(146 days)
The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.
The Instratek ToeTac™ 10° Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver, as well as a single packaged implant.
The provided text is a 510(k) summary for the ToeTac™ 10° Hammertoe Fixation System. It describes the device and its intended use, but it does not contain information about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information from the text. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics, supported by general performance testing.
Here's how I would structure the answer if the information were available:
Acceptance Criteria and Study for the ToeTac™ 10° Hammertoe Fixation System
The provided text does not contain the specific acceptance criteria or detailed study results to address the requested information. The document is a 510(k) summary focused on establishing substantial equivalence, and while it mentions "Performance testing consisted of tests for pull out, torque and static and dynamic bend strength," it does not provide the quantitative criteria, the reported device performance against those criteria, or the methodology of the study in detail.
Therefore, I cannot populate the table or answer most of the specific questions.
If the information were present, it would typically look like this:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pull-out Strength | [e.g., > X Newtons] | [e.g., Y Newtons (passes)] |
| Torsional Strength | [e.g., > A N-mm] | [e.g., B N-mm (passes)] |
| Static Bending Strength | [e.g., > P Newtons] | [e.g., Q Newtons (passes)] |
| Dynamic Bending (Fatigue) | [e.g., > Z cycles at load L] | [e.g., W cycles at load L (passes)] |
2. Sample size used for the test set and the data provenance
- Sample size: (Information not provided in the text)
- Data provenance: (Information not provided in the text, but for mechanical testing, it would likely be laboratory-generated data.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is more applicable to studies involving human interpretation (e.g., imaging studies, clinical outcomes). For mechanical device testing, the "ground truth" is typically defined by engineering standards and measurement accuracy, not expert consensus. Information is not provided in the text.
4. Adjudication method for the test set
- Not applicable for typical mechanical device testing. Information is not provided in the text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, the text mentions "Performance testing consisted of tests for pull out, torque and static and dynamic bend strength," which are biomechanical tests, not clinical MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- For the mentioned performance tests (pull-out, torque, bending), the "ground truth" would be established by validated mechanical testing methodologies and instrumentation, typically referencing relevant ASTM or ISO standards for medical device testing.
8. The sample size for the training set
- Not applicable for a physical medical device in this context. There is no information about an "AI training set."
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Restore Surgical LLC Dba Instratek Jeff Seavey President 15200 Middlebrook Dr., Suite G Houston, Texas 77058
November 22, 2016
Re: K161778
Trade/Device Name: ToeTac™ 10° Hammertoe Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 17, 2016 Received: November 18, 2016
Dear Mr. Seavey:
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 (reporting of medical devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. 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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161778
Device Name ToeTac™ 10° Fixation System
Indications for Use (Describe)
The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.
| 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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SECTION 007: 510(K) SUMMARY
| Submission Correspondentand Owner: | Restore Surgical LLC, dba Instratek15200 Middlebrook Dr., Suite GHouston, TX 77058USAPhone: 281-890-8020Fax: 281-890-8068Email: jeff@instratek.comContact: Mr. Jeff SeaveyPresident |
|---|---|
| Date summary prepared: | June 28, 2016 |
| Device trade name: | ToeTac™ 10° Hammertoe Fixation System |
| Device classification name: | Bone Screw, Fixation, fastener |
| Classification: | Class II |
| Product Code: | HWC |
| Regulation/Description: | 880.3040, Smooth or threaded metallic bone fixation |
| Predicate Devices | ToeTac™ Hammertoe Fixation System, K150443Kirschner Wire, K112254 |
| Description of the device: | The Instratek ToeTac™ 10° Hammertoe Fixation System includes athreaded PEEK implant for bone fixation and a set of instrumentsused for implant site preparation and delivery. The device is offeredin a sterile packaged kit that contains the implant, bone preparationinstrumentation and a driver, as well as a single packaged implant. |
| Intended use of the device: | The ToeTac™ Hammertoe Fixation System indicated for thefixation of osteotomies and reconstruction of the lesser toesfollowing correction procedures for hammertoe, claw toe, andmallet toe. |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate devices. |
| Testing: | Performance testing consisted of tests for pull out, torque and staticand dynamic bend strength. |
| Conclusions: | The results of the comparison of design, materials, intended use andtechnological characteristics demonstrate that the device is as safeand effective as the legally marketed predicate devices. |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.