(90 days)
The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.
The StarFuse Interphalangeal Pin is a fusion device available in a range of profile diameters and lengths as well as straight or pre-bent options. Implants are made from 316LVM Stainless Steel per ASTM F138 and range in size from 3 to 4 mm in diameter and 16 to 30 mm in length.
The provided text is a 510(k) premarket notification for a medical device called the StarFuse Interphalangeal Pin. This document outlines the regulatory approval process for a physical medical device (a bone fixation fastener), not a software-based AI/ML device.
Therefore, the information required to answer your query about acceptance criteria and studies for an AI/ML device (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in the provided document.
The "Performance Data" section specifically mentions: "Static and dynamic 3-point bending testing (per ASTM 1264-14) confirmed that the Subject device performed as intended." This refers to biomechanical testing of the physical pin, not the performance of an algorithm.
In summary, this document does not contain the information needed to describe the acceptance criteria and study proving an AI/ML device meets those criteria.
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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, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Phalanx Innovations % Ms. Cheryl Wagoner Principal Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K160194
Trade/Device Name: StarFuse Interphalangeal Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 8, 2016 Received: April 11, 2016
Dear Ms. Wagoner:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 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) K160194
Device Name StarFuse Interphalangeal Pin
Indications for Use (Describe)
The StarFuse Interphalangeal Pin is indicated for use with osteotomies, and reconstruction procedures involving the correction of the lesser digits of the toes.
| 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
(as required by 21 CFR 807.92)
| Date Prepared | April 8, 2016 |
|---|---|
| Manufacturer | Phalanx Innovations |
| Address | 200 Cobb Pkwy N |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel Lanois |
| General Manager | |
| Address | Phalanx Innovations |
| 200 Cobb Pkwy N | |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| daniel@phalanxinnovations.com |
| Trade Name | StarFuse Interphalangeal Pin | |
|---|---|---|
| Common Name | Intramedullary Bone Fastener | |
| Panel Code | Orthopaedics/87 | |
| Classification Name | Smooth or threaded metallic bone fixation fastener | |
| Class | Class II | |
| Regulation Number | 21 CFR 888.3040 | |
| Product Code | HTY | |
| Name of Predicate Device | 510(k) # | Manufacturer |
| ARROW-LOK Digital Fusion System | K112675 | Arrowhead Medical Device Technologies, LLC |
| Description | |
|---|---|
| The StarFuse Interphalangeal Pin is a fusion device available in a rangeof profile diameters and lengths as well as straight or pre-bent options.Implants are made from 316LVM Stainless Steel per ASTM F138 andrange in size from 3 to 4 mm in diameter and 16 to 30 mm in length. |
| Indications andIntended Use | StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes. |
|---|---|
| --------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Subject device, issubstantially equivalent to the Predicate ARROW-LOK Digital FusionSystem (K112675). The Subject device is substantially equivalent to thepredicate device in intended use, indications for use, materials,technological characteristics, performance and labeling. |
|---|---|
| Performance Data | Static and dynamic 3-point bending testing (per ASTM 1264-14)confirmed that the Subject device performed as intended. |
| Conclusion | Based on the intended use, indications for use, technologicalcharacteristics, materials, and comparison to predicate device, theSubject device has been shown to be substantially equivalent to legallymarketed predicate devices. |
§ 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.