(53 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a sternal cable system, with no mention of AI or ML technology.
No
The device is used to stabilize the sternum to promote fusion after sternotomy or fracture, which is a supportive role in the healing process rather than directly treating a disease or condition itself.
No
The device, the Pioneer SilCoat Sternal Cable System, is described as being used for the "closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion." This indicates a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device description clearly states it consists of physical components (cables, crimps, needles) made of biocompatible materials, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion." This describes a surgical implant used to physically stabilize bone, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The device consists of "cables and associated crimps" made of biocompatible materials. This is consistent with a surgical implant, not an IVD which typically involves reagents, instruments for analysis, or software for interpreting results from biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Pioneer SilCoat Sternal Cable System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.
Product codes
JDQ
Device Description
The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with silver, a monofilament wire is welded to one end of the cable with an attached needle. The cables will be offered with various types of needles, and in several cable lengths. A cylindrical crimp supplied with each cable is used to crimp the cable. The crimp and cable are made of similar biocompatible materials. The system will be double barrier sterile packaged in various quantities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
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
Static tests comparing the Songer™ Sternal Cable System with the Pioneer SilCoat cable system show they are similar. An ANOVA of the yield load with an α=0.01, P-value=0.017 shows no difference. Fatigue life curves show the SilCoat cable to be equivalent to the non-coated cable construct.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
NOV 23 1999
SPECIAL 510(k) DEVICE SUMMARY VI.
Pioneer Surgical Technology Special 510(k): Device Modification For Pioneer SilCoat Sternal Cable
ADMINISTRATIVE INFORMATION
| Manufacturer Identification
And Sponsor | Pioneer Surgical Technology
375 River Park Circle
Marquette, Michigan 49855-1781
Telephone: (906) 226-9909
Facsimile: (906) 226-9932 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Amy H. Mommaerts, Manager
Regulatory Affairs |
Date Prepared
September 30, 1999
MODIFIED DEVICE IDENTIFICATION
| Proprietary Name | Pioneer SilCoat Sternal Cable |
|---|---|
| Common Name | Cerclage, Bone Fixation |
| Classification Name | |
| And Reference | Cerclage, Bone Fixation |
| Regulation Number: CFR 888.3010 | |
| Classification Number: 87JDQ II | |
| Previously Cleared Device | |
| Name and 510(k) Numbers | SONGER™ Cable System: |
| K922952; K935481; and K941213 |
Modified Device Description
The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with silver, a monofilament wire is welded to one end of the cable with an attached needle. The cables will be offered with various types of needles, and in several cable lengths. A cylindrical crimp supplied with each cable is used to crimp the cable. The crimp and cable are made of similar biocompatible materials. The system will be double barrier sterile packaged in various quantities.
1
Intended Use
The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.
Technological Characteristic Compared to Previously Cleared Device
Pioneer Surgical Technology considers the SilCoat cable to be substantially equivalent in function, design, and use to the Songer™ Sternal Cable System without the silver coating.
Performance Data
Static tests comparing the Songer™ Sternal Cable System with the Pioneer SilCoat cable system show they are similar. An ANOVA of the yield load with an α=0.01, P-value=0.017 shows no difference. Fatigue life curves show the SilCoat cable to be equivalent to the non-coated cable construct.
Pioneer Surgical Technology makes no claim in regard to the silver coated cables effect on reducing infection. No clinical studies have been performed to make any such claims.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three wavy lines representing the body and head. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Ms. Amy H. Mommaerts Manager, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855-0627
K993286 Re: Pioneer SilCoat Sternal Cable Trade Name: Regulatory Class: II Product Code: JDQ Dated: November 10, 1999 November 12, 1999 Received:
Dear Ms. Mommaerts:
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 Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.
3
Page 2 - Ms. Amy H. Mommaerts
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,
Neil R.P. Ogden for
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Pioneer Surgical Technology
Indications for Use For Pioneer SilCoat Sternal Cable System
The Pioneer SilCoat Sternal Cable is indicated for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the stemum to promote fusion.
Nro for
(Division Off)
Director General Restorative Devices K993286
Divisiol 5 1.Jiki Number -
ర్య Prescription Use J (Per 21 CFR 801.109)
Pioneer Surgical Technology