(29 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to a previously cleared device, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as an implant for temporary internal fixation and stabilization of osteotomies and fractures during normal healing, which is a therapeutic function.
No
Explanation: The device is an implant for temporary internal fixation and stabilization of osteotomies and fractures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "implant device" consisting of "various cannulated and partially threaded solid screws" fabricated from "medical grade titanium alloy," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SafetyFix Easy Out System is described as an implant device used for temporary internal fixation and stabilization of osteotomies and fractures. This involves physically placing the device within the body to support bone healing.
- Intended Use: The intended use clearly states its purpose is for fixation and stabilization of osteotomies and fractures, which is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the SafetyFix Easy Out System is a surgical implant device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SafetyFix Easy Out System is indicated for temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
Product codes
HWC
Device Description
The SafetyFix Easy Out System is an implant device previously cleared by the FDA for temporary internal fixation and stabilization of osteotomies and fractures during normal healing (Easy Out K141401). The only changes from the previously cleared device are the name change, addition of cannulated screws and the addition of a cannulated screw head option. There are no other changes to the SafetyFix Easy Out System when compared to the device cleared under K141401.
The SafetyFix Easy Out System consists of various cannulated and partially threaded solid screws designed to create lag compression and used for temporary internal fixation small bones and fragments. The SafetyFix Easy Out bone screws are self-tapping, self-drilling screws with thread diameters of 2.0, 2.5, 3.0, 3.5 and 4.0 mm, and lengths that range from 8 to 60 mm. All compression screws are fabricated from medical grade titanium alloy (per ASTM F-136). Associated instrumentation is available. All compression screws are offered non-sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, elbow and small bones such as those in the foot and wrist
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)
Performance testing was conducted to further characterize the performance of the SafetyFix Easy Out System's addition of the cannulated screws and modified screw head. The device functioned as intended and the test results demonstrate substantial equivalence to the previously cleared device (K141401). Static and dynamic 3-point bend tests, static torsional tests and axial pull-out tests were conducted to support substantial equivalence. Static and dynamic Three Point Bend testing was conducted in accordance with ASTM F1264-03 (07), Standard Specification and Test Method for Intramedullary Fixation Devices. Additionally, testing was conducted to characterize the torsional strength of the screw as well as axial pullout per ASTM F543-07(e1), Standard Specification and Test Methods for Metallic Medical Bone Screws.
Furthermore, an engineering analysis was performed against the predicates to evaluate torsional strength and pullout strength performance.
The results of this testing demonstrate that SafetyFix Easy Out System performs as intended and that the device is substantially equivalence to the previously cleared device (K141401).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(k) Summary
SafetyFix Easy Out System
K 180753
1. Submission Sponsor
SafetyFix Medical Technologies, Inc.
8637 Delmar Blvd.
St. Louis, MO 63124 USA
Phone: (314) 983-0303
Fax: (314) 983-2777
Contact: Dr. Michael Horwitz
Title: President/CEO
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746 USA
Phone: (512) 327.9997
Contact: Ken Pilgrim
Title: Senior RA/QA Consultant
3. Date Prepared
22 March 2018
4. Purpose of the Submission
The purpose of this notification is to seek clearance for the modifications to the Easy Out system to: 1) Change the name to SafetyFix Easy Out System; 2) Incorporate the addition of cannulated screws; and 3) Incorporate the addition of a modified screw head for the cannulated screws.
5. Device Identification
Trade/Proprietary Name: SafetyFix Easy Out System
Common/Usual Name: Screw, Fixation, Bone
1
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Regulation Number: | 888.3040 |
| Product Code: | HWC |
| Device Class: | Class II |
| Classification Panel: | Orthopedic |
6. Legally Marketed Predicate Device
| Primary Predicate: | K141401, Easy Out system, SafetyFix Medical Technologies, Inc. (formally
known as Feet For Life Podiatry Centers) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| Secondary Predicates: | K071092, Asnis™ Micro Cannulated Screw, Howmedica Osteonics Corp. |
| | |
| | K014154, Vilex/Duval/Orthex Cannulated Bone Screw Double Thread, Vilex,
Inc. |
7. Indications for Use Statement
The SafetyFix Easy Out System is indicated for temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
8. Device Description
The SafetyFix Easy Out System is an implant device previously cleared by the FDA for temporary internal fixation and stabilization of osteotomies and fractures during normal healing (Easy Out K141401). The only changes from the previously cleared device are the name change, addition of cannulated screws and the addition of a cannulated screw head option. There are no other changes to the SafetyFix Easy Out System when compared to the device cleared under K141401.
The SafetyFix Easy Out System consists of various cannulated and partially threaded solid screws designed to create lag compression and used for temporary internal fixation small bones and fragments. The SafetyFix Easy Out bone screws are self-tapping, self-drilling screws with thread diameters of 2.0, 2.5, 3.0, 3.5 and 4.0 mm, and lengths that range from 8 to 60 mm. All compression screws are fabricated from medical grade titanium alloy (per ASTM F-136). Associated instrumentation is available. All compression screws are offered non-sterilization prior to use.
9. Description of Modification
This is a Special 510(k): Device Modification Submission. The basis for this submission is to: 1) Change the product name to SafetyFix Easy Out System; 2) Incorporate the addition of cannulated screws: and 3) Incorporate the addition of a modified screw head option for the cannulated screws. The verification activities have been summarized to demonstrate that the cannulated screws have equivalent dynamic and static testing results as the screws cleared in K141401.
2
10. Substantial Equivalence Discussion
The SafetyFix Easy Out System intended use and indications for use (cleared under K141401) remain identical. There have been no changes made to the principles of operation, manufacturing processes, or materials from those that were previously cleared. Other than the incorporation of the design modifications described above, there have been no further modifications to the device.
| Manufacturer | SafetyFix Medical
Technologies, Inc. | Feet for Life Podiatry
Centers | Similarities and Differences |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | SafetyFix Easy Out | Easy Out | |
| 510(k) Number | K180753 | K141401 | Not applicable |
| Common Name | Screw, Fixation, Bone | Screw, Fixation, Bone | Identical |
| Product Code | HWC | HWC | Identical |
| Regulation
Number | 21 CFR § 888.3040 | 21 CFR § 888.3040 | Identical |
| Regulation
Name | Smooth or threaded
metallic bone fixation
fastener | Smooth or threaded
metallic bone fixation
fastener | Identical |
| Intended Use | Intended to be used for
internal bone fixation | Intended to be used for
internal bone fixation | Identical |
| Indications for
Use | The SafetyFix Easy Out
System is indicated for
temporary internal
fixation and stabilization
of osteotomies and
fractures during normal
healing of ankle, elbow
and small bones such as
those in the foot and
wrist. | The Easy Out system is
indicated for temporary
internal fixation and
stabilization of
osteotomies and fractures
during normal healing of
ankle, elbow and small
bones such as those in the
foot and wrist | Identical, apart from the product name
change |
| Overall Design | Medical grade titanium
alloy, partially threaded
Solid and Cannulated
screws | Medical grade titanium
alloy solid, partially
threaded screws | The device modification is the addition of
the cannulated screws to K141401, which
only included solid screws. While minor
design differences exist, the intended use
and principle of operation is substantially
equivalent. Performance testing
demonstrates the safety and efficacy of
the cannulated screws. |
| Material | Medical grade titanium
alloy (Ti-6Al-4V ELI) per
ASTM F-136 | Medical grade titanium
alloy (Ti-6Al-4V ELI) per
ASTM F-136 | Identical |
| Complies with
ISO 10993-1 | Yes | Yes | Identical |
| Noncannulated | Ø2.0, Ø2.5, Ø3.0, Ø3.5, | Ø2.0, Ø2.5, Ø3.0, Ø3.5, | Identical screw options |
| Table 5A – Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | SafetyFix Medical | ||
| Technologies, Inc. | Feet for Life Podiatry | ||
| Centers | Similarities and Differences | ||
| Trade Name | SafetyFix Easy Out | Easy Out | |
| Screw | |||
| Diameters | and Ø4.0 mm | and Ø4.0 mm | |
| Noncannulated | |||
| Screw Lengths | 12 to 60 mm | 12 to 60 mm | Identical |
| Cannulated | |||
| Screw | |||
| Diameters | Ø2.0, Ø2.5, Ø3.0, and | ||
| Ø4.0 mm | |||
| Wedge head option | |||
| available in Ø2.0 mm | |||
| only | Not available; Removed | ||
| from K141401 | Different – This submission adds the | ||
| cannulated screws. Performance testing | |||
| confirms the equivalence to the data | |||
| provided in K141401. | |||
| Static and dynamic 3-point bend tests, | |||
| static torsional tests and axial pull-out | |||
| tests were conducted to support | |||
| substantial equivalence. | |||
| The addition of the cannulated screws | |||
| does not raise any new safety or efficacy | |||
| concerns | |||
| Cannulated | |||
| Screw Lengths | 8 to 60 mm | ||
| Wedge head option | |||
| available in 8 to 30 mm | |||
| only | Not available; Removed | ||
| from K141401 | Different – This submission adds the | ||
| cannulated screws. Performance testing | |||
| confirms equivalence to the data | |||
| provided in K141401. | |||
| The addition of the cannulated screws | |||
| does not raise any new safety or efficacy | |||
| concerns | |||
| Compression | |||
| mechanisms | Spherical Compression | ||
| Ball with Square Screw | |||
| Head | Spherical Compression Ball | ||
| with Square Screw Head | Identical | ||
| Compression Wedge | |||
| Head design with a Hex | |||
| driver | Not applicable | Different - the subject system introduces | |
| a more conservative compression wedge | |||
| head design. The addition of the modified | |||
| screw head does not raise any new safety | |||
| or efficacy concerns. | |||
| Sterile | Provided Non-sterile | Provided Non-sterile | Identical |
| Single-Use | Yes | Yes | Identical |
| Standards | |||
| complied with | ASTM F1264-03 (07), | ||
| ASTM F543-07e1 | ASTM F1264-03 (07), | ||
| ASTM F543-07e1 | Identical |
3
11. Non-Clinical Performance Data
Performance testing was conducted to further characterize the performance of the SafetyFix Easy Out System's addition of the cannulated screws and modified screw head. The device functioned as intended and the test results demonstrate substantial equivalence to the previously cleared device (K141401). Static and dynamic 3-point bend tests, static torsional tests and axial pull-out tests were conducted to support substantial equivalence. Static and dynamic Three Point Bend testing was conducted in accordance with ASTM F1264-03 (07), Standard Specification and Test Method for Intramedullary
4
Fixation Devices. Additionally, testing was conducted to characterize the torsional strength of the screw as well as axial pullout per ASTM F543-07(e1), Standard Specification and Test Methods for Metallic Medical Bone Screws.
Furthermore, an engineering analysis was performed against the predicates to evaluate torsional strength and pullout strength performance.
The results of this testing demonstrate that SafetyFix Easy Out System performs as intended and that the device is substantially equivalence to the previously cleared device (K141401).
12. Statement of Substantial Equivalence
The SafetyFix Easy Out System has the Identical intended use, principles of operation, and performance to the predicate device. The additional design characteristics of the modified device were tested in accordance with design controls, and verified to meet specifications. The SafetyFix Easy Out System, as modified, is determined to be substantially equivalent to the Easy Out system device cleared in K141401.
5
Image /page/5/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 the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SafetyFix Medical Technologies, Inc. % Ken Pilgrim Senior RA / QA Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K180753
Trade/Device Name: SafetyFix EasyOut System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 22, 2018 Received: March 22, 2018
Dear Ken Pilgrim:
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
6
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 (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.
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.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known) K180753
Device Name SafetyFix Easy Out System
Indications for Use (Describe)
The SafetyFix Easy Out System is indicated for temporary internal fixation of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
===
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