(24 days)
Not Found
No
The summary describes a mechanical bone fixation device and its associated instruments. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are bench tests, not clinical studies involving data analysis that might utilize AI/ML.
No
The device is indicated for fixation and reconstruction following correction procedures, which is a structural and support function, not a therapeutic treatment of a disease or condition itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device is for "fixation of osteotomies and reconstruction," which are treatment procedures, not diagnostic ones. There is no mention of the device identifying or characterizing a disease or condition.
No
The device description clearly states it is a bone fixation device consisting of a physical implant (PEEK or titanium alloy) and instruments, indicating it is a hardware medical device.
No, the HammerFiX device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HammerFiX Function: The HammerFiX device is a surgical implant used for the physical fixation of bones in the lesser toes. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "fixation of osteotomies and reconstruction of the lesser toes." This describes a surgical procedure, not a diagnostic test.
- Device Description: The description details a "bone fixation device consisting of a sterile, threaded PEEK or titanium alloy implant." This is a description of a physical implant, not a diagnostic reagent or instrument.
Therefore, based on the provided information, the HammerFiX device falls under the category of a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The HammerFiX device is a bone fixation device consisting of a sterile, threaded PEEK or titanium alloy implant and a set of instruments used for implant site preparation and delivery. The device is offered in extra small, small, medium and large implant sizes to allow for use in the proximal interphalangeal (PIP) joints of the lesser toes of the foot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal (PIP) joints of the lesser toes of the 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)
Bench testing, including pull-out, torque and bending was performed and compared to the predicate device.
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
§ 888.3040 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.
0
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 a stylized image of three human profiles facing to the right, overlapping each other.
September 8, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K152710
Trade/Device Name: HammerFix Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 18, 2015 Received: September 21, 2015
Dear Mr. Brian Smekal:
This letter corrects our substantially equivalent letter of October 15, 2015.
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 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
1
device-related 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.
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" (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 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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See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known)
Device Name HammerFiX Device
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Special 510(k) Summary of Safety and Effectiveness:
HammerFiX Device
| Submitter: | Extremity Medical, LLC.
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
VP, Regulatory Affairs and Quality Assurance
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | October 13, 2015 |
| Trade Name | HammerFiX Device |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener |
| Classification Name
and Number | 21 CFR 888.3040 |
| Product Code | HWC (screw, fixation, bone) |
| Predicate Devices | K133636 - HammerFiX (Extremity Medical) |
| Device Description | The HammerFiX device is a bone fixation device consisting of a sterile, threaded
PEEK or titanium alloy implant and a set of instruments used for implant site
preparation and delivery. The device is offered in extra small, small, medium and
large implant sizes to allow for use in the proximal interphalangeal (PIP) joints
of the lesser toes of the foot. |
| 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. |
| Statement of
Technological
Comparison | The HammerFiX device and predicate devices are equivalent in terms of
indications for use, design, and material mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out, torque and bending was performed 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, design, test data and principles of
operation. |