, the proposed device was subjected to the following performance tests to support the assertion of substantial equivalence:
- . Corrosion resistance testing per ASTM F2129, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- . Transformation temperature thermal analysis testing per ASTM F2004-17, Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
- 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 assertion of safety
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.
Image /page/4/Picture/10 description: The image shows the MedShape logo. The logo consists of a blue abstract shape on the left, resembling a stylized chain link or interconnected circles with a square in the upper portion. To the right of the shape is the word "MEDSHAPE" in gray, block letters. The logo appears to be for a medical or healthcare-related company.
§ 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.