(88 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional medical device components, with no mention of AI or ML.
Yes
The device is used to fix and stabilize fractures in various anatomical sites, which is a therapeutic purpose.
No
The device description and intended use indicate it is a surgical implant designed for fixation of fractures and reattachment, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (cables, crimp lugs, instrumentation) made of cobalt chromium alloy, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in fixing and stabilizing bone fractures and grafts within the body. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components (cables, crimp lugs) made of cobalt chromium alloy, designed for internal fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes related to in vitro testing.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
"The system.is intended for use in femur and tibia fractures, prophylactic banding, trochanteric reattachment, olecranon fractures, patella fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing techniques, sternum fixation after open chest surgery and stabilization of cortical onlay strut grafts."
Product codes
JDQ
Device Description
"The new Peri-Prosthetic Cabling system consists of cables, crimp lugs (cable sleeves) and associated instrumentation. The cables and crimp lugs are made of cobalt chromium alloy. All cables have a 7x7 strand construction, with the overall cable having a 1.8mm diameter."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, trochanteric, olecranon, patella, ankle, 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
Pre-clinical data including tensile and crimp pull-out testing. Tensile testing demonstrates that the Peri-Prosthetic Cabling System meets or exceeds the requirements of ASTM F2180. The crimp pull-out testing demonstrates that both the Peri-Prosthetic Cabling System and the predicate device meet the minimum requirements for pull out strength.
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
Section 5 — 510(k) Summary
JAN 2 7 2014
| Submitted by: | Biomet Trauma
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Phone: (305) 269-6391
Fax: (305) 269-6400 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Largent, Regulatory Affairs Specialist |
| Date Prepared: | October 25, 2013 |
| Proprietary Name: | Peri-Prosthetic Cabling System |
| Common Name: | Cerclage Cable System |
| Classification Name: | Bone fixation cerclage (21 CFR § 888.3010) |
| Product Code: | JDQ |
| Predicate Devices: | The Peri-Prosthetic Cabling System is substantially equivalent to
currently marketed Cable Plate System (K982545). |
| Device Description: | The new Peri-Prosthetic Cabling system consists of cables, crimp lugs
(cable sleeves) and associated instrumentation. The cables and
crimp lugs are made of cobalt chromium alloy. All cables have a 7x7
strand construction, with the overall cable having a 1.8mm
diameter. |
| Indications for Use: | The system.is intended for use in femur and tibia fractures,
prophylactic banding, trochanteric reattachment, olecranon
fractures, patella fractures, ankle fractures, fixation of spiral
fractures in conjunction with intramedullary nailing and screwing
techniques, sternum fixation after open chest surgery and
stabilization of cortical onlay strut grafts. |
| Technological
Characteristics: | The technological characteristics of the Peri-Prosthetic Cabling
System are similar to the predicate device including design,
dimensions and material. The minor technological differences
include cable diameter and a spike incorporated on the Peri-
Prosthetic Cabling System crimp lug for bone purchase. The |
: 上一篇:
.
Page 46 of 97
・
.
1
K133354
predicate device offers the cables in two diameters, while the Peri-Prosthetic Cabling System offers the cable in one diameter. The cable diameter of the Peri-Prosthetic Cabling System is within the range of the cable diameters of the predicate device.
Summary of Substantial Equivalence:
The Peri-Prosthetic Cabling System is substantially equivalent to the currently marketed device as demonstrated with pre-clinical data including tensile and crimp pull-out testing. Tensile testing demonstrates that the Peri-Prosthetic Cabling System meets or exceeds the requirements of ASTM F2180. The crimp pull-out testing demonstrates that both the Peri-Prosthetic Cabling System and the predicate device meet the minimum requirements for pull out strength. No new issues of safety or efficacy have been raised.
Peri-Prosthetic Cabling System - Traditional 510(k) Biomet Trauma
Page 47 of 97
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2014
Biomet, Incorporated Ms. Julie Largent Regulatory Affairs Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K133354
Trade/Device Name: Peri-Prosthetic Cabling System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: December 20, 2013 Received: December 30, 2013
Dear Ms. Largent:
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 or any is 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Julie Largent
forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Vincent Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
K133354 510(k) Number:
Peri-Prosthetic Cabling System Device Name:
Indications For Use:
Intended for use in femur and tibia fractures, prophylactic banding, trochanteric reattachment, olecranon fractures, patella fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing techniques, sternum fixation after open chest surgery and stabilization of cortical onlay strut grafts.
× Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ElizabethFrank -S
Division of Orthopedic Devices
Page 1 of 1
Page 45 of 97