(112 days)
Not Found
No
The summary describes a mechanical bone fixation device and its performance testing, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for fixation of bone fractures, fusions, or for bone reconstructions, directly treating a medical condition.
No
The device is an internal bone staple system used for fixation of bone fractures, fusions, or for bone reconstructions. It is a treatment device, not a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical bone staple system, not a software-only device.
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 Function: The description clearly states the device is an "Internal Bone Staple System" used for "fixation of bone fractures, fusions, or for bone reconstructions." This is a surgical implant used directly on the bone within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely mechanical fixation.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The First Ray Internal Bone Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Product codes (comma separated list FDA assigned to the subject device)
JDR, HWC
Device Description
The Internal Bone Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Nonclinical Testing:
All necessary testing has been performed for the worst-case Internal Bone Staple to assure substantial equivalence to its predicates and demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.
The Internal Bone Staple System performance was characterized through static pullout testing in bone analog material and static and fatigue four-point bend testing per ASTM F564-10 (2015) with a side-by-side comparison to the predicate device. Clinical data were not needed to support the safety and effectiveness of the subject device.
Side-by-side performance testing demonstrates the substantial equivalence of the Internal Bone Staple System to the Richards Staple pre-amendment device. The Internal Bone Staple System is substantially equivalent to the Richards Staple pre-amendment device and NewDeal Uni-Clip Staple (K011716) with respect to its indications for use, material, design, performance and function.
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.
NewDeal Uni-Clip Staple (K011716), Synthes Cannulated Screw (K963192)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, black line drawing style. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
First Ray LLC Mr. Robert Hov Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K153622 Trade/Device Name: First Ray Internal Bone 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, HWC Dated: March 21, 2016 Received: March 23, 2016
Dear Mr. Hoy:
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 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 yours,
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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Indications for Use
510(k) Number (if known) K153622
Device Name
First Ray Internal Bone Staple System
Indications for Use (Describe)
The First Ray Internal Bone Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
| Device Trade Name: | First Ray Internal Bone Staple System |
|---|---|
| Manufacturer: | First Ray LLC |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@surgicalfrontiers.com | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | April 7, 2016 |
| Common Name: | Staple, Fixation, Bone; |
| Screw, Fixation, Bone | |
| Classification: | 21 CFR 888.3030, 21 CFR 888.3040 |
| Class: | II |
| Product Codes: | JDR, HWC |
Indications for Use:
The First Ray Internal Bone Staple System is indicated for fixation of bone fractures, fusions or for bone reconstructions, including:
- Arthrodesis in hand or foot surgery ●
- Mono or bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand
- Distal or proximal metatarsal or metacarpal osteotomies ●
- . Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Device Description:
The Internal Bone Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
4
Predicate Device:
The Richards Staple (pre-amendment), NewDeal Uni-Clip Staple (K011716) and Synthes Cannulated Screw (K963192) serve as the predicate devices.
Technological Characteristics Comparison:
The Internal Bone Staple System and its predicates are similar in design, size and material. Each device is designed to secure bone fragments in close apposition to allow for healing. The Internal Bone Staple System and its predicates are manufactured from titanium alloy conforming to ASTM F136. This is a material with well-established biocompatibility and a long history of use in orthopedic implants. The subject device Bone Screws have the same design and are made of the same material as the predicate screws. The mechanical testing demonstrates that the minor design differences between the Internal Bone Staple and the Richards Staple introduce no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the worst-case Internal Bone Staple to assure substantial equivalence to its predicates and demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.
The Internal Bone Staple System performance was characterized through static pullout testing in bone analog material and static and fatigue four-point bend testing per ASTM F564-10 (2015) with a side-by-side comparison to the predicate device. Clinical data were not needed to support the safety and effectiveness of the subject device.
Conclusion:
Side-by-side performance testing demonstrates the substantial equivalence of the Internal Bone Staple System to the Richards Staple pre-amendment device. The Internal Bone Staple System is substantially equivalent to the Richards Staple pre-amendment device and NewDeal Uni-Clip Staple (K011716) with respect to its indications for use, material, design, performance and function.