(84 days)
No
The description focuses on a mechanical device for bone fixation and makes no mention of AI or ML.
Yes
The device is described as providing "internal fixation of fractured bone" and is used in conjunction with other components for this purpose. This falls under the definition of a therapeutic device as it directly addresses and treats a medical condition (fractures).
No
Explanation: The device is described as an internal fixation device used to treat fractures, not to diagnose them. It provides "internal fixation of fractured bone" and "increased compression."
No
The device description clearly describes a physical implantable device (Hex Button) used in conjunction with other physical components (cerclage device, bone screws, plates) for bone fixation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the internal fixation of fractured bone. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device used in conjunction with cerclage and bone screws to stabilize bone fractures. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a surgical implant used to aid in the mechanical stabilization of bone fractures.
N/A
Intended Use / Indications for Use
The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone.
The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.
The Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments.
Product codes
87HTN
Device Description
The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button and the artists a device that is used while a cerclage device and bone screws. The Flex Button device links the cable and bone screw together. The button is position hex recess of a bone screw. The cerclage cable is passed through the button and around the bone, afterwhich the cerclage device is crimped to lock the cable in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Hex Button device was predicated on the use of the Cerclage cable with Hex Button device (K974016). The Cerclage cable with Hex Button device (K974016) was tested in static yicld and crevice corrosion fatigue. In both tests, the cerclage cable was the failure mode with the Hex Button showing little if no wear. In no test cases did the Hex Button fail.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cerclage Cable with Hex Button Device (K974016)
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
Pioneer Laboratories
Hex Button Device
Indications for Use
The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone.
The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.
Prescription Use
(Per 21 CFR 801.109)
Pcotufo 8
(Division Sign-Off) Division of General Restorative Devices Kgg2b 510(k) Numbe
1
OCT 2 7 1999
V. 510(K) SUMMARY
Pioneer Laboratories 510(K) Notification Summary For Hex Button
Administrative Information
| Manufacturer Identification and Sponsor: | Pioneer Laboratories
375 River Park Circle
Marquette, MI 49855-1781
Telephone: 906-226-9909
FAX: 906-226-9932 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Burns Severson |
| Official Contact: | Burns Severson
Vice President, Regulatory Affairs/Quality Assurance |
| Date Prepared: | August 3. 1999 |
August 3, 1999
Device Identification
| Proprietary Name: | Hex Button |
|---|---|
| Common Name: | Washer, Bolt, Nut, Orthopedic |
| Classification Name and Reference: | Washer, Bolt, Nut, Orthopedic |
| Regulation Number: | CFR 888.3030 |
| Classification Number: | 87HTN |
| Device Class: | II |
| Devices on Which Substantial Equivalence is Claimed: |
Cerclage Cable with Hex Button Device (K974016)
Device Description
The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button and the artists a device that is used while a cerclage device and bone screws. The Flex
Button device links the cable and bone screw together. The button is position
2
510(K) SUMMARY (Continued) V.
hex recess of a bone screw. The cerclage cable is passed through the button and around the bone, afterwhich the cerclage device is crimped to lock the cable in place.
Intended Use
The Hex Button device is indicated for use where wire or cable is used in conjunction with bone screws and/or plating. The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone. The system is designed to provide increased compression as compared to only a screw and/or plate in situations where there is inadequate bone stock, multiple fractures or butterfly fragments
Technological Characteristic Compared to Predicate Device
The Hex Button device is the same button used in the predicate Cerclage cable with Hex Button device (K974016). For both devices, a cerclaging device is passed through the hole in the Hex Button after the button is positioned in the hex recess of a seated bone screw.
Performance Data
The Hex Button device was predicated on the use of the Cerclage cable with Hex Button device (K974016). The Cerclage cable with Hex Button device (K974016) was tested in static yicld and crevice corrosion fatigue. In both tests, the cerclage cable was the failure mode with the Hex Button showing little if no wear. In no test cases did the Hex Button fail.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing a family or community, with their arms raised in a gesture of support or unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1999
Mr. Burns O. Severson nr. Barns of belident, Regulatory Affairs/Quality Assurance Pioneer Surqical Technology 375 River Park Circle Marquette, Michigan 49855
Re : K992617 Trade Name: Hex Button Requlatory Class: II Product Code: HTN Dated: August 2, 1999 Received: August 4, 1999
Dear Mr. Severson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Burns O. Severson
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fu Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure