(122 days)
The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK implant and a set of instruments used for implant site preparation and delivery. The device is offered in small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.
The provided text describes a 510(k) summary for the HammerFiX device, a bone fixation device. However, it explicitly states that no clinical testing was performed. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them cannot be fully provided from the given document as it pertains to clinical performance. The 510(k) relies on non-clinical bench testing to establish substantial equivalence to predicate devices, rather than clinical efficacy or specific performance criteria from a clinical study.
Here's a breakdown of the available information based on the provided text, acknowledging the lack of clinical study data:
Acceptance Criteria and Study Details for HammerFiX Device (Based on Non-Clinical Testing)
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed to evaluate performance against clinical acceptance criteria, the table below reflects the non-clinical testing performed and the general statement of equivalence based on those tests. Specific quantitative acceptance criteria or detailed numerical performance metrics from the bench testing are not provided in this summary.
| Acceptance Criteria Category (Non-Clinical) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Pull-out Strength | Performed and compared to predicate devices. (Details not specified) |
| Torque Strength | Performed and compared to predicate devices. (Details not specified) |
| Static Bending | Performed and compared to predicate devices. (Details not specified) |
| Dynamic Bending | Performed and compared to predicate devices. (Details not specified) |
| Overall Equivalence | The HammerFiX device is substantially equivalent to its predicate device based on indications for use, principles of operation, design, and mechanical test data. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided summary. This refers to the number of devices or constructs tested during non-clinical bench testing.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. No country of origin for data is stated, and it is inherently prospective for the specific bench tests conducted to support the 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. For non-clinical bench testing, "ground truth" as it relates to expert clinical opinion is not established. The "ground truth" for mechanical testing is typically defined by standardized test methods and engineering specifications. The tests compare the device's measured mechanical properties to those of predicate devices or established engineering standards.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies, especially when multiple readers or experts assess subjective outcomes. For non-clinical mechanical testing, results are typically objective measurements, not subject to adjudication in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The HammerFiX device is a physical bone fixation implant, not a software algorithm or AI-based device. No standalone algorithm performance evaluation would be relevant.
7. The Type of Ground Truth Used:
- Non-Clinical Mechanical Standards and Predicate Device Performance: For the non-clinical testing, the "ground truth" was established by comparing the HammerFiX device's mechanical properties (pull-out, torque, static, and dynamic bending) against:
8. The Sample Size for the Training Set:
- Not Applicable. This question is relevant for AI/ML algorithm development. Since the HammerFiX device is a physical implant and no AI/ML component is mentioned, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See explanation above for training set.
Summary: The 510(k) clearance for the HammerFiX device was based on non-clinical bench testing demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating human performance or clinical outcomes. The document clearly states that "No clinical testing was performed."
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510(k) Summary of Safety and Effectiveness: HammerFiX Device
| Submitter: | Extremity Medical, LLC.300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Brian Smekal, MS, RACDirector, Regulatory AffairsPhone: (973) 588-8988Email: bsmekal@extremitymedical.com |
| Date Prepared | January 31, 2014 |
| Trade Name | HammerFiX |
| Classification Nameand Number | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
| Product Code | HWC (screw, fixation, bone) |
| Predicate Devices | K120645 - PRO-TOET™ VO Hammertoe Implant System (Wright Medical)K120165 - Intraosseous Fixation System (Ortho Helix Surgical Designs, Inc.)K073674 - Kirschner Wires (Signal Medical Corp.)K061164 - ActivaPin™ Pin (Bioretec Ltd.)K071498 - Subtalar Implant (Biomet Sports Medicine)K120449 - Healix ADVANCE™ PEEK Anchor (Depuy Mitek) |
| Device Description | The HammerFiX device is a bone fixation device consisting of a sterile,threaded PEEK implant and a set of instruments used for implant sitepreparation and delivery. The device is offered in small, medium and largeimplant sizes to allow for use in the proximal interphalangeal (PIP) joints ofthe lesser toes of the foot. |
| Indications for use | The HammerFiX device is indicated for the fixation of osteotomies andreconstruction of the lesser toes following correction procedures forhammertoe, claw toe and mallet toe. |
| Statement ofTechnologicalComparison | The HammerFiX device and predicate devices are equivalent in terms ofindications for use, design, and material mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out, torque, static and dynamic bending wereperformed and compared to the predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The HammerFiX device is substantially equivalent to its predicate device.This conclusion is based upon indications for use, principles of operation,design, and mechanical test data. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
Extremity Medical, L.L.C. Mr. Brian Smekal, M.S., RAC Director, Regulatory Affairs 300 Interspace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K133636
Trade/Device Name: HammerFiX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 14, 2014 Received: February 18, 2014
Dear Mr. Smekal:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Brian Smekal, M.S., RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address htto://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Lori A. Wiggins
- for
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): K133636 Device Name: HammerFiX Indications for Use:
The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet标逐渐被冻rank -S
Division of Orthopedic 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.