(142 days)
Not Found
No
The summary describes a mechanical staple system and its performance testing, with no mention of AI or ML.
Yes.
The device is used for fixation of fractures, fusions, and osteotomies in the hand and foot, which are therapeutic medical interventions.
No
The device is a system of staples used for fixation in the hand and foot, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of physical staples made from a nickel titanium alloy, which are hardware components.
No, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The OrthoHelix™ Staple System is a system of implantable staples made of nickel titanium alloy. These staples are used for fixation (holding things together) in the hand and foot during surgical procedures.
- Intended Use: The intended use is for fixation in the hand and foot including fractures, fusions, and osteotomies. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical implant used for structural support within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.
Product codes
JDR
Device Description
The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and 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)
Engineering calculations, finite element analysis, mechanical bending and pullout tests per ASTM F564, and corrosion testing per ASTMF2129 were performed to demonstrate substantial equivalence of the subject to the predicate devices. No new issues of safety and effectiveness have been raised.
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
§ 888.3030 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
:
. .
510(k) SUMMARY
Submitter Information
| Submitter's Name: | OrthoHelix Surgical Designs, Inc. |
|---|---|
| Address: | 1065 Medina Rd, Suite 500 |
| Medina, Ohio 44256 | |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Liz Altenau, Brian Hockett, and Caitlin Miller |
| Contact Person: | Brian Hockett or Derek Lewis |
| Date Prepared: | 3/13/2013 |
| Device Information | |
| Trade Name: | OrthoHelix™ Staple System |
| Common Name: | Bone Staple |
| Classification Name: | Staple, Fixation, Bone |
| Device Classification: | Single/multiple component metallic bone fixation appliances and accessories |
| Class II per 21 CFR 888.3030 | |
| Panel: Orthopedic, Product Code: JDR | |
| Material Composition: | Nickel Titanium Alloy |
| Device Description: | The OrthoHelix™ Staple System consists of various sizes of staples used for |
| fixation in the hand and foot. The staples are offered in different lengths, | |
| widths, and thicknesses. All implantable devices within this system are | |
| manufactured from shape memory nickel titanium alloy. | |
| Intended Use: | The OrthoHelix™ Staple System is indicated for fixation in the hand and foot |
| including fractures, fusions, and osteotomies. | |
| Substantial Equivalence: | The new OrthoHelix™ staples are substantially equivalent to the Stryker |
| (Memometal Technologies) EasyClip Staple (K070031) and the BioMedical | |
| Enterprises Inc. Speed Staple (K993714). The OrthoHelix™ Staple System | |
| conforms to ASTM F2063 Standard Specification for Wrought Nickel-Titanium | |
| Shape Memory Alloys for Medical Devices and Surgical implants. Engineering | |
| calculations, finite element analysis, mechanical bending and pullout tests per | |
| ASTM F564, and corrosion testing per ASTMF2129 were performed to | |
| demonstrate substantial equivalence of the subject to the predicate devices. | |
| No new issues of safety and effectiveness have been raised. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15. 2013
OrthoHelix Surgical Designs, Incorporated % Mr. Brian Hockett Portfolio Manager 1065 Medina Road, Suite 500 Medina, Ohio 44256
Re: K130832
Trade/Device Name: OrthoHelix™ Staple System 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: July 2, 2013 Received: July 3, 2013
Dear Mr. Hockett:
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
2
Page 2 - Mr. Brian Hockett
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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,
Erin - Erin - Erin - Erin - The Bring - Ering - Ering - Ering - Ering - Ering - The Bring - The Bring - The Bring - The Bring - The Bring - The Bring - The Bring - The Bring
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K130832
Device Name: OrthoHelix™ Staple System
Indications for Use:
The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.
Prescription Use _ X
AND/OR
Over-The-Counter-Use_ (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices