(174 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and substantial equivalence to existing orthopedic staples, with no mention of AI or ML.
No
The device is an implant used for fracture and osteotomy fixation and joint arthrodesis, which is a structural rather than a therapeutic function.
No
Explanation: The device is an implant for fracture fixation and joint arthrodesis, which are treatments rather than diagnostic procedures. Its description focuses on its mechanical function in securing bone.
No
The device description clearly states that the ExoToe Staple is an implant made of stainless steel, provided in a sterile package, and used with physical tools (sizing templates and forceps) for surgical fixation. This indicates a physical medical device, not a software-only one.
Based on the provided information, the ExoToe Staple is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation." This describes a surgical procedure performed directly on the patient's body to treat a physical condition.
- Device Description: The device is an "implant that is crimped onto bone with forceps." This is a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The ExoToe Staple does not interact with or analyze such specimens.
The ExoToe Staple is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The ExoToe Staple is an implant that is crimped onto bone with forceps after a k-wire has been placed to achieve fixation. The ExoToe Staple is provided in a sterile package. A kit containing four sizing templates and forceps is provided non-sterile. The staple is comprised of stainless steel and is pre-formed during manufacturing. The sizing templates and pliers are comprised of stainless steel. The sizing templates are used to select staple size. The forceps are used by a surgeon to conduct the final deformation required to anchor the staple to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-clinical performance testing was performed to verify that the performance of the ExoToe Staple device is substantially equivalent to currently marketed orthopedic instruments. Biomechanical testing verified that the ExoToe staple is substantially equivalent to the Memodyn Staple (K161587), the Z-Staple (K121277), and the Compressyn Staple (K140358) devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
January 11, 2018
Image /page/0/Picture/1 description: The image contains 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.
ExoToe LLC % Jerzy Wojcik Sr Director, QA/RA EdgeOne Medical 455 N Campbell Ave. Suite #2N Chicago, Illinois 60612
Re: K172205
Trade/Device Name: ExoToe 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: December 4, 2017 Received: December 4, 2017
Dear Jerzy Wojcik:
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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -S
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)
K172205
Device Name ExoToe Staple
Indications for Use (Describe)
ExoToe Staple is intended for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation.
| 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)
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510(k) Summary
| Date Summary Prepared: | July 18, 2017 | |
|---|---|---|
| 510(k) Owner: | ExoToe LLC | |
| Contact Person: | Avi Roop | |
| ExoToe LLC, CEO | ||
| PO Box 548 | ||
| Grimes, Iowa 50111 | ||
| 510(k) Consultant Contact: | Jerzy Wojcik | |
| Sr Director RA/QA, EdgeOne Medical | ||
| 455 N Campbell Ave, Suite 2N | ||
| Chicago IL, 60612 | ||
| 312-300-6643 | ||
| jerzy.wojcik@edgeonemedical.com | ||
| Device Name: | Device Name: | |
| Trade Name: | ||
| Common Name: | ||
| Classification: | ||
| Class: | ||
| Product Code: | ExoToe Staple | |
| ExoToe Staple | ||
| Staple, Fixation, Bone | ||
| 888.3030 | ||
| II | ||
| JDR | ||
| Predicate Device(s): | Primary Predicates | |
| K161587 | ||
| K121277 | ||
| K140358 | Memodyn Staple | |
| Z-Staple | ||
| Compressyn Staple | ||
| Device Description: | The ExoToe Staple is an implant that is crimped onto bone | |
| with forceps after a k-wire has been placed to achieve | ||
| fixation. The ExoToe Staple is provided in a sterile package. | ||
| A kit containing four sizing templates and forceps is provided | ||
| non-sterile. The staple is comprised of stainless steel and is | ||
| pre-formed during manufacturing. The sizing templates and | ||
| pliers are comprised of stainless steel. The sizing templates | ||
| are used to select staple size. The forceps are used by a | ||
| surgeon to conduct the final deformation required to anchor | ||
| the staple to the bone. | ||
| Statement of Intended Use: | The ExoToe Staple is intended for fracture and osteotomy | |
| fixation and joint arthrodesis of the foot in conjunction with | ||
| k-wire fixation. | ||
| Comparison of Technological | ||
| Characteristics with Predicate | ||
| Devices: | The proposed ExoToe Staple device has the same | |
| technology, indications, and fundamental characteristics as | ||
| the predicate. Both devices are permanent implants which |
4
achieve compression fixation using a stainless steel staple. Both contain barbs to maintain fixation.
Non-Clinical Performance Data:
Non-clinical performance testing was performed to verify that the performance of the ExoToe Staple device is substantially equivalent to currently marketed orthopedic instruments. Biomechanical testing verified that the ExoToe staple is substantially equivalent to the Memodyn Staple (K161587), the Z-Staple (K121277), and the Compressyn Staple (K140358) devices.
| Evaluation | Conclusion |
|---|---|
| Dorsal pull-off | Substantially Equivalent |
| Static 4-point bend | Substantially Equivalent |
| Dynamic 4-point bend | Substantially Equivalent |
| Protrusion | Substantially Equivalent |
Overall Conclusions: Based on the indication for use, technological characteristics, and comparison to the predicate devices, ExoToe Staple has been shown to be substantially equivalent to the predicates and is safe and effective for its intended use.