(55 days)
No
The document describes a mechanical bone staple system and its performance testing, with no mention of AI or ML technologies.
Yes
The device is indicated for fixation of bone fractures, fusions, or for bone reconstructions, which are therapeutic interventions.
No
Explanation: The device is indicated for fixation of bone fractures, fusions, or bone reconstructions, which are therapeutic and not diagnostic actions.
No
The device description clearly states it is a "Stealth Staple System" used for "fixation of bone fractures, fusions, or for bone reconstructions," and describes how it "fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together." This indicates a physical implantable device, not software. The performance studies also describe testing on a physical device (Static Testing, Fatigue Testing, Pullout Testing).
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.
- Stealth Staple System Function: The description clearly states that the Stealth Staple System is used for the fixation of bone fractures, fusions, or bone reconstructions by physically holding bone fragments together. This is a surgical implant used within the body, not a test performed on a sample outside the body.
The information provided about the device's intended use, description, and performance testing all point to it being a surgical implant for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stealth 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
JDR, HWC
Device Description
The Stealth 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
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)
Nonclinical Testing:
The subject device design was evaluated with the following performance tests, using the same methods performed on the predicate device in submission K153622:
- Static Testing
- Fatigue Testing
- Pullout Testing ●
The results of this testing demonstrate that the Stealth Staple System met the predetermined acceptance criteria. Therefore, the differences between the subject and predicate devices introduce no new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Internal Bone Staple System (K153622), K153395, K124045
Reference Device(s)
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.
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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 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 right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2017
First Ray LLC Robert Hoy Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K163440 Trade/Device Name: Stealth 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: December 7, 2016 Received: December 8, 2016
Dear Robert 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 Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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.
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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Indications for Use
510(k) Number (if known) K163440
Device Name Stealth Staple System
Indications for Use (Describe)
The Stealth 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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510(k) Summary
| Device Trade Name: | Stealth 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: | January 24, 2017 |
| Common Names: | Staple, Fixation, Bone; Screw, Fixation, Bone |
| Classifications: | 21 CFR 888.3030 - Single/multiple component metallic |
| bone fixation appliances and accessories | |
| 21 CFR 888.3040 - Smooth or threaded metallic bone | |
| fixation fastener | |
| Class: | II |
| Product Codes: | JDR, HWC |
Indications for Use:
The Stealth 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. .
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Device Description:
The Stealth Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.
Predicate Devices:
The Internal Bone Staple System (K153622), marketed as the Stealth Staple System, is the predicate device. The Richards Staple (pre-amendment device), In2Bones, Inc. OS2®-C Compression Staple (K153395) and the Solana Surgical LLC Fuse Force Nitinol Staple (K124045) serve as additional predicates.
Technological Characteristics Comparison:
The Stealth Staple System has the same design and function as its predicate device. The devices consist of two cylindrical staple legs connected by staple bridges. The non-parallel legs are designed to create compression between the fragments when the implant is fully seated. Radial rib features that augment bony purchase are present on the proximal portion of each staple leg. Like the predicate, the Stealth Staple is designed to have no dorsal prominence once inserted. In addition, both the subject and predicate systems contain an optional Cannulated Bone Screw. The Stealth Staple implants are offered in polyetheretherketone (PEEK) as well as the previously cleared titanium alloy. Bone staples with similar indications are manufactured from PEEK and contain the same size ranges as the subject device. There are no substantial differences in technological characteristics between the subject device and predicates. As such, the Stealth Staple System introduces no new issues of safety or effectiveness.
Nonclinical Testing:
The subject device design was evaluated with the following performance tests, using the same methods performed on the predicate device in submission K153622:
- Static Testing
- Fatigue Testing
- Pullout Testing ●
The results of this testing demonstrate that the Stealth Staple System met the predetermined acceptance criteria. Therefore, the differences between the subject and predicate devices introduce no new issues of safety or effectiveness.
Conclusion:
The Stealth Staple met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Indications/Intended Use and the fundamental scientific technology of the Stealth Staple System are the same as those described in the predicate device. Based on similarities to its predicate, the Stealth Staple System is substantially equivalent to the predicate Internal Bone Staple System (K152236).