(124 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and material of the staples, with no mention of AI or ML.
Yes.
The device is intended for "bone fragment and osteotomy fixation of the foot," which describes a physical intervention to treat a medical condition.
No
The device description indicates it is a system of superelastic staples used for bone fragment and osteotomy fixation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the EasyStep system includes superelastic staples fabricated from Nitinol, which are physical implants. The performance studies also focus on mechanical and material properties of these staples.
No, this 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.
- Device Description: The EasyStep system is a surgical implant (staples) used for bone fixation within the body. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "bone fragment and osteotomy fixation of the foot," which is a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, based on the provided information, the EasyStep system is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include: - Bone fragment fixation - Osteotomy fixation
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Stryker GmbH EasyStep system includes superelastic staples fabricated from Nitinol (Nickel-Titanium alloy) per ASTM F 2063. The staples range in size from 4 mm to 12 mm in 2 mm increments where the staple size refers to the step size associated with each staple. The legs of each staple are barbed to provide anchorage within the bone fragments. All implants within the system are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
Indicated Patient Age Range
adult patients
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 laboratory testing was performed on the worst case subject staples to determine substantial equivalence. Testing demonstrated that the EasyStep system is equivalent in mechanical performance to the predicate device, the Biomedical Enterprises, Inc. Memograph Staple System.
The following testing was performed:
- Pull-Out Testing per ASTM F564 .
- Four-Point Bending Testing per ASTM F564
- Cyclic Potentiodynamic Polarization (Corrosion) Test per ASTM F2129
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72
Testing to determine the compatibility of the EasyStep system in an MR environment was also performed. These tests included an assessment of:
- Magnetically Induced Displacement Force per ASTM F2052
- . Magnetically Induced Torque per ASTM F2213
- Heating by RF Fields per ASTM F2182
- Image Artifacts per ASTM F 2119
Clinical testing was not required for this submission.
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.
Biomedical Enterprises Inc. Memograph Staple System, K993714
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
Stryker GmbH Garry Hayeck, Ph.D. Associate Manager. Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K160813 Trade/Device Name: EasyStep 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: June 24, 2016 Received: June 27, 2016
Dear Dr. Hayeck:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Vincent J. Devlin -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) K160813
Device Name EasyStep
Indications for Use (Describe)
The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include:
- · Bone fragment fixation
- Osteotomy fixation
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| Submission Number: | K160813 |
|---|---|
| Proprietary Name: | EasyStep |
| Common Name: | Staple, fixation, bone |
| Regulation Description: | Single/multiple component metallic bone fixation appliance |
| and accessories | |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | JDR |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Garry T. Hayeck, Ph.D. |
| Associate Manager, Regulatory Affairs | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6802 | |
| Fax: (201) 831-2802 | |
| Date Prepared: | July 22, 2016 |
| Primary Predicate: | Biomedical Enterprises Inc. Memograph Staple System |
| (K993714) |
510(k) Summary
Description
The Stryker GmbH EasyStep system includes superelastic staples fabricated from Nitinol (Nickel-Titanium alloy) per ASTM F 2063. The staples range in size from 4 mm to 12 mm in 2 mm increments where the staple size refers to the step size associated with each staple. The legs of each staple are barbed to provide anchorage within the bone fragments. All implants within the system are provided sterile.
Indications for Use
The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients.
Indications include:
- Bone fragment fixation
- Osteotomy fixation
4
Summary of Technologies
A comparison of the systems demonstrated that the subject EasyStep system is substantially equivalent to the Biomedical Enterprises Inc. Memograph Staple System in regards to intended use, material, design, and operational principles.
Non-Clinical Testing
Non-clinical laboratory testing was performed on the worst case subject staples to determine substantial equivalence. Testing demonstrated that the EasyStep system is equivalent in mechanical performance to the predicate device, the Biomedical Enterprises, Inc. Memograph Staple System.
The following testing was performed:
- Pull-Out Testing per ASTM F564 .
- Four-Point Bending Testing per ASTM F564
- Cyclic Potentiodynamic Polarization (Corrosion) Test per ASTM F2129
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72
Testing to determine the compatibility of the EasyStep system in an MR environment was also performed. These tests included an assessment of:
- Magnetically Induced Displacement Force per ASTM F2052
- . Magnetically Induced Torque per ASTM F2213
- Heating by RF Fields per ASTM F2182
- Image Artifacts per ASTM F 2119
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject EasyStep system is substantially equivalent to the predicate Biomedical Enterprises Inc. Memograph Staple System.